Stoma Sensor Patch

Abstract

A sensor patch (50) for attachment to a base plate of an ostomy appliance, and a method for manufacturing such a sensor patch are disclosed. The sensor patch has a proximal side and a distal side. The distal side is adapted to be attached to an adhesive surface of the base plate, wherein the adhesive surface of the base plate is adapted to attach the base plate to a skin surface of a user. The sensor patch includes: a sensor assembly (204), the sensor assembly including a plurality of electrodes (216); and a first adhesive sensor layer (52), the first adhesive sensor layer forming the proximal side of the sensor patch and adapted to attach the sensor patch to the skin surface of the user. The first adhesive sensor layer includes a first central portion (62) having a first central thickness and a first peripheral portion (64) surrounding the first central portion. The first peripheral portion has a first peripheral thickness that decreases in a radial direction from adjacent to the first central portion to a first outer periphery of the first adhesive sensor layer.

Description

[0001] The present disclosure relates to a sensor patch for attachment to a base plate of an ostomy appliance. In particular, the present disclosure relates to the thickness of such a sensor patch. Background Art

[0002] Stoma discharge often contains body fluids and visceral contents that are aggressive to both the user's skin and the ostomy appliance, which have a detrimental effect on the efficiency and integrity of the adhesive material used to attach the ostomy appliance to the user's skin surface. For the average user, there is clearly a great need for safe, reliable and efficient ostomy appliances.

[0003] However, the main and lasting concern of a large number of ostomists is still the failure of the base plate adhesive that attaches the ostomy appliance to the skin surface of the user, because such failure almost inevitably leads to embarrassing and shameful leakage events. It is known from several user interviews that such events then lead to a decline in the quality of life. The adhesive failure of the base plate adhesive may be caused by different reasons. The most common is, for example, due to the poor attachment of the base plate to the skin caused by the uneven skin surface or skin folds, the leakage event caused by the stoma discharge entering the proximal surface of the base plate and the skin of the user. This undesirable progress of the stoma discharge "below" the adhesive causes the deterioration and / or weakening of the adhesive material that bears the weight and provides the seal of the ostomy appliance. Usually, such failure can occur unexpectedly quickly, and can only be detected by the user when the failure has become so serious that leakage occurs, thereby requiring the ostomy appliance to be replaced immediately and possibly the user's clothes.

[0004] In other instances, the primary factor in adhesive failure is simply a matter of how much time has passed since the base plate of the ostomy appliance was first applied to the skin surface of the user. In addition to the discharge from the stoma itself, the peristomal skin surface also constantly secretes some moisture (e.g., sweat). To mitigate this, the base plate adhesive of the ostomy device most commonly includes a hydrocolloid material that is capable of absorbing high levels of moisture, thereby stabilizing the polymer matrix of the adhesive material and extending the useful life ("wear time") of the base plate. However, eventually the adhesive properties of the base plate are no longer able to support the forces exerted on the base plate by the load of the discharge collection bag, and the appliance must be replaced.

[0005] Because there can be considerable variability in the severity and / or speed with which adhesive failures and potential leaks occur, which variability is at least in part related to a variety of factors, including those described above, a mere indication that a failure or leak is about to occur, or that a failure or leak has already occurred, does not provide a reliable and satisfactory solution to the problem of avoiding unexpected embarrassing and shameful ostomy appliance leaking events. In other words, users of ostomy appliances could greatly benefit from appliance solutions that provide users with better guidance and options about how, and especially how quickly, to respond to the onset of adhesive failure or leaking of the base plate of an appliance. More generally, ostomates and healthcare professionals would appreciate improvements in ostomy devices that reduce or eliminate the occurrence of unexpected leaking events. Summary of the invention

[0006] It is an object of the present disclosure to provide a sensor patch and base plate for facilitating reliable and / or improved detection of risk of failure of ostomy appliances and / or improved detection of risk of leakage. The disclosed sensor patch and base plate may be provided to facilitate detection of risk of failure and / or risk of leakage with respect to an adhesive base plate of an ostomy appliance.

[0007] Another object of the present disclosure is to provide a way to facilitate attaching a sensor patch to an ostomy appliance, such as a base plate of an ostomy appliance, which reduces the risk of compromising the ability of the ostomy appliance to avoid leakage, especially leakage between the skin surface of the user and the adhesive surface of the base plate. Specifically, an object of the present disclosure is to reduce the edge of the sensor patch so that the transition from the adhesive surface of the base plate to the adhesive surface of the sensor patch attached to the base plate is as smooth as possible. In other words, an object of the present disclosure is to reduce the edge formed between the adhesive surface of the base plate and the sensor patch attached to the adhesive surface. Specifically, it is envisioned that the presence of such an edge may adversely affect the quality of the adhesion of the base plate / sensor patch to the skin surface of the user, and therefore, the goal is to reduce such an edge.

[0008] Thus, the present disclosure relates to a sensor patch and a method for manufacturing a sensor patch.Furthermore, the present disclosure relates to a base plate of an ostomy appliance.

[0009] Accordingly, a sensor patch for attachment to a base plate of an ostomy appliance is disclosed. The sensor patch has a proximal side and a distal side. The distal side is adapted to be attached to an adhesive surface of the base plate, wherein the adhesive surface of the base plate is adapted to attach the base plate to a skin surface of a user.

[0010] The sensor patch includes: a sensor assembly including a plurality of electrodes including a first electrode and a second electrode for forming a first sensor; and a first adhesive sensor layer forming a proximal side of the sensor patch and adapted to attach the sensor patch to the skin surface of the user. The first adhesive sensor layer includes a first central portion having a first central thickness and a first peripheral portion surrounding the first central portion. The first peripheral portion has a first peripheral thickness that decreases in a radial direction from adjacent to the first central portion to a first outer periphery of the first adhesive sensor layer. The first peripheral thickness adjacent to the central portion is the first central thickness, and the first peripheral thickness at the first outer periphery of the first adhesive sensor layer is a first minimum peripheral thickness.

[0011] The sensor patch is adapted to form a stoma opening having a central point. The stoma opening is configured to allow discharge to pass through the stoma opening and into an ostomy bag attached to the base plate.

[0012] A sensor patch having a beveled edge is thereby provided, thereby providing a smooth transition between a base plate and a sensor patch attached to the base plate. A sensor patch having a beveled edge can reduce potential adverse effects of attaching the sensor patch to an adhesive surface of the base plate, such as the effect that the attached sensor patch may have on the quality of adhesion to the skin surface.

[0013] Also disclosed is a method for manufacturing a sensor patch such as the sensor patch disclosed above, such as a sensor patch having a proximal side and a distal side and adapted to attach the distal side to an adhesive surface of a base plate of an ostomy appliance, wherein the adhesive surface of the base plate is adapted to attach the base plate to a skin surface of a user.

[0014] The method includes setting a first adhesive sensor material and laying down a first adhesive sensor material layer for forming a first adhesive sensor layer of the sensor patch, wherein the first adhesive sensor material is laid down to form a first center portion and a first outer edge portion surrounding the first center portion, wherein the first center portion has a first center thickness and the first outer edge portion has a first outer edge thickness that gradually decreases along a radial direction from adjacent to the first center portion to a first outer periphery of the first adhesive sensor layer, and wherein the first outer edge thickness adjacent to the first center portion is the first center thickness and the first outer edge thickness at the first outer periphery of the first adhesive sensor layer is a first minimum outer edge thickness.

[0015] The method includes providing a sensor assembly including a plurality of electrodes including a first electrode and a second electrode for forming a first sensor.

[0016] The method includes disposing the sensor assembly on a distal side of the first adhesive sensor layer, wherein a proximal side of the first adhesive sensor layer is adapted to attach the sensor patch to a skin surface of the user.

[0017] There is thereby provided a method for manufacturing a sensor patch having a chamfered edge that promotes a smooth transition between a base plate and a sensor patch attached to the base plate.

[0018] Also disclosed is a base plate of an ostomy appliance having a proximal adhesive surface adapted to attach the base plate to a skin surface of a user. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Embodiments of the present disclosure will be described in more detail below with respect to the accompanying drawings. The drawings illustrate one way of implementing the invention and should not be interpreted as limiting other possible embodiments that fall within the scope of the appended claims.

[0020] Figure 1 schematically illustrates an exploded view of an exemplary base plate,

[0021] Figure 2 schematically illustrates an exploded view of an exemplary sensor patch,

[0022] Figure 3 An exemplary electrode configuration is schematically shown,

[0023] Figure 4 is a schematic diagram showing a cross section of a sensor patch, and

[0024] Figure 5 is a schematic block diagram of an exemplary method. DETAILED DESCRIPTION

[0025] In the following specific embodiments, reference is made to the accompanying drawings, which form a part of the specific embodiments, and wherein the specific embodiments of the present invention can be put into practice by way of illustration. In this regard, with respect to the orientation of the (multiple) accompanying drawings described, directional terms are used, such as "top", "bottom", "front", "back", "leading", "back" etc. Because the parts of the embodiments can be positioned in a plurality of different orientations, directional terms are used for illustrative purposes and are by no means restrictive. It should be understood that other embodiments can be utilized without departing from the scope of the present invention, and structural or logical changes can be made. Therefore the following specific embodiments should not be considered as restrictive, and the scope of the present invention is limited by the appended claims.

[0026] It should be understood that the features of the various exemplary embodiments described herein may be combined with each other, unless specifically stated otherwise.

[0027] Throughout this disclosure, the words "stoma" and "ostomy" are used to represent an opening formed by surgery to bypass the intestinal or urinary tract system of a person. These words are used interchangeably and do not have distinct meanings. The same applies to any words or phrases derived from these words, such as "stoma", "ostomy", etc. In addition, solid and liquid waste coming out of the stoma can be interchangeably referred to as stoma "discharge", "waste" and "fluid". The subject undergoing ostomy surgery can be referred to as a "stoma person" or "ostomy person", in addition, also referred to as a "patient" or "user". However, in some cases, a "user" may also relate to or refer to a health care professional (HCP), such as a surgeon or ostomy care nurse or other person. In these cases, it will be explicitly stated or implied from the context that the "user" is not the "patient" himself or herself.

[0028] In the following, whenever the proximal side of a device or a part of a device is mentioned, reference is made to the side that faces the skin when the ostomy appliance is worn by a user. Likewise, whenever the distal side of a device or a part of a device is mentioned, reference is made to the side that faces away from the skin when the ostomy appliance is worn by a user. In other words, the proximal side is the side that is closest to the user when the appliance is fitted to the user, and the distal side is the opposite side, i.e. the side that is farthest from the user during use.

[0029] The axial direction is defined as the direction of the stoma when the user wears the appliance. Thus, the axial direction is generally perpendicular to the user's skin or abdominal surface.

[0030] The radial direction is defined as being transverse to the axial direction which is transverse to the stoma direction, i.e. "across" the distal / proximal surface of the base plate. In some statements, the words "inner" and "outer" may be used. These qualifiers should generally be understood with reference to the radial direction, so that a reference to an "outer" element means that the element is further away from the central part of the ostomy appliance than the element referred to as "inner". Furthermore, "innermost" should be interpreted as that part of a component forming the center of the component and / or adjacent to the center of the component. Similarly, "outermost" should be interpreted as that part of a component forming the outer edge or outer contour of the component and / or adjacent to the outer edge or outer contour.

[0031] The present disclosure uses the word “substantially” as a modifier of certain features or effects and is intended to simply mean that any deviation is within the tolerance normally expected by those skilled in the relevant art.

[0032] The use of the word "substantially" as a modifier of certain features or effects in this disclosure is intended only to mean that: for structural features, a majority or predominant portion of this feature exhibits the property in question, and for functional features or effects: most results involving the property provide the effect, but abnormal results do not provide the effect.

[0033] The word "substantially" is used in this disclosure as a modifier of certain structural and functional features or effects to emphasize what is the most important focus of something or a fact about something (i.e., a feature may have or satisfy multiple effects, but when this disclosure discusses one effect as "substantially" provided, that is the focal and most important effect relevant to this disclosure).

[0034] Throughout this disclosure, the use of the terms "first," "second," "third," and "fourth," "primary," "secondary," "tertiary," etc. does not imply any particular order or importance, but is included merely to identify independent elements. Furthermore, labeling a first element does not imply the existence of a second element, and vice versa.

[0035] A sensor patch for attachment to a base plate of an ostomy appliance is disclosed. Such as to facilitate detection of moisture propagation in an adhesive material arranged to attach the base plate to a user's skin surface and to detect an increased risk of leakage. For example, the sensor patch may allow electronic measurement of the properties of the base plate and / or facilitate detection of an increase in the risk of leakage and / or facilitate detection of a decrease in adhesion of the base plate to the user's skin.

[0036] The ostomy appliance comprises a base plate and an ostomy bag (also referred to as an ostomy pocket). The ostomy appliance may be a colostomy appliance, an ileostomy appliance or a urethrostomy appliance. The ostomy appliance may be a two-piece ostomy appliance, i.e., the base plate and the ostomy bag may be releasably connected, for example, by mechanical and / or adhesive connection, such as to allow one base plate to be used (exchanged) with a plurality of ostomy bags. For example, the base plate may include a coupling ring for connecting the ostomy bag to the base plate. Further, the two-piece ostomy appliance may facilitate the correct application of the base plate to the skin, such as to obtain an improved observation of the stoma area by the user. Alternatively, the ostomy appliance may be a one-piece ostomy appliance, i.e., the base plate and the ostomy bag may be securely attached to each other. The base plate is configured to be connected to the skin around the stoma and / or the stoma of the user, such as the peristomal skin area.

[0037] Base plate can comprise the first adhesive layer, i.e. the first adhesive material layer. During use, the proximal surface of the first adhesive layer adheres to the peri-stoma region of the skin of the user and / or adheres to an additional seal, such as a sealing paste, a sealing tape and / or a sealing ring. The first adhesive layer can be made of a first composition. The first composition can comprise one or more polyisobutylenes and / or styrene-isoprene-styrene. The first composition can comprise one or more hydrocolloids. The first composition can comprise one or more water-soluble or water-swellable hydrocolloids. The first composition can be a pressure-sensitive adhesive composition suitable for medical purposes, comprising a rubbery elastomeric substrate and one or more water-soluble or water-swellable hydrocolloids. The first adhesive layer can comprise a distal surface and a proximal surface. The proximal surface of the first adhesive layer can be configured to adhere to the skin of the user. The distal surface of the first adhesive layer can be configured to deviate from the skin of the user.

[0038] The first adhesive layer may form an adhesive surface of the base plate, which is adapted to attach the base plate to a user's skin surface. The first adhesive layer may form a portion of the adhesive surface of the base plate, which is adapted to attach the base plate to a user's skin surface.

[0039] The bottom plate may include a second adhesive layer, ie a second adhesive material layer, also referred to as an edge adhesive layer. The second adhesive layer may have an adhesive material different from that of the first adhesive layer.

[0040] The second adhesive layer can be made of the second composition. The second composition can include one or more polyisobutylenes and / or styrene-isoprene-styrene. The second composition can include one or more hydrocolloids. The second composition can include one or more water-soluble or water-swellable hydrocolloids. The second composition can be a pressure-sensitive adhesive composition suitable for medical purposes, including a rubbery elastomeric substrate and one or more water-soluble or water-swellable hydrocolloids.

[0041] The second adhesive layer can include a distal surface and a proximal surface. The proximal surface of the second adhesive layer can be configured to adhere to the skin of the user, for example, at least at the marginal portion of the second adhesive layer. The distal surface of the second adhesive layer can be configured to deviate from the skin of the user. The second adhesive layer can cover an area larger than the first adhesive layer, for example, so that the proximal surface of the second adhesive layer forms an adhesive edge around the first adhesive layer.

[0042] The different ratios of inclusions can change the properties of the first adhesive layer and / or the second adhesive layer. The second adhesive layer and the first adhesive layer can have different properties. The second adhesive layer (second composition) and the first adhesive layer (first composition) can have polyisobutylene, styrene-isoprene-styrene, and / or hydrocolloids with different ratios. For example, compared with the attachment to skin provided by the first adhesive layer, the second adhesive layer can provide a stronger attachment to the skin. Alternatively or additionally, the second adhesive layer can be thinner than the first adhesive layer. Alternatively or additionally, the second adhesive layer can be less water-absorbent and / or sweat-absorbent than the first adhesive layer. Alternatively or additionally, the second adhesive layer can be lower in moldability than the first adhesive layer. The second adhesive layer can provide a second anti-leakage barrier.

[0043] The second adhesive layer may form a portion of the adhesive surface of the base plate, which is adapted to attach the base plate to the skin surface of the user. The first adhesive layer and the second adhesive layer may form the adhesive surface of the base plate, which is adapted to attach the base plate to the skin surface of the user.

[0044] The first adhesive layer and / or the second adhesive layer can include a center portion with a center thickness and an outer edge portion around the center portion. The outer edge portion can have, for example, an outer edge thickness that is reduced from the adjacent first center portion to the outer periphery of the first adhesive layer and / or the second adhesive layer in a radial direction. The outer edge thickness can be convex, concave or substantially linearly reduced from the adjacent center portion to the outer periphery in a radial direction. The outer edge thickness of the adjacent center portion can be a center thickness. The outer edge thickness at the outer periphery can be a minimum outer edge thickness. The center thickness can be between 0.5mm and 1.5mm. The minimum outer edge thickness can be less than 0.5mm, such as less than 0.4mm, such as less than 0.3mm, such as less than 0.1mm.

[0045] The first adhesive layer and / or the second adhesive layer can surround an opening, such as a stoma opening. The first adhesive layer and / or the second adhesive layer can have an inner edge portion surrounded by a central portion. The inner edge portion can have an inner edge thickness that increases from the inner periphery of the first adhesive layer and / or the second adhesive layer to the central portion in a radial direction. The inner edge thickness can be convex, concave or substantially linearly increased from the inner periphery to the central portion in a radial direction. The inner edge thickness adjacent to the central portion can be a central thickness. The inner edge thickness at the inner periphery can be a minimum inner edge thickness. The minimum inner edge thickness can be less than 0.5mm, such as less than 0.4mm, such as less than 0.3mm, such as less than 0.1mm.

[0046] Providing a base plate in which the adhesive (e.g., the first adhesive layer and / or the second adhesive layer) has a reduced outer edge and / or an increased inner edge promotes a smoother transition between the base plate and the user's skin at the edge of the base plate. Thereby, the risk of clothing adhering to the edge of the base plate and possibly peeling the base plate from the skin can be reduced. Therefore, the risk of leakage due to the base plate not being adequately adhered to the user's skin is reduced.

[0047] The base plate may include a release liner, and the user may peel off the release liner before the base plate is applied to the skin. The release liner may be configured to protect the adhesive layer before the base plate is applied to the skin. The release liner may include a distal surface and a proximal surface. The release liner may be configured to, for example, cover the proximal surface of the first adhesive layer and / or cover the proximal surface of the second adhesive layer before the base plate is applied to the skin, such as the proximal surface of the second adhesive layer that is not covered by the first adhesive layer. The distal surface of the release liner may be configured to, for example, face the proximal surface of the first adhesive layer and / or the proximal surface of the second adhesive layer before the base plate is applied to the skin, such as the proximal surface of the second adhesive layer that is not covered by the first adhesive layer.

[0048] The base plate can include a backing layer. The backing layer can be a protective layer that protects adhesive layer, such as the first adhesive layer and / or the second adhesive layer from external strain and stress during use. In addition, the backing layer can also cover adhesive layer, such as the first adhesive layer and / or the second adhesive layer, so that the adhesive layer does not adhere to the clothes worn on the base plate. The backing layer can include a distal surface and a proximal surface. The distal surface of the backing layer can be configured to turn away from the skin of the user. The proximal surface of the backing layer can face the second adhesive layer. The second adhesive layer can be arranged on the proximal surface of the backing layer.

[0049] The base plate may include a stoma opening. Each layer of the base plate may include a stoma opening for forming the stoma opening of the base plate together. The stoma opening may be arranged in the central portion of the base plate. The central portion of the base plate may surround the stoma opening. The stoma opening may be configured to receive the stoma of the user, and / or the stoma opening may be configured to allow discharge from the stoma to pass through the stoma opening, into an ostomy bag attached to the base plate. For example, the stoma opening may be configured to allow discharge to flow from the proximal side of the base plate to the distal side of the base plate. The size and / or shape of the stoma opening may typically be adjusted by the user or a nurse to adapt to the stoma of the user before applying the base plate.

[0050] A sensor patch according to the present disclosure is adapted to be attached to a base plate. For example, the sensor patch can be configured to be positioned between the user's skin and the proximal side of the base plate. For example, the sensor patch can be adapted to be attached to the first adhesive layer of the base plate. For example, the distal side of the sensor patch can be configured to face the proximal surface of the first adhesive layer of the base plate. For example, the distal side of the sensor patch, such as the sensor patch, can be configured to adhere to the proximal surface of the first adhesive layer of the base plate.

[0051] The sensor patch may include a stoma opening and / or the sensor patch may be adapted to form a stoma opening. As described below, each layer of the sensor patch may include a stoma opening and / or be adapted to form a stoma opening for jointly forming the stoma opening of the sensor patch. The stoma opening of the sensor patch may be configured to align with the stoma opening of the base plate, such as for jointly forming a stoma opening of a combined base plate and sensor patch. The size and / or shape of the stoma opening of the sensor patch may be adjusted by the user or nurse to accommodate the user's stoma before applying the sensor patch. The size and / or shape of the stoma opening of the sensor patch may be adjusted together with the adjustment of the stoma opening of the base plate, for example, after the sensor patch has been attached to the base plate. (Multiple) stoma openings may have a center point.

[0052] The sensor patch includes a sensor component. The sensor component may form a sensor component layer. The sensor component has a distal side and a proximal side. The sensor patch may be configured to be positioned on a base plate such that a distal surface of the sensor component is coupled to a proximal adhesive surface of the base plate.

[0053] The sensor assembly includes a plurality of electrodes. The plurality of electrodes include a first electrode and a second electrode for forming a first sensor. The plurality of electrodes may include a third electrode, a fourth electrode, a fifth electrode and / or a sixth electrode. The first electrode may be a common ground electrode. For example, the second sensor may be formed by the first electrode and the third electrode, the third sensor may be formed by the first electrode and the fourth electrode, the fourth electrode may be formed by the first electrode and the fifth electrode, and / or the fifth electrode may be formed by the first electrode and the sixth electrode. Each electrode may have a corresponding connection portion for connecting the electrode to a corresponding terminal element of the monitoring device.

[0054] The multiple electrodes are conductive and may include one or more of the following: metallic materials (e.g., silver, copper, gold, titanium, aluminum, stainless steel), ceramic materials (e.g., ITO), polymer materials (e.g., PEDOT, PANI, PPy), and carbonaceous materials (e.g., carbon black, carbon nanotubes, carbon fibers, graphene, graphite).

[0055] The plurality of electrodes may form a ring and / or an open ring. The open ring electrode(s) enable the arrangement of electrodes in few or a single electrode layer.

[0056] The sensor assembly may include, for example, a support layer having a proximal surface and a distal surface. The plurality of electrodes may be arranged, such as formed, on the proximal surface of the support layer, for example, the plurality of electrodes may be positioned on the proximal surface of the support layer.

[0057] The sensor assembly may include, for example, a shielding element having a proximal surface and a distal surface. The shielding element may be configured to electrically insulate at least a portion of the plurality of electrodes from a proximal layer, such as a first adhesive sensor layer. For example, the shielding element may cover or overlap a portion of the plurality of electrodes when viewed in an axial direction.

[0058] The sensor patch includes, for example, a first adhesive sensor layer having a proximal side and a distal side. The first adhesive sensor layer can be arranged on the proximal side of the sensor assembly. The first adhesive sensor layer, such as the proximal side of the first adhesive sensor layer, forms the proximal side of the sensor patch. The proximal side of the first adhesive sensor layer can be configured to adhere to the user's skin. Therefore, after being applied to the base plate, the combined base plate and the sensor patch can form an adhesive proximal surface configured to be applied to the user's skin surface. The first adhesive sensor layer can be made of a first adhesive sensor material, such as a first composition, a second composition, or a third composition. The third composition may include one or more polyisobutylenes and / or styrene-isoprene-styrene. The third composition may include one or more hydrocolloids. The third composition may include one or more water-soluble or water-swellable hydrocolloids. The third composition may be a pressure-sensitive adhesive composition suitable for medical purposes, including a rubbery elastomeric substrate and one or more water-soluble or water-swellable hydrocolloids.

[0059] The first bonding sensor layer includes a first central portion. The first central portion has a first central thickness. The first bonding sensor layer includes a first outer edge portion surrounding the first central portion. The first outer edge portion has a first outer edge thickness that decreases in a radial direction from adjacent to the first central portion to a first outer periphery of the first bonding sensor layer. The first outer edge thickness may decrease convexly, concavely, or substantially linearly in a radial direction from adjacent to the first central portion to a first outer periphery of the first bonding sensor layer. The first outer edge thickness adjacent to the first central portion is a first central thickness. The first outer edge thickness at the first outer periphery of the first bonding sensor layer is a first minimum outer edge thickness. The first central thickness may be between 0.5 mm and 1.5 mm. The first minimum outer edge thickness may be less than 0.5 mm, such as less than 0.4 mm, such as less than 0.3 mm, such as less than 0.1 mm. The radial distance from the center point to the first outer edge portion adjacent to the first central portion may be between 15 mm and 35 mm. The radial distance from the first outer edge portion adjacent to the first central portion to the first outer periphery of the first bonding sensor layer may be between 0.5 mm and 20 mm. The radial distance from the center point to the first outer periphery of the first adhesive sensor layer may be between 15.5 mm and 55 mm, such as between 20 mm and 45 mm, such as between 25 mm and 40 mm, such as between 30 mm and 35 mm.

[0060] A sensor patch, in particular a first adhesive sensor layer of the sensor patch, having a beveled edge is thereby provided, thereby providing a smooth transition between the adhesive surface of the base plate and the sensor patch attached to the adhesive surface. The smooth transition reduces potential adverse effects of attaching the sensor patch to the adhesive surface of the base plate. For example, the presence of an un-beveled edge may increase the risk of leakage from the base plate, for example due to insufficient adhesion to the skin surface, or increase the risk of skin irritation, for example due to the un-beveled edge irritating the skin.

[0061] The first adhesive sensor layer may surround an opening, such as a stoma opening and / or an opening larger than the stoma opening. The first adhesive sensor layer may have a first inner edge portion surrounded by a first central portion. The first inner edge portion may have a first inner edge thickness that increases from a first inner periphery of the first adhesive sensor layer to the first central portion in a radial direction. The first inner edge thickness may increase convexly, concavely, or substantially linearly from a first inner periphery of the first adhesive sensor layer to the first central portion in a radial direction. The first inner edge thickness adjacent to the first central portion may be a first central thickness. The first inner edge thickness at the first inner periphery of the first adhesive sensor layer may be a first minimum inner edge thickness. The first minimum inner edge thickness may be less than 0.5 mm, such as less than 0.4 mm, such as less than 0.3 mm, such as less than 0.1 mm. The radial distance from the center point to the first inner edge portion adjacent to the first central portion may be between 10 mm and 30 mm. The radial distance from the first inner periphery of the first adhesive sensor layer to the first central portion, such as the first central portion adjacent to the first inner edge portion, may be between 0.5 mm and 20 mm. The radial distance from the center point to the first center portion, such as the first center portion adjacent to the inner edge portion, can be between 10.5mm and 50mm, such as between 15mm and 40mm, such as between 20mm and 35mm, such as between 20mm and 30mm.

[0062] According to the above, in manufacturing the sensor patch, a first adhesive sensor material may be provided, and a first adhesive sensor material layer for forming a first adhesive sensor layer may be laid to form a first central portion, a first outer edge portion and / or a first inner edge portion.

[0063] The first adhesive sensor layer may include a hydrocolloid. The hydrocolloid arranged along the first outer periphery of the first adhesive sensor layer, such as the hydrocolloid arranged in the first outer edge portion, may have a first outer edge average particle size and / or a first outer edge maximum particle size. The hydrocolloid arranged in the first center portion may have a first center average particle size and / or a first center maximum particle size. The hydrocolloid arranged along the first inner periphery of the first adhesive sensor layer, such as the hydrocolloid arranged in the first inner edge portion, may have a first inner edge average particle size and / or a first inner edge maximum particle size. The average particle size of the hydrocolloid may be less than 0.2 mm, such as less than 0.1 mm. The maximum particle size of the hydrocolloid may be less than 0.3 mm, such as less than 0.2 mm, such as less than 0.1 mm. The first outer edge average particle size may be less than 0.2 mm, such as less than 0.1 mm. The first outer edge maximum particle size may be less than 0.3 mm, such as less than 0.2 mm, such as less than 0.1 mm. The first inner edge average particle size may be less than 0.2 mm, such as less than 0.1 mm. The first inner edge maximum particle size can be less than 0.3 mm, such as less than 0.2 mm, such as less than 0.1 mm. The first center average particle size can be less than 0.2 mm, such as less than 0.1 mm. The first center maximum particle size can be less than 0.3 mm, such as less than 0.2 mm, such as less than 0.1 mm.

[0064] The hydrocolloid can be arranged so that the first outer edge average / maximum particle size and / or the first inner edge average / maximum particle size are less than the center average / maximum particle size. For example, the first outer edge average / maximum particle size and / or the first inner edge average / maximum particle size can be less than half of the center average / maximum particle size. Alternatively, the first outer edge average / maximum particle size, the first inner edge average / maximum particle size and the center average / maximum particle size can be substantially the same.

[0065] The hydrocolloids may be sorted to achieve a smaller particle size, for example to allow a thinner outer perimeter and / or inner perimeter of the first adhesive sensor layer. Providing the first adhesive sensor material for forming the first adhesive sensor layer may include sorting the hydrocolloids of the first adhesive sensor material according to particle size. For example, sorting the hydrocolloids of the first adhesive sensor material may include sorting the hydrocolloids to achieve an average / maximum particle size of the hydrocolloids of less than 0.3 mm, such as less than 0.2 mm, such as less than 0.1 mm. Thus, despite the reduction in the thickness of the adhesive comprising the hydrocolloids, the properties of the hydrocolloids are retained. Alternatively or additionally, laying the first adhesive sensor material layer may include: laying a first adhesive sensor material layer for forming a first central portion, wherein the hydrocolloid has a first central average / maximum particle size; laying a first adhesive sensor material layer for forming a first outer edge portion, wherein the hydrocolloid has a first outer edge average / maximum particle size; and / or laying a first adhesive sensor material layer for forming a first inner edge portion, wherein the hydrocolloid has a first inner edge average / maximum particle size.

[0066] Laying down the first layer of adhesive sensor material for forming the first adhesive sensor layer may include extruding the first adhesive sensor layer. Alternatively or additionally, laying down the first layer of adhesive sensor material for forming the first adhesive sensor layer may include molding, such as injection molding, the first adhesive sensor layer. According to the above, the mold may have a non-planar surface that is shaped to provide the shape of the first outer edge, the first center portion and / or the first inner edge. Alternatively or additionally, according to the above, laying down the first layer of adhesive sensor material for forming the first adhesive sensor layer may include scraping the first adhesive sensor material onto a non-planar surface that is shaped to provide the contour of the first outer edge, the first center portion and / or the first inner edge, such as a distal surface of a first release liner or a proximal surface of a sensor assembly.

[0067] In an embodiment, the sensor patch includes, for example, a second adhesive sensor layer having a proximal side and a distal side. The second adhesive sensor layer can be arranged on the distal side of the sensor assembly. The distal side of the second adhesive sensor layer can be configured to adhere to the proximal surface of the base plate, such as the proximal surface of the first adhesive layer of the base plate. The second adhesive sensor layer can be made of a second adhesive sensor material, such as a first composition, a second composition, a third composition, or a fourth composition. The fourth composition may include one or more polyisobutylenes and / or styrene-isoprene-styrene. The fourth composition may include one or more hydrocolloids. The fourth composition may include one or more water-soluble or water-swellable hydrocolloids. The fourth composition may be a pressure-sensitive adhesive composition suitable for medical purposes, including a rubbery elastomeric substrate and one or more water-soluble or water-swellable hydrocolloids. The second adhesive sensor material may be the same as the first adhesive sensor material. When arranged on the distal side of the sensor assembly, the second adhesive sensor layer can provide a symmetrical sensor patch so that each side of the sensor patch can be adhered to the skin surface, or the second adhesive sensor layer can be used to encapsulate the sensor assembly.

[0068] The second bonding sensor layer may include a second center portion. The second center portion may have a second center thickness. The second bonding sensor layer may include a second outer edge portion surrounding the second center portion. The second outer edge portion may have a second outer edge thickness that decreases, for example, from adjacent to the second center portion to the second outer periphery of the second bonding sensor layer in a radial direction. The second outer edge thickness may decrease convexly, concavely, or substantially linearly from adjacent to the second center portion to the second outer periphery of the second bonding sensor layer in a radial direction. The second outer edge thickness adjacent to the second center portion may be a second center thickness. The second outer edge thickness at the second outer periphery of the second bonding sensor layer may be a second minimum outer edge thickness. The second center thickness may be between 0.5 mm and 1.5 mm. The second minimum outer edge thickness may be less than 0.5 mm, such as less than 0.4 mm, such as less than 0.3 mm, such as less than 0.1 mm. The radial distance from the center point to the second outer edge portion adjacent to the second center portion may be between 15 mm and 35 mm. The radial distance from the second outer edge portion adjacent to the second center portion to the second outer periphery of the second bonding sensor layer may be between 0.5 mm and 25 mm. The radial distance from the second center point to the second outer periphery of the second adhesive sensor layer may be between 15.5 mm and 60 mm, such as between 20 mm and 50 mm, such as between 25 mm and 40 mm, such as between 30 mm and 35 mm.

[0069] The second adhesive sensor layer may surround an opening, such as a stoma opening and / or an opening larger than the stoma opening. The second adhesive sensor layer may have a second inner edge portion surrounded by a second central portion. The second inner edge portion may have a second inner edge thickness that increases from the second inner periphery of the second adhesive sensor layer to the second central portion in a radial direction. The second inner edge thickness may increase convexly, concavely, or substantially linearly from the second inner periphery of the second adhesive sensor layer to the second central portion in a radial direction. The second inner edge thickness adjacent to the second central portion may be a second central thickness. The second inner edge thickness at the second inner periphery of the second adhesive sensor layer may be a second minimum inner edge thickness. The second minimum inner edge thickness may be less than 0.5 mm, such as less than 0.4 mm, such as less than 0.3 mm, such as less than 0.1 mm. The radial distance from the center point to the second inner edge portion adjacent to the second central portion may be between 10 mm and 30 mm. The radial distance from the second inner periphery of the second adhesive sensor layer to the second central portion, such as the second central portion adjacent to the second inner edge portion, may be between 0.5 mm and 20 mm. The radial distance from the center point to the second center portion, such as the second center portion adjacent to the second inner edge portion, can be between 10.5mm and 50mm, such as between 15mm and 40mm, such as between 20mm and 35mm, such as between 20mm and 30mm.

[0070] According to the above, in manufacturing the sensor patch, a second adhesive sensor material may be provided, and a second adhesive sensor material layer for forming a second adhesive sensor layer may be laid to form a second center portion, a second outer edge portion and / or a second inner edge portion.

[0071] The second adhesive sensor layer may include a hydrocolloid. The hydrocolloid arranged along the second outer periphery of the second adhesive sensor layer, such as the hydrocolloid arranged in the second outer edge portion, may have a second outer edge average particle size and / or a second outer edge maximum particle size. The hydrocolloid arranged in the second center portion may have a second center average particle size and / or a second center maximum particle size. The hydrocolloid arranged along the second inner periphery of the second adhesive sensor layer, such as the hydrocolloid arranged in the second inner edge portion, may have a second inner edge average particle size and / or a second inner edge maximum particle size. The average particle size of the hydrocolloid may be less than 0.2 mm, such as less than 0.1 mm. The maximum particle size of the hydrocolloid may be less than 0.3 mm, such as less than 0.2 mm, such as less than 0.1 mm. The second outer edge average particle size may be less than 0.2 mm, such as less than 0.1 mm. The second outer edge maximum particle size may be less than 0.3 mm, such as less than 0.2 mm, such as less than 0.1 mm. The second inner edge average particle size may be less than 0.2 mm, such as less than 0.1 mm. The second inner edge maximum particle size can be less than 0.3 mm, such as less than 0.2 mm, such as less than 0.1 mm. The second center average particle size can be less than 0.2 mm, such as less than 0.1 mm. The second center maximum particle size can be less than 0.3 mm, such as less than 0.2 mm, such as less than 0.1 mm.

[0072] The hydrocolloid can be arranged so that the second outer edge average / maximum particle size and / or the second inner edge average / maximum particle size are less than the center average / maximum particle size. For example, the second outer edge average / maximum particle size and / or the second inner edge average / maximum particle size can be less than half of the center average / maximum particle size. Alternatively, the second outer edge average / maximum particle size, the second inner edge average / maximum particle size and the center average / maximum particle size can be substantially the same.

[0073] Providing a second bonding sensor material for forming a second bonding sensor layer may include sorting the hydrocolloids of the second bonding sensor material according to particle size. For example, sorting the hydrocolloids of the second bonding sensor material may include sorting the hydrocolloids to achieve an average / maximum particle size of these hydrocolloids of less than 0.3 mm, such as less than 0.2 mm, such as less than 0.1 mm. Alternatively or additionally, laying the second bonding sensor material layer may include: laying a second bonding sensor material layer for forming a second central portion, wherein the hydrocolloid has a second central average / maximum particle size; laying a second bonding sensor material layer for forming a second outer edge portion, wherein the hydrocolloid has a second outer edge average / maximum particle size; and / or laying a second bonding sensor material layer for forming a second inner edge portion, wherein the hydrocolloid has a second inner edge average / maximum particle size.

[0074] Laying down the second adhesive sensor material layer for forming the second adhesive sensor layer may include extruding the second adhesive sensor layer. Alternatively or additionally, laying down the second adhesive sensor material layer for forming the second adhesive sensor layer may include molding, such as injection molding, the second adhesive sensor layer. According to the above, the mold may have a non-planar surface that is shaped to provide the shape of the second outer edge, the second center portion and / or the second inner edge. Alternatively or additionally, according to the above, laying down the second adhesive sensor material layer for forming the second adhesive sensor layer may include scraping the second adhesive sensor material onto a non-planar surface that is shaped to provide the contour of the second outer edge, the second center portion and / or the second inner edge, such as the proximal surface of the second release liner or the distal surface of the sensor assembly.

[0075] A sensor assembly including a plurality of electrodes may be arranged on the distal side of a first adhesive sensor layer and / or on the proximal side of a second adhesive sensor layer. A plurality of electrodes of the sensor assembly may be arranged about the inner edge portion and / or the outer edge portion of the first adhesive sensor layer and / or the second adhesive sensor layer. Specifically, the plurality of electrodes may be arranged to measure, for example, on a portion of an adhesive layer, wherein the adhesive layers have a substantially uniform thickness. This arrangement may facilitate the reliability of the measurement and / or the subsequent interpretation of the measured value. The plurality of electrodes of the sensor assembly may, for example, form a ring around a center point, such as an open ring or a closed ring. The first electrode may form a first ring, the second electrode may form a second ring, the third electrode may form a third ring, the fourth electrode may form a fourth ring, the fifth electrode may form a fifth ring, and / or the sixth electrode may form a sixth ring. The electrode, such as the first electrode, may form a plurality of rings, such as the first electrode may form a plurality of first rings, for example, including a first primary ring, a first secondary ring, a first tertiary ring, and the like.

[0076] The radial distance from the center point to the first ring formed by the first electrode, to the second ring formed by the second electrode, to the third ring formed by the third electrode, to the fourth ring formed by the fourth electrode, to the fifth ring formed by the fifth electrode, and / or to the sixth ring formed by the sixth electrode may be smaller than the radial distance from the center point to the first outer edge portion, such as the first outer edge portion adjacent to the first center portion. The radial distance from the center point to the first ring formed by the first electrode, to the second ring formed by the second electrode, to the third ring formed by the third electrode, to the fourth ring formed by the fourth electrode, to the fifth ring formed by the fifth electrode, and / or to the sixth ring formed by the sixth electrode may be larger than the radial distance from the center point to the first inner edge portion, such as the first inner edge portion adjacent to the first center portion.

[0077] The radial distance from the center point to the first ring formed by the first electrode, to the second ring formed by the second electrode, to the third ring formed by the third electrode, to the fourth ring formed by the fourth electrode, to the fifth ring formed by the fifth electrode, and / or to the sixth ring formed by the sixth electrode may be smaller than the radial distance from the center point to the second outer edge portion, such as to the second outer edge portion adjacent to the second center portion. The radial distance from the center point to the first ring formed by the first electrode, to the second ring formed by the second electrode, to the third ring formed by the third electrode, to the fourth ring formed by the fourth electrode, to the fifth ring formed by the fifth electrode, and / or to the sixth ring formed by the sixth electrode may be larger than the radial distance from the center point to the second inner edge portion, such as to the second inner edge portion adjacent to the second center portion.

[0078] The radial distance from the center point to the second ring may be smaller than the radial distance from the center point to the first ring. The radial distance from the center point to the third ring may be smaller than the radial distance from the center point to the second ring. The radial distance from the center point to the fourth ring may be smaller than the radial distance from the center point to the third ring. The radial distance from the center point to the fifth ring may be smaller than the radial distance from the center point to the fourth ring. The radial distance from the center point to the sixth ring may be smaller than the radial distance from the center point to the fifth ring.

[0079] The sensor patch may include one or more sensor release liners, such as a first sensor release liner and / or a second sensor release liner.

[0080] The first sensor release liner may include a distal surface and a proximal surface. The first sensor release liner may be arranged to protect the first adhesive sensor layer, for example, the distal surface of the first sensor release liner may face the proximal surface of the first adhesive sensor layer. The first sensor release liner may be configured to be peeled off by a user before applying the base plate with the attached sensor patch to the skin. A first adhesive sensor material layer may be laid on the distal side of the first sensor release liner.

[0081] The second sensor release liner may include a distal surface and a proximal surface. The second sensor release liner may be arranged to protect the second adhesive sensor layer, for example, the proximal surface of the second sensor release liner may face the distal surface of the second adhesive sensor layer. The second sensor release liner may be configured to be peeled off by a user before attaching the sensor patch to the base plate. A second adhesive sensor material layer may be laid on the proximal side of the second sensor release liner.

[0082] The sensor patch may include a monitor interface. The monitor interface may be configured to electrically and / or mechanically connect the sensor patch, such as a plurality of electrodes of the sensor patch, to a monitoring device. The monitor interface may be configured to wirelessly connect the sensor patch, such as electrodes of the sensor patch, to a monitoring device. The monitor interface may be configured to electrically and / or mechanically couple the sensor patch and the monitoring device.

[0083] The disclosed sensor patch can be combined with a base plate, such as to form an integral, one-piece base plate, such as integrated with a sensor assembly component, such as the above-mentioned sensor assembly component. For example, the base plate can include a sensor assembly, such as the sensor assembly described with respect to the sensor patch. For example, the sensor assembly can be positioned between a first adhesive layer and a second adhesive layer. The distal surface of the first adhesive layer can face the proximal side of the sensor assembly and / or the distal side of the sensor assembly can face the proximal side of the second adhesive layer. For example, the first adhesive layer and / or the second adhesive layer of the base plate can be set as described with respect to the first adhesive sensor layer and / or the second adhesive sensor layer, respectively.

[0084] The radial distance from the center point to the first ring formed by the first electrode, to the second ring formed by the second electrode, to the third ring formed by the third electrode, to the fourth ring formed by the fourth electrode, to the fifth ring formed by the fifth electrode, and / or to the sixth ring formed by the sixth electrode may be less than the radial distance from the center point to the outer edge portion of the first adhesive layer and / or the second adhesive layer, such as to the outer edge portion adjacent to the center portion of the first adhesive layer and / or the second adhesive layer. The radial distance from the center point to the first ring formed by the first electrode, to the second ring formed by the second electrode, to the third ring formed by the third electrode, to the fourth ring formed by the fourth electrode, to the fifth ring formed by the fifth electrode, and / or to the sixth ring formed by the sixth electrode may be greater than the radial distance from the center point to the inner edge portion of the first adhesive layer and / or the second adhesive layer, such as to the inner edge portion adjacent to the center portion of the first adhesive layer and / or the second adhesive layer.

[0085] Figure 1Schematically illustrated is an exploded view of an exemplary base plate 4 of an ostomy appliance. The base plate 4 includes a first adhesive layer 200 having a distal surface 200A and a proximal surface 200B. During use, the proximal surface 200B of the first adhesive layer 200 adheres to the skin of the user. The base plate 4 includes a second adhesive layer 202 having a distal surface 202A and a proximal surface 202B. As illustrated, the second adhesive layer 202 spans a larger surface area than the first adhesive layer 200, such as to provide an edge of the proximal surface 202 of the second adhesive layer 202 that surrounds the proximal surface 200 of the first adhesive layer 200.

[0086] The base plate 4 includes a release liner 206, which the user peels off before applying the base plate 4 to the skin. The release liner 206 includes a distal surface 206A and a proximal surface 206B. The distal surface 206A of the release liner 206 covers the proximal surface of the first adhesive layer 200 and covers the proximal surface of the second adhesive layer 202 that is not covered by the first adhesive layer 200.

[0087] Base plate 4 comprises backing layer 208.Backing layer 208 is a protective layer that protects adhesive layer, such as first adhesive layer 200 and / or second adhesive layer 202 from external strain and stress during use.In addition, backing layer 208 also covers adhesive layer, such as first adhesive layer 200 and / or second adhesive layer 202, so that adhesive layer 200,202 does not adhere to the clothes worn on base plate 4.Backing layer 208 comprises distal surface 208A and proximal surface 208B.The distal surface 208A of backing layer 208 is configured to turn away from the skin of the user.The proximal surface 208B of backing layer 208 covers second adhesive layer 202.

[0088] The base plate 4 is a two-part ostomy appliance and therefore comprises a coupling ring 209 for coupling an ostomy bag to the base plate 4 , such as to the distal side of the base plate 4 .

[0089] The base plate 4 comprises a stoma opening.The layers of the base plate 4 (such as the first adhesive layer 200, the second adhesive layer 202 and the backing layer 208 as illustrated) may comprise a stoma opening 18 for collectively forming the stoma opening of the base plate.

[0090] Figure 2 Schematically illustrates an exemplary sensor patch 50, such as one adapted to be attached to a base plate (such as Figure 14). The sensor patch 50 is configured to be positioned between the user's skin and the proximal side of the base plate 4. For example, the sensor patch can be adapted to be attached to the first adhesive layer 200 of the base plate 4, such as the proximal surface 200B of the first adhesive layer 200. The sensor patch 50 is configured to be attached to the base plate such that the distal side 50A of the sensor patch 50 is attached to the proximal side of the base plate, such as the proximal surface 200B of the first adhesive layer 200 of the base plate 4.

[0091] The sensor patch 50 comprises a sensor assembly 204 comprising a plurality of electrodes 216. Each electrode 216 has a respective connection portion 217 for connecting the plurality of electrodes 216 to a respective terminal element of a monitoring device. The sensor assembly 204 may form a sensor assembly layer.

[0092] The sensor assembly 204 has a distal side 204A and a proximal side 204B. The sensor assembly 204 includes a support layer 214 having a proximal surface 214B. The electrode 216 can be disposed, such as formed, on the proximal surface 214B of the support layer 214, for example, the electrode 216 can be positioned on the proximal surface 214B of the support layer 214.

[0093] Electrode assembly 204 includes a masking element 218 having a distal surface 218A and a proximal surface 218B. Masking element 218 is configured to electrically insulate at least a portion of electrode 216 from adjacent layers, such as first adhesive sensor layer 52. Masking element 218 covers or overlaps a portion of electrode 216 when viewed in the axial direction.

[0094] The sensor patch 50 includes a first adhesive sensor layer 52 having a proximal side 52B and a distal side 52A. The first adhesive sensor layer 52 is disposed on the proximal side 204B of the sensor assembly 204. The proximal side 52B of the first adhesive sensor layer 52 is configured to adhere to the skin of the user. Thus, after being applied to the base plate, the combined base plate and sensor patch 50 form an adhesive proximal surface configured to be applied to the skin surface of the user.

[0095] The sensor patch includes a first sensor release liner 54. The first sensor release liner 54 may include a distal surface 54A and a proximal surface 54B. The first sensor release liner 54 may be arranged to protect the first adhesive sensor layer 52. The distal surface 54A of the first sensor release liner 54 faces the proximal surface 52B of the first adhesive sensor layer 52. The first sensor release liner 54 is configured to be peeled off by the user before applying the base plate with the attached sensor patch to the skin. The first adhesive sensor layer 52 may be laid on the distal side 54A of the first sensor release liner 54.

[0096] Sensor patch 50 includes second adhesive sensor layer 56 having proximal side 56B and distal side 56A. Second adhesive sensor layer 56 is disposed on distal side 204A of sensor assembly 204. Proximal side 56B of second adhesive sensor layer 52 is configured to adhere to a substrate, such as a proximal surface of the first adhesive layer of a substrate.

[0097] The exemplary sensor patch includes a second sensor release liner 58. The second sensor release liner 58 may include a distal surface 58A and a proximal surface 58B. The second sensor release liner 58 may be arranged to protect the second adhesive sensor layer 56. The proximal surface 58B of the second sensor release liner 58 faces the distal surface 56A of the second adhesive sensor layer 56. The second sensor release liner 58 is configured to be peeled off by a user before applying the sensor patch to the base plate. The second adhesive sensor layer 56 may be laid on the proximal side 58B of the second sensor release liner 58.

[0098] Although the illustrated exemplary sensor patch 50 includes a second adhesive sensor layer 56 disposed on the distal side 204A of the sensor assembly 204, it is contemplated that an alternative sensor patch according to the present disclosure may be provided without such a second adhesive sensor layer 56 and an accompanying second sensor release liner 58. Instead, in such an alternative sensor patch, it is contemplated that the distal surface of the sensor patch is a distal surface of the sensor assembly 204, specifically a distal surface of the support layer 214. In such an alternative sensor patch, the distal surface of the support layer 214 may be configured for attachment to an adhesive surface of a base plate. Thus, although a sensor patch 50 having a first adhesive sensor layer 52 and a second adhesive sensor layer 56 is illustrated and described, it is contemplated that a similar sensor patch without such a second adhesive sensor layer 56 and an accompanying second sensor release liner 58 may be provided according to the present disclosure.

[0099] The sensor patch 50 includes a stoma opening. The layers of the sensor patch 50 (such as the first adhesive sensor layer 52, the support layer 214, and the second adhesive sensor layer 56 as shown) may include a stoma opening 60 for collectively forming the stoma opening of the sensor patch 50. The stoma opening of the sensor patch is configured to align with the stoma opening of the base plate, such as for collectively forming the stoma opening of the combined base plate and sensor patch 50.

[0100] Figure 3 Schematically illustrates an exemplary sensor assembly, such as Figure 2 An exemplary electrode configuration 220 of electrodes 216 of sensor assembly 204 is depicted. Plurality of electrodes 216 includes a first electrode 222, a second electrode 224, a third electrode 226, a fourth electrode 228, a fifth electrode 230, and a sixth electrode 232.

[0101] The first electrode 222 includes a first connection portion 222A, and the second electrode 224 includes a second connection portion 224A. The third electrode 226 includes a third connection portion 226A. The fourth electrode 228 includes a fourth connection portion 228A. The fifth electrode 230 includes a fifth connection portion 230A. The sixth electrode 232 includes a sixth connection portion 232A.

[0102] The first electrode 222 may be a common ground electrode, such as to form a sensor with respect to the remaining electrodes. The first electrode 222 includes a first electrode portion 234 for forming a ground for the second electrode 224. The first electrode 222 includes a second electrode portion 236 for forming a ground for the third electrode 226. The first electrode 222 includes a third electrode portion 238 for forming a ground for the fourth electrode 228. The first electrode 222 includes a fourth electrode portion 240 for forming a ground for the fifth electrode 230 and the sixth electrode 232.

[0103] Figure 4 The sensor patch 50 is schematically shown, for example, Figure 2 A cross section of the described sensor patch 50. For illustration purposes, the layers of the sensor patch 50 are shown separated. The sensor patch 50 comprises a stoma opening 60 having a center point 19. In some exemplary sensor patches, the stoma opening 60 can be manufactured by the user, i.e. the sensor patch can be manufactured and / or sold without the stoma opening 60 but with an area adapted to form the stoma opening 60 having the center point 19.

[0104] Also about Figure 2 As depicted, the sensor patch 50 includes the sensor assembly 204 and the first adhesive sensor layer 52, the second adhesive sensor layer 56, the first sensor release liner 54, and the second sensor release liner 58. In other exemplary sensor patches, one or more of the first adhesive sensor layer 52, the second adhesive sensor layer 56, the first sensor release liner 54, and the second sensor release liner 58 may be omitted. Specifically, although the illustrated exemplary sensor patch 50 includes the second adhesive sensor layer 56 disposed on the distal side of the sensor assembly 204, it is contemplated that an alternative sensor patch according to the present disclosure may be provided without such a second adhesive sensor layer 56 and the accompanying second sensor release liner 58. Instead, in such an alternative sensor patch, the distal surface of the sensor patch may be the distal surface of the sensor assembly 204.

[0105] The first adhesive sensor layer 52 includes a first central portion 62. The first adhesive sensor layer 52 includes a first outer edge portion 64. The first adhesive sensor layer 52 includes a first inner edge portion 66. The first central portion 62 surrounds the first inner edge portion 66. The first outer edge portion 64 surrounds the first central portion 62. The first outer edge portion 64 and the first inner edge portion 66 are features also referred to as chamfered edges of the sensor patch 50. In other words, the chamfered edges of the sensor patch 50 are embodied in the sensor patch by the reduction / increase in thickness of the first outer edge portion 64 and the first inner edge portion 66.

[0106] The radial distance D82 of the first outer edge portion 64 is from the first outer edge portion 64 adjacent to the first center portion 62 to the first outer periphery 68 of the first bonded sensor layer 52. The radial distance D86 of the first inner edge portion 66 is from the first inner periphery 69 of the first bonded sensor layer 52 to the first center portion 62, such as to the first center portion 62 adjacent to the first inner edge portion 66. Also shown is the radial distance D84 from the center point 19 to the first center portion 62 adjacent to the first inner edge portion 66. Also shown is the radial distance D80 from the center point 19 to the first outer edge portion 64 adjacent to the first center portion 62.

[0107] The first central portion 62 has a first central thickness D62. The first outer edge portion 64 has a first outer edge thickness that decreases in a radial direction from adjacent to the first central portion 62 to a first outer periphery 68 of the first bonded sensor layer 52. The first outer edge thickness adjacent to the first central portion 62 is the first central thickness D62. The first outer edge thickness at the first outer periphery 68 of the first bonded sensor layer 52 is a first minimum outer edge thickness D68.

[0108] The first inner edge portion 66 has a first inner edge thickness that increases in a radial direction from a first inner periphery 69 of the first adhesive sensor layer 52 to the first center portion 62. The first inner edge thickness adjacent to the first center portion 62 is a first center thickness D62, and the first inner edge thickness at the first inner periphery 69 of the first adhesive sensor layer 52 is a first minimum inner edge thickness D69.

[0109] The second adhesive sensor layer 56 includes a second central portion 72. The second adhesive sensor layer 56 includes a second outer edge portion 74. The second adhesive sensor layer 56 includes a second inner edge portion 76. The second central portion 72 surrounds the second inner edge portion 76. The second outer edge portion 74 surrounds the second central portion 72.

[0110] The radial distance D92 of the second outer edge portion 74 is from the second outer edge portion 74 adjacent to the second center portion 72 to the second outer periphery 78 of the second bonded sensor layer 56. The radial distance D96 of the second inner edge portion 76 is from the second inner periphery 79 of the second bonded sensor layer 56 to the second center portion 72, such as the second center portion 72 adjacent to the second inner edge portion 76. Also shown is the radial distance D94 from the center point 19 to the second center portion 72 adjacent to the second inner edge portion 76. Also shown is the radial distance D90 from the center point 19 to the second outer edge portion 74 adjacent to the second center portion 72.

[0111] The second center portion 72 has a second center thickness D72. The second outer edge portion 74 has a second outer edge thickness that decreases in the radial direction from adjacent to the second center portion 72 to a second outer periphery 78 of the second bonded sensor layer 56. The second outer edge thickness adjacent to the second center portion 72 is the second center thickness D72. The second outer edge thickness at the second outer periphery 78 of the second bonded sensor layer 56 is a second minimum outer edge thickness D78.

[0112] The second inner edge portion 76 has a second inner edge thickness that increases in the radial direction from the second inner periphery 79 of the second adhesive sensor layer 56 to the second center portion 72. The second inner edge thickness adjacent to the second center portion 72 is a second center thickness D72, and the second inner edge thickness at the second inner periphery 79 of the second adhesive sensor layer 56 is a second minimum inner edge thickness D79.

[0113] In the illustrated example, the first outer edge thickness, the first inner edge thickness, the second outer edge thickness, and the second inner edge thickness are shown as decreasing / increasing substantially linearly. Alternatively, one or more of the first outer edge thickness, the first inner edge thickness, the second outer edge thickness, and the second inner edge thickness may decrease / increase convexly or concavely in the radial direction.

[0114] A radial distance D10 from the center point to a first ring formed by a first electrode of the plurality of electrodes 216 is less than a radial distance D80 from the center point 19 to a first outer edge portion 64, such as to a first outer edge portion 64 adjacent to the first center portion 62. A radial distance D10 from the center point to the first ring is less than a radial distance D90 from the center point 19 to a second outer edge portion 74, such as to a second outer edge portion 74 adjacent to the second center portion 72.

[0115] The radial distance D12 from the center point to the second ring formed by the second electrode of the plurality of electrodes 216 is less than the radial distance D80 from the center point 19 to the first outer edge portion 64, such as to the first outer edge portion 64 adjacent to the first center portion 62. The radial distance D12 from the center point to the second ring is less than the radial distance D90 from the center point 19 to the second outer edge portion 74, such as to the second outer edge portion 74 adjacent to the second center portion 72. The radial distance D12 from the center point to the second ring is less than the radial distance D10 from the center point to the first ring.

[0116] A radial distance D14 from the center point to a third ring formed by a third electrode of the plurality of electrodes 216 is less than a radial distance D80 from the center point 19 to the first outer edge portion 64, such as to the first outer edge portion 64 adjacent to the first center portion 62. A radial distance D14 from the center point to the third ring is less than a radial distance D90 from the center point 19 to the second outer edge portion 74, such as to the second outer edge portion 74 adjacent to the second center portion 72. A radial distance D14 from the center point to the third ring is less than a radial distance D12 from the center point to the second ring.

[0117] Figure 5 is a schematic block diagram of an exemplary method 1000 for manufacturing a sensor patch, such as a sensor patch as described with respect to one or more of the previous figures.

[0118] The method 1000 includes providing 1002 a first adhesive sensor material and laying down 1004 a first adhesive sensor material layer for forming a first adhesive sensor layer of a sensor patch. The first adhesive sensor material is laid down 1004 to form a first center portion and a first outer edge portion surrounding the first center portion, wherein the first center portion has a first center thickness, and the first outer edge portion has a first outer edge thickness that decreases gradually along a radial direction from adjacent to the first center portion to a first outer periphery of the first adhesive sensor layer. Further, the first adhesive sensor material is laid down 1004 such that the first outer edge thickness adjacent to the first center portion is the first center thickness, and the first outer edge thickness at the first outer periphery of the first adhesive sensor layer is a first minimum outer edge thickness. Laying down 1004 the first adhesive sensor material may further include forming a first inner edge portion surrounded by the first center portion, and wherein the first inner edge portion has a first outer edge thickness that increases gradually along a radial direction from the first inner periphery of the first adhesive sensor layer to the first center portion adjacent to the first inner edge portion.

[0119] Laying down 1004 the first adhesive sensor material layer for forming the first adhesive sensor layer may include extruding the first adhesive sensor layer, molding, such as injection molding, the first adhesive sensor layer, and / or scraping the first adhesive sensor layer onto the indented surface. Laying down 1004 the first adhesive sensor material layer may include post-processing to form or improve edge portions.

[0120] Method 1000 includes providing 1006 a sensor assembly including a plurality of electrodes, such as a sensor assembly as described with respect to previous figures. The electrodes include at least a first electrode and a second electrode for forming a first sensor.

[0121] The method 1000 includes arranging 1008 a sensor assembly on a distal side of a first adhesive sensor layer, wherein a proximal side of the first adhesive sensor layer is adapted to attach the sensor patch to a skin surface of a user.

[0122] The method 1000 optionally includes providing 1010 a first sensor release liner. Laying down 1004 a first layer of adherent sensor material may include laying down 1004 a first layer of adherent sensor material on a distal side of the first sensor release liner.

[0123] Providing 1002 the first adhesive sensor material may optionally include sorting 1012 the hydrocolloid of the first adhesive sensor material according to particle size. For example, the hydrocolloid may be sorted 1012 to achieve a smaller average and / or maximum particle size, such as to provide a thinner edge portion of the first adhesive layer. Alternatively or additionally, laying 1004 the first adhesive sensor material layer may include respectively: laying a first adhesive sensor material layer for forming a first central portion, whose hydrocolloid has a first central average particle size and / or a first central maximum particle size; and laying a first adhesive sensor material layer for forming a first outer edge portion and / or a first inner edge portion, whose hydrocolloid has a first outer edge average particle size and / or a first outer edge average particle size and / or a first inner edge average particle size, wherein the first outer edge average / maximum particle size and / or the first inner edge average / maximum particle size is smaller than the first central average / maximum particle size. Thereby, the first edge portion may achieve a thinner thickness than the first central portion, for example at the periphery.

[0124] In an embodiment, method 1000 may include providing 1102 a second adhesive sensor material and laying down 1104 a second adhesive sensor material layer for forming a second adhesive sensor layer of the sensor patch. Although the illustrated / disclosed method includes providing 1102 a second adhesive sensor material for forming a second adhesive sensor layer, it is contemplated that an alternative method omits steps involving such a second adhesive sensor layer, such that the resulting sensor patch has a distal surface that is a distal surface of the sensor assembly, and such that the resulting sensor patch has only a first adhesive sensor layer. The second adhesive sensor material is laid down 1104 to form a second central portion and a second peripheral portion surrounding the second central portion, wherein the second central portion has a second central thickness, and the second peripheral portion has a second peripheral thickness that decreases in a radial direction from adjacent the second central portion to a second peripheral periphery of the second adhesive sensor layer. Further, the second adhesive sensor material is laid down 1104 such that the second peripheral thickness adjacent the second central portion is the second central thickness, and the second peripheral thickness at the second peripheral periphery of the second adhesive sensor layer is the second minimum peripheral thickness. Laying 1104 the second bonded sensor material may further include forming a second inner edge portion surrounded by the second center portion, and wherein the second inner edge portion has a second outer edge thickness that gradually increases along a radial direction from a second inner periphery of the second bonded sensor layer to a second center portion adjacent to the second inner edge portion.

[0125] Laying down 1104 the second adhesive sensor material layer for forming the second adhesive sensor layer may include extruding the second adhesive sensor layer, molding, such as injection molding, the second adhesive sensor layer, and / or scraping the second adhesive sensor layer onto the indented surface. Laying down 1104 the second adhesive sensor material layer may include post-processing to form or improve edge portions.

[0126] The method 1000 optionally includes providing 1110 a second sensor release liner. Laying down 1104 a second layer of adherent sensor material may include laying down 1104 a second layer of adherent sensor material on a proximal side of the second sensor release liner.

[0127] Providing 1102 the second adhesive sensor material may optionally include sorting 1112 the hydrocolloid of the second adhesive sensor material according to particle size. For example, the hydrocolloid may be sorted 1112 to achieve a smaller average and / or maximum particle size, such as to provide a thinner edge portion of the second adhesive layer. Alternatively or additionally, laying 1104 the second adhesive sensor material layer may include respectively: laying a second adhesive sensor material layer for forming a second central portion, whose hydrocolloid has a second central average / maximum particle size; and laying a second adhesive sensor material layer for forming a second outer edge portion and / or a second inner edge portion, whose hydrocolloid has a second outer edge average / maximum particle size and / or a second inner edge average / maximum particle size, wherein the second outer edge average / maximum particle size and / or the second inner edge average / maximum particle size is smaller than the second central average / maximum particle size. Thereby, the second edge portion may achieve a thinner thickness than the second central portion, for example at the periphery.

[0128] Providing a sensor patch in which the adhesive has a reduced outer edge and / or an increased inner edge promotes a smoother transition at the interface between the sensor patch and the adhesive surface of the base plate to which the sensor patch is applied. Thereby, the risk of possible wrinkles between the user's skin and the adhesive surface of the sensor patch and the base plate is reduced. Wrinkles between the adhesive surface and the user's skin may reduce adhesion and may lead to an increased risk of leakage. Therefore, by providing a reduced outer edge and / or an increased inner edge, the risk of leakage caused by the sensor patch can be reduced.

[0129] Although specific embodiments have been shown and described herein, it will be appreciated by those skilled in the art that a variety of alternative and / or equivalent embodiments may be substituted for the specific embodiments shown and described without departing from the scope of the invention. This application is intended to cover any changes or variations of the body side members of ostomy appliances as discussed herein. Therefore, the present invention is intended to be limited only by the claims and their equivalents.

Claims

1. A sensor patch for attachment to a base plate of an ostomy appliance, the sensor patch having a proximal side and a distal side, the distal side being adapted for attachment to an adhesive surface of the base plate, wherein the adhesive surface of the base plate being adapted for attaching the base plate to a skin surface of a user, and wherein the sensor patch is adapted for forming a stoma opening having a central point, the stoma opening being configured to allow discharge to pass through the stoma opening and into an ostomy bag attached to the base plate, The sensor patch comprises: - a sensor assembly comprising a plurality of electrodes including a first electrode and a second electrode for forming a first sensor, and - A first adhesive sensor layer, which forms the proximal side of the sensor patch and is adapted to attach the sensor patch to the skin surface of the user, wherein the first adhesive sensor layer includes a first central portion having a first central thickness and a first outer edge portion surrounding the first central portion, wherein the first outer edge portion has a first outer edge thickness that decreases along a radial direction from adjacent to the first central portion to a first outer periphery of the first adhesive sensor layer, and wherein the first outer edge thickness adjacent to the first central portion is the first central thickness and the first outer edge thickness at the first outer periphery of the first adhesive sensor layer is a first minimum outer edge thickness.

2. The sensor patch according to claim 1, wherein: The first center thickness is between 0.5 mm and 1.5 mm.

3. The sensor patch according to claim 1, wherein: The first minimum outer edge thickness is less than 0.5 mm.

4. The sensor patch according to any one of claims 1 to 3, wherein: A radial distance from the center point to a first outer edge portion adjacent to the first center portion is between 15 mm and 35 mm.

5. The sensor patch according to any one of claims 1 to 3, wherein: A radial distance from a first outer edge portion adjacent to the first central portion to a first outer periphery of the first adhesive sensor layer is between 0.5 mm and 20 mm.

6. The sensor patch according to any one of claims 1 to 3, wherein: The first bonding sensor layer has a first inner edge portion surrounded by the first center portion, wherein the first inner edge portion has a first inner edge thickness that increases along a radial direction from a first inner periphery of the first bonding sensor layer to the first center portion, and wherein the first inner edge thickness adjacent to the first center portion is the first center thickness and the first inner edge thickness at the first inner periphery of the first bonding sensor layer is a first minimum inner edge thickness.

7. The sensor patch according to claim 6, wherein: The first minimum inner edge thickness is less than 0.5 mm.

8. The sensor patch according to claim 6, wherein: A radial distance from the center point to a first center portion adjacent to the first inner edge portion is between 10 mm and 30 mm.

9. The sensor patch according to claim 6, wherein: A radial distance of the first inner edge portion from a first inner periphery of the first adhesive sensor layer to the first center portion is between 0.5 mm and 20 mm.

10. The sensor patch according to any one of claims 1 to 3, wherein: The first adhesive sensor layer includes a hydrocolloid.

11. The sensor patch according to claim 10, wherein: The hydrocolloids are arranged such that the hydrocolloids arranged along a first outer periphery of the first adhesive sensor layer have a first outer edge average particle size, and wherein the hydrocolloids arranged in the first central portion have a first central average particle size, and wherein the first outer edge average particle size is smaller than the first central average particle size.

12. The sensor patch according to claim 11, wherein: The first outer edge average particle size is less than half of the first center average particle size.

13. The sensor patch according to claim 10, wherein: The average particle size of the hydrocolloid is less than 0.2 mm.

14. The sensor patch according to any one of claims 1 to 3 comprises a first sensor release liner, which is arranged to protect the first adhesive sensor layer and is configured to be peeled off by the user before applying the base plate with the attached sensor patch to the skin.

15. The sensor patch according to any one of claims 1 to 3, wherein: The first electrode forms a first ring around the center point, and wherein a radial distance from the center point to the first ring is smaller than a radial distance from the center point to the first outer edge portion.

16. The sensor patch according to claim 15, wherein: The second electrode forms a second ring around the center point, and wherein a radial distance from the center point to the second ring is smaller than a radial distance from the center point to the first ring.

17. The sensor patch according to any one of claims 1 to 3, wherein: The first outer edge thickness decreases convexly along the radial direction from adjacent the first central portion to a first outer periphery of the first adhesive sensor layer.

18. The sensor patch according to any one of claims 1 to 3, wherein: The first outer edge thickness decreases concavely along the radial direction from adjacent to the first central portion to a first outer periphery of the first adhesive sensor layer.

19. The sensor patch according to any one of claims 1 to 3, wherein: The first outer edge thickness decreases linearly along the radial direction from adjacent the first central portion to a first outer periphery of the first adhesive sensor layer.

20. A method for manufacturing a sensor patch, the sensor patch being a sensor patch according to any one of claims 1 to 19, the sensor patch having a proximal side and a distal side and being adapted for attaching the distal side to an adhesive surface of a base plate of an ostomy appliance, wherein The adhesive surface of the base plate is adapted for attaching the base plate to a skin surface of a user, the method comprising: - providing a first bonding sensor material; - laying down a first adhesive sensor material layer for forming a first adhesive sensor layer of the sensor patch, wherein the first adhesive sensor material is laid down to form a first central portion and a first peripheral portion surrounding the first central portion, wherein the first central portion has a first central thickness and the first peripheral portion has a first peripheral thickness that gradually decreases in a radial direction from adjacent to the first central portion to a first peripheral edge of the first adhesive sensor layer, and wherein the first peripheral thickness adjacent to the first central portion is the first central thickness and the first peripheral thickness at the first peripheral edge of the first adhesive sensor layer is a first minimum peripheral thickness; - providing a sensor assembly comprising a plurality of electrodes including a first electrode and a second electrode for forming a first sensor; and - arranging the sensor assembly on a distal side of the first adhesive sensor layer, wherein the proximal side of the first adhesive sensor layer is adapted for attaching the sensor patch to a skin surface of the user.

21. The method of claim 20, comprising providing a first sensor release liner, and wherein: Laying down the first layer of adherent sensor material includes laying down the first layer of adherent sensor material on a distal side of the first sensor release liner.

22. The method according to any one of claims 20 to 21, wherein: Providing the first bound sensor material includes sorting the hydrocolloid of the first bound sensor material according to particle size.

23. The method according to claim 22, wherein: Laying the first bonding sensor material layer includes laying a first bonding sensor material layer for forming the first central portion with a hydrocolloid having a first central average particle size, and laying a first bonding sensor material layer for forming the first outer edge portion with a hydrocolloid having a first outer edge average particle size, wherein the first outer edge average particle size is smaller than the first central average particle size.

24. The method according to claim 22, wherein: Sorting the hydrocolloid includes sorting the hydrocolloid to achieve an average particle size of the hydrocolloid of less than 0.2 mm.

25. The method according to any one of claims 20 to 21, wherein: Laying down a first layer of bonded sensor material for forming the first bonded sensor layer includes extruding the first bonded sensor layer.

26. The method according to any one of claims 20 to 21, wherein: Laying down a first layer of bonding sensor material for forming the first bonding sensor layer includes molding the first bonding sensor layer, wherein the mold has a non-planar surface shaped to provide a first outer edge thickness that gradually decreases along the radial direction from adjacent the first center portion to a first outer periphery of the first bonding sensor layer.

27. The method according to any one of claims 20 to 21, wherein: Laying down a first layer of bonded sensor material for forming the first bonded sensor layer includes scraping the first bonded sensor material onto a non-planar surface shaped to provide a first outer edge thickness that gradually decreases along the radial direction from adjacent the first center portion to a first outer periphery of the first bonded sensor layer.

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