Assembly and ostomy appliance

Abstract

An assembly (100) for use as part of an ostomy appliance (1000), the assembly comprising: an adhesive layer (101) comprising a continuous portion (102) having a skin-engageable surface (103) and a distal surface (103). The continuous portion has a thickness of at least about 200 pm. The continuous portion is made of an adhesive composition comprising a blend of one or more pressure sensitive adhesive polymers and one or more hydrocolloids. The adhesive composition has a water absorption at 30 minutes of at least about 0.05 g / cm2, and / or the one or more hydrocolloids are present in an amount of at least about 30 wt.% based on the weight of the adhesive composition. The assembly further comprises an electrode arrangement (105) comprising at least one electrode pair (106). Each electrode contacts the continuous portion, and the continuous portion extends at least from the respective electrode to the skin-engageable surface.

Description

ASSEMBLY AND OSTOMY APPLIANCEFIELD

[0001] The present disclosure relates to an assembly for use as part of an ostomy appliance, an ostomy appliance comprising the assembly, and use of an adhesive layer to monitor for a potential liquid leak in an ostomy appliance.BACKGROUND

[0002] Ostomy surgery is used to treat various diseases of the urinary or digestive systems, and generally involves creating a stoma in the body, through which stomal waste (e.g. faeces and / or urine) can exit.

[0003] Ostomy appliances are medical devices that can collect and hold stomal waste. Ostomy appliances typically include a baseplate for attaching to skin around a stoma of an ostomate, and an ostomy bag for collecting and holding stomal waste. The baseplate is typically attached to the skin using an adhesive.

[0004] An ostomy appliance can take a variety of forms. For example, a one-piece ostomy appliance includes the baseplate and the ostomy bag provided as one, whereas a two-piece ostomy appliance includes the baseplate and the ostomy bag provided as separate releasably connectable elements.

[0005] A particular concern of ostomates is the prospect of stomal waste leaking from their ostomy appliance. Such leak may develop between the ostomy appliance and the skin. Undesirably, a leak exposes the ostomate to unsanitary conditions, and may result in the ostomate experiencing discomfort and inconvenience.SUMMARY

[0006] According to a first aspect of the present disclosure, there is provided an assembly for use as part of an ostomy appliance, the assembly comprising: an adhesive layer comprising a continuous portion having a skin-engageable surface and a distal surface, wherein the continuous portion has a thickness of at least about 200 pm, the continuous portion being made of an adhesive composition comprising a blend of one or more pressure sensitive adhesive polymers and one or more hydrocolloids, wherein: the adhesive composition has a water absorption at 30 minutes of at least about 0.05 g / cm2, and / orthe one or more hydrocolloids are present in an amount of at least about 30 wt.% based on the weight of the adhesive composition; and an electrode arrangement comprising at least one electrode pair, wherein each electrode contacts the continuous portion, the continuous portion extending at least from the respective electrode to the skin-engageable surface.

[0007] In some examples, the thickness of the continuous portion is from about 200 pm to about 700 pm.

[0008] In some examples, the thickness of the continuous portion is from about 250 pm to about 450 pm.

[0009] In some examples, the water absorption at 30 minutes of the adhesive composition is at least about 0.10 g / cm2.

[0010] In some examples, the water absorption at 30 minutes of the adhesive composition is at least about 0.14 g / cm2.

[0011] In some examples, the one or more hydrocolloids are present in an amount of at least about 40 wt.% based on the total weight of the adhesive composition.

[0012] In some examples, the one or more hydrocolloids are present in an amount of at least about 50 wt.% based on the total weight of the adhesive composition.

[0013] In some examples, the one or more hydrocolloids are selected from the group comprising polyacrylic acid, polyvinyl alcohol, gelatine, pectin, alginate, starch, modified starch, natural vegetable gum, cellulose, a cellulose derivative, an alkali metal salt of a cellulose derivative, and a combination thereof.

[0014] In some examples, the one or more hydrocolloids are selected from the group comprising polyacrylic acid, cellulose, a cellulose derivative, an alkali metal salt of a cellulose derivative, pectin, gelatin, and a combination thereof.

[0015] In some examples, the one or more hydrocolloids are selected from the group comprising a cellulose derivative, an alkali metal salt of a cellulose derivative, pectin, gelatin, and a combination thereof.

[0016] In some examples, the one or more hydrocolloids are selected from the group comprising a cellulose derivative, an alkali metal salt of a cellulose derivative, pectin, gelatin, and a combinationthereof, wherein the cellulose derivative is hydroxyethyl cellulose, hydroxypropyl cellulose, or carboxymethyl cellulose.

[0017] In some examples, the one or more hydrocolloids are selected from the group comprising an alkali metal salt of a cellulose derivative, pectin, gelatin, and a combination thereof, wherein the alkali metal salt of the cellulose derivative is sodium carboxymethyl cellulose.

[0018] In some examples, the one or more pressure sensitive adhesive polymers comprise one or more thermoplastic materials selected from the group comprising polyalkenes, styrene copolymers, butyl rubber, and a combination thereof. In a preferred example, the one or more pressure sensitive adhesive polymers comprise a polyalkene, particularly preferred is wherein the polyalkene is polyisobutylene.

[0019] In some examples, the mass fraction of polyalkene based on the total mass of the one or more pressure sensitive adhesive polymers is at least about 50 %.

[0020] In some examples, the adhesive composition comprises a styrene copolymer in an amount of no greater than about 30 wt.%, based on the total weight of the adhesive composition.

[0021] In some examples, the adhesive composition does not comprise a styrene copolymer.

[0022] In some examples, the adhesive composition comprises butyl rubber in an amount of no greater than about 30 wt.%, based on the total weight of the adhesive composition.

[0023] In some examples, the adhesive composition does not comprise butyl rubber.

[0024] In some examples, the thickness of the continuous portion comprises at least a first thicknessLi and a second thickness L2, the second thickness L2 being greater than the first thickness Li, wherein each electrode contacts a part of the continuous portion having the first thickness Li.

[0025] In some examples, the assembly comprises one or more further adhesive layers, wherein the or each of the further adhesive layers is made of an adhesive composition.

[0026] In some examples, the or each electrode pair is provided such that liquid can flow between the pair of electrodes of the or each electrode pair and / or around the or each respective electrode pair.

[0027] In some examples, the at least one electrode pair may be arranged in use to receive an alternating electrical signal and provide an output signal in response to applying the alternating electrical signal to the continuous portion, the output signal indicative of an electrical property of the continuous portion.

[0028] In some examples, the electrical property comprises an impedance of the continuous portion between the electrodes of the or each electrode pair.

[0029] In some examples, the thickness of the continuous portion is from about 250 pm to about 450 pm, and wherein the one or more hydrocolloids are present in an amount of at least about 40 wt.% based on the total weight of the adhesive composition.

[0930] In some examples, the adhesive composition comprises a styrene copolymer in an amount of no greater than about 30 wt.%, based on the total weight of the adhesive composition, or the adhesive composition does not comprise a styrene copolymer; and the adhesive composition comprises butyl rubber in an amount of no greater than about 30 wt.%, based on the total weight of the adhesive composition, or the adhesive composition does not comprise butyl rubber.

[0031] In some examples, the continuous portion radially extends from a first location to a second location, the first location being radially inward of the at least one electrode pair and the second location being radially outward of the at least one electrode pair.

[0032] According to a second aspect of the present disclosure, there is provided an ostomy appliance comprising: the assembly according to the first aspect of the present disclosure; a baseplate, wherein the baseplate is configured to attach to the assembly.

[0033] According to a third aspect of the present disclosure, there is provided a use of an adhesive layer to monitor for a stomal waste leak in an ostomy appliance, the adhesive layer comprising a continuous portion having a skin-engageable surface and a distal surface, wherein the continuous portion has a thickness of at least about 200 pm, the continuous portion being made of an adhesive composition comprising one or more pressure sensitive adhesives and one or more hydrocolloids, wherein: the adhesive composition has a water absorption at 30 minutes of at least about 0.05 g / cm2; and / or the one or more hydrocolloids are present in an amount of at least about 30 wt.% based on the weight of the adhesive composition.

[0034] In some examples, the ostomy appliance is defined according to the second aspect of the present disclosure.

[0035] According to a broad aspect of the present disclosure, there is provided an assembly for use as part of an ostomy appliance, the assembly comprising: an adhesive layer comprising a continuous portion having a skin-engageable surface and a distal surface, the continuous portion being made of an adhesive composition comprising a blend of one or more pressure sensitive adhesive polymers and one or more hydrocolloids, wherein: the adhesive composition has a water absorption at 30 minutes of at least about 0.05 g / cm2, and / or the one or more hydrocolloids are present in an amount of at least about 30 wt.% based on the weight of the adhesive composition; and an electrode arrangement comprising at least one electrode pair, wherein each electrode contacts the continuous portion, the continuous portion extending at least from the respective electrode to the skin-engageable surface.

[0036] In some examples, the continuous portion has a thickness of at least about 100 pm.

[0037] In some examples, the continuous portion has a thickness of at least about 200 pm.

[0038] In some examples, the assembly of the broad aspect of the present disclosure is defined by any features of the assembly according to the first aspect of the present disclosure.

[0039] In some examples, the assembly in the second, third, or any subsequent aspect of the present disclosure, may be defined according to the broad aspect of the present disclosure.BRIEF DESCRIPTION OF THE DRAWINGS

[0040] The present disclosure will now be described, by way of example only, with reference to the accompanying drawings in which:

[0041] FIG. 1 schematically illustrates an example ostomy appliance according to the present disclosure in exploded view;

[0042] FIG. 2 schematically illustrates an electrode arrangement of the ostomy appliance of Fig. 1 in plan view;

[0043] FIG. 3 schematically illustrates the ostomy appliance of Fig. 1 prior to attachment to the skin around a stoma of an ostomate, in cross-sectional, side view;

[0044] FIG. 4A schematically illustrates part of a continuous portion and an electrode pair of the ostomy appliance of Fig. 1, when exposed to moisture from perspiration, in cross-sectional, side view;

[0045] FIG. 4B schematically illustrates the continuous portion and an electrode pair of the ostomy appliance of Fig. 1, when exposed to liquid from stomal waste, in cross-sectional, side view;

[0046] FIG. 5A schematically illustrates an example ostomy appliance according to the present disclosure in plan view;

[0047] FIG. 5B schematically illustrates part of a continuous portion and an electrode pair of the ostomy appliance of Fig. 5A in cross-sectional, side view;

[0048] FIG. 6A schematically illustrates an example ostomy appliance according to the present disclosure in plan view;

[0049] FIG. 6B schematically illustrates part of a continuous portion and an electrode pair of the ostomy appliance of Fig. 6A in cross-sectional, side view;

[0050] FIG. 7 schematically illustrates liquid transport as a result of exposure to moisture from perspiration in part of the continuous portion of the ostomy appliance of Fig. 5 A, in cross-sectional, side view;

[0051] FIG. 8 schematically illustrates part of an example ostomy appliance according to the present disclosure in cross-sectional, side view;

[0052] FIG. 9 schematically illustrates part of an example ostomy appliance according to the present disclosure in cross-sectional, side view;

[0053] FIG. 10 schematically illustrates liquid transport as a result of exposure to moisture from perspiration in part of the ostomy appliance of Fig. 8, in cross-sectional, side view;

[0054] FIG. 11 schematically illustrates part of an example ostomy appliance according to the present disclosure in cross-sectional, side view; and

[0055] FIG. 12 is a chart that illustrates the data of Table I.

[0056] While the disclosure is susceptible to various modifications and alternative forms, specific approaches are shown by way of example in the drawings and are herein described in detail. It should be understood however that the drawings and detailed description are not intended to limit the disclosure to the particular form disclosed but rather the disclosure is to cover all modifications, equivalents and alternatives falling within the spirit and scope of the claimed invention.

[0057] It will be recognised that the features of the disclosure can conveniently and interchangeably be used in any suitable combination.DETAILED DESCRIPTION

[0058] Discussion of examples will now be provided with reference to the attached figures.

[0059] Features of the present disclosure are discussed under various sections below. It is to be understood that the features are not limited to the section in which they are presented and may be combined with features from other sections as supported elsewhere in this specification, including the appended claim and worked Examples.Example Assemblies and Ostomy Appliances

[0060] Figs. 1 to 11 show example assemblies 100 according to the first aspect of the present disclosure, and example ostomy appliances 1000 according to the second aspect of the present disclosure.

[0061] The assembly 100 is for use as part of an ostomy appliance 1000. The assembly 100 comprises an adhesive layer 101. The adhesive layer 101 comprises a continuous portion 102 having a skin-engageable surface 103 and a distal surface 104. The continuous portion 102 has a thickness of at least about 200 pm. The continuous portion is made of an adhesive composition comprising a blend of one or more pressure sensitive adhesive polymers and one or more hydrocolloids. The adhesive composition has a water absorption at 30 minutes of at least about 0.05 g / cm2, and / or the hydrocolloids are present in an amount of at least about 30 wt.% based on the weight of the adhesive composition. The assembly 100 comprises an electrode arrangement 105 comprising at least one electrode pair 106. Each electrode 107, 108 of the at least one electrode pair 106 contacts the continuous portion 102. The continuous portion 102 extends at least from the respective electrode 107, 108 to the skin-engageable surface 103.

[0062] The ostomy appliance 1000 comprises the assembly 100 and a baseplate 200. The baseplate 200 is configured to attach to the assembly 100. For example, the baseplate 200 has a proximal surface 201 and a distal surface 202. For example, the proximal surface 201 is configured to attach to the distal surface 104 of the continuous portion 102 of the assembly (e.g. by an adhesive layer 203 applied to the proximal surface 201). The ostomy appliance 1000 may comprise an ostomy bag 300. The baseplate 200 may be configured to attach (or attached) to the ostomy bag 300. For example, the distal surface 202 may be configured to attach (or attached) to the ostomy bag 300.

[0063] In normal operation of an ostomy appliance, stomal waste exits the stoma and passes directly to the ostomy bag, ideally without contacting the skin around the stoma of the ostomate. In somecases, however, stomal waste may leak to a location between the skin-engageable surface of an adhesive layer and skin around the stoma of an ostomate.

[0064] A “stomal waste leak” is where, in use, stomal waste is located between the skin-engageable surface of an adhesive layer (particularly the continuous portion 102 in the context of the present disclosure) and skin around the stoma of an ostomate and has not progressed to an external location. An “external stomal waste leak” is where, in use, stomal waste is located between the skin-engageable surface of an adhesive layer (particularly the continuous portion 102 in the context of the present disclosure) and skin around the stoma of an ostomate and has progressed to an external location. In this context, the adhesive layer is part of an assembly or ostomy appliance, as applicable. In this context, the assembly or ostomy appliance, as applicable, is adhered to the skin by the adhesive layer. The “external location” is external from the assembly or the ostomy appliance, as applicable.

[0065] Thus, a stomal waste leak can be considered as a precursor to an external stomal waste leak. Undesirably, an external stomal waste leak may result in stomal waste contacting the clothing and / or other body parts of the ostomate, for example.Advantages and Surprising Results

[0066] The present inventors have identified that prior art ostomy appliances may be ineffective at detecting a stomal waste leak. The present inventors have found that prior art ostomy appliances may be unable to distinguish between moisture from perspiration and a stomal waste leak, such that the ostomy appliance may falsely identify the former as the latter and thereby prompt replacement of the ostomy appliance before this is in fact required. Thereby, materials are wasted and additional time is spent replacing ostomy appliances, which increase costs and reduce efficiency.

[0067] The assemblies 100 and ostomy appliances 1000 of the present disclosure address this problem. In this regard, the properties, arrangement, and configuration of the assemblies 100 and ostomy appliances 1000 of the present disclosure facilitate effective and reliable detection of a stomal waste leak, which is located between the skin-engageable surface 103 and the skin 2000 during use, and a reduced likelihood of false detection.]0068[ Without wishing to be bound by a particular theory, it is believed that in use, moisture from perspiration (and other liquid in trace amounts) is absorbed by and distributed through the continuous portion 102, particularly via the hydrocolloids therein. As a result of the moisture being distributed through the continuous portion (e.g. rather than collecting adjacent to the electrodes 107, 108), the moisture is unlikely to cause the electrodes 107, 108 to detect a change in an electrical property (e.g. voltage) that falsely indicates the presence of a stomal waste leak. By contrast, it is believed that liquid from a stomal waste leak, which presents in far greater amounts that moisture fromperspiration, will penetrate through the continuous portion 102 and result in a liquid concentration adjacent to the electrodes 107, 108 that causes the electrodes 107, 108 to detect a change in an electrical property (e.g. voltage) that correctly indicates the presence of a stomal waste leak.

[0069] The present inventors have identified that in prior art ostomy appliances in which the electrodes are directly exposed to the skin, moisture from perspiration may collect adjacent to the electrodes, causing the electrodes to detect a change in an electrical property (e.g. voltage) that falsely indicates the presence of a stomal waste leak. Such a problem is avoided in assemblies 100 and ostomy appliances 1000 of the present disclosure, with the continuous portion 102 providing a barrier and facilitating liquid distribution.]0070[ The assemblies 100 and ostomy appliances 1000 can be efficiently manufactured. For example, the electrodes 107, 108 may be provided in contact with the continuous portion 102, without the need for any structural complexity as to the nature of the contact. By contrast, in prior art ostomy appliances having electrodes provided over through holes in an adhesive layer, it must be ensured that the electrodes are aligned with the holes, otherwise the ostomy appliance may not function as intended. Indeed, in such ostomy appliances the alignment may be disrupted overtime, having a negative impact on performance. The assemblies 100 and ostomy appliances 1000 of the present disclosure thereby have improved robustness and reliability.Adhesive Laver and Continuous Portion

[0071] The adhesive layer 101 facilitates adhesion of the assembly 100 to the skin around a stoma 2001 of an ostomate. The skin to which the adhesive layer 101 adheres may be the peristomal skin.

[0072] The adhesive layer 101 comprises the continuous portion 102. Thus, the adhesive 101 may include, but not be limited to, the continuous portion 102. Thus, the adhesive layer 101 may include the continuous portion 102 and at least one further portion.

[0073] The adhesive layer 101 may be provided in various forms and is not limited in terms of, for example, its shape, size or profile. For example, the adhesive layer 101 may be substantially planar. For example, the outer perimeter 111 of the adhesive layer 101 may be substantially circular, substantially oval, or substantially polygonal (e.g. square or rectangular). The continuous portion 102 may similarly be provided in various forms. For example, the continuous portion 102 may be substantially planar. For example, the outer perimeter 111 of the continuous portion 102 may be substantially circular, substantially oval, or substantially polygonal (e.g. square or rectangular). The outer perimeter of the adhesive layer 101 and the outer perimeter of the continuous portion 102 may form the same shape or a different shape, the present disclosure is not limited in this respect. In theexamples of Figs. 1 to 11, the continuous portion 102 is substantially planar and has a substantially circular outer perimeter 111. The present disclosure is not, however, limited to this arrangement.

[0074] It is to be understood that the continuous portion 102 is substantially absent any apertures (e.g. holes). In the present disclosure, this is what is meant by the term “continuous”. Thus, a fluid traversing though the continuous portion 102 is absorbed by the adhesive composition from which the continuous portion 102 is made.

[0075] The skin-engageable surface 103 is for adhering to the skin (e.g. the peristomal skin) around the stoma of an ostomate, as illustrated in Fig. 3. In use, when the skin-engageable surface 103 is adhered to the skin, the distal surface 104 faces away from the skin.

[0076] The continuous portion 102 has a thickness of at least about 200 pm. The thickness of the continuous portion 102 refers to the extent of the continuous portion 102 measured from the skin- engageable surface 103 to the distal surface 104 thereof. The thickness of the continuous portion 102 is measured orthogonally to the plane or lateral extent of the continuous portion 102.

[0077] The continuous portion 102 may have a thickness of at least about 250 pm.

[0078] The continuous portion 102 may have a thickness of no greater than about 700 pm. The continuous portion 102 may have a thickness of no greater than about 650 pm. The continuous portion 102 may have a thickness of no greater than about 600 pm. The continuous portion 102 may have a thickness of no greater than about 550 pm. The continuous portion 102 may have a thickness of no greater than about 500 pm. The continuous portion 102 may have a thickness of no greater than about 450 pm.

[0079] The continuous portion 102 may have a thickness of from about 200 pm to about 700 pm. The continuous portion 102 may have a thickness of from about 200 pm to about 650 pm. The continuous portion 102 may have a thickness of from about 200 pm to about 600 pm. The continuous portion 102 may have a thickness of from about 200 pm to about 550 pm. The continuous portion 102 may have a thickness of from about 200 pm to about 500 pm. The continuous portion 102 may have a thickness of from about 200 pm to about 450 pm.

[0080] The continuous portion 102 may have a thickness of from about 250 pm to about 700 pm. The continuous portion 102 may have a thickness of from about 250 pm to about 650 pm. The continuous portion 102 may have a thickness of from about 250 pm to about 600 pm. The continuous portion 102 may have a thickness of from about 250 pm to about 550 pm. The continuous portion 102 may have a thickness of from about 250 pm to about 500 pm. The continuous portion 102 may have a thickness of from about 250 pm to about 450 pm.

[0081] It will be appreciated that in other examples, the thickness of the continuous portion 102 may differ. For example, the continuous portion may have a thickness at least 100 pm. For example, the continuous portion may have a thickness at least 150 pm.

[0082] In Figs. 1 to 7, each electrode 107, 108 of the or each electrode pair 106 is provided on the distal surface 104 of the continuous portion 102. In other examples, each electrode 107, 108 of the or each electrode pair 106 may be provided within the continuous portion 102. By “provided within” is meant that each electrode 107, 108 is encased partially or fully by the continuous portion 102. In some examples, each electrode 107, 108 is encased fully by the continuous portion 102.

[0083] The thickness of the continuous portion 102 may comprise a thickness Li extending from the respective electrode 107, 108 to the skin-engageable surface 103. In some examples, the thickness of the continuous portion 102 consists of the thickness Li extending from the respective electrode 107, 108 to the skin-engageable surface 103. The thickness Li may be referred to as the first thickness. The thickness Li is measured at the part 102’ of the continuous portion 102 extending from the respective electrode 107, 108 to the skin-engageable surface 103. Thus, the continuous portion 102 may comprise at least one part 102’ (e.g. a plurality of parts 102’) having the thickness Li.

[0084] Each electrode 107, 108 may contact a part 102’ having the thickness Li. In Figs. 5A to 7, each electrode 107, 108 of the electrode pair(s) 106 contacts a part 102’ having the thickness Li.

[0085] The thickness Li may be at least about 200 pm.

[0086] The thickness Li may be at least about 250 pm.

[0087] The thickness Li may be no greater than about 700 pm. The thickness Li may be no greater than about 650 pm. The thickness Li may be no greater than about 600 pm. The thickness Li may be no greater than about 550 pm. The thickness Li may be no greater than about 500 pm. The thickness Li may be no greater than about 450 pm.

[0088] The thickness Li may be from about 200 pm to about 700 pm. The thickness Li may be from about 200 pm to about 650 pm. The Li may be from about 200 pm to about 600 pm. The thickness Li may be from about 200 pm to about 550 pm. The thickness Li may be from about 200 pm to about 500 pm. The thickness Li may be from about 200 pm to about 450 pm.

[0089] The thickness Li may be from about 250 pm to about 700 pm. The thickness Li may be from about 250 pm to about 650 pm. The thickness Li may be from about 250 pm to about 600 pm. The thickness Li may be from about 250 pm to about 550 pm. The thickness Li may be from about 250 pm to about 500 pm. The thickness Li may be from about 250 pm to about 450 pm.

[0090] It will be understood by the person skilled in the art that the values for thickness Li may be combined with the thickness noted above for the continuous portion. In some examples, the continuous portion has a thickness of at least about 200 pm and a thickness Li which is at least about 200 pm.

[0091] The thickness of the continuous portion 102 may comprise a second thickness L2. For example, the thickness of the continuous portion 102 may comprise a first thickness Li and a second thickness L2. The second thickness L2 may be greater than the first thickness Li.

[0092] The second thickness L2 is measured at a part 102” of the continuous portion 102 that does not extend between the respective electrode 107, 108 and the skin-engageable surface 103. The second thickness L2 is measured at a part 102” of the continuous portion 102 that does not contact a respective electrode 106, 107. Thus, the continuous portion 102 may comprise at least one part 102” (e.g. a plurality of parts 102”) having the thickness L2.

[0093] The continuous portion 102 may comprise a part 102’ having a second thickness L2 which is at least about 10% greater than the first thickness Li. The continuous portion 102 may comprise a part 102’ having a second thickness L2 which is at least about 20% greater than the first thickness Li. The continuous portion 102 may comprise a part 102’ having a second thickness L2 which is at least about 30% greater than the first thickness Li. The continuous portion 102 may comprise a part 102’ having a second thickness L2 which is at least about 40% greater than the first thickness Li. The continuous portion 102 may comprise a part 102’ having a second thickness L2 which is at least about 50% greater than the first thickness Li.

[0094] The thickness L2 may at least about 350 pm. The thickness L2 may at least about 400 pm. The thickness L2 may at least about 450 pm. The thickness L2 may at least about 550 pm. The thickness L2 may at least about 650 pm. The thickness L2 may at least about 750 pm

[0095] The thickness L2 may be no greater than about 2000 pm. The thickness L2 may be no greater than about 1800 pm. The thickness L2 may be no greater than about 1500 pm. The thickness L2 may be no greater than about 1000 pm. The thickness L2 may be no greater than about 750 pm. The thickness L2 may be no greater than about 850 pm.

[0096] The thickness L2 may be from about 350 pm to about 2000 pm. The thickness L2 may be from about 400 pm to about 1800 pm. The thickness L2 may be from about 450 pm to about 1500 pm. The thickness L2 may be from about 550 pm to about 1000 pm. The thickness L2 may be from about 650 pm to about 500 pm. The thickness L2 may be from about 750 pm to about 850 pm.

[0097] The present inventors have identified that providing the continuous portion 102 with at least a first thickness and a second thickness can further reduce the likelihood of false detection of a stomal waste leak. In this regard, parts 102” of the continuous portion 102 having a second thickness may have a greater liquid absorption capacity than parts 102’ of the continuous portion 102 having a first thickness, the second thickness being greater than the first thickness. Liquid absorbed into the parts 102’ may also be able to diffuse into the parts 102”. The liquid transport from the parts 102’ to the parts 102” is thereby able to reduce the concentration of the liquid in the parts 102’. This functionality is schematically illustrated in Fig. 7, in which moisture from perspiration (“Sweat”) is shown to be absorbed by hydrocolloids 500 within continuous portion 102, resulting in swollen hydrocolloids 501. Over time, the moisture is shown to be distributed within the hydrocolloids 500 throughout the continuous portion 102. A stomal waste leak will result in a far greater quantity of liquid to be absorbed by the continuous portion 102, which causes a rapid increase in liquid concentration adjacent to the electrodes 107, 108. Consequently, the electrodes 107, 108 will correctly detect a change in an electrical property (e.g. voltage) indicative of the presence of a stomal waste leak.

[0098] A part 102’ having the thickness Li may transition to a part 102” having the thickness L2.

[0099] In Figs. 5A to 7, the thickness of the continuous portion 102 comprises a first thickness Li and a second thickness L2. In Figs. 5A to 7, a part 102’ having the thickness Li transitions to a part 102” having the thickness L2, and L2 is greater than Li. The first and second thicknesses may have the relationship defined above, for example, the second thickness may be at least about 10% greater than the first thickness.

[0100] With reference to Figs. 5B and 6B, a part 102’ having the thickness Li may continuously (or gradually) transition to a part 102” having the thickness L2. Alternatively, with reference to Fig. 7, a part 102’ having the thickness Li may discontinuously transition (e.g. in a stepped form) to a part 102” having the thickness L2. Each of these arrangements are provided as an example, the present disclosure is not limited to either arrangement.

[0101] The continuous portion 102 may comprise an alternating arrangement of the at least one part 102’ having the thickness Li and the at least one part 102” having the thickness L2 (i.e. part 102’, then part 102”, then part 102’ (etc.); or part 102”, then part 102’, then part 102” (etc.)). Such an arrangement is shown in Figs. 5A to 6B. The at least one part 102’ having the thickness Li and the at least one part 102” having the thickness L2 may be arranged to alternate along a radial extent of the continuous portion 102. Such an arrangement is shown in Figs. 5A to 6B. For example, the continuous portion 102 may have an undulated or corrugated form (e.g. when viewed side-on).

[0102] The at least one part 102’ having the thickness Li and the at least one part 102” having the thickness L2 may be arranged to alternate along a radial extent of the continuous portion 102, the parts 102”, 102’ alternating radially from an inner location to an outer location (e.g. the outer periphery 111 of the continuous portion 102), e.g. such that the continuous portion 102 has an undulated or corrugated form when viewed side-on. The inner location may correspond to the stomal opening 109 of the adhesive layer 101. The inner location may be at or towards the centre of the continuous portion 102.[01031 In Fig. 5A, the continuous portion 102 comprises an alternating arrangement of at the least one part 102” (e.g. two being shown in Fig. 5A) having the thickness L2 and the at least one part 102’ (e.g. one being shown in Fig. 5A) having the thickness Li, the parts 102”, 102’ alternating radially from an inner (e.g. central) location to an outer location (e.g. the outer periphery 111 of the continuous portion 102), such that the continuous portion 102 has an undulating form (e.g. when viewed side -on).

[0104] In Fig. 6A, the continuous portion 102 comprises an alternating arrangement of the at least one part 102” (e.g. three being shown in Fig. 6A) having the thickness L2 and the at least one part 102’ (e.g. two being shown in Fig. 6A) having the thickness Li, the parts 102”, 102’ alternating radially from an inner (e.g. central) location to an outer location (e.g. the outer periphery of the continuous portion), such that the continuous portion 102 has an undulating form (e.g. when viewed side-on).

[0105] A part 102” having the second thickness L2 may extend radially outwards from the or each electrode pair 106. For example, referring to Figs. 5A and 5B, a part 102” having the second thickness L2 extends radially outwards from each electrode pair 106. The or each electrode pair 106 may contact a part 102’ having the thickness Li. A part 102” having the second thickness L2 may extend radially outward from the part 102’ having the thickness Li. Such arrangements are shown in Figs. 5A and 5B.

[0106] Providing the electrodes 107, 108 of an electrode pair 106 in contact with a first part 102’ having the first thickness Li, and a second part 102” having the second thickness L2 extending radially outwards from the electrode pair 106, can effectively reduce the likelihood of false detection of a potential leak.

[0107] A part 102” having the second thickness L2 may be between the electrodes 107, 108 of the or each electrode pair 106. Each electrode 107, 108 may contact a respective part 102’ having the thickness Li. A part 102” having the second thickness L2 may extend between the respective parts102’ having the thickness Li. A part 102” having the second thickness L2 may extend radially outward from the part 102’ having the thickness Li. Such arrangements are shown in Figs. 6A and 6B.

[0108] Providing each electrode 107, 108 of an electrode pair 106 in contact with a respective first part 102’ having the first thickness Li, and a second part 102” having the second thickness L2 between the pair of electrodes 106, 107 of the electrode pair 106, can effectively reduce the likelihood of false detection of a potential leak.

[0019] As already noted herein, the adhesive layer 102 may comprise a stomal opening 109. It will be appreciated that the adhesive layer 101 need not necessarily comprise a stomal opening 109. For example, the adhesive layer 101 may comprise an openable (e.g. stretchable, moldable or removable, e.g. cuttable) portion 110 which may be opened to form a stomal opening 109 in the adhesive layer 101. For example, an openable portion 110 is shown in Figs. 5A and 6A.[01101 The continuous portion 102 may radially extend from a first location to a second location.The first location may be radially inward of the electrode pair 106. The second location being radially outward of the electrode pair 106. Such an arrangement is illustrated in Figs. 1 to 3. The first location may be towards or to the inner perimeter 109 of the adhesive layer 101, or towards or to the stomal opening 109, or towards or to the openable portion 110. The second location may be towards or to the outer perimeter 111 of the adhesive layer 101. As shown in Figs. 2 and 3, the continuous portion 102 may radially extend from the stomal opening 109 towards or to the outer perimeter 111 of the adhesive layer 101. As shown in Figs. 2 and 3, the continuous portion 102 may radially extend from the openable portion 110 towards or to the outer perimeter 111 of the adhesive layer 101.Adhesive Composition

[0111] The continuous portion 102 is made of an adhesive composition comprising a blend of one or more pressure sensitive adhesive polymers and one or more hydrocolloids.Pressure Sensitive Adhesive Polymers

[0112] The term “pressure sensitive adhesive polymer” is known in the art of the present disclosure, and refers to a polymer which forms a bond to a surface when pressure is applied to bond the polymer to the surface. Such materials are widely available in the art including various commercial sources. Examples of suitable polymers are provided below.[Oil 3] The one or more pressure sensitive adhesive polymers in the present disclosure may comprise one or more thermoplastic materials. The one or more thermoplastic materials may be selected from the group comprising polyalkenes, polyacrylates, silicones, polyurethanes, ethylene -vinyl acetate, styrene copolymers, butyl rubber, and a combination thereof. The one or more pressure sensitiveadhesive polymers in the present disclosure may comprise one or more thermoplastic materials. The one or more thermoplastic materials may be selected from the group comprising polyalkenes, styrene copolymers, butyl rubber, and a combination thereof. The one or more thermoplastic materials may be selected from the group comprising polyalkenes, butyl rubber, and a combination thereof. The styrene copolymers may be hydrogenated or unhydrogenated, and may be styrene-diene copolymers, such as styrene-diene block copolymers. In some examples, the styrene copolymer may be styrene-isoprene- styrene.[0U4| The polyalkene used as one or more of the thermoplastic materials is not limited and may be any thermoplastic polyalkene known in the art. In some examples the polyalkene may be a polyethylene, polypropylene, polybutene, polypentene, or copolymers and isomers thereof. In some examples the polyalkene may be polyisobutylene, ethylene propylene rubber, ethylene propylene diene monomer rubber, or a combination thereof.

[0115] In some examples, the one or more thermoplastic materials may comprise a polyalkene and butyl rubber. In some examples, the one or more thermoplastic materials may comprise a polyalkene and a styrene copolymer. In some examples, the one or more thermoplastic materials may comprise a polyalkene, butyl rubber, and a styrene copolymer. The polyalkene and styrene copolymer in each of these examples being as defined above.

[0116] In preferred examples, the polyalkene may be a polyisobutylene. In preferred examples, the styrene copolymer may be a styrene-isoprene-styrene. The adhesive composition may comprise the one or more thermoplastic materials in an amount of at least about 10 wt.%, based on the total weight of the adhesive composition. The adhesive composition may comprise the one or more thermoplastic materials in an amount of at least about 15 wt.%, based on the total weight of the adhesive composition. The adhesive composition may comprise the one or more thermoplastic materials in an amount of at least about 20 wt.%, based on the total weight of the adhesive composition. The adhesive composition may comprise the one or more thermoplastic materials in an amount of at least about 25 wt.%, based on the total weight of the adhesive composition. The adhesive composition may comprise the one or more thermoplastic materials in an amount of at least about 30 wt.%, based on the total weight of the adhesive composition. The adhesive composition may comprise the one or more thermoplastic materials in an amount of at least about 35 wt.%, based on the total weight of the adhesive composition.

[0117] The adhesive composition may comprise the one or more thermoplastic materials in an amount of no greater than about 70 wt.%, based on the total weight of the adhesive composition. The adhesive composition may comprise the one or more thermoplastic materials in an amount of no greater than about 65 wt.%, based on the total weight of the adhesive composition. The adhesivecomposition may comprise the one or more thermoplastic materials in an amount of no greater than about 60 wt.%, based on the total weight of the adhesive composition. The adhesive composition may comprise the one or more thermoplastic materials in an amount of no greater than about 55 wt.%, based on the total weight of the adhesive composition. The adhesive composition may comprise the one or more thermoplastic materials in an amount of no greater than about 50 wt.%, based on the total weight of the adhesive composition. The adhesive composition may comprise the one or more thermoplastic materials in an amount of no greater than about 45 wt.%, based on the total weight of the adhesive composition.]0118] The adhesive composition may comprise the one or more thermoplastic materials in an amount of from about 10 wt.% to about 70 wt.%, based on the total weight of the adhesive composition. The adhesive composition may comprise the one or more thermoplastic materials in an amount of from about 15 wt.% to about 60 wt.%, based on the total weight of the adhesive composition. The adhesive composition may comprise the one or more thermoplastic materials in an amount of from about 20 wt.% to about 50 wt.%, based on the total weight of the adhesive composition. The adhesive composition may comprise the one or more thermoplastic materials in an amount of from about 20 wt.% to about 45 wt.%, based on the total weight of the adhesive composition. The adhesive composition may comprise the one or more thermoplastic materials in an amount of from about 25 wt.% to about 45 wt.%, based on the total weight of the adhesive composition. The adhesive composition may comprise the one or more thermoplastic materials in an amount of from about 30 wt.% to about 45 wt.%, based on the total weight of the adhesive composition. The adhesive composition may comprise the one or more thermoplastic materials in an amount of from about 35 wt.% to about 45 wt.%, based on the total weight of the adhesive composition.

[0119] When the one or more thermoplastic materials comprises a polyalkene as defined above, the adhesive composition may comprise polyalkene in an amount of at least about 5 wt.%, based on the total weight of the adhesive composition. The adhesive composition may comprise polyalkene in an amount of at least about 10 wt.%, based on the total weight of the adhesive composition. The adhesive composition may comprise polyalkene in an amount of at least about 15 wt.%, based on the total weight of the adhesive composition. The adhesive composition may comprise polyalkene in an amount of at least about 20 wt.%, based on the total weight of the adhesive composition. The adhesive composition may comprise polyalkene in an amount of at least about 22 wt.%, based on the total weight of the adhesive composition. The adhesive composition may comprise polyalkene in an amount of at least about 25 wt.%, based on the total weight of the adhesive composition.

[0120] The adhesive composition may comprise polyalkene in an amount of no greater than about 70 wt.%, based on the total weight of the adhesive composition. The adhesive composition may comprisepolyalkene in an amount of no greater than about 65 wt.%, based on the total weight of the adhesive composition. The adhesive composition may comprise polyalkene in an amount of no greater than about 60 wt.%, based on the total weight of the adhesive composition. The adhesive composition may comprise polyalkene in an amount of no greater than about 55 wt.%, based on the total weight of the adhesive composition. The adhesive composition may comprise polyalkene in an amount of no greater than about 50 wt.%, based on the total weight of the adhesive composition. The adhesive composition may comprise polyalkene in an amount of no greater than about 45 wt.%, based on the total weight of the adhesive composition.

[0121] The adhesive composition may comprise polyalkene in an amount of from about 5 wt.% to about 70 wt.%, based on the total weight of the adhesive composition. The adhesive composition may comprise polyalkene in an amount of from about 5 wt.% to about 50 wt.%, based on the total weight of the adhesive composition. The adhesive composition may comprise polyalkene in an amount of from about 5 wt.% to about 45 wt.%, based on the total weight of the adhesive composition. The adhesive composition may comprise polyalkene in an amount of from about 10 wt.% to about 45 wt.%, based on the total weight of the adhesive composition. The adhesive composition may comprise polyalkene in an amount of from about 20 wt.% to about 45 wt.%, based on the total weight of the adhesive composition. The adhesive composition may comprise polyalkene in an amount of from about 30 wt.% to about 45 wt.%, based on the total weight of the adhesive composition. The adhesive composition may comprise polyalkene in an amount of from about 35 wt.% to about 45 wt.%, based on the total weight of the adhesive composition.

[0122] In any of the above examples, the polyalkene may be as defined above, for example the polyalkene may be a polyethylene, polypropylene, polybutene, polypentene, or copolymers and isomers thereof. In some examples the polyalkene may be polyisobutylene, ethylene propylene rubber, ethylene propylene diene monomer rubber, or a combination thereof. In preferred examples, the polyalkene may be a polyisobutylene.

[0123] When the one or more thermoplastic material of the pressure sensitive adhesive polymers comprises a polyalkene, the mass fraction of polyalkene based on the total mass of the one or more pressure sensitive adhesive polymers may be at least about 50 %. The mass fraction of polyalkene based on the total mass of the one or more pressure sensitive adhesive polymers may be at least about 60 %. The mass fraction of polyalkene based on the total mass of the one or more pressure sensitive adhesive polymers may be at least about 70 %. The mass fraction of polyalkene based on the total mass of the one or more pressure sensitive adhesive polymers may be at least about 80 %. The mass fraction of polyalkene based on the total mass of the one or more pressure sensitive adhesive polymers may be at least about 90 %. The mass fraction of polyalkene based on the total mass of the one or more pressure sensitive adhesive polymers may be at least about 95 %. The mass fraction ofpolyalkene based on the total mass of the one or more pressure sensitive adhesive polymers may be at least about 97.5 %. The mass fraction of polyalkene based on the total mass of the one or more pressure sensitive adhesive polymers may be at least about 99 %. In any of the above examples, the polyalkene may be as defined above, for example the polyalkene may be a polyethylene, polypropylene, polybutene, polypentene, or copolymers and isomers thereof. In some examples the polyalkene may be polyisobutylene, ethylene propylene rubber, ethylene propylene diene monomer rubber, or a combination thereof. In preferred examples, the polyalkene may be a polyisobutylene.]0124[ The one or more pressure sensitive adhesive polymers may consist essentially of polyalkene. The one or more pressure sensitive adhesive polymers may consist of polyalkene. The polyalkene may be as defined above, for example the polyalkene may be a polyethylene, polypropylene, polybutene, polypentene, or copolymers and isomers thereof. In some examples the polyalkene may be polyisobutylene, ethylene propylene rubber, ethylene propylene diene monomer rubber, or a combination thereof. In preferred examples, the polyalkene may be a polyisobutylene such that the one or more pressure sensitive adhesive polymers consist of polyisobutylene.

[0125] The one or more pressure sensitive adhesive polymers may have a weight-average molecular weight of from about 50 000 g / mol to about 1 200 000 g / mol. Where present, the polyalkene may have a weight-average molecular weight of from about 50 000 g / mol to about 1120 000 g / mol.

[0126] The polyalkene may be as defined above, for example the polyalkene may be a polyethylene, polypropylene, polybutene, polypentene, or copolymers and isomers thereof. In some examples the polyalkene may be polyisobutylene, ethylene propylene rubber, ethylene propylene diene monomer rubber, or a combination thereof. In preferred examples, the polyalkene may be a polyisobutylene.

[0127] In some examples, the weight average molecular weight of the polyisobutylene may be from about 50 000 g / mol to about 110 000 g / mol. The weight average molecular weight of the polyisobutylene may be from about 55 000 g / mol to about 90 000 g / mol. The weight average molecular weight of the polyisobutylene may be from about 60 000 g / mol to about 80 000 g / mol.]0128[ The polyisobutylene may have a dispersity of from about 2.6 to about 3.8. The polyisobutylene may have a dispersity of from about 2.8 to about 3.6. The polyisobutylene may have a dispersity of from about 3.0 to about 3.4.

[0129] The polyisobutylene may have a Staudinger Index of from about 20 cm3 / g to about 55 cm3 / g. The polyisobutylene may have a Staudinger Index of from about 25 cm3 / g to about 50 cm3 / g. The polyisobutylene may have a Staudinger Index of from about 34 cm3 / g to about 39 cm3 / g.

[0130] In some examples, the one or more thermoplastic materials (e.g. the polyisobutylene) may comprise a polyisobutylene (a first polyisobutylene) and a second polyisobutylene. The weight average molecular weight of the first polyisobutylene may be less than the weight average molecular weight of the second polyisobutylene.

[0131] The weight average molecular weight of the first polyisobutylene may be from about 50 000 g / mol to about 110 000 g / mol. The weight average molecular weight of the first polyisobutylene may be from about 55 000 g / mol to about 90 000 g / mol. The weight average molecular weight of the first polyisobutylene may be from about 60 000 g / mol to about 80 000 g / mol. The weight average molecular weight of the second polyisobutylene may be from about 500 000 g / mol to about 1 200 000 g / mol. The weight average molecular weight of the second polyisobutylene may be from about 800 000 g / mol to about 1 150 000 g / mol. The weight average molecular weight of the second polyisobutylene may be from about 1 000 000 g / mol to about 1 100 000 g / mol. The weight average molecular weight of the first polyisobutylene may be from about 50 000 g / mol to about 110 000 g / mol and the weight average molecular weight of the second polyisobutylene may be from about 500 000 g / mol to about 1 200 000 g / mol. The weight average molecular weight of the first polyisobutylene may be from about 55 000 g / mol to about 90 000 g / mol and the weight average molecular weight of the second polyisobutylene may be from about 800 000 g / mol to about 1 150 000 g / mol. The weight average molecular weight of the first polyisobutylene may be from about 60 000 g / mol to about 80 000 g / mol and the weight average molecular weight of the second polyisobutylene may be from about 1 000 000 g / mol to about 1 100 000 g / mol.

[0132] The first polyisobutylene may have a dispersity of from about 2.6 to about 3.8. The first polyisobutylene may have a dispersity of from about 2.8 to about 3.6. The first polyisobutylene may have a dispersity of from about 3.0 to about 3.4. The second polyisobutylene may have a dispersity of from about 1.8 to about 3.0. The second polyisobutylene may have a dispersity of from about 2.0 to about 2.8. The second polyisobutylene may have a dispersity of from about 2.2 to about 2.6. The first polyisobutylene may have a dispersity of from about 2.6 to about 3.8 and the second polyisobutylene may have a dispersity of from about 2.0 to about 3.0. The first polyisobutylene may have a dispersity of from about 2.8 to about 3.6 and the second polyisobutylene may have a dispersity of from about 2.2 to about 2.6. The first polyisobutylene may have a dispersity of from about 3.0 to about 3.4 and the second polyisobutylene may have a dispersity of from about 2.2 to about 2.6.

[0133] The first polyisobutylene may have a Staudinger Index of from about 20 cm3 / g to about 55 cm3 / g. The first polyisobutylene may have a Staudinger Index of from about 25 cm3 / g to about 50 cm3 / g. The first polyisobutylene may have a Staudinger Index of from about 34 cm3 / g to about 39 cm3 / g. The second polyisobutylene may have a Staudinger Index of from about 125 cm3 / g to about 275 cm3 / g. The second polyisobutylene may have a Staudinger Index of from about 150 cm3 / g toabout 250 cm3 / g. The second polyisobutylene may have a Staudinger Index of from about 178 cm3 / g to about 236 cm3 / g. The first polyisobutylene may have a Staudinger Index of from about 20 cm3 / g to about 55 cm3 / g and the second polyisobutylene may have a Staudinger Index of from about 125 cm3 / g to about 275 cm3 / g. The first polyisobutylene may have a Staudinger Index of from about 25 cm3 / g to about 50 cm3 / g and the second polyisobutylene may have a Staudinger Index of from about 150 cm3 / g to about 250 cm3 / g. The first polyisobutylene may have a Staudinger Index of from about 34 cm3 / g to about 39 cm3 / g and the second polyisobutylene may have a Staudinger Index of from about 178 cm3 / g to about 236 cm3 / g. 0134 j The mass ratio of the first polyisobutylene to the second polyisobutylene may be from about 1 : 1 to about 3: 1. The mass ratio of the first polyisobutylene to the second polyisobutylene may be from about 1.2: 1 to about 2.5: 1. The mass ratio of the first polyisobutylene to the second poly isobutylene may be from about 1.5 : 1 to about 2.2: 1.

[0135] Any of the above features concerning weight average molecular weight, Staudinger Index, dispersity, and mass ratio may be combined with any other features of the adhesive composition. For instance, the one or more pressure sensitive adhesive polymers may comprise a first polyisobutylene having a weight-average molecular weight of from about 60 000 g / mol to about 80 000 g / mol and a second polyisobutylene having a weight-average molecular weight of from about 1 000 000 g / mol to about 1 100 000 g / mol, the polyisobutylene (first and second) being present in a mass fraction of at least about 50% of the one or more pressure sensitive adhesive polymers.

[0136] Herein, it is to be understood that the weight average molecular weight may be determined by gel permeation chromatography. For example, the weight average molecular weight of a sample may be determined using a Waters Alliance 2695 system and a Styragel HR 5E mixed bed column with a 2K - 4M range. Determining the weight average molecular weight of a sample may include dissolving the sample (5 mg) in tetrahydrofuran (3 mb) at room temperature to provide a sample solution; filtering the sample solution through a 0.1 pm filter; and calculating the weight average molecular weight using a polystyrene standard. In the dissolving step, the sample may be left in tetrahydrofuran overnight (e.g. for at least 12 hours) at room temperature (e.g. approximately 20°C). Each sample may be tested in triplicate.

[0137] Herein, it is to be understood that the dispersity (otherwise known as “polydispersity index”) is determined using the following formula:wherein D is the dispersity, Mwis the weight average molecular weight, and Mnis the number average molecular weight.

[0138] Herein, it is to be understood that the number average molecular weight may be determined by gel permeation chromatography. For example, the number average molecular weight of a sample may be determined using a Waters Alliance 2695 system and a Styragel HR 5E mixed bed column with a 2K - 4M range. Determining the number average molecular weight of a sample may include dissolving the sample (5 mg) in tetrahydrofuran (3 mb) at room temperature to provide a sample solution; filtering the sample solution through a 0.1 pm filter; and calculating the number average molecular weight using a polystyrene standard. In the dissolving step, the sample may be left in tetrahydrofuran overnight (e.g. for at least 12 hours) at room temperature (e.g. approximately 20°C). Each sample may be tested in triplicate.

[0139] The Staudinger Index may be calculated in various ways. For example, the Staudinger Index may be calculated at 20°C using an Ubbelohde viscometer and isooctane as a solvent.

[0140] The present inventors have identified that the presence or increased amounts of viscous polymers (e.g. styrene copolymer and / or butyl rubber) in the adhesive composition can restrict liquid transport and distribution in the adhesive composition. Consequently, when such compositions are used, a stomal waste leak may progress to an external stomal waste leak as defined hereinabove, before being detected by the electrodes. In this regard, the present inventors have identified that adhesive compositions having a reduced amount of such polymers and an increased amount of hydrocolloids exhibit excellent liquid transport and distribution, which facilitate rapid detection of a stomal waste leak.]0141 ] Hence, the adhesive composition may comprise a styrene copolymer in an amount of no greater than about 30 wt.%, based on the total weight of the adhesive composition. The adhesive composition may comprise a styrene copolymer in an amount of no greater than about 25 wt.%, based on the total weight of the adhesive composition. The adhesive composition may comprise a styrene copolymer in an amount of no greater than about 20 wt.%, based on the total weight of the adhesive composition. The adhesive composition may comprise a styrene copolymer in an amount of no greater than about 15 wt.%, based on the total weight of the adhesive composition. The adhesive composition may comprise a styrene copolymer in an amount of no greater than about 10 wt.%, based on the total weight of the adhesive composition. The adhesive composition may comprise a styrene copolymer in an amount of no greater than about 5 wt.%, based on the total weight of the adhesive composition. The adhesive composition may not comprise a styrene copolymer. The styrene copolymer may be as defined above. For example, the styrene copolymers may be hydrogenated or unhydrogenated, andmay be styrene-diene copolymers, such as styrene-diene block copolymers. In some examples, the styrene copolymer may be styrene-isoprene-styrene.

[0142] Similarly the adhesive composition may comprise butyl rubber in an amount of no greater than about 30 wt.%, based on the total weight of the adhesive composition. The adhesive composition may comprise butyl rubber in an amount of no greater than about 25 wt.%, based on the total weight of the adhesive composition. The adhesive composition may comprise butyl rubber in an amount of no greater than about 20 wt.%, based on the total weight of the adhesive composition. The adhesive composition may comprise butyl rubber in an amount of no greater than about 15 wt.%, based on the total weight of the adhesive composition. The adhesive composition may comprise butyl rubber in an amount of no greater than about 10 wt.%, based on the total weight of the adhesive composition. The adhesive composition may comprise butyl rubber in an amount of no greater than about 5 wt.%, based on the total weight of the adhesive composition. The adhesive composition may not comprise butyl rubber.

[0143] The adhesive composition may comprise butyl rubber in an amount of from about 1 wt.% to about 20 wt.% based on the total weight of the adhesive composition. The adhesive composition may comprise butyl rubber in an amount of from about 2 wt.% to about 18 wt.% based on the total weight of the adhesive composition. The adhesive composition may comprise butyl rubber in an amount of from about 5 wt.% to about 15 wt.% based on the total weight of the adhesive composition.

[0144] The butyl rubber may have a weight average molecular weight of from about 350 000 g / mol to about 550 000 g / mol. The butyl rubber may have a weight average molecular weight of from about 375 000 g / mol to about 500 000 g / mol. The butyl rubber may have a weight average molecular weight of from about 400 000 g / mol to about 450 000 g / mol.

[0145] Any of the above features concerning the styrene copolymer and / or butyl rubber may be combined with any other features of the adhesive composition.Hydrocolloids

[0146] The term “hydrocolloid” is known in the art of the present disclosure, and typically refers to a hydrophilic material (e.g. particle) that forms a colloid (typically a gel) when contacted with water. The one or more hydrocolloids in the present disclosure may be in the form of particles. In some examples, the one or more pressure sensitive adhesive polymers may be in the form of a matrix and the one or more hydrocolloids (e.g. in the form of particles) may be dispersed in said matrix.

[0147] The one or more hydrocolloids may be selected from the group comprising polyacrylic acid, polyvinyl alcohol, gelatine, pectin, alginates, starch, modified starch, natural vegetable gum, cellulose, a cellulose derivative, an alkali metal salt of a cellulose derivative, and a combination thereof.

[0018] It is to be understood that polyacrylic acid and polyvinyl alcohol are sometimes referred to as “hydrophilic polymers”.

[0149] The one or more hydrocolloids may be selected from the group comprising polyacrylic acid, cellulose, a cellulose derivative, an alkali metal salt of a cellulose derivative, pectin, gelatin, and a combination thereof.

[0150] The one or more hydrocolloids may be selected from the group comprising a cellulose derivative, an alkali metal salt of a cellulose derivative, pectin, gelatin, and a combination thereof.

[0151] It is to be understood that a “cellulose derivative” is physically and / or chemically modified cellulose. For example, a cellulose derivative may be considered as a compound that is derived from cellulose by a chemical reaction in which one or more hydroxyl groups of cellulose are partially or fully reacted with a reagent. For example, a cellulose derivative may be considered as a compound that is derived from crosslinking cellulose with a crosslinking agent. The cellulose derivative may be hydroxyethyl cellulose, hydroxypropyl cellulose, or carboxymethyl cellulose. In preferred examples, the cellulose derivative may be carboxymethyl cellulose.

[0152] The alkali metal salt of the cellulose derivative may be an alkali metal salt of hydroxy ethyl cellulose, an alkali metal salt of hydroxypropyl cellulose, or an alkali metal salt of carboxymethyl cellulose. In preferred examples, the alkali metal salt of the cellulose derivative may be an alkali metal salt of carboxymethyl cellulose.

[0153] The alkali metal salt of the cellulose derivative may be a sodium salt of a cellulose derivative, or a calcium salt of a cellulose derivative. In preferred examples, the alkali metal salt of the cellulose derivative may be sodium carboxymethyl cellulose.

[0154] The alginate may be sodium alginate.

[0015] It is to be understood that “starch” means “native starch”, which is starch in its natural, unmodified state, as extracted from its source. The source of the starch is not limited. The starch may be potato starch, com starch, maize starch, or tapioca starch.

[0156] It is to be understood that “modified starch” is prepared by physically, enzymatically, or chemically treating starch (i.e. native starch), e.g. to change one or more of its properties. Such properties may include structural stability and viscosity, for example. The modified starch may be aphysically modified starch and / or a chemically modified starch. The modified starch may be pregelatinised. The modified starch may be acetylated distarch adipate or hydroxypropyl distarch phosphate. The modified starch may be pregelatinised acetylated distarch adipate or pregelatinised hydroxypropyl distarch phosphate.

[0157] The natural vegetable gum may be carob gum, karaya gum, guar gum, or gum arabic.

[0158] The one or more hydrocolloids may be present in an amount of at least about 30 wt.% based on the total weight of the adhesive composition. The one or more hydrocolloids may be present in an amount of at least about 35 wt.% based on the total weight of the adhesive composition. The one or more hydrocolloids may be present in an amount of at least about 40 wt.% based on the total weight of the adhesive composition. The one or more hydrocolloids may be present in an amount of at least about 45 wt.% based on the total weight of the adhesive composition. The one or more hydrocolloids may be present in an amount of at least about 50 wt.% based on the total weight of the adhesive composition. The one or more hydrocolloids may be present in an amount of at least about 55 wt.% based on the total weight of the adhesive composition.

[0159] The one or more hydrocolloids may be present in an amount of no greater than about 90 wt. % based on the total weight of the adhesive composition. The one or more hydrocolloids may be present in an amount of no greater than about 85 wt. % based on the total weight of the adhesive composition. The one or more hydrocolloids may be present in an amount of no greater than about 80 wt. % based on the total weight of the adhesive composition. The one or more hydrocolloids may be present in an amount of no greater than about 75 wt. % based on the total weight of the adhesive composition. The one or more hydrocolloids may be present in an amount of no greater than about 70 wt. % based on the total weight of the adhesive composition. The one or more hydrocolloids may be present in an amount of no greater than about 65 wt. % based on the total weight of the adhesive composition.

[0160] The one or more hydrocolloids may be present in an amount of from about 30 wt.% to about 90 wt. % based on the total weight of the adhesive composition. The one or more hydrocolloids may be present in an amount of from about 35 wt.% to about 85 wt. % based on the total weight of the adhesive composition. The one or more hydrocolloids may be present in an amount of from about 40 wt.% to about 80 wt. % based on the total weight of the adhesive composition. The one or more hydrocolloids may be present in an amount of from about 40 wt.% to about 75 wt. % based on the total weight of the adhesive composition. The one or more hydrocolloids may be present in an amount of from about 40 wt.% to about 65 wt. % based on the total weight of the adhesive composition. The one or more hydrocolloids may be present in an amount of from about 50 wt.% to about 70 wt. % based on the total weight of the adhesive composition. The one or more hydrocolloids may be presentin an amount of from about 55 wt.% to about 65 wt. % based on the total weight of the adhesive composition.

[0161] Any of the above ranges relating to the one or more hydrocolloids may be combined with any of the above ranges relating to the one or more pressure sensitive adhesive polymers. For example, the adhesive composition may comprise the one or more thermoplastic materials in an amount of from about 10 wt.% to about 70 wt.% based on the total weight of the adhesive composition and the one or more hydrocolloids in an amount of from about 30 wt.% to about 90 wt. % based on the total weight of the adhesive composition. The adhesive composition may comprise the one or more thermoplastic materials in an amount of from about 15 wt.% to about 60 wt.% based on the total weight of the adhesive composition and the one or more hydrocolloids in an amount of from about 35 wt.% to about 85 wt. % based on the total weight of the adhesive composition. The adhesive composition may comprise the one or more thermoplastic materials in an amount of from about 20 wt.% to about 50 wt.% based on the total weight of the adhesive composition and the one or more hydrocolloids in an amount of from about 40 wt.% to about 80 wt. % based on the total weight of the adhesive composition. The adhesive composition may comprise the one or more thermoplastic materials in an amount of from about 20 wt.% to about 45 wt.% based on the total weight of the adhesive composition and the one or more hydrocolloids in an amount of from about 40 wt.% to about 65 wt. % based on the total weight of the adhesive composition. The adhesive composition may comprise the one or more thermoplastic materials in an amount of from about 20 wt.% to about 45 wt.% based on the total weight of the adhesive composition and the one or more hydrocolloids in an amount of from about 55 wt.% to about 65 wt. % based on the total weight of the adhesive composition. The adhesive composition may comprise the one or more thermoplastic materials in an amount of from about 35 wt.% to about 45 wt.% based on the total weight of the adhesive composition and the one or more hydrocolloids in an amount of from about 55 wt.% to about 65 wt. % based on the total weight of the adhesive composition.

[0162] The one or more hydrocolloids may be present in an amount of at least about 30 wt.% based on the total weight of the adhesive composition, wherein the one or more hydrocolloids are selected from the group comprising polyacrylic acid, cellulose, a cellulose derivative, an alkali metal salt of a cellulose derivative, pectin, gelatin, and a combination thereof. The one or more hydrocolloids may be present in an amount of at least about 35 wt.% based on the total weight of the adhesive composition, wherein the one or more hydrocolloids are selected from the group comprising polyacrylic acid, cellulose, a cellulose derivative, an alkali metal salt of a cellulose derivative, pectin, gelatin, and a combination thereof. The one or more hydrocolloids may be present in an amount of at least about 40 wt.% based on the total weight of the adhesive composition, wherein the one or more hydrocolloids are selected from the group comprising polyacrylic acid, cellulose, a cellulose derivative, an alkalimetal salt of a cellulose derivative, pectin, gelatin, and a combination thereof. The one or more hydrocolloids may be present in an amount of at least about 45 wt.% based on the total weight of the adhesive composition, wherein the one or more hydrocolloids are selected from the group comprising polyacrylic acid, cellulose, a cellulose derivative, an alkali metal salt of a cellulose derivative, pectin, gelatin, and a combination thereof. The one or more hydrocolloids may be present in an amount of at least about 50 wt.% based on the total weight of the adhesive composition, wherein the one or more hydrocolloids are selected from the group comprising polyacrylic acid, cellulose, a cellulose derivative, an alkali metal salt of a cellulose derivative, pectin, gelatin, and a combination thereof. The one or more hydrocolloids may be present in an amount of at least about 55 wt.% based on the total weight of the adhesive composition, wherein the one or more hydrocolloids are selected from the group comprising polyacrylic acid, cellulose, a cellulose derivative, an alkali metal salt of a cellulose derivative, pectin, gelatin, and a combination thereof.

[0163] The one or more hydrocolloids may be present in an amount of no greater than about 90 wt. % based on the total weight of the adhesive composition, wherein the one or more hydrocolloids are selected from the group comprising polyacrylic acid, cellulose, a cellulose derivative, an alkali metal salt of a cellulose derivative, pectin, gelatin, and a combination thereof. The one or more hydrocolloids may be present in an amount of no greater than about 85 wt. % based on the total weight of the adhesive composition, wherein the one or more hydrocolloids are selected from the group comprising polyacrylic acid, cellulose, a cellulose derivative, an alkali metal salt of a cellulose derivative, pectin, gelatin, and a combination thereof. The one or more hydrocolloids may be present in an amount of no greater than about 80 wt. % based on the total weight of the adhesive composition, wherein the one or more hydrocolloids are selected from the group comprising polyacrylic acid, cellulose, a cellulose derivative, an alkali metal salt of a cellulose derivative, pectin, gelatin, and a combination thereof. The one or more hydrocolloids may be present in an amount of no greater than about 75 wt. % based on the total weight of the adhesive composition, wherein the one or more hydrocolloids are selected from the group comprising polyacrylic acid, cellulose, a cellulose derivative, an alkali metal salt of a cellulose derivative, pectin, gelatin, and a combination thereof. The one or more hydrocolloids may be present in an amount of no greater than about 70 wt. % based on the total weight of the adhesive composition, wherein the one or more hydrocolloids are selected from the group comprising polyacrylic acid, cellulose, a cellulose derivative, an alkali metal salt of a cellulose derivative, pectin, gelatin, and a combination thereof. The one or more hydrocolloids may be present in an amount of no greater than about 65 wt. % based on the total weight of the adhesive composition, wherein the one or more hydrocolloids are selected from the group comprising polyacrylic acid, cellulose, a cellulose derivative, an alkali metal salt of a cellulose derivative, pectin, gelatin, and a combination thereof.

[0164] The one or more hydrocolloids may be present in an amount of from about 30 wt.% to about 90 wt. % based on the total weight of the adhesive composition, wherein the one or more hydrocolloids are selected from the group comprising polyacrylic acid, cellulose, a cellulose derivative, an alkali metal salt of a cellulose derivative, pectin, gelatin, and a combination thereof. The one or more hydrocolloids may be present in an amount of from about 35 wt.% to about 85 wt. % based on the total weight of the adhesive composition, wherein the one or more hydrocolloids are selected from the group comprising polyacrylic acid, cellulose, a cellulose derivative, an alkali metal salt of a cellulose derivative, pectin, gelatin, and a combination thereof. The one or more hydrocolloids may be present in an amount of from about 40 wt.% to about 80 wt. % based on the total weight of the adhesive composition, wherein the one or more hydrocolloids are selected from the group comprising polyacrylic acid, cellulose, a cellulose derivative, an alkali metal salt of a cellulose derivative, pectin, gelatin, and a combination thereof. The one or more hydrocolloids may be present in an amount of from about 40 wt.% to about 75 wt. % based on the total weight of the adhesive composition, wherein the one or more hydrocolloids are selected from the group comprising polyacrylic acid, cellulose, a cellulose derivative, an alkali metal salt of a cellulose derivative, pectin, gelatin, and a combination thereof. The one or more hydrocolloids may be present in an amount of from about 40 wt.% to about 65 wt. % based on the total weight of the adhesive composition, wherein the one or more hydrocolloids are selected from the group comprising polyacrylic acid, cellulose, a cellulose derivative, an alkali metal salt of a cellulose derivative, pectin, gelatin, and a combination thereof. The one or more hydrocolloids may be present in an amount of from about 55 wt.% to about 65 wt. % based on the total weight of the adhesive composition, wherein the one or more hydrocolloids are selected from the group comprising polyacrylic acid, cellulose, a cellulose derivative, an alkali metal salt of a cellulose derivative, pectin, gelatin, and a combination thereof.]0165] The one or more hydrocolloids may be present in an amount of at least about 30 wt.% based on the total weight of the adhesive composition, wherein the one or more hydrocolloids are selected from the group comprising an alkali metal salt of a cellulose derivative, pectin, gelatin, and a combination thereof, wherein the alkali metal salt of the cellulose derivative is sodium carboxymethyl cellulose. The one or more hydrocolloids may be present in an amount of at least about 35 wt.% based on the total weight of the adhesive composition, wherein the one or more hydrocolloids are selected from the group comprising an alkali metal salt of a cellulose derivative, pectin, gelatin, and a combination thereof, wherein the alkali metal salt of the cellulose derivative is sodium carboxymethyl cellulose. The one or more hydrocolloids may be present in an amount of at least about 40 wt.% based on the total weight of the adhesive composition, wherein the one or more hydrocolloids are selected from the group comprising an alkali metal salt of a cellulose derivative, pectin, gelatin, and a combination thereof, wherein the alkali metal salt of the cellulose derivative is sodium carboxymethyl cellulose. The one or more hydrocolloids may be present in an amount of at least about 45 wt.% basedon the total weight of the adhesive composition, wherein the one or more hydrocolloids are selected from the group comprising an alkali metal salt of a cellulose derivative, pectin, gelatin, and a combination thereof, wherein the alkali metal salt of the cellulose derivative is sodium carboxymethyl cellulose. The one or more hydrocolloids may be present in an amount of at least about 50 wt.% based on the total weight of the adhesive composition, wherein the one or more hydrocolloids are selected from the group comprising an alkali metal salt of a cellulose derivative, pectin, gelatin, and a combination thereof, wherein the alkali metal salt of the cellulose derivative is sodium carboxymethyl cellulose. The one or more hydrocolloids may be present in an amount of at least about 55 wt.% based on the total weight of the adhesive composition, wherein the one or more hydrocolloids are selected from the group comprising an alkali metal salt of a cellulose derivative, pectin, gelatin, and a combination thereof, wherein the alkali metal salt of the cellulose derivative is sodium carboxymethyl cellulose.

[0166] The one or more hydrocolloids may be present in an amount of no greater than about 90 wt. % based on the total weight of the adhesive composition, wherein the one or more hydrocolloids are selected from the group comprising an alkali metal salt of a cellulose derivative, pectin, gelatin, and a combination thereof, wherein the alkali metal salt of the cellulose derivative is sodium carboxymethyl cellulose. The one or more hydrocolloids may be present in an amount of no greater than about 85 wt. % based on the total weight of the adhesive composition, wherein the one or more hydrocolloids are selected from the group comprising an alkali metal salt of a cellulose derivative, pectin, gelatin, and a combination thereof, wherein the alkali metal salt of the cellulose derivative is sodium carboxymethyl cellulose. The one or more hydrocolloids may be present in an amount of no greater than about 80 wt. % based on the total weight of the adhesive composition, wherein the one or more hydrocolloids are selected from the group comprising an alkali metal salt of a cellulose derivative, pectin, gelatin, and a combination thereof, wherein the alkali metal salt of the cellulose derivative is sodium carboxymethyl cellulose. The one or more hydrocolloids may be present in an amount of no greater than about 75 wt. % based on the total weight of the adhesive composition, wherein the one or more hydrocolloids are selected from the group comprising an alkali metal salt of a cellulose derivative, pectin, gelatin, and a combination thereof, wherein the alkali metal salt of the cellulose derivative is sodium carboxymethyl cellulose. The one or more hydrocolloids may be present in an amount of no greater than about 70 wt. % based on the total weight of the adhesive composition, wherein the one or more hydrocolloids are selected from the group comprising an alkali metal salt of a cellulose derivative, pectin, gelatin, and a combination thereof, wherein the alkali metal salt of the cellulose derivative is sodium carboxymethyl cellulose. The one or more hydrocolloids may be present in an amount of no greater than about 65 wt. % based on the total weight of the adhesive composition, wherein the one or more hydrocolloids are selected from the group comprising an alkali metal salt of a cellulose derivative, pectin, gelatin, and acombination thereof, wherein the alkali metal salt of the cellulose derivative is sodium carboxymethyl cellulose.

[0167] The one or more hydrocolloids may be present in an amount of from about 30 wt.% to about 90 wt. % based on the total weight of the adhesive composition, wherein the one or more hydrocolloids are selected from the group comprising an alkali metal salt of a cellulose derivative, pectin, gelatin, and a combination thereof, wherein the alkali metal salt of the cellulose derivative is sodium carboxymethyl cellulose. The one or more hydrocolloids may be present in an amount of from about 35 wt.% to about 85 wt. % based on the total weight of the adhesive composition, wherein the one or more hydrocolloids are selected from the group comprising an alkali metal salt of a cellulose derivative, pectin, gelatin, and a combination thereof, wherein the alkali metal salt of the cellulose derivative is sodium carboxymethyl cellulose. The one or more hydrocolloids may be present in an amount of from about 40 wt.% to about 80 wt. % based on the total weight of the adhesive composition, wherein the one or more hydrocolloids are selected from the group comprising an alkali metal salt of a cellulose derivative, pectin, gelatin, and a combination thereof, wherein the alkali metal salt of the cellulose derivative is sodium carboxymethyl cellulose. The one or more hydrocolloids may be present in an amount of from about 40 wt.% to about 75 wt. % based on the total weight of the adhesive composition, wherein the one or more hydrocolloids are selected from the group comprising an alkali metal salt of a cellulose derivative, pectin, gelatin, and a combination thereof, wherein the alkali metal salt of the cellulose derivative is sodium carboxymethyl cellulose. The one or more hydrocolloids may be present in an amount of from about 40 wt.% to about 65 wt. % based on the total weight of the adhesive composition, wherein the one or more hydrocolloids are selected from the group comprising an alkali metal salt of a cellulose derivative, pectin, gelatin, and a combination thereof, wherein the alkali metal salt of the cellulose derivative is sodium carboxymethyl cellulose. The one or more hydrocolloids may be present in an amount of from about 50 wt.% to about 70 wt. % based on the total weight of the adhesive composition, wherein the one or more hydrocolloids are selected from the group comprising an alkali metal salt of a cellulose derivative, pectin, gelatin, and a combination thereof, wherein the alkali metal salt of the cellulose derivative is sodium carboxymethyl cellulose. The one or more hydrocolloids may be present in an amount of from about 55 wt.% to about 65 wt. % based on the total weight of the adhesive composition, wherein the one or more hydrocolloids are selected from the group comprising an alkali metal salt of a cellulose derivative, pectin, gelatin, and a combination thereof, wherein the alkali metal salt of the cellulose derivative is sodium carboxymethyl cellulose.

[0168] Any of the above ranges relating to the one or more hydrocolloids may be combined with any of the above ranges relating to the one or more pressure sensitive adhesive polymers.

[0169] The adhesive composition may comprise the alkali metal salt of a cellulose derivative in an amount of at least about 5 wt.% based on the total weight of the adhesive composition. The adhesive composition may comprise the alkali metal salt of a cellulose derivative in an amount of at least about 10 wt.% based on the total weight of the adhesive composition. The adhesive composition may comprise the alkali metal salt of a cellulose derivative in an amount of at least about 15 wt.% based on the total weight of the adhesive composition. Preferably, the alkali metal salt of the cellulose derivative is sodium carboxymethyl cellulose.]0170[ The adhesive composition may comprise the alkali metal salt of a cellulose derivative in an amount of no greater than about 60 wt.% based on the total weight of the adhesive composition. The adhesive composition may comprise the alkali metal salt of a cellulose derivative in an amount of no greater than about 50 wt.% based on the total weight of the adhesive composition. The adhesive composition may comprise the alkali metal salt of a cellulose derivative in an amount of no greater than about 30 wt.% based on the total weight of the adhesive composition. Preferably, the alkali metal salt of the cellulose derivative is sodium carboxymethyl cellulose.

[0171] The adhesive composition may comprise the alkali metal salt of a cellulose derivative in an amount of from about 5 wt.% to about 60 wt.% based on the total weight of the adhesive composition. The adhesive composition may comprise the alkali metal salt of a cellulose derivative in an amount of from about 10 wt.% to about 50 wt.% based on the total weight of the adhesive composition. The adhesive composition may comprise the alkali metal salt of a cellulose derivative in an amount of from about 15 wt.% to about 30 wt.% based on the total weight of the adhesive composition. The adhesive composition may comprise the alkali metal salt of a cellulose derivative in an amount of from about 40 wt.% to about 65 wt.% based on the total weight of the adhesive composition. The adhesive composition may comprise the alkali metal salt of a cellulose derivative in an amount of from about 45 wt.% to about 65 wt.% based on the total weight of the adhesive composition. Preferably, the alkali metal salt of the cellulose derivative is sodium carboxymethyl cellulose.

[0172] Any of the above ranges relating to the one or more hydrocolloids may be combined with any of the above ranges relating to the one or more pressure sensitive adhesive polymers.

[0173] The adhesive composition may comprise pectin in an amount of at least about 5 wt.% based on the total weight of the adhesive composition. The adhesive composition may comprise pectin in an amount of at least about 10 wt.% based on the total weight of the adhesive composition. The adhesive composition may comprise pectin in an amount of at least about 15 wt.% based on the total weight of the adhesive composition.

[0174] The adhesive composition may comprise pectin in an amount of no greater than about 40 wt.% based on the total weight of the adhesive composition. The adhesive composition may comprise pectin in an amount of no greater than about 30 wt.% based on the total weight of the adhesive composition. The adhesive composition may comprise pectin in an amount of no greater than about 25 wt.% based on the total weight of the adhesive composition.

[0175] The adhesive composition may comprise pectin in an amount of from about 5 wt.% to about 40 wt.% based on the total weight of the adhesive composition. The adhesive composition may comprise pectin in an amount of from about 10 wt.% to about 30 wt.% based on the total weight of the adhesive composition. The adhesive composition may comprise pectin in an amount of from about 15 wt.% to about 25 wt.% based on the total weight of the adhesive composition.

[0176] The adhesive composition may comprise gelatin in an amount of at least about 5 wt.% based on the total weight of the adhesive composition. The adhesive composition may comprise gelatin in an amount of at least about 10 wt.% based on the total weight of the adhesive composition. The adhesive composition may comprise gelatin in an amount of at least about 15 wt.% based on the total weight of the adhesive composition.

[0177] The adhesive composition may comprise gelatin in an amount of no greater than about 40 wt.% based on the total weight of the adhesive composition. The adhesive composition may comprise gelatin in an amount of no greater than about 30 wt.% based on the total weight of the adhesive composition. The adhesive composition may comprise gelatin in an amount of no greater than about 25 wt.% based on the total weight of the adhesive composition.

[0178] The adhesive composition may comprise gelatin in an amount of from about 5 wt.% to about 40 wt.% based on the total weight of the adhesive composition. The adhesive composition may comprise gelatin in an amount of from about 10 wt.% to about 30 wt.% based on the total weight of the adhesive composition. The adhesive composition may comprise gelatin in an amount of from about 15 wt.% to about 25 wt.% based on the total weight of the adhesive composition.

[0179] Any of the above ranges relating to the one or more hydrocolloids may be combined with any other ranges disclosed herein, for example any ranges relating to the one or more pressure sensitive adhesive polymers.

[0180] As noted above, the one or more hydrocolloids may be in the form of particles. The one or more hydrocolloids may have a mean average particle size of at least about 100 pm. The one or more hydrocolloids may have a mean average particle size of at least about 150 pm. The one or more hydrocolloids may have a mean average particle size of at least about 200 pm.

[0181] The one or more hydrocolloids may have a mean average particle size of no greater than about 800 pm. The one or more hydrocolloids may have a mean average particle size of no greater than about 750 pm. The one or more hydrocolloids may have a mean average particle size of no greater than about 700 pm.

[0182] The one or more hydrocolloids may have a median particle size of from about 10 pm to about 200 pm. The one or more hydrocolloids may have a median particle size of from about 20 pm to about 150 pm. The one or more hydrocolloids may have a median particle size of from about 30 pm to about 120 pm. The median particle size may be the D50 particle size. For example, if the one or more hydrocolloids have a D50 of 100 pm, 50% of the one or more hydrocolloids (by mass) have a particle size no greater than 100 pm. It is to be understood that the median average particle size and / or D50 particle size may be determined using laser diffraction.

[0183] Any of the above particle size features may be combined with any features relating to the adhesive composition including the chemical identity of the hydrocolloid and amount thereof in the adhesive composition.Additional Components

[0184] The adhesive composition may further comprise one or more additional components. For example, the adhesive composition may comprise one or more tackifiers. For example, the adhesive composition may comprise one or more plasticisers. For example, the adhesive composition may comprise one or more antioxidants. For example, the adhesive composition may comprise one or more tackifiers and / or one or more plasticisers and / or one or more antioxidants.

[0185] The one or more tackifiers may be selected from the group comprising rosins, rosin derivatives, terpenes, modified terpenes, cycloaliphatic resins, aromatic resins, hydrogenated hydrocarbon resins, terpene -phenol resins, and a combination thereof. It is to be understood that “rosin derivatives” means chemically modified rosins, e.g. partially or fully hydrogenated rosins.

[0186] The one or more tackifiers may be present in an amount of no greater than about 30 wt. %, based on the total weight of the adhesive composition. The one or more tackifiers may be present in an amount of no greater than about 25 wt. %, based on the total weight of the adhesive composition. The one or more tackifiers may be present in an amount of no greater than about 20 wt. %, based on the total weight of the adhesive composition. The one or more tackifiers may be present in an amount of no greater than about 15 wt. %, based on the total weight of the adhesive composition.

[0187] The one or more tackifiers may be present in an amount of at least about 1 wt. %, based on the total weight of the adhesive composition. The one or more tackifiers may be present in an amountof at least about 2 wt. %, based on the total weight of the adhesive composition. The one or more tackifiers may be present in an amount of at least about 5 wt. %, based on the total weight of the adhesive composition. The one or more tackifiers may be present in an amount of at least about 10 wt. %, based on the total weight of the adhesive composition.

[0188] The one or more tackifiers may be present in an amount of from about 1 wt. % to about 30 wt. %, based on the total weight of the adhesive composition. The one or more tackifiers may be present in an amount of from about 2 wt. % to about 25 wt.%, based on the total weight of the adhesive composition. The one or more tackifiers may be present in an amount of from about 5 wt. % to about 20 wt.%, based on the total weight of the adhesive composition. The one or more tackifiers may be present in an amount of from about 10 wt. % to about 15 wt.%, based on the total weight of the adhesive composition. The adhesive composition may not comprise one or more tackifiers.

[0189] The one or more plasticisers may be selected from the group comprising oil, fat, and a combination thereof. The oil may be mineral oil.

[0190] The one or more plasticisers may be present in an amount of no greater than about 30 wt. %, based on the total weight of the adhesive composition. The one or more plasticisers may be present in an amount of no greater than about 25 wt. %, based on the total weight of the adhesive composition. The one or more plasticisers may be present in an amount of no greater than about 20 wt. %, based on the total weight of the adhesive composition. The one or more plasticisers may be present in an amount of no greater than about 15 wt. %, based on the total weight of the adhesive composition.

[0191] The one or more plasticisers may be present in an amount of at least about 1 wt. %, based on the total weight of the adhesive composition. The one or more plasticisers may be present in an amount of at least about 2 wt. %, based on the total weight of the adhesive composition. The one or more plasticisers may be present in an amount of at least about 5 wt. %, based on the total weight of the adhesive composition. The one or more plasticisers may be present in an amount of at least about 10 wt. %, based on the total weight of the adhesive composition.

[0192] The one or more plasticisers may be present in an amount of from about 1 wt. % to about 30 wt. %, based on the total weight of the adhesive composition. The one or more plasticisers may be present in an amount of from about 2 wt. % to about 25 wt.%, based on the total weight of the adhesive composition. The one or more plasticisers may be present in an amount of from about 5 wt. % to about 20 wt.%, based on the total weight of the adhesive composition. The one or more plasticisers may be present in an amount of from about 10 wt. % to about 15 wt.%, based on the total weight of the adhesive composition. The adhesive composition may not comprise one or more plasticisers.

[0193] The one or more antioxidants may be varied. For example, the one or more antioxidants may be a phenolic antioxidant.

[0194] The one or more antioxidants may be present in an amount of no greater than about 5 wt. %, based on the total weight of the adhesive composition. The one or more antioxidants may be present in an amount of no greater than about 2 wt. %, based on the total weight of the adhesive composition. The one or more antioxidants may be present in an amount of no greater than about 1 wt. %, based on the total weight of the adhesive composition.

[0015] The one or more antioxidants may be present in an amount of at least about 0.05 wt. %, based on the total weight of the adhesive composition. The one or more antioxidants may be present in an amount of at least about 0. 1 wt. %, based on the total weight of the adhesive composition. The one or more antioxidants may be present in an amount of at least about 0.2 wt. %, based on the total weight of the adhesive composition.

[0196] The one or more antioxidants may be present in an amount of from about 0.05 wt. % to about 5 wt.%, based on the total weight of the adhesive composition. The one or more antioxidants may be present in an amount of from about 0. 1 wt. % to about 2 wt.%, based on the total weight of the adhesive composition. The one or more antioxidants may be present in an amount of from about 0.2 wt. % to about 1 wt.%, based on the total weight of the adhesive composition. The adhesive composition may not comprise one or more antioxidants.Water Absorption

[0197] The adhesive composition may be defined by its water absorption. Water absorption is a concept recognised in the art and the measurement method is set out below. The adhesive composition may have a water absorption at 30 minutes of at least about 0.05 g / cm2. The adhesive composition may have a water absorption at 30 minutes of at least about 0.08 g / cm2. The adhesive composition may have a water absorption at 30 minutes of at least about 0.10 g / cm2. The adhesive composition may have a water absorption at 30 minutes of at least about 0. 12 g / cm2. The adhesive composition may have a water absorption at 30 minutes of at least about 0. 14 g / cm2.]0198[ The adhesive composition may have a water absorption at 30 minutes of no greater than about 0.30 g / cm2. The adhesive composition may have a water absorption at 30 minutes of at least about 0.28 g / cm2. The adhesive composition may have a water absorption at 30 minutes of at least about 0.24 g / cm2.

[0199] The adhesive composition may have a water absorption at 30 minutes of at least about 0.20 g / cm2.

[0200] The adhesive composition may have a water absorption at 30 minutes of at least about 0.18 g / cm2.

[0201] The adhesive composition may have a water absorption at 30 minutes of from about 0.05 g / cm2to about 0.30 g / cm2. The adhesive composition may have a water absorption at 30 minutes of from about 0.08 g / cm2to about 0.28 g / cm2. The adhesive composition may have a water absorption at 30 minutes of from about 0.10 g / cm2to about 0.24 g / cm2. The adhesive composition may have a water absorption at 30 minutes of from about 0. 12 g / cm2to about 0.20 g / cm2. The adhesive composition may have a water absorption at 30 minutes of from about 0.14 g / cm2to about 0.18 g / cm2.

[0202] It is to be understood that the water absorption at 30 minutes of the adhesive composition is measured by:1. providing a dry sample of the adhesive composition having a length of 25 mm, a width of 25 mm, and a thickness of 1 mm (the dry sample defining a square outer perimeter);2. attaching one of the two surfaces of the sample to an impermeable (e.g. polystyrene) plate (e.g. using double-sided tape), such that the plate substantially seals said surface from liquid ingress;3. immersing the sample attached to the plate in 300 ml to 400 ml (an excess) of 0.9 wt.% NaCl solution (aq.) held at a temperature of 32 °C (such that the sample is fully submerged);4. weighing the sample, having immersed the sample for 30 minutes, and recording said weight (Ww) in g;5. drying the sample to remove the water from the sample (e.g. using an oven);6. weighing the dried sample, and recording said weight (WD) in g; and7. calculating the water absorption in g / cm2(e.g. (Ww - WD) / 0.625).

[0203] Any of the above features as to water absorption may be combined with any features relating to the adhesive composition.

[0204] In some examples, the one or more thermoplastic materials may be selected from the group comprising polyalkenes, polyacrylates, silicones, polyurethanes, ethylene-vinyl acetate, styrene copolymers, butyl rubber, and a combination thereof. In some examples, the one or more thermoplastic materials comprise a polyalkene. In such examples the adhesive composition may not comprise a styrene copolymer and / or butyl rubber. In some examples, the one or more thermoplastic materials comprise a polyalkene and a styrene copolymer. In such examples the adhesive composition may not comprise butyl rubber. In some examples, the one or more thermoplastic materials comprisea polyalkene and butyl rubber. In such examples the adhesive composition may not comprise a styrene copolymer. In some examples, the one or more thermoplastic materials comprise a polyalkene, a styrene copolymer, and butyl rubber.

[0205] In any of the above examples, the one or more thermoplastic materials may be as defined herein, for example in terms of type and / or amount. In any of the above examples, the one or more hydrocolloids in the adhesive compositions of the above examples may be as defined herein, for example in terms of type and / or amount.

[0206] In any of the above examples, the polyalkene may be as defined herein, for example the polyalkene may be a polyethylene, polypropylene, polybutene, polypentene and copolymers and isomers thereof. In some examples the polyalkene may be polyisobutylene, ethylene propylene rubber, ethylene propylene diene monomer rubber, or a combination thereof. In preferred examples, the polyalkene may be a polyisobutylene. The polyalkene may be present in any amount defined herein.

[0207] In any of the above examples, the cellulose derivative may be as defined herein. For example, the cellulose derivative may be hydroxyethyl cellulose, hydroxypropyl cellulose, or carboxymethyl cellulose. In preferred examples, the cellulose derivative is carboxymethyl cellulose. In preferred examples the alkali metal salt of the cellulose derivative is sodium carboxymethyl cellulose. The cellulose derivative may be present in any amount defined herein.

[0208] In some examples, the adhesive composition comprises: the one or more thermoplastic materials in an amount of from about 20 wt.% to about 45 wt.% based on the total weight of the adhesive composition, wherein the one or more thermoplastic materials are selected from the group comprising polyalkenes, styrene copolymers, and butyl rubber; the one or more hydrocolloids in an amount of from about 40 wt.% to about 65 wt.% based on the total weight of the adhesive composition, wherein the one or more hydrocolloids is selected from the group comprising an alkali metal salt of a cellulose derivative, pectin, gelatin, and a combination thereof, optionally wherein the adhesive composition has a water absorption at 30 minutes of from about 0.06 g / cm2to about 0.18 g / cm2, wherein the continuous portion 102 has a thickness (e.g. L1) of from about 250 pm to about 450 pm.

[0209] In some examples, the adhesive composition comprises:the one or more thermoplastic materials in an amount of from about 20 wt.% to about 45 wt.% based on the total weight of the adhesive composition, wherein the one or more thermoplastic materials are selected from the group comprising polyalkenes, styrene copolymers, and butyl rubber; the one or more hydrocolloids in an amount of from about 40 wt.% to about 65 wt.% based on the total weight of the adhesive composition, wherein the one or more hydrocolloids comprises an alkali metal salt of a cellulose derivative and one or more of pectin and gelatin, optionally wherein the adhesive composition has a water absorption at 30 minutes of at least about 0.06 g / cm2, optionally from about 0.06 g / cm2to about 0.18 g / cm2, wherein the continuous portion 102 has a thickness (e.g. L1) of from about 250 pm to about 450 pm.

[0210] In any of the above examples, the polyalkene may be as defined herein, for example the polyalkene may be a polyethylene, polypropylene, polybutene, polypentene and copolymers and isomers thereof. In some examples the polyalkene may be polyisobutylene, ethylene propylene rubber, ethylene propylene diene monomer rubber, or a combination thereof. In preferred examples, the polyalkene may be a polyisobutylene. The polyalkene may be present in any amount defined herein.

[0211] In any of the above examples, the cellulose derivative may be as defined herein. For example, the cellulose derivative may be hydroxyethyl cellulose, hydroxypropyl cellulose, or carboxymethyl cellulose. In preferred examples, the cellulose derivative is carboxymethyl cellulose. In preferred examples the alkali metal salt of the cellulose derivative is sodium carboxymethyl cellulose. The cellulose derivative may be present in any amount defined herein.

[0212] In some examples, the adhesive composition comprises: the one or more thermoplastic materials in an amount of from about 20 wt.% to about 45 wt.%, based on the total weight of the adhesive composition, wherein the one or more thermoplastic materials are selected from the group comprising polyisobutylene, optionally wherein the mass fraction of polyisobutylene based on the total mass of the one or more pressure sensitive adhesive polymers is at least about 99 %, optionally wherein the adhesive composition does not comprise a styrene copolymer, optionally wherein the adhesive composition does not comprise butyl rubber; the one or more hydrocolloids in an amount of from about 55 wt.% to about 65 wt.%, based on the total weight of the adhesive composition, wherein the one or more hydrocolloids are selected from the group comprising an alkali metal salt of a cellulose derivative, pectin, gelatin, and a combination thereof, optionally wherein the alkali metal salt of the cellulose derivative is sodium carboxymethyl cellulose,optionally wherein the polyisobutylene has a weight average molecular weight of from about 60 000 g / mol to about 80 000 g / mol, or the polyisobutylene comprises a first polyisobutylene and a second poly isobutylene, the weight average molecular weight of the first polyisobutylene being from about 60 000 g / mol to about 80 000 g / mol and the weight average molecular weight of the second polyisobutylene being from about 1 000 000 g / mol to about 1 100 000 g / mol, optionally wherein the mass ratio of the first polyisobutylene to the second polyisobutylene is from about 1.5: 1 to about 2.2: 1, optionally wherein the adhesive composition has a water absorption at 30 minutes of at least about 0.06 g / cm2, optionally from about 0.06 g / cm2to about 0.18 g / cm2, wherein the continuous portion 102 has a thickness (e.g. L1) of from about 250 pm to about 450 pm.

[0213] In some examples, the adhesive composition comprises: the one or more thermoplastic materials in an amount of from about 20 wt.% to about 45 wt.%, based on the total weight of the adhesive composition, wherein the one or more thermoplastic materials are selected from the group comprising polyisobutylene, optionally wherein the mass fraction of polyisobutylene based on the total mass of the one or more pressure sensitive adhesive polymers is at least about 99 %, optionally wherein the adhesive composition does not comprise a styrene copolymer, optionally wherein the adhesive composition does not comprise butyl rubber; the one or more hydrocolloids in an amount of from about 55 wt.% to about 65 wt.%, based on the total weight of the adhesive composition, wherein the one or more hydrocolloids are selected from the group comprising an alkali metal salt of a cellulose derivative, pectin, gelatin, and a combination thereof, wherein the alkali metal salt of the cellulose derivative is sodium carboxymethyl cellulose, wherein the alkali metal salt of a cellulose derivative is present in an amount of from about 15 wt.% to about 25 wt. % based on the total weight of the adhesive composition, optionally wherein pectin is present in an amount of from about 15 wt.% to about 25 wt.% based on the total weight of the adhesive composition; optionally wherein gelatin is present in an amount of from about 15 wt.% to about 25 wt.% based on the total weight of the adhesive composition, optionally wherein the polyisobutylene has a weight average molecular weight of from about 60 000 g / mol to about 80 000 g / mol, or the polyisobutylene comprises a first polyisobutylene and a second poly isobutylene, the weight average molecular weight of the first polyisobutylene being from about 60 000 g / mol to about 80 000 g / mol and the weight average molecular weight of the secondpolyisobutylene being from about 1 000 000 g / mol to about 1 100 000 g / mol, optionally wherein the mass ratio of the first polyisobutylene to the second polyisobutylene is from about 1.5: 1 to about 2.2: 1, optionally wherein the adhesive composition has a water absorption at 30 minutes of at least about 0.14 g / cm2, optionally from about 0.14 g / cm2to about 0.18 g / cm2, wherein the continuous portion 102 has a thickness (e.g. L1) of from about 250 pm to about 450 pm.

[0214] In some examples, the adhesive composition comprises: the one or more thermoplastic materials in an amount of from about 35 wt.% to about 45 wt.%, based on the total weight of the adhesive composition, wherein the one or more thermoplastic materials are selected from the group comprising polyisobutylene, optionally wherein the mass fraction of polyisobutylene based on the total mass of the one or more pressure sensitive adhesive polymers is at least about 99 %, optionally wherein the adhesive composition does not comprise a styrene copolymer, optionally wherein the adhesive composition does not comprise butyl rubber; the one or more hydrocolloids in an amount of from about 55 wt.% to about 65 wt.%, based on the total weight of the adhesive composition, wherein the one or more hydrocolloids are selected from the group comprising an alkali metal salt of a cellulose derivative, pectin, gelatin, and a combination thereof, wherein the alkali metal salt of the cellulose derivative is sodium carboxymethyl cellulose, wherein the alkali metal salt of a cellulose derivative is present in an amount of from about 15 wt.% to about 25 wt. % based on the total weight of the adhesive composition, optionally wherein pectin is present in an amount of from about 15 wt.% to about 25 wt.% based on the total weight of the adhesive composition; optionally wherein gelatin is present in an amount of from about 15 wt.% to about 25 wt.% based on the total weight of the adhesive composition, optionally wherein the polyisobutylene has a weight average molecular weight of from about 60 000 g / mol to about 80 000 g / mol, optionally wherein the adhesive composition has a water absorption at 30 minutes of at least about 0.14 g / cm2, optionally from about 0.14 g / cm2to about 0.18 g / cm2, wherein the continuous portion 102 has a thickness (e.g. L1) of from about 250 pm to about 450 pm.

[0215] In some examples, the adhesive composition comprises:the one or more thermoplastic materials in an amount of from about 35 wt.% to about 45 wt.%, based on the total weight of the adhesive composition, wherein the one or more thermoplastic materials are selected from the group comprising polyisobutylene, optionally wherein the mass fraction of polyisobutylene based on the total mass of the one or more pressure sensitive adhesive polymers is at least about 99 %, optionally wherein the adhesive composition does not comprise a styrene copolymer, optionally wherein the adhesive composition does not comprise butyl rubber; the one or more hydrocolloids in an amount of from about 55 wt.% to about 65 wt.%, based on the total weight of the adhesive composition, wherein the one or more hydrocolloids are selected from the group comprising an alkali metal salt of a cellulose derivative, wherein the alkali metal salt of the cellulose derivative is sodium carboxymethyl cellulose, optionally wherein the polyisobutylene has a weight average molecular weight of from about 60 000 g / mol to about 80 000 g / mol, optionally wherein the adhesive composition has a water absorption at 30 minutes of at least about 0.14 g / cm2, optionally from about 0.14 g / cm2to about 0.18 g / cm2, wherein the continuous portion 102 has a thickness (e.g. L1) of from about 250 pm to about 450 pm.

[0216] In some examples, the adhesive composition comprises: the one or more thermoplastic materials in an amount of from about 20 wt.% to about 30 wt.%, based on the total weight of the adhesive composition, wherein the one or more thermoplastic materials are selected from the group comprising polyisobutylene, optionally wherein the mass fraction of polyisobutylene based on the total mass of the one or more pressure sensitive adhesive polymers is at least about 99 %, optionally wherein the adhesive composition does not comprise a styrene copolymer, optionally wherein the adhesive composition does not comprise butyl rubber; the one or more hydrocolloids in an amount of from about 55 wt.% to 65 wt.%, based on the total weight of the adhesive composition, wherein the one or more hydrocolloids are selected from the group comprising an alkali metal salt of a cellulose derivative, pectin, gelatin, and a combination thereof, wherein the alkali metal salt of the cellulose derivative is sodium carboxymethyl cellulose, wherein the alkali metal salt of a cellulose derivative is present in an amount of from about 15 wt.% to about 25 wt. % based on the total weight of the adhesive composition, optionally wherein pectin is present in an amount of from about 15 wt.% to about 25 wt.% based on the total weight of the adhesive composition;optionally wherein gelatin is present in an amount of from about 15 wt.% to about 25 wt.% based on the total weight of the adhesive composition, optionally wherein the polyisobutylene has a weight average molecular weight of from about 60 000 g / mol to about 80 000 g / mol, or the polyisobutylene comprises a first polyisobutylene and a second poly isobutylene, the weight average molecular weight of the first polyisobutylene being from about 60 000 g / mol to about 80 000 g / mol and the weight average molecular weight of the second polyisobutylene being from about 1 000 000 g / mol to about 1 100 000 g / mol, optionally wherein the mass ratio of the first polyisobutylene to the second polyisobutylene is from about 1.5: 1 to about 2.2: 1, optionally wherein the adhesive composition has a water absorption at 30 minutes of at least about 0.14 g / cm2, optionally from about 0.14 g / cm2to about 0.18 g / cm2, wherein the continuous portion 102 has a thickness (e.g. L1) of from about 250 pm to about 450 pm.

[0217] In some examples, the adhesive composition comprises: the one or more thermoplastic materials in an amount of from 20 wt.% to 30 wt.%, based on the total weight of the adhesive composition, wherein the one or more thermoplastic materials are selected from the group comprising polyisobutylene and butyl rubber, optionally wherein the adhesive composition does not comprise a styrene copolymer; wherein polyisobutylene is present in an amount of from 5 wt.% to 15 wt.%, based on the total weight of the adhesive composition, wherein butyl rubber is present in an amount of from 10 wt.% to 20 wt.%, based on the total weight of the adhesive composition the one or more hydrocolloids in an amount of from 55 wt.% to 65 wt.%, based on the total weight of the adhesive composition, wherein the one or more hydrocolloids are selected from the group comprising an alkali metal salt of a cellulose derivative, wherein the alkali metal salt of the cellulose derivative is sodium carboxymethyl cellulose, optionally wherein the polyisobutylene has a weight average molecular weight of from about 60 000 g / mol to about 80 000 g / mol, optionally wherein the adhesive composition has a water absorption at 30 minutes of from about 0. 12 g / cm2to about 0.18 g / cm2, wherein the continuous portion 102 has a thickness (e.g. L1) of from about 250 pm to about 450 pm.Electrode Arrangement

[0218] The assembly 100 comprises an electrode arrangement 105 comprising at least one electrode pair 106. Each electrode 107, 108 of the at least one electrode pair 106 contacts the continuous portion 102, and the continuous portion 102 extends at least between the respective electrode 107, 108 and the skin-engageable surface 103. For example, the assembly 100 may comprise a plurality of electrode pairs 106, wherein each electrode 107, 108 contacts the continuous portion 102, and the continuous portion 102 extends at least between the respective electrode 107, 108 and the skin-engageable surface 103. Such an arrangement is best shown in Figs. 3 to 4B, 5B, 6B, and 7 to 10. As described herein, each electrode 107, 108 of the at least one electrode pair 106 may be provided on the distal surface 104 of the continuous portion 102, as illustrated in Figs. 3 to 4B, 5B, 6B, and 7 to 10; or may be provided within the continuous portion 102 as defined herein.

[0219] The electrodes 107, 108 of the or each electrode pair 106 may be provided in various forms. In some examples, each electrode 107, 108 may be an electrode pathway.

[0220] Referring particularly to Figs. 1, 2, 3, 5A, and 6A, the or each electrode pair 106 may at least partially surround a location (e.g. 109 or 110) of the continuous portion 102. The location 109, 110 may be towards or at the centre of the continuous portion 102, or towards or at the stomal opening 109 (where present). For example, the or each electrode pair 106 may substantially surround the location 109, 110 of the continuous portion 102.

[0221] The electrodes 107, 108 of the or each electrode pair 106 may be arranged at different distances from the location 109, 110 of the continuous portion 102. That is, the distance from one electrode 107, 108 to the location 109, 110 is different from the distance from any other electrode107, 108 to the location 109, 110. Such an arrangement is apparent from Fig. 5A, for example, in which the electrode 107 is closer to the centre 109, 110 of the continuous portion than the electrode108.

[0222] Where multiple electrode pairs 106 are present, the electrode pairs 106 may be arranged at different distances from the location 109, 110 of the continuous portion 102. That is, the distance from one electrode pair 106 to the location 109, 110 is different from the distance from any other electrode pair 106 to the location 109, 110. Such an arrangement is apparent from Fig. 2, for example. Where multiple electrode pairs 106 are present, the electrode pairs 106 may be spaced apart from each other.

[0223] Referring to Figs. 1 to 3, 5A, and 6A, the or each electrode pair 106 may be arranged concentrically around the location 109, 110. For example, as shown in Figs. 1 and 2, each electrode pair 106 maybe arranged concentrically around the location 109, 110. In some examples, the location is the stomal opening 109.

[0224] In some examples, the or each electrode pair 106 is provided such that liquid can flow between the pair of electrodes 107, 108 of the or each electrode pair 106 and / or around the or each respective electrode pair 106.

[0225] The at least one electrode pair 106 may be arranged in use to receive an alternating electrical signal and provide an output signal in response to applying the alternating electrical signal to a portion (e.g. the continuous portion 102) of the adhesive layer 101, the output signal indicative of an electrical property of the portion (e.g. the continuous portion 102) of the adhesive layer 101.

[0226] The present inventors have identified that an alternating electrical signal (such as an alternating current, AC) can be used to determine whether an electrical property of a portion of an adhesive layer has changed in response to the presence of liquid. This can therefore be used to determine a leakage state associated with an ostomy appliance.

[0227] Indeed, the present inventors have identified that use of an alternating electrical signal rather than a non-alternating electrical signal (such as a direct current, DC) provides a number of advantages. For example, by using an alternating electrical signal rather than a non-alternating electrical signal (such as a direct current, DC), assemblies 100 and ostomy appliances 1000 of the present disclosure are able to provide useful information relating to stomal waste leak. In particular, one or more signal processing techniques can be performed on the output signal to provide an earlier detection of liquid, a faster detection of liquid, and a characterisation of one or more properties associated with the liquid, such as a classification into a type of liquid (e.g. perspiration or stomal waste) and a position and movement of the liquid.

[0228] Indeed, with an alternating electrical signal, an impedance of the adhesive layer (particularly the continuous portion 102) can be determined. Unlike resistance, which can be measured in a nonalternating signal arrangement (such as DC), the impedance of the adhesive in an alternating electrical signal arrangement gradually decreases before a short-circuit occurs in the presence of liquid. Indeed, dry adhesive behaves as an insulator with high resistance. However, the dielectric properties of the adhesive change as the adhesive absorbs liquid (such as water), which results in a decreasing impedance even though the liquid has not penetrated across the full thickness of the adhesive between electrodes of an electrode pair. Thus, an output signal can be determined during a time period when the electrical properties of the adhesive (i.e. its impedance) are changing, and this can be used to determine various properties of the liquid, such as classifying the liquid into perspiration or stomal waste, which would not otherwise be possible in a DC implementation.

[0229] Furthermore, the present inventors have identified that in a direct signal arrangement, such as using DC and measuring a resistance between electrodes to detect the presence of a leak associated with an ostomy appliance, the direct current will charge one side of the electrode constantly. Thiscreates a bias charge that can affect the accuracy of the signal measurement. Thus, the present sensor device provides increased signal measurement accuracy as bias caused by charging one side of an electrode pair is avoided.

[0230] The electrical property may comprise an impedance of the portion (e.g. the continuous portion 102) of the adhesive layer 101 between the electrodes 107, 108 of the or each electrode pair 106.

[0231] The output signal may correspond to an electrical parameter associated with the electrode arrangement 104. The electrical parameter may be selected from current, voltage, resistivity, impedance, capacitance, conductance, and inductance.

[0232] The electrode arrangement 104 may be arranged to provide an output signal indicative of whether liquid is present in the portion (e.g. the continuous portion 102) of the adhesive layer 101.

[0233] The alternating electrical signal may comprise an alternating current or alternating voltage. The alternating electrical signal may have a frequency in a range between 5Hz and 500kHz.

[0234] The assembly 100 may comprise an input signal interface connectable to a control device for receiving the alternating electrical signal, and an output signal interface connectable to the control device for providing the output signal to the control device such that the output signal is measurable by the control device. The assembly 100 may comprise the control device configured to provide the alternating electrical signal and determine the output signal from the sensor device. The control device may be configured to sample the output signal over a time period.]0235[ In some examples, the ostomy appliance 1000 comprises the control device configured to provide the alternating electrical signal and determine the output signal from the sensor device. In such examples, the assembly 100 comprises an input signal interface connectable (or connected) to the control device, and an output signal interface connectable (or connected) to the control device) for providing the output signal to the control device such that the output signal is measurable (or measured) by the control device.Substrate

[0236] Referring to Figs. 8 and 9, the assembly 100 may comprise a substrate 113. The or each electrode pair 106 may be provided on the substrate 113. The or each electrode pair 106 may be attached to the substrate 113. For example, the or each electrode pair 106 may be supported by the substrate 113. The substrate 113 may be liquid permeable.

[0237] In some examples, such as that of Fig. 8, the substrate 113 may be formed as a continuous fdm layer. The continuous fdm layer 113 may be liquid permeable.

[0238] In some examples, such as that of Fig. 9, the substrate 113 may comprise one or more openings 114. The substrate 113 may be a film layer 113 comprising the one or more openings 114. Liquid may permeate through the openings 114.

[0239] The substrate 113 may be a support sheet (which may be impermeable). In some examples, each electrode 107, 108 is not arranged in contact with a support sheet. In some examples, the assembly 100 does not comprise a support sheet.

[0240] The present inventors have found that the use of a liquid permeable substrate 113 can facilitate liquid transport, for example to different parts of the ostomy appliance 1000, which can increase wear time.Further Adhesive Layer

[0241] The assembly 100 may comprise one or more further adhesive layers. The or each further adhesive layer may be made of an adhesive composition. The adhesive composition from which the or each further adhesive layer is made may comprise a blend of one or more pressure sensitive adhesive polymers and one or more hydrocolloids. The adhesive composition from which the or each further adhesive layer is made may have any features of the adhesive composition from which the continuous portion 102 is made, as defined herein. The amount of pressure sensitive adhesive polymers in the adhesive composition from which the a further adhesive layer (e.g. one or more of said layers) is made may be greater that the amount of pressure sensitive adhesive polymers in the adhesive composition from which the continuous portion 102 is made (the amount being in wt. % based on the total weight of the respective adhesive composition). The amount of hydrocolloids in the adhesive composition from which a further adhesive layer (e.g. one or more of said layers) is made may be less that the amount of hydrocolloids in the adhesive composition from which the continuous portion 102 is made (the amount being in wt. % based on the total weight of the respective adhesive composition).

[0242] In some examples, the continuous portion 102 and the one or more further adhesives layers made be made of different adhesive compositions. In some examples, the continuous portion 103 and the one or more further adhesives layers made have different thicknesses. Different adhesive compositions and / or thicknesses may be used to tailor the liquid absorption profile of the assembly 100, as desired.

[0243] In some examples, the one or more further adhesive layers comprises a second adhesive layer 115. Fig. 11 shows a second adhesive layer 115. The second adhesive layer 115 may extend radially over the outer perimeter of the adhesive layer 101, e.g. over the outer perimeter of the continuous portion 102. The second adhesive layer 115 may be attached to the adhesive layer 101, e.g. the continuous portion 102, e.g. the distal surface 104 thereof. The second adhesive layer 115 maysurround the adhesive layer 101, e.g. the continuous portion 102. For example, the second adhesive layer 115 may be arranged concentrically around the adhesive layer 101, e.g. the continuous portion 102. The second adhesive layer 115 may extend radially outwardly from the adhesive layer 101, e.g. the continuous portion 102. The second adhesive layer may be for adhering to skin.

[0244] For example, the second adhesive layer 115 may have a skin-facing surface and a distal surface. A part of the skin-facing surface may be attached to the adhesive layer 101, e.g. the continuous portion 102, e.g. the distal surface 104 thereof. A part of the skin-facing surface may be for adhering to the skin of an ostomate.

[0245] The second adhesive layer 115 may define an outer perimeter. A portion of the second adhesive layer 115 extending to the outer perimeter thereof may be tapered or bevelled. Said portion may partially or completely extend around the outer perimeter of the second adhesive layer 115. Advantageously, the present inventors have found that such a configuration helps reduce the risk of “edge lifting”, whereby portions of the adhesive layer 115 (e.g. towards the outer perimeter thereof) inadvertently lift or peel from the skin in use.

[0246] The present inventors have found that the use of a further (e.g. second) adhesive layer 115 can improve adhesion of the assembly 100 to the skin 2000 in use. This is particularly advantageous in examples in which the continuous portion 102 is made of an adhesive composition having a hydrocolloid content of at least about 30 wt.% based on the total weight of the adhesive composition.Baseplate

[0247] As discussed, the ostomy appliance 1000 comprises a baseplate 200. In some examples, however, the assembly 100 comprises a baseplate 200.

[0248] The baseplate 200 has a proximal surface 201 and a distal surface 202. The proximal surface 201 of the baseplate 200 may be configured to attach (or be attached) to the distal surface 104 of the continuous portion 102. The attachment may be provided in various forms, though is typically provided by an adhesive. For example, the baseplate 200 may comprise an adhesive layer 203. The adhesive layer 203 may be applied to the proximal surface 201 of the baseplate 200. The adhesive layer 203 may be configured to adhere (or be adhered) to the distal surface 104 of the continuous portion 102. Such an arrangement is apparent from Figs. 1 and 3, in which the adhesive layer 203 is configured to adhere to the distal surface 104 of the continuous portion 102. Where the adhesive layer 203 attaches (e.g. adheres) to the distal surface 104 of the continuous portion 102, the or each electrode pair 106 may be arranged between the adhesive layer 203 of the baseplate 200 and the adhesive layer 101 (or the continuous portion 102) of the assembly 100.

[0249] The present inventors have found that by attaching the adhesive layer 203 of the baseplate 200 to the continuous portion 102 of the adhesive layer 101, moisture from perspiration entering the continuous portion 102 may be transported to and distributed throughout the adhesive layer 203. Such liquid transport and distribution reduces the concentration of moisture in the part or parts 102’ of the continuous portion 102 adjacent to the electrodes 107, 108, and therefore reduces the likelihood of false detection of a stomal waste leak.

[0250] The adhesive layer 203 may be made of an adhesive composition. The adhesive composition may be varied. The adhesive composition may comprise a blend of one or more pressure sensitive adhesive polymers and one or more hydrocolloids. The adhesive composition from which the adhesive layer 203 is made may have any features of the adhesive composition from which the continuous portion 102 is made, as defined herein.

[0251] Where the adhesive layer 203 of the baseplate 200 is attached to the continuous portion 102 of the adhesive layer 101, the adhesive layer 203 may surround the adhesive layer 101, e.g. the continuous portion 102. For example, where the adhesive layer 203 of the baseplate 200 is attached to the continuous portion 102 of the adhesive layer 101, the adhesive layer 203 may be arranged concentrically around the adhesive layer 101, e.g. the continuous portion 102. For example, where the adhesive layer 203 of the baseplate 200 is attached to the continuous portion 102 of the adhesive layer 101, the adhesive layer 203 may extend radially outwardly from the adhesive layer 101, e.g. the continuous portion 102.

[0252] The baseplate 200 may be configured to attach to an ostomy bag 300. It will be understood that an ostomy bag is suitable for collecting and holding stomal waste. The baseplate 200 may comprise an adaptor configured to releasably attach to an ostomy bag 300. The adaptor may be provided at the distal surface 202 of the baseplate 200. It will be understood that the manner in which the baseplate 200 may attach to an ostomy bag 300 may vary in form.

[0253] The ostomy appliance 1000 may comprise an ostomy bag 300. The ostomy bag 300 may be configured to attach (e.g. releasably) to the baseplate 200. For example, the ostomy bag may be configured to attach (e.g. releasably) to the distal surface 202 of the baseplate 200. Ostomy appliances in which the ostomy bag is configured to releasably attach to the baseplate are known in the art as “two piece” ostomy appliances. The ostomy appliance 1000 may be a two piece ostomy appliance. By contrast, ostomy appliances in which the ostomy bag is fixedly (non-releasably) attached to the baseplate are known in the art as “single piece” ostomy appliances. In single piece ostomy appliances, the ostomy bag is not intended to be detached from the baseplate. In some examples, the ostomy appliance 1000 may be a single piece ostomy appliance.Use

[0254] Use of the assembly 100 and ostomy appliance 1000 will now be described, with particular reference to Figs. 1, 3, 4A and 4B.

[0255] The ostomy appliance 1000 may be assembled by attaching the assembly 100 to the baseplate 200 (e.g. the proximal surface 201), and attaching the ostomy bag 300 to the baseplate 200 (e.g. the distal surface 202). The assembly 100 may be attached to the baseplate 200 before or after the ostomy bag 200 is attached to the baseplate. The ostomy appliance 1000 may be secured around the stoma of an ostomate, by attaching (e.g. adhering) the skin-engageable surface 103 of the assembly 100 to the skin (e.g. the peristomal skin) of the ostomate. The skin-engageable surface 103 may be attached to the skin before or after the assembly 100 is attached to the baseplate 200. The skin-engageable surface 103 may be attached to the skin before or after the ostomy bag 300 is attached to the baseplate 200.[0256[ Naturally, the skin (e.g. the peristomal skin) generates perspiration. It is understood that moisture from the perspiration is absorbed by the one or more hydrocolloids in the continuous portion, such that the hydrocolloids swell and increase in size. This is schematically illustrated in Fig. 4A, in which the hydrocolloids prior to contact with moisture from perspiration are indicated by numeral 500, and the swollen hydrocolloids are indicated by numeral 501. The moisture is advantageously distributed in the continuous portion 102 so as not to cause the electrodes 107, 108 to falsely detect a stomal waste leak.

[0257] By contrast, when stomal waste is located between the skin (e.g. the peristomal skin) and the continuous portion 102, liquid from the stomal waste is absorbed by the hydrocolloids, whereupon the hydrocolloids swell and increase in size. This is schematically illustrated in Fig. 4B, in which the hydrocolloids prior to contact with stomal waste are indicated by numeral 500, and the swollen hydrocolloids are indicated by numeral 501. Due to the increased concentration of liquid in the continuous portion 102 adjacent to the electrodes 107, 108, the electrodes 107, 108 detect a change in an electrical property (e.g. voltage) indicative of the stomal waste leak.

[0258] Having detected the stomal waste leak, the ostomy appliance 1000 may generate a notification (e.g. a sound and / or a message) that informs the ostomate and / or a healthcare worker of the stomal waste leak and advises them to replace the ostomy appliance 1000.

[0259] According to a third aspect of the present disclosure there is provided use of an adhesive layer 101 to monitor for a stomal waste leak in an ostomy appliance 1000, the adhesive layer 101 comprising a continuous portion 102 having a skin-engageable surface 103 and a distal surface 104, wherein the continuous portion 102 has a thickness of at least about 200 pm, the continuous portion102 being made of an adhesive composition comprising one or more pressure sensitive adhesives and one or more hydrocolloids, wherein: the adhesive composition has a water absorption at 30 minutes of at least about 0.05 g / cm2; and / or the one or more hydrocolloids are present in an amount of at least about 30 wt.% based on the weight of the adhesive composition.

[0260] According to a fourth aspect of the present disclosure there is provided use of an assembly 100 according to the first aspect of the present disclosure to monitor for a stomal waste leak in an ostomy appliance.

[0261] According to a fifth aspect of the present disclosure there is provided use of an ostomy appliance 1000 according to the second aspect of the present disclosure to monitor for a stomal waste leak in the ostomy appliance.

[0262] The stomal waste leak may occur between the skin-engageable surface 103 of the assembly 100 and the skin 2000 of an ostomate, in use. The stomal waste leak is as defined herein.Methods

[0263] According to a sixth aspect of the present disclosure there is provided a method of manufacturing an assembly 100 according to the first aspect of the present disclosure, the method comprising: providing an adhesive layer 101 comprising a continuous portion 102 having a skin-engageable surface 103 and a distal surface 104, wherein the continuous portion 102 has a thickness of at least about 200 pm, the continuous portion 102 being made of an adhesive composition comprising a blend of one or more pressure sensitive adhesive polymers and one or more hydrocolloids, wherein: the adhesive composition has a water absorption at 30 minutes of at least about 0.05 g / cm2, and / or the hydrocolloids are present in an amount of at least about 30 wt.% based on the weight of the adhesive composition; and providing an electrode arrangement 105 comprising at least one electrode pair 106; and arranging each electrode 107, 108 to contact the continuous portion 102, such that the continuous portion 102 extends at least from the respective electrode 107, 108 to the skin-engageable surface 103.

[0264] The adhesive layer 101 and features thereof, and the electrode arrangement 105 and features thereof, may be as defined herein.

[0265] According to a seventh aspect of the present disclosure there is provided a method of manufacturing an ostomy appliance 1000 according to the second aspect of the present disclosure, the method comprising: providing an providing an adhesive layer 101 comprising a continuous portion 102 having a skin- engageable surface 103 and a distal surface 104, wherein the continuous portion 102 has a thickness of at least about 200 pm, the continuous portion 102 being made of an adhesive composition comprising a blend of one or more pressure sensitive adhesive polymers and one or more hydrocolloids, wherein: the adhesive composition has a water absorption at 30 minutes of at least about 0.05 g / cm2, and / or the hydrocolloids are present in an amount of at least about 30 wt.% based on the weight of the adhesive composition; and providing an electrode arrangement 105 comprising at least one electrode pair 106; providing a baseplate 200; optionally providing an ostomy bag 300; arranging each electrode 107, 108 to contact the continuous portion 102, such that the continuous portion 102 extends at least from the respective electrode 107, 108 to the skin-engageable surface 103, thereby to form an assembly 100; attaching the baseplate 200 to the assembly 100; and optionally attaching the ostomy bag 300 to the baseplate 200.

[0266] The assembly 100, the electrode arrangement 105, the baseplate 200, and the ostomy bag 300, may be as defined herein.Kit

[0267] According to an eighth aspect of the present disclosure there is provided a kit of parts comprising: the assembly 100 according to the first aspect of the present disclosure; the baseplate 200; and a set of instructions.]0268[ The kit of parts may comprise an ostomy bag 300.

[0269] The set of instructions may comprise instructions on how to assemble the assembly 100 and the baseplate 200 (and optionally the ostomy bag 300) to form the ostomy appliance 1000. The instructions may alternatively or additionally comprise instructions on how to use the assembly 100 and / or the baseplate 200 and / or the ostomy appliance 1000.

[0270] The assembly 100, the baseplate, the ostomy bag 300, and the ostomy appliance, may be as defined herein.Experimental

[0271] Continuous portions 102, Al to F2, according to Table I and II below were prepared.

[0272] The thickness Li of each of the continuous portions 102 was measured as described herein.

[0273] The water absorption at 30 minutes of each of the adhesive compositions A to F from which the continuous portions 102 were made was measured as described herein. This included:1. providing a dry sample of the adhesive composition having a length of 25 mm, a width of 25 mm, and a thickness of 1 mm (the dry sample defining a square outer perimeter);2. attaching one of the two surfaces of the sample to an impermeable (e.g. polystyrene) plate (e.g. using double-sided tape), such that the plate seals said surface from liquid ingress;3. immersing the sample attached to the plate in 300 ml to 400 ml (an excess) of 0.9 wt.% NaCl solution (aq.) held at a temperature of 32 °C (such that the sample is fully submerged);4. weighing the sample, having immersed the sample for 30 minutes, and recording said weight (Ww) in g;5. drying the sample to remove the water from the sample (e.g. using an oven);6. weighing the dried sample, and recording said weight (WD) in g; and7. calculating the water absorption in g / cm2(e.g. (Ww - WD) / 0.625).

[0274] Table I below shows the thickness Li, the water absorption at 30 minutes, and the penetration time Tp, for each of the continuous portions 102. The data in Table I is graphically illustrated in Fig. 12.

[0275] Table I

[0276] Table II

[0277] “Polyisobutylene (medium MW)” was polyisobutylene having a weight average molecular weight of 70 000 g / mol, a dispersity of 3.2, and a Staudinger Index of 34.5 to 39.0 cm3 / g.

[0278] “Polyisobutylene (high MW) wt. %” was polyisobutylene having a weight average molecular weight of 1 050 000 g / mol, a dispersity of 2.4, and a Staudinger Index of 178 to 236 cm3 / g.

[0279] The butyl rubber had a weight average molecular weight of about 425 000 g / mol and a dispersity of about 3.3.

[0280] The weight average molecular weight may be determined by gel permeation chromatography. For example, the weight average molecular weight of a sample may be determined using a Waters Alliance 2695 system and a Styragel HR 5E mixed bed column with a 2K - 4M range. Determining the weight average molecular weight of a sample may include dissolving the sample (5 mg) in tetrahydrofuran (3 mb) at room temperature to provide a sample solution; filtering the sample solution through a 0.1 pm filter; and calculating the weight average molecular weight using a polystyrene standard. In the dissolving step, the sample may be left in tetrahydrofiiran overnight (e.g. for at least 12 hours) at room temperature (e.g. approximately 20°C). Each sample may be tested in triplicate.

[0281] The dispersity may be determined using the following formula:wherein D is the dispersity, Mwis the weight average molecular weight, and Mnis the number average molecular weight.

[0282] The number average molecular weight may be determined by gel permeation chromatography. For example, the number average molecular weight of a sample may be determined using a Waters Alliance 2695 system and a Styragel HR 5E mixed bed column with a 2K - 4M range. Determining the number average molecular weight of a sample may include dissolving the sample (5 mg) in tetrahydrofuran (3 mb) at room temperature to provide a sample solution; fdtering the sample solution through a 0.1 pm fdter; and calculating the number average molecular weight using a polystyrene standard. In the dissolving step, the sample may be left in tetrahydrofuran overnight (e.g. for at least 12 hours) at room temperature (e.g. approximately 20°C). Each sample may be tested in triplicate.

[0283] The Staudinger Index may be calculated in various ways. For example, the Staudinger Index may be calculated at 20°C using an Ubbelohde viscometer and isooctane as a solvent.

[0284] Weight percent (“wt. %”) is based on the total mass of the adhesive composition.

[0285] The tackifier was a rosin.

[0286] The antioxidant was a phenolic antioxidant.Electrode Sensitivity

[0287] The continuous portions 102 were subjected to electrode sensitivity testing. This included:(A) contacting the distal surface 104 of the continuous portion 102 with an electrode pair 107, 108 of an electrode arrangement 106;(B) contacting the skin-engageable surface 103 of the continuous portion 102 having the electrode pair 107, 108 in contact with the distal surface 104, with a quantity of water indicative of moisture from perspiration; specifically, this included: creating an plastic (e.g. polyethylene) cover with a square outer perimeter of 1.5 cm by 1.5 cm; arranging the continuous portion 102 such that the skin-engageable surface 103 faced vertically upwards; depositing 22.5 pL of water onto the skin-engageable surface 103 (e.g. using a micropipette); and moving the cover over the continuous portion 102, such that the skin-engageable surface 103 and the inner bottom surface of the cover were face-to-face, so as to distribute thewater over the skin-engageable surface 103, and such that the continuous portion 102 was exposed to 10 pL / cm2of water;(C) determining whether and to what extent the electrode pair 107, 108 detected the presence of the water; specifically, this included monitoring the voltage across the electrode pair 107, 108 over time.

[0288] The present inventors have identified that a stomal waste leak is typically characterised by a voltage decrease from the original voltage (i.e. the voltage across the dry continuous portion 102 in step (A), prior to the contacting step (B)) of at least 50%.

[0289] The present inventors observed that for continuous portions 102 having a thickness Li of less than about 200 pm, the electrode sensitivity testing resulted in the electrode pair 107, 108 rapidly detecting the presence of water, with the voltage measured across the electrode pair 107, 108 decreasing by at least 50% of the original voltage. Such a result indicated that moisture from perspiration can cause the electrode arrangement 105 to falsely detect the presence of a stomal waste leak.

[0290] The present inventors observed improved performance for continuous portions 102 having a thickness Li of greater than about 200 pm. The electrode sensitivity testing of these continuous portions 102 typically did not result in a voltage decrease from the original voltage across the electrode pair 107, 108, or resulted in a modest (less than 50%) voltage decrease from the original voltage across the electrode pair 107, 108.

[0291] The present inventors observed further improved performance for continuous portions 102 having a thickness Li of greater than about 250 pm. The electrode sensitivity testing of these continuous portions 102 typically did not result in a voltage decrease from the original voltage across the electrode pair 107, 108.Penetration Time

[0292] The continuous portions 102 were subjected to penetration time testing.

[0293] Penetration time Tp provides a useful indication as to the responsiveness of the continuous portion 102 to a stomal waste leak. A low Tpmeans that water slowly travels through the continuous portion 102 and therefore a substantial amount of time may pass before the electrodes 107, 108 detect the presence of a stomal waste leak (which ultimately may progress to an external stomal waste leak). By contrast, a high Tpmeans that water rapidly travels through the continuous portion 102 and therefore the electrodes 107, 108 rapidly detect the presence of a stomal waste leak.

[0294] The penetration time testing included:(A) contacting the distal surface 104 of the continuous portion 102 with an electrode pair 107, 108 of an electrode arrangement 106;(B) contacting the skin-engageable surface 103 of the continuous portion 102 having the electrode pair 107, 108 in contact with the distal surface 104, with a quantity of water indicative of a stomal waste leak; specifically, this included: arranging the continuous portion 102 such that the skin-engageable surface 103 faced vertically upwards; depositing a quantity of water onto the skin-engageable surface 103 to substantially cover the skin-engageable surface 103 with water, without water flowing over the sides of the skin-engageable surface 103; and repeating the depositing step such that the skin-engageable surface 103 was substantially covered with water, without water flowing over the sides of the skin-engageable surface 103, throughout the testing;(C) determining the time taken for the voltage measured across the electrode pair 107, 108 to decrease by at least 50 %, the time being measured from the first depositing of water onto the skin-engageable surface.

[0295] For ostomy applications, the present inventors found that a Tpof less than 45 minutes was preferable, less than 25 minutes was more preferable, and less than 20 minutes was most preferable.

[0296] The present inventors have therefore developed assemblies 100 and ostomy appliances 1000 that facilitate effective and reliable detection of a stomal waste leak, and that are less susceptible to false detection due to moisture from perspiration (or other liquid in trace amounts).

[0297] Although illustrative teachings of the disclosure have been described in detail herein with reference to the accompanying drawings, it is to be understood that the invention is not limited to those precise teachings, and that various changes and modifications can be effected therein by one skilled in the art without departing from the scope and spirit of the invention as defined by the appended claims.

Claims

CLAIMS1. An assembly for use as part of an ostomy appliance, the assembly comprising: an adhesive layer comprising a continuous portion having a skin-engageable surface and a distal surface, wherein the continuous portion has a thickness of at least about 200 pm, the continuous portion being made of an adhesive composition comprising a blend of one or more pressure sensitive adhesive polymers and one or more hydrocolloids, wherein: the adhesive composition has a water absorption at 30 minutes of at least about 0.05 g / cm2, and / or the one or more hydrocolloids are present in an amount of at least about 30 wt.% based on the weight of the adhesive composition; and an electrode arrangement comprising at least one electrode pair, wherein each electrode contacts the continuous portion, the continuous portion extending at least from the respective electrode to the skin-engageable surface.

2. The assembly according to claim 1, wherein the thickness of the continuous portion is from about 200 pm to about 700 pm.

3. The assembly according to claim 1 or 2, wherein the thickness of the continuous portion is from about 250 pm to about 450 pm.

4. The assembly according to any one of claims 1 to 3, wherein the water absorption at 30 minutes of the adhesive composition is at least about 0.10 g / cm2.

5. The assembly according to any one of claims 1 to 4, wherein the water absorption at 30 minutes of the adhesive composition is at least about 0.14 g / cm2.

6. The assembly according to any one of claims 1 to 5, wherein the one or more hydrocolloids are present in an amount of at least about 40 wt.% based on the total weight of the adhesive composition.

7. The assembly according to any one of claims 1 to 6, wherein the one or more hydrocolloids are present in an amount of at least about 50 wt.% based on the total weight of the adhesive composition.

8. The assembly according to any one of claims 1 to 7, wherein the one or more hydrocolloids are selected from the group comprising polyacrylic acid, polyvinyl alcohol, gelatine, pectin, alginate, starch, modified starch, natural vegetable gum, cellulose, a cellulose derivative, an alkali metal salt of a cellulose derivative, pectin, gelatin, and a combination thereof.

9. The assembly according to any one of claims 1 to 8, wherein the one or more hydrocolloids are selected from the group comprising polyacrylic acid, cellulose, a cellulose derivative, an alkali metal salt of a cellulose derivative, pectin, gelatin, and a combination thereof.

10. The assembly according to any one of claims 1 to 9, wherein the one or more hydrocolloids are selected from the group comprising a cellulose derivative, an alkali metal salt of a cellulose derivative, pectin, gelatin, and a combination thereof.

11. The assembly according to any one of claims 1 to 10, wherein the one or more hydrocolloids are selected from the group comprising an alkali metal salt of a cellulose derivative, pectin, gelatin, and a combination thereof, wherein the alkali metal salt of the cellulose derivative is sodium carboxymethyl cellulose.

12. The assembly according to any one of claims 1 to 11, wherein the one or more pressure sensitive adhesive polymers comprise one or more thermoplastic materials selected from the group comprising polyalkene, styrene copolymer, butyl rubber, and a combination thereof, preferably wherein the polyalkene is polyisobutylene.

13. The assembly according to claim 12, wherein the mass fraction of polyalkene based on the total mass of the one or more pressure sensitive adhesive polymers is at least about 50 %.

14. The assembly according to any one of claims 1 to 13, wherein the adhesive composition comprises a styrene copolymer in an amount of no greater than about 30 wt.%, based on the total weight of the adhesive composition.

15. The assembly according to any one of claims 1 to 14, wherein the adhesive composition does not comprise a styrene copolymer.

16. The assembly according to any one of claims 1 to 15, wherein the adhesive composition comprises butyl rubber in an amount of no greater than about 30 wt.%, based on the total weight of the adhesive composition.

17. The assembly according to any one of claims 1 to 16, wherein the adhesive composition does not comprise butyl rubber.

18. The assembly according to any one of claims 1 to 17, wherein the thickness of the continuous portion comprises at least a first thickness Li and a second thickness L2, the second thickness L2 being greater than the thickness Li, wherein each electrode contacts a part of the continuous portion having the first thickness Li.

19. The assembly according to any one of claims 1 to 18, wherein the assembly comprises one or more further adhesive layers, wherein the or each further adhesive layer is made of an adhesive composition.

20. The assembly according to any one of claims 1 to 19, wherein the or each electrode pair is provided such that liquid can flow between the pair of electrodes of the or each electrode pair and / or around the or each respective electrode pair.

21. The assembly according to any one of claims 1 to 20, wherein the at least one electrode pair may be arranged in use to receive an alternating electrical signal and provide an output signal in response to applying the alternating electrical signal to the continuous portion, the output signal indicative of an electrical property of the continuous portion.

22. The assembly according to claim 21, wherein the electrical property comprises an impedance of the continuous portion between the electrodes of the or each electrode pair.

23. The assembly according to any one of claims 1 to 22, wherein the thickness of the continuous portion is from about 250 pm to about 450 pm, and wherein the one or more hydrocolloids are present in an amount of at least about 40 wt.% based on the total weight of the adhesive composition.

24. The assembly according to claim 23, wherein the one or more hydrocolloids are selected from the group comprising an alkali metal salt of a cellulose derivative, pectin, gelatin, and a combination thereof, wherein the alkali metal salt of the cellulose derivative is sodium carboxymethyl cellulose.

25. The assembly according to claim 23 or 24, wherein: the adhesive composition comprises a styrene copolymer in an amount of no greater than about 30 wt.%, based on the total weight of the adhesive composition, or the adhesive composition does not comprise a styrene copolymer; andthe adhesive composition comprises butyl rubber in an amount of no greater than about 30 wt.%, based on the total weight of the adhesive composition, or the adhesive composition does not comprise butyl rubber.

26. The assembly according to any one of claims 23 to 25, wherein the continuous portion radially extends from a first location to a second location, the first location being radially inward of the at least one electrode pair and the second location being radially outward of the at least one electrode pair.

27. An ostomy appliance comprising: the assembly according to any one of claims 1 to 26; a baseplate, wherein the baseplate is configured to attach to the assembly.

28. Use of an adhesive layer to monitor for a stomal waste leak in an ostomy appliance, the adhesive layer comprising a continuous portion having a skin-engageable surface and a distal surface, wherein the continuous portion has a thickness of at least about 200 pm, the continuous portion being made of an adhesive composition comprising one or more pressure sensitive adhesives and one or more hydrocolloids, wherein: the adhesive composition has a water absorption at 30 minutes of at least about 0.05 g / cm2; and / or the one or more hydrocolloids are present in an amount of at least about 30 wt.% based on the weight of the adhesive composition.

29. The use according to claim 28, wherein the ostomy appliance is defined according to claim27.

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