Stoma sensor patch

Abstract

To provide a sensor patch (50) for attachment to a base plate for an ostomy appliance, and a method of manufacturing the sensor patch.SOLUTION: A sensor patch has a proximal side and a distal side. The distal side is adapted to attach to an adhesive surface of a base plate, and an adhesive surface of the base plate is adapted to attach the base plate to a user's skin surface. The sensor patch comprises a sensor assembly (204) including a plurality of electrodes (216), and a first adhesive sensor layer (52) forming a proximal side of the sensor patch and adapted to attach the sensor patch to the user's skin surface. The first adhesive sensor layer includes a first central portion (62) having a first central thickness and a first outer rim portion (64) surrounding the first central portion. The first outer rim portion has a first outer rim thickness that decreases along a radial direction from a portion of the first adhesive sensor layer adjacent to the first central portion to the first outer circumference.SELECTED DRAWING: Figure 2

Description

[Technical field]

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

[0002] Stoma output often contains bodily fluids and visceral contents that are aggressive to both the user's skin and the ostomy appliance, which can adversely affect the efficiency and integrity of the adhesive material used to attach the ostomy appliance to the user's skin surface. In general, a safe, reliable and efficient ostomy appliance for the user is highly desirable.

[0003] However, the large ostomy community continues to have a particularly large and persistent concern about failure of the baseplate adhesive that attaches the ostomy appliance to the skin surface of the user, since such failure almost certainly results in embarrassing and stigmatizing leakage events. Moreover, such events have been found to cause a sense of reduced quality of life, as interviews with several users have shown. Adhesion failure of the baseplate adhesive can result from a variety of reasons. In most cases, leakage events are caused by stoma output getting between the proximal surface of the baseplate and the skin of the user, which is due to, for example, a non-optimal attachment of the baseplate to the skin, resulting, for example, from an uneven skin surface or skin wrinkles. This undesirable penetration of stoma output "under" the adhesive leads to degradation and / or weakening of the adhesive material that supports the weight of the ostomy appliance and provides its seal. Such failures often occur surprisingly quickly, and only the user knows, once the failure has already become severe enough to cause leakage, that the ostomy appliance and possibly the user's clothing also need to be changed quickly.

[0004] In other instances, the primary cause of adhesion 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 waste from the stoma itself, the peristomal skin surface continually secretes some moisture (e.g., sweat). To reduce this, in most cases, base plate adhesives for ostomy appliances contain hydrocolloid materials that can absorb high levels of moisture, thereby stabilizing the polymer matrix of the adhesive material and extending the life ("wear time") of the base plate. However, eventually, the adhesive properties of the base plate can no longer support the forces applied to the base plate from the load of the waste collection bag, and the appliance must be replaced.

[0005] Although there may be considerable differences in the severity and / or speed of adhesive failure and possible leakage, such differences are at least in part correlated to various factors, including those mentioned above, and the mere indication of impending or already occurring failure or leakage fails to provide a reliable and satisfactory solution to the problem of avoiding sudden, embarrassing and stigmatizing leakage events in ostomy appliances. In other words, users of ostomy appliances would benefit greatly from appliance solutions that give users better guidance and options regarding how and - in particular - how quickly to react to the onset of adhesive failure or leakage of the appliance base plate. More generally, ostomists and health care professionals would also welcome improvements in ostomy devices that reduce or eliminate the occurrence of sudden leakage events. Summary of the Invention [Problem to be solved by the invention]

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

[0007] A further object of the present disclosure is to provide a method for facilitating attachment of a sensor patch to an ostomy appliance, for example a base plate of the ostomy appliance, thereby reducing the risk of compromising the ability of the ostomy appliance to avoid leakage, in particular between the skin surface of the user and the adhesive surface of the base plate. In particular, it is an object of the present disclosure to thin the edges 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 adhesive surface of the base plate is as smooth as possible. In other words, it is an object of the present disclosure to thin the edges formed between the adhesive surface of the base plate and the sensor patch attached thereto. In particular, it is envisaged that the presence of such edges may cause unfavourable effects on the quality of the adhesion of the base plate / sensor patch to the skin surface of the user, and therefore the object is to thin such edges. [Means for solving the problem]

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

[0009] Accordingly, a sensor patch for attachment to a base plate for an ostomy appliance is disclosed, the sensor patch having a proximal side and a distal side, the distal side adapted for attachment to an adhesive surface of the base plate, the adhesive surface of the base plate adapted for attachment of 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, to form 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 a skin surface of a user. The first adhesive sensor layer includes a first central portion having a first central thickness and a first outer rim portion surrounding the first central portion. The first outer rim portion has a first outer rim thickness that decreases along a radial direction from adjacent the first central portion of the first adhesive sensor layer to a first outer rim thickness. The first outer rim thickness adjacent the central portion is a first central thickness, and the first outer rim thickness at the first outer rim thickness of the first adhesive sensor layer is a first minimum outer rim thickness.

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

[0012] This provides a sensor patch with a chamfered edge, which provides a smooth transition between the base plate and the sensor patch attached to the base plate, which may reduce potentially undesirable effects of having a sensor patch attached to the adhesive surface of a base plate, such as the effect the attached sensor patch may have on the quality of adhesion to the skin surface.

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

[0014] The method includes providing a first adhesive sensor material and laying out the layer of the first adhesive sensor material to form a first adhesive sensor layer of the sensor patch, the first adhesive sensor material being laid out to form a first central portion and a first outer rim portion surrounding the first central portion, the first central portion having a first central thickness, and the first outer rim portion having a first outer rim thickness that gradually decreases along a radial direction from adjacent the first central portion to a first outer rim thickness of the first adhesive sensor layer, the first outer rim thickness adjacent the first central portion being the first central thickness, and the first outer rim thickness at the first outer rim thickness of the first adhesive sensor layer being a first minimum outer rim thickness.

[0015] The method includes providing a sensor assembly including a plurality of electrodes, including a first electrode and a second electrode, to form a first sensor.

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

[0017] Thereby, a method is provided for manufacturing a sensor patch having chamfered edges that facilitate a smooth transition between a base plate and a sensor patch attached to the base plate.

[0018] Also disclosed is a base plate for an ostomy appliance having a proximal adhesive surface adapted for attaching the base plate to a skin surface of a user.

[0019] Embodiments of the present disclosure are described in more detail below with reference to the accompanying drawings, which illustrate one way of implementing the invention and are not to be considered as limiting other possible embodiments falling within the scope of the appended claims. [Brief description of the drawings]

[0020] [Figure 1] 1 illustrates a schematic exploded view of an exemplary base plate. [Diagram 2] 2A and 2B illustrate schematic diagrams of exploded views of an exemplary sensor patch. [Diagram 3] 1A-1C are schematic diagrams illustrating exemplary electrode configurations; [Figure 4] 2A and 2B show schematic cross-sectional views of a sensor patch. [Diagram 5] FIG. 2 is a schematic block diagram of an exemplary method. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0021] In the following detailed description, reference is made to the accompanying drawings, which form a part hereof, and which show, by way of illustration, specific embodiments in which the present invention may be practiced. In this regard, directional terms, such as "top", "bottom", "front", "rear", "top", "bottom", etc., are used with reference to the orientation of the drawings being described. Because components of the embodiments may be positioned in a number of different orientations, the directional terms are used for purposes of explanation and are not intended to be limiting. It is to be understood that other embodiments may be utilized and structural or logical changes may be made without departing from the scope of the present invention. Therefore, the following detailed description is not to be taken in a limiting sense, and the scope of the present invention is defined by the appended claims.

[0022] It will be understood that the features of the various exemplary embodiments described herein can be combined with each other, unless specifically stated otherwise.

[0023] Throughout this disclosure, the words "stoma" and "ostomy" are used to denote a surgically created opening that bypasses a person's intestinal or urinary system. These words are used interchangeably and no differential meaning is intended. The same applies to any words or expressions derived therefrom, such as "stoma's", "ostomy", etc. Also, both solid and liquid waste from the stoma may be referred to interchangeably as stoma "output", "waste" and "fluid". A subject who has undergone an ostomy operation may also be referred to as an "ostomist" or "ostomate" - or even as a "patient" or "user". However, in some cases, the "user" may also relate to or refer to a health care professional (HCP), such as a surgeon or an ostomy care nurse. In such cases, it is specified or implied that the "user" is not the "patient" himself / herself.

[0024] In the following, whenever a proximal side of a device or part of a device is mentioned, it is referring to the side that faces the skin when the ostomy appliance is worn by a user. Similarly, whenever a distal side of a device or part of a device is mentioned, it is referring 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 attached to the user, and the distal side refers to the opposite side - the side that is furthest from the user during use.

[0025] The axial direction is defined as the direction of the stoma when the appliance is worn by the user, and is therefore approximately perpendicular to the user's skin or abdominal surface.

[0026] Radial is defined as being perpendicular to the axial direction, i.e. perpendicular to the direction of the stoma, i.e. "across" the distal / proximal surfaces of the base plate. In some texts, the words "inner" and "outer" may be used. These modifiers are generally understood with reference to the radial direction, and reference to an "outer" element means that this element is further from the central portion of the ostomy appliance than the element referred to as "inner". Furthermore, "innermost" should be interpreted as the portion of the component that forms the center of the component and / or is adjacent to the center of the component. Similarly, "outermost" should be interpreted as the portion of the component that forms the outer edge or contour of the component and / or is adjacent to the outer edge or contour.

[0027] The use of the word "substantially" as a modifier to certain features or advantages in the present disclosure is intended to mean merely that any deviations are within the tolerance that would normally be expected by one of ordinary skill in the art.

[0028] The use of the word "generally" as a modifier to certain features or effects in this disclosure is intended to mean merely that - for structural features, a majority or major portion of such features exhibit that feature, and for functional features or effects, a majority of results that include that feature produce the effect, but exceptionally, a plurality of results do not produce the effect.

[0029] The use of the word "essentially" as a modifier to certain structural and functional features or advantages in this disclosure is used to emphasize what the primary focus or fact regarding something is (i.e., a feature may have or serve various advantages, but when this disclosure describes one advantage as being "essentially" provided, this is the focus and primary advantage regarding this disclosure).

[0030] Throughout this disclosure, the use of the terms "first," "second," "third," "fourth," "primary," "secondary," "tertiary," etc. do not imply any particular order or importance, but are merely included to identify particular elements. Further, the labeling of a first element does not imply the presence of a second element and vice versa.

[0031] A sensor patch for attachment to a base plate for an ostomy appliance is disclosed, such as to facilitate detection of moisture transmitted through an adhesive material provided for attachment of the base plate to a user's skin surface and to detect an increased risk of leakage. For example, the sensor patch may enable electronic measurement of the performance of the base plate and / or may facilitate detection of an increased risk of leakage and / or may facilitate detection of a reduced adhesion of the base plate to the user's skin.

[0032] The ostomy appliance includes a base plate and an ostomy pouch (also called an ostomy bag). The ostomy appliance may be a colostomy appliance, an ileostomy appliance or an artificial bladder appliance. The ostomy appliance may be a two-part ostomy appliance, i.e. the base plate and the ostomy pouch may be releasably coupled, for example, by mechanical and / or adhesive coupling, for example, allowing for the use (interchange) of multiple ostomy pouches with one base plate. For example, the base plate may include a connecting ring for coupling the ostomy pouch to the base plate. Furthermore, the two-part ostomy appliance may facilitate correct application of the base plate to the skin, for example improving the user's view of the stoma area. Alternatively, the ostomy appliance may be a one-part ostomy appliance, i.e. the base plate and the ostomy pouch may be fixedly attached to each other. The base plate is configured to couple to a user's stoma and / or the skin surrounding the stoma, for example, a peristomal skin area.

[0033] The base plate may include a first adhesive layer, i.e., a first layer of adhesive material. In use, the proximal surface of the first adhesive layer adheres to the skin of the user at the peristomal area and / or to an additional seal, such as a sealing paste, a sealing tape, and / or a sealing ring. The first adhesive layer may be made of a first composition. The first composition may include one or more polyisobutenes and / or styrene-isoprene-styrene. The first composition may include one or more hydrocolloids. The first composition may include one or more water-soluble or water-swellable hydrocolloids. The first composition may be a pressure-sensitive adhesive composition suitable for medical purposes, including a rubbery elastomeric base and one or more water-soluble or water-swellable hydrocolloids. The first adhesive layer may include a distal surface and a proximal surface. The proximal surface of the first adhesive layer may be configured to adhere to the skin of the user. The distal surface of the first adhesive layer may be configured to face away from the skin of the user.

[0034] The first adhesive layer may form an adhesive surface of the base plate adapted to attach the base plate to a skin surface of a user. The first adhesive layer may form a part of an adhesive surface of the base plate adapted to attach the base plate to a skin surface of a user.

[0035] The base plate may include a second layer of adhesive material, also referred to as a second adhesive layer, i.e., a rim adhesive layer. The second adhesive layer may be a different adhesive material than the first adhesive layer. The second adhesive layer may be made of a second composition. The second composition may include one or more polyisobutenes and / or styrene-isoprene-styrene. The second composition may include one or more hydrocolloids. The second composition may include one or more water-soluble or water-swellable hydrocolloids. The second composition may be a pressure-sensitive adhesive composition suitable for medical purposes, including a rubbery elastomeric base and one or more water-soluble or water-swellable hydrocolloids. The second adhesive layer may include a distal surface and a proximal surface. The proximal surface of the second adhesive layer may be configured to adhere to the skin of a user, for example, at least at the rim portion of the second adhesive layer. The distal surface of the second adhesive layer may be configured to face away from the skin of the user. The second adhesive layer may cover a larger area than the first adhesive layer, for example such that the proximal surface of the second adhesive layer forms an adhesive rim that surrounds the first adhesive layer.

[0036] The different content ratios may change the properties of the first adhesive layer and / or the second adhesive layer. The second adhesive layer and the first adhesive layer may have different properties. The second adhesive layer (second composition) and the first adhesive layer (first composition) may have different ratios of polyisobutene, styrene-isoprene-styrene and / or hydrocolloid. For example, the second adhesive layer may provide a stronger attachment to the skin compared to the attachment to the skin provided by the first adhesive layer. Alternatively or in addition, the second adhesive layer may be thinner than the first adhesive layer. Alternatively or in addition, the second adhesive layer may absorb less water and / or sweat than the first adhesive layer. Alternatively or in addition, the second adhesive layer may be more difficult to mold than the first adhesive layer. The second adhesive layer may provide a second barrier against leakage.

[0037] The second adhesive layer may form part of an adhesive surface of the base plate adapted to attach the base plate to a skin surface of a user. The first adhesive layer and the second adhesive layer may form an adhesive surface of the base plate adapted to attach the base plate to a skin surface of a user.

[0038] The first adhesive layer and / or the second adhesive layer may include a central portion having a central thickness and an outer rim portion surrounding the central portion. The outer rim portion may have an outer rim thickness that decreases, for example, along a radial direction from adjacent the central portion of the first adhesive layer and / or the second adhesive layer to the outer periphery. The outer rim thickness may decrease in a convex, concave or substantially linear manner along a radial direction from adjacent the central portion to the outer periphery. The outer rim thickness adjacent the central portion may be a central thickness. The outer rim thickness at the outer periphery may be a minimum outer rim thickness. The central thickness may be between 0.5 mm and 1.5 mm. The minimum outer rim thickness may be less than 0.5 mm, such as 0.4 mm, such as less than 0.3 mm, such as less than 0.1 mm.

[0039] The first adhesive layer and / or the second adhesive layer may surround an opening, e.g., a stoma opening. The first adhesive layer and / or the second adhesive layer may have an inner rim portion surrounded by a central portion. The inner rim portion may have an inner rim thickness that increases along a radial direction from an inner circumference of the first adhesive layer and / or the second adhesive layer to the central portion. The inner rim thickness may increase in a convex, concave or substantially linear manner along a radial direction from the inner circumference to the central portion. The inner rim thickness adjacent the central portion may be a central thickness. The inner rim thickness at the inner circumference may be a minimum inner rim thickness. The minimum inner rim thickness may be less than 0.5 mm, such as less than 0.4 mm, such as less than 0.3 mm, e.g. less than 0.1 mm.

[0040] Providing a base plate with a thinner outer rim and / or thicker inner rim of the adhesive, e.g., the first adhesive layer and / or the second adhesive layer, facilitates a smoother transition between the base plate and the user's skin at the edge of the base plate, which may reduce the risk of clothing sticking to the edge of the base plate and potentially peeling the base plate off the skin, thus reducing the risk of leakage due to the base plate not adhering well to the user's skin.

[0041] The base plate may include a release liner that can be peeled off by a user before applying the base plate to the skin. The release liner may be configured to protect the adhesive layer before applying the base plate to the skin. The release liner may include a distal surface and a proximal surface. The release liner may be configured, for example, to cover the proximal surface of the first adhesive layer and / or cover the proximal surface of the second adhesive layer, e.g., the proximal surface of the second adhesive layer that is not covered by the first adhesive layer, before applying the base plate to the skin. The distal surface of the release liner may be configured, for example, to face the proximal surface of the first adhesive layer and / or the proximal surface of the second adhesive layer, e.g., the proximal surface of the second adhesive layer that is not covered by the first adhesive layer, before applying the base plate to the skin.

[0042] The base plate may include a backing layer. The backing layer may be a protective layer that protects the adhesive layer, e.g., the first adhesive layer and / or the second adhesive layer, from external strain and stress during use. Additionally, the backing layer may cover the adhesive layer, e.g., the first adhesive layer and / or the second adhesive layer, to prevent the adhesive layer from adhering to clothing worn on top of the base plate. The backing layer may include a distal surface and a proximal surface. The distal surface of the backing layer may be configured to face away from the user's skin. The proximal surface of the backing layer may face the second adhesive layer. The second adhesive layer may be provided on the proximal surface of the backing layer.

[0043] The base plate may include a stoma opening. Each layer of the base plate may include a respective stoma opening that collectively form the stoma opening of the base plate. The stoma opening may be provided in a 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 a user's stoma and / or the stoma opening may be configured to allow waste from the stoma to pass through the stoma opening and into an ostomy pouch attached to the base plate. For example, the stoma opening may be configured to allow waste to pass from a proximal side of the base plate to a distal side of the base plate. The size and / or shape of the stoma opening may generally be adjusted by the user or nurse to fit the user's stoma prior to application of the base plate.

[0044] The 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 skin of a user and a proximal side of the base plate. For example, the sensor patch can be adapted to be attached to a first adhesive layer of the base plate. For example, a distal side of the sensor patch can be configured to face a proximal side of the first adhesive layer of the base plate. For example, the sensor patch, e.g., a distal side of the sensor patch, can be configured to adhere to a proximal side of the first adhesive layer of the base plate.

[0045] 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 may 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 be aligned with the stoma opening of the base plate, for example, for jointly forming the stoma opening of the 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 fit the stoma of the user 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 is attached to the base plate. One or more stoma openings may have a center point.

[0046] The sensor patch includes a sensor assembly. The sensor assembly may form a sensor assembly layer. The sensor assembly may have a distal side and a proximal side. The sensor patch may be configured to be positioned on the base plate such that a distal surface of the sensor assembly is coupled to a proximal adhesive surface of the base plate.

[0047] The sensor assembly includes a plurality of electrodes. The plurality of electrodes includes 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 respective connection for connecting the electrode to a respective terminal element of a monitoring device.

[0048] The multiple electrodes are electrically conductive and may include one or more of metallic materials (e.g., silver, copper, gold, titanium, aluminum, stainless steel), ceramic materials (e.g., ITO), polymeric materials (e.g., PEDOT, PANI, PPy), and carbonaceous materials (e.g., carbon black, carbon nanotubes, carbon fibers, graphene, graphite).

[0049] The electrodes may form loops and / or open loops. One or more open loop electrodes allow for electrode configurations in several or a single electrode layer.

[0050] The sensor assembly can include, for example, a support layer having a proximal surface and a distal surface. A plurality of electrodes can be provided, e.g., formed, e.g., positioned on the proximal surface of the support layer.

[0051] The sensor assembly can include, for example, a masking element having a proximal surface and a distal surface. The masking element can be configured to electrically insulate at least a portion of the plurality of electrodes from a proximal layer, for example, the first adhesive sensor layer. The masking element can cover or overlap portions of the plurality of electrodes, for example, when viewed axially.

[0052] The sensor patch includes, for example, a first adhesive sensor layer having a proximal side and a distal side. The first adhesive sensor layer may be disposed on the proximal side of the sensor assembly. The first adhesive sensor layer, for example, 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 may be configured to adhere to the skin of a user. Thus, the combined base plate and the sensor patch after being applied to the base plate may form an adhesive proximal surface configured to be applied to a skin surface of a user. The first adhesive sensor layer may be made of a first adhesive sensor material, for example, the first composition, the second composition, or the third composition. The third composition may include one or more polyisobutenes 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, comprising a rubbery elastomeric base and one or more water-soluble or water-swellable hydrocolloids.

[0053] The first adhesive sensor layer includes a first central portion. The first central portion has a first central thickness. The first adhesive sensor layer includes a first outer rim portion surrounding the first central portion. The first outer rim portion has a first outer rim thickness that decreases along a radial direction from adjacent the first central portion of the first adhesive sensor layer to the first outer periphery. The first outer rim thickness can decrease in a convex, concave or substantially linear manner along a radial direction from adjacent the first central portion of the first adhesive sensor layer to the first outer periphery. The first outer rim thickness adjacent the first central portion is a first central thickness. The first outer rim thickness at the first outer periphery of the first adhesive sensor layer is a first minimum outer rim thickness. The first central thickness can be between 0.5 mm and 1.5 mm. The first minimum outer rim thickness can 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 rim portion adjacent the first central portion can be 15-35mm. The radial distance from the first outer rim portion adjacent the first central portion of the first adhesive sensor layer to the first outer periphery can be 0.5-20mm. The radial distance from the center point of the first adhesive sensor layer to the first outer periphery can be 15.5-55mm, 20-45mm, 25-40mm, 30-35mm.

[0054] It is thereby provided that the sensor patch, in particular the first adhesive sensor layer of the sensor patch, has a chamfered edge, thereby providing a smooth transition between the adhesive surface of the base plate and the sensor patch attached thereto. The smooth transition reduces the potentially undesirable effects of having the sensor patch attached to the adhesive surface of the base plate. For example, the presence of a non-chamfered edge may increase the risk of leakage from the base plate, for example due to insufficient adhesion to the skin surface, or may increase the risk of skin irritation, for example due to the non-chamfered edge irritating the skin.

[0055] The first adhesive sensor layer may surround an opening, for example a stoma opening and / or an opening larger than the stoma opening. The first adhesive sensor layer may have a first inner rim portion surrounded by a first central portion. The first inner rim portion may have a first inner rim thickness that increases along a radial direction from a first inner circumference of the first adhesive sensor layer to the first central portion. The first inner rim thickness may increase in a convex, concave or substantially linear manner along a radial direction from the first inner circumference of the first adhesive sensor layer to the first central portion. The first inner rim thickness adjacent the first central portion may be a first central thickness. The first inner rim thickness at the first inner circumference of the first adhesive sensor layer may be a first minimum inner rim thickness. The first minimum inner rim 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 rim portion adjacent to the first central portion may be 10-30 mm. The radial distance from the first inner circumference of the first adhesive sensor layer to the first central portion, e.g. the first central portion adjacent to the first inner rim portion, may be 0.5-20 mm. The radial distance from the center point to the first central portion, e.g. the first central portion adjacent to the inner rim portion, may be 10.5-50 mm, e.g. 15-40 mm, e.g. 20-35 mm, e.g. 20-30 mm.

[0056] In manufacturing the sensor patch, a first adhesive sensor material may be provided and a layer of the first adhesive sensor material may be laid out to form a first adhesive sensor layer to form a first central portion, a first outer rim portion and / or a first inner rim portion as described above.

[0057] The first adhesive sensor layer may include a hydrocolloid. The hydrocolloid disposed along the first outer periphery of the first adhesive sensor layer, e.g., the hydrocolloid disposed in the first outer rim portion, may have a first outer rim average particle size and / or a first outer rim maximum particle size. The hydrocolloid disposed in the first central portion may have a first central average particle size and / or a first central maximum particle size. The hydrocolloid disposed on the first inner periphery of the first adhesive sensor layer, e.g., the hydrocolloid disposed in the first inner rim portion, may have a first inner rim average particle size and / or a first inner rim maximum particle size. The average particle size of the hydrocolloid may be less than 0.2 mm, e.g., less than 0.1 mm. The maximum particle size of the hydrocolloid may be less than 0.3 mm, e.g., less than 0.2 mm, e.g., less than 0.1 mm. The average particle size of the first outer rim may be less than 0.2 mm, e.g., less than 0.1 mm. The maximum grain size of the first outer rim may be less than 0.3 mm, such as less than 0.2 mm, for example less than 0.1 mm. The average grain size of the first inner rim may be less than 0.2 mm, for example less than 0.1 mm. The maximum grain size of the first inner rim may be less than 0.3 mm, such as less than 0.2 mm, for example less than 0.1 mm. The first central average grain size may be less than 0.2 mm, for example less than 0.1 mm. The first central maximum grain size may be less than 0.3 mm, such as less than 0.2 mm, for example less than 0.1 mm.

[0058] The hydrocolloids may be arranged such that the first outer rim average / maximum particle size and / or the first inner rim average / maximum particle size are less than the central average / maximum particle size. For example, the first outer rim average / maximum particle size and / or the first inner rim average / maximum particle size may be less than half the central average / maximum particle size. Alternatively, the first outer rim average / maximum particle size, the first inner rim average / maximum particle size and the central average / maximum particle size may be substantially the same.

[0059] The hydrocolloid may be sorted to achieve a smaller grain size, for example to allow the outer and / or inner periphery of the first adhesive sensor layer to be thinner. Providing the first adhesive sensor material to form the first adhesive sensor layer may include sorting the hydrocolloid of the first adhesive sensor material according to grain size. For example, sorting the hydrocolloid of the first adhesive sensor material may include sorting the hydrocolloid to achieve an average / maximum grain size of the hydrocolloid of less than 0.3 mm, for example less than 0.2 mm, for example less than 0.1 mm. Thereby, the properties of the hydrocolloid are retained despite the thickness of the adhesive containing the hydrocolloid being reduced. Alternatively or additionally, laying out the layer of the first adhesive sensor material may include laying out the layer of the first adhesive sensor material to form a first central portion having hydrocolloids with a first central average / maximum grain size, laying out the layer of the first adhesive sensor material to form a first outer rim portion having hydrocolloids with a first outer rim average / maximum grain size, and / or laying out the layer of the first adhesive sensor material to form a first inner rim portion having hydrocolloids with a first inner rim average / maximum grain size.

[0060] Laying out the layer of the first adhesive sensor material to form the first adhesive sensor layer may include extruding the first adhesive sensor layer. Alternatively or in addition, laying out the layer of the first adhesive sensor material to form the first adhesive sensor layer may include molding, e.g., injection molding, the first adhesive sensor layer. The mold may have a non-planar surface shaped to provide the shape of the first outer rim, the first central portion and / or the first inner rim in accordance with the above. Alternatively or in addition, laying out the layer of the first adhesive sensor material to form the first adhesive sensor layer may include smoothing the first adhesive sensor material on a non-planar surface, e.g., on a distal surface of a first release liner or a proximal surface of a sensor assembly shaped to provide the contour of the first outer rim, the first central portion and / or the first inner rim in accordance with the above.

[0061] In some embodiments, the sensor patch includes a second adhesive sensor layer having, for example, a proximal side and a distal side. The second adhesive sensor layer can be disposed on the distal side of the sensor assembly. The distal side of the second adhesive sensor layer can be configured to adhere to a proximal surface of the base plate, for example, to a 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, for example, the first composition, the second composition, the third composition, or the fourth composition. The fourth composition can include one or more polyisobutenes and / or styrene-isoprene-styrene. The fourth composition can include one or more hydrocolloids. The fourth composition can include one or more water-soluble or water-swellable hydrocolloids. The fourth composition can be a pressure-sensitive adhesive composition suitable for medical purposes, including a rubbery elastomer base and one or more water-soluble or water-swellable hydrocolloids. The second adhesive sensor material can be the same as the first adhesive sensor material. The second adhesive sensor layer, when placed distal to the sensor assembly, can provide a symmetrical sensor patch with each side of the sensor patch adhering to the skin surface, or the second adhesive sensor layer can serve to encapsulate the sensor assembly.

[0062] The second adhesive sensor layer may include a second central portion. The second central portion may have a second central thickness. The second adhesive sensor layer may include a second outer rim portion surrounding the second central portion. The second outer rim portion may have a second outer rim thickness that decreases, for example, along a radial direction from adjacent the second central portion of the second adhesive sensor layer to the second outer periphery. The second outer rim thickness may decrease in a convex, concave or substantially linear manner along a radial direction from adjacent the second central portion of the second adhesive sensor layer to the second outer periphery. The second outer rim thickness adjacent the second central portion may be a second central thickness. The second outer rim thickness at the second outer periphery of the second adhesive sensor layer may be a second minimum outer rim thickness. The second central thickness may be between 0.5 mm and 1.5 mm. The second minimum outer rim thickness may be less than 0.5 mm, for example less than 0.4 mm, for example less than 0.3 mm, for example less than 0.1 mm. The radial distance from the center point to the second outer rim portion adjacent the second central portion may be 15-35mm. The radial distance from the second outer rim portion adjacent the second central portion of the second adhesive sensor layer to the second outer periphery may be 0.5-25mm. The radial distance from the second center point to the second outer periphery of the second adhesive sensor layer may be 15.5-60mm, such as 20-50mm, for example 25-40mm, for example 30-35mm.

[0063] The second adhesive sensor layer may surround an opening, for example a stoma opening and / or an opening larger than the stoma opening. The second adhesive sensor layer may have a second inner rim portion surrounded by a second central portion. The second inner rim portion may have a second inner rim thickness that increases along a radial direction from the second inner circumference of the second adhesive sensor layer to the second central portion. The second inner rim thickness may increase radially from the second inner circumference of the second adhesive sensor layer to the second central portion in a convex, concave or substantially linear manner. The second inner rim thickness adjacent the second central portion may be a second central thickness. The second inner rim thickness at the second inner circumference of the second adhesive sensor layer may be a second minimum inner rim thickness. The second minimum inner rim 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 central point to the second inner rim portion adjacent the second central portion may be between 10 and 30 mm. The radial distance from the second inner circumference of the second adhesive sensor layer to the second central portion, e.g. the second central portion adjacent to the second inner rim portion, may be 0.5-20 mm. The radial distance from the center point to the second central portion, e.g. the second central portion adjacent to the second inner rim portion, may be 10.5-50 mm, such as 15-40 mm, for example 20-35 mm, for example 20-30 mm.

[0064] In manufacturing the sensor patch, a second adhesive sensor material may be provided and a layer of the second adhesive sensor material may be laid out to form a second adhesive sensor layer to form a second central portion, a second outer rim portion and / or a second inner rim portion in accordance with the above.

[0065] The second adhesive sensor layer may include a hydrocolloid. The hydrocolloid disposed along the second outer periphery of the second adhesive sensor layer, e.g., the hydrocolloid disposed in the second outer rim portion, may have a second outer rim average particle size and / or a second outer rim maximum particle size. The hydrocolloid disposed in the second central portion may have a second central average particle size and / or a second central maximum particle size. The hydrocolloid disposed along the second inner periphery of the second adhesive sensor layer, e.g., the hydrocolloid disposed in the second inner rim portion, may have a second inner rim average particle size and / or a second inner rim maximum particle size. The average particle size of the hydrocolloid may be less than 0.2 mm, e.g., less than 0.1 mm. The maximum particle size of the hydrocolloid may be less than 0.3 mm, e.g., less than 0.2 mm, e.g., less than 0.1 mm. The second outer rim average particle size may be less than 0.2 mm, e.g., less than 0.1 mm. The second outer rim maximum grain 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 rim average grain size may be less than 0.2 mm, such as less than 0.1 mm. The second inner rim maximum grain size may be less than 0.3 mm, such as less than 0.2 mm, such as less than 0.1 mm. The second central average grain size may be less than 0.2 mm, such as less than 0.1 mm. The second central maximum grain size may be less than 0.3 mm, such as less than 0.2 mm, such as less than 0.1 mm.

[0066] The hydrocolloids may be arranged such that the second outer rim average / maximum particle size and / or the second inner rim average / maximum particle size are less than the central average / maximum particle size. For example, the second outer rim average / maximum particle size and / or the second inner rim average / maximum particle size may be less than half the central average / maximum particle size. Alternatively, the second outer rim average / maximum particle size, the second inner rim average / maximum particle size and the central average / maximum particle size may be substantially the same.

[0067] Providing the second adhesive sensor material to form the second adhesive sensor layer may include sorting the hydrocolloids of the second adhesive sensor material according to particle size. For example, sorting the hydrocolloids of the second adhesive sensor material may include sorting the hydrocolloids to achieve an average / maximum particle size of the hydrocolloids less than 0.3 mm, such as less than 0.2 mm, such as less than 0.1 mm. Alternatively or additionally, laying out the layer of the second adhesive sensor material may include laying out the layer of the second adhesive sensor material to form a second central portion having hydrocolloids with a second central average / maximum particle size, laying out the layer of the second adhesive sensor material to form a second outer rim portion having hydrocolloids with a second outer rim average / maximum particle size, and / or laying out the layer of the second adhesive sensor material to form a second inner rim portion having hydrocolloids with a second inner rim average / maximum particle size.

[0068] Laying out a layer of the second adhesive sensor material to form the second adhesive sensor layer may include extruding the second adhesive sensor layer. Alternatively or in addition, laying out a layer of the second adhesive sensor material to form the second adhesive sensor layer may include molding, e.g., injection molding, the second adhesive sensor layer. The mold may have a non-planar surface shaped to provide the shape of the second outer rim, the second central portion and / or the second inner rim in accordance with the above. Alternatively or in addition, laying out a layer of the second adhesive sensor material to form the second adhesive sensor layer may include smoothing the second adhesive sensor material on a non-planar surface, e.g., on a proximal surface of a second release liner or a distal surface of a sensor assembly shaped to provide the contours of the second outer rim, the second central portion and / or the second inner rim in accordance with the above.

[0069] A sensor assembly including a plurality of electrodes may be disposed on the distal side of the first adhesive sensor layer and / or on the proximal side of the second adhesive sensor layer. The plurality of electrodes of the sensor assembly may be disposed relative to the inner and / or outer rim portions of the first adhesive sensor layer and / or the second adhesive sensor layer. In particular, the plurality of electrodes may be disposed, for example, to measure portions of the adhesive layer where the adhesive layer has a substantially uniform thickness. Such an arrangement may facilitate the reliability of the measurement and / or the interpretation of the subsequent measurements. The plurality of electrodes of the sensor assembly may, for example, form loops surrounding a central point, for example, open loops or closed loops. The first electrode may form a first loop, the second electrode may form a second loop, the third electrode may form a third loop, the fourth electrode may form a fourth loop, the fifth electrode may form a fifth loop, and / or the sixth electrode may form a sixth loop. An electrode, e.g., a first electrode, may form multiple loops, e.g., the first electrode may form multiple first loops, e.g., including a first primary loop, a first secondary loop, a first tertiary loop, etc.

[0070] The radial distance from the center point to the first loop formed by the first electrode, the second loop formed by the second electrode, the third loop formed by the third electrode, the fourth loop formed by the fourth electrode, the fifth loop formed by the fifth electrode, and / or the sixth loop formed by the sixth electrode may be less than the radial distance from the center point to the first outer rim portion, e.g., the first outer rim portion adjacent to the first central portion. The radial distance from the center point to the first loop formed by the first electrode, the second loop formed by the second electrode, the third loop formed by the third electrode, the fourth loop formed by the fourth electrode, the fifth loop formed by the fifth electrode, and / or the sixth loop formed by the sixth electrode may be greater than the radial distance from the center point to the first inner rim portion, e.g., the first inner rim portion adjacent to the first central portion.

[0071] The radial distance from the center point to the first loop formed by the first electrode, the second loop formed by the second electrode, the third loop formed by the third electrode, the fourth loop formed by the fourth electrode, the fifth loop formed by the fifth electrode, and / or the sixth loop formed by the sixth electrode may be less than the radial distance from the center point to a second outer rim portion, e.g., the second outer rim portion adjacent to the second central portion. The radial distance from the center point to the first loop formed by the first electrode, the second loop formed by the second electrode, the third loop formed by the third electrode, the fourth loop formed by the fourth electrode, the fifth loop formed by the fifth electrode, and / or the sixth loop formed by the sixth electrode may be greater than the radial distance from the center point to a second inner rim portion, e.g., the second inner rim portion adjacent to the second central portion.

[0072] The radial distance from the center point to the second loop may be less than the radial distance from the center point to the first loop. The radial distance from the center point to the third loop may be less than the radial distance from the center point to the second loop. The radial distance from the center point to the fourth loop may be less than the radial distance from the center point to the third loop. The radial distance from the center point to the fifth loop may be less than the radial distance from the center point to the fourth loop. The radial distance from the center point to the sixth loop may be less than the radial distance from the center point to the fifth loop.

[0073] The sensor patch can include one or more sensor release liners, such as a first sensor release liner and / or a second sensor release liner.

[0074] The first sensor release liner can include a distal surface and a proximal surface. The first sensor release liner can be positioned to protect the first adhesive sensor layer, e.g., the distal surface of the first sensor release liner can face the proximal surface of the first adhesive sensor layer. The first sensor release liner can be configured to be peeled off by a user prior to applying the base plate with the attached sensor patch to the skin. A layer of a first adhesive sensor material can be laid out on the distal side of the first sensor release liner.

[0075] The second sensor release liner can include a distal surface and a proximal surface. The second sensor release liner can be positioned to protect the second adhesive sensor layer, e.g., the proximal surface of the second sensor release liner can face the distal surface of the second adhesive sensor layer. The second sensor release liner can be configured to be peeled off by a user prior to attaching the sensor patch to the base plate. A layer of a second adhesive sensor material can be laid out on the proximal side of the second sensor release liner.

[0076] The sensor patch may include a monitor interface. The monitor interface may be configured to electrically and / or mechanically connect the sensor patch, e.g., the electrodes of the sensor patch, to a monitoring device. The monitor interface may be configured to wirelessly connect the sensor patch, e.g., the 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.

[0077] The sensor patch of the present disclosure may be combined with a base plate to form, for example, a monolithic one-piece base plate integrated with a sensor assembly portion, for example, as described above. For example, the base plate may include a sensor assembly, for example, as described with respect to the sensor patch. For example, the sensor assembly may be positioned between a first adhesive layer and a second adhesive layer. A distal surface of the first adhesive layer may face a proximal side of the sensor assembly, and / or a distal side of the sensor assembly may face a proximal side of the second adhesive layer. For example, the first adhesive layer and / or the second adhesive layer of the base plate may be provided as described for the first adhesive sensor layer and / or the second adhesive sensor layer, respectively.

[0078] The radial distance from the center point to the first loop formed by the first electrode, the second loop formed by the second electrode, the third loop formed by the third electrode, the fourth loop formed by the fourth electrode, the fifth loop formed by the fifth electrode, and / or the sixth loop formed by the sixth electrode may be less than the radial distance from the center point to an outer rim portion of the first adhesive layer and / or the second adhesive layer, such as an outer rim portion adjacent to a central portion of the first adhesive layer and / or the second adhesive layer. The radial distance from the center point to the first loop formed by the first electrode, the second loop formed by the second electrode, the third loop formed by the third electrode, the fourth loop formed by the fourth electrode, the fifth loop formed by the fifth electrode, and / or the sixth loop formed by the sixth electrode may be greater than the radial distance from the center point to an inner rim portion of the first adhesive layer and / or the second adhesive layer, such as an inner rim portion adjacent to a central portion of the first adhesive layer and / or the second adhesive layer.

[0079] 1 illustrates generally 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 a 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 that the proximal surface 202 of the second adhesive layer 202 provides a rim that surrounds the proximal surface 200 of the first adhesive layer 200.

[0080] The base plate 4 includes a release liner 206 that can be peeled off by a user prior to application of 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.

[0081] The base plate 4 includes a backing layer 208. The backing layer 208 is a protective layer that protects the adhesive layers, e.g., the first adhesive layer 200 and / or the second adhesive layer 202, from external strain and stress during use. In addition, the backing layer 208 also covers the adhesive layers, e.g., the first adhesive layer 200 and / or the second adhesive layer 202, to prevent the adhesive layers 200, 202 from adhering to clothing worn on top of the base plate 4. The backing layer 208 includes a distal surface 208A and a proximal surface 208B. The distal surface 208A of the backing layer 208 is configured to face away from the skin of the user. The proximal surface 208B of the backing layer 208 covers the second adhesive layer 202.

[0082] The base plate 4 includes a connection ring 209 for coupling an ostomy pouch to the base plate 4, for example, on the distal side of the base plate 4, since the base plate 4 is a two-piece ostomy appliance.

[0083] The base plate 4 includes 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 shown, may each include a stoma opening 18 for collectively forming the stoma opening of the base plate.

[0084] 2 illustrates a schematic exploded view of an exemplary sensor patch 50, e.g., a sensor patch 50 adapted to be attached to a base plate, e.g., the base plate 4 as shown in FIG. 1. The sensor patch 50 is configured to be positioned between a user's skin and a proximal side of the base plate 4. For example, the sensor patch may be adapted to be attached to a first adhesive layer 200 of the base plate 4, e.g., a proximal surface 200B of the first adhesive layer 200. The sensor patch 50 is configured to be attached to the base plate such that a distal side 50A of the sensor patch 50 is attached to a proximal side of the base plate, e.g., a proximal surface 200B of the first adhesive layer 200 of the base plate 4.

[0085] The sensor patch 50 includes a sensor assembly 204 that includes a plurality of electrodes 216. Each electrode 216 has a respective connection 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.

[0086] 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 electrodes 216 may be provided, e.g., formed, on the proximal surface 214B of the support layer 214 such that the electrodes 216 may be positioned on the proximal surface 214B of the support layer 214.

[0087] The electrode assembly 204 includes a masking element 218 having a distal surface 218A and a proximal surface 218B. The masking element 218 is configured to electrically insulate at least portions of the electrode 216 from adjacent layers, such as the first adhesive sensor layer 52. The masking element 218 covers or overlaps portions of the electrode 216 when viewed axially.

[0088] 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 a user. Thus, after being affixed to the base plate, the combined base plate and sensor patch 50 form an adhesive proximal surface configured to be affixed to a skin surface of a user.

[0089] 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 positioned 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 a user prior to applying the base plate with the attached sensor patch to the skin. The first adhesive sensor layer 52 may be laid out on the distal side 54A of the first sensor release liner 54.

[0090] The sensor patch 50 includes a second adhesive sensor layer 56 having a proximal side 56B and a distal side 56A. The second adhesive sensor layer 56 is disposed on the distal side 204A of the sensor assembly 204. The proximal side 56B of the second adhesive sensor layer 52 is configured to adhere to a base plate, for example, a proximal surface of the first adhesive layer of the base plate.

[0091] The exemplary sensor patch includes a second sensor release liner 58. The second sensor release liner 58 can include a distal surface 58A and a proximal surface 58B. The second sensor release liner 58 can be positioned 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 prior to application of the sensor patch to a base plate. The second adhesive sensor layer 56 can be laid out on the proximal side 58B of the second sensor release liner 58.

[0092] While 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 alternative sensor patches may be provided in accordance with the present disclosure that lack such a second adhesive sensor layer 56 and associated second sensor release liner 58. Rather, in such alternative sensor patches, it is contemplated that the distal surface of the sensor patch is the distal surface of the sensor assembly 204, and in particular the distal surface of the support layer 214. In such alternative sensor patches, the distal surface of the support layer 214 may be configured for attachment to an adhesive surface of a base plate. Thus, while a sensor patch 50 having a first adhesive sensor layer 52 and a second adhesive sensor layer 56 is shown and described, it is contemplated that a similar sensor patch may be provided in accordance with the present disclosure that lacks the second adhesive sensor layer 56 and associated second sensor release liner 58.

[0093] 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 each include a stoma opening 60 to collectively form a 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, for example, to collectively form a stoma opening of the combined base plate and sensor patch 50.

[0094] 3 illustrates generally an exemplary electrode configuration 220 of the electrodes 216 of an exemplary sensor assembly, such as the sensor assembly 204 described with respect to FIG. 2. The 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.

[0095] 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.

[0096] The first electrode 222 may be a common ground electrode to form a sensor for 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.

[0097] 4 shows a schematic cross-sectional view of a sensor patch 50, such as the sensor patch 50 described in relation to FIG. 2. For purposes of illustration, the layers of the sensor patch 50 are shown separated. The sensor patch 50 includes a stoma opening 60 having a center point 19. In some exemplary sensor patches, the stoma opening 60 may be user-created, i.e., the sensor patch may be manufactured and / or sold without a stoma opening 60, but with an area that is adapted to form a stoma opening 60 having a center point 19.

[0098] 2, 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. In particular, while the illustrated exemplary sensor patch 50 includes a second adhesive sensor layer 56 disposed distal to the sensor assembly 204, it is envisioned that alternative sensor patches according to the present disclosure may be provided without such a second adhesive sensor layer 56 and associated second sensor release liner 58. Rather, in such alternative sensor patches, the distal surface of the sensor patch may be the distal surface of the sensor assembly 204.

[0099] The first adhesive sensor layer 52 includes a first central portion 62. The first adhesive sensor layer 52 includes a first outer rim portion 64. The first adhesive sensor layer 52 includes a first inner rim portion 66. The first central portion 62 surrounds the first inner rim portion 66. The first outer rim portion 64 surrounds the first central portion 62. The first outer rim portion 64 and the first inner rim 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 a decrease / increase in thickness of the first outer rim portion 64 and the first inner rim portion 66.

[0100] The radial distance D82 of the first outer rim portion 64 is from the first outer rim portion 64 adjacent the first central portion 62 of the first adhesive sensor layer 52 to the first outer periphery 68. The radial distance D86 of the first inner rim portion 66 is from the first inner periphery 69 of the first adhesive sensor layer 52 to the first central portion 62, e.g., the first central portion 62 adjacent the first inner rim portion 66. Also shown is the radial distance D84 from the center point 19 to the first central portion 62 adjacent the first inner rim portion 66. Also shown is the radial distance D80 from the center point 19 to the first outer rim portion 64 adjacent the first central portion 62.

[0101] The first central portion 62 has a first central thickness D62. The first outer rim portion 64 has a first outer rim thickness that decreases radially from adjacent the first central portion 62 to the first outer periphery 68 of the first adhesive sensor layer 52. The first outer rim thickness adjacent the first central portion 62 is the first central thickness D62. The first outer rim thickness at the first outer periphery 68 of the first adhesive sensor layer 52 is a first minimum outer rim thickness D68.

[0102] The first inner rim portion 66 has a first inner rim thickness that increases radially from the first inner circumference 69 of the first adhesive sensor layer 52 to the first central portion 62. The first inner rim thickness adjacent the first central portion 62 is a first central thickness D62, and the first inner rim thickness at the first inner circumference 69 of the first adhesive sensor layer 52 is a first minimum inner rim thickness D69.

[0103] The second adhesive sensor layer 56 includes a second central portion 72. The second adhesive sensor layer 56 includes a second outer rim portion 74. The second adhesive sensor layer 56 includes a second inner rim portion 76. The second central portion 72 surrounds the second inner rim portion 76. The second outer rim portion 74 surrounds the second central portion 72.

[0104] The radial distance D92 of the second outer rim portion 74 is from the second outer rim portion 74 adjacent the second central portion 72 of the second adhesive sensor layer 56 to the second outer periphery 78. The radial distance D96 of the second inner rim portion 76 is from the second inner periphery 79 of the second adhesive sensor layer 56 to the second central portion 72 adjacent the second inner rim portion 76. Also shown is the radial distance D94 from the center point 19 to the second central portion 72 adjacent the second inner rim portion 76. Also shown is the radial distance D90 from the center point 19 to the second outer rim portion 74 adjacent the second central portion 72.

[0105] The second central portion 72 has a second central thickness D72. The second outer rim portion 74 has a second outer rim thickness that decreases radially from adjacent the second central portion 72 to the second outer periphery 78 of the second adhesive sensor layer 56. The second outer rim thickness adjacent the second central portion 72 is the second central thickness D72. The second outer rim thickness at the second outer periphery 78 of the second adhesive sensor layer 56 is a second minimum outer rim thickness D78.

[0106] The second inner rim portion 76 has a second inner rim thickness that increases radially from the second inner circumference 79 of the second adhesive sensor layer 56 to the second central portion 72. The second inner rim thickness adjacent the second central portion 72 is a second central thickness D72, and the second inner rim thickness at the second inner circumference 79 of the second adhesive sensor layer 56 is a second minimum inner rim thickness D79.

[0107] In the illustrative examples, the first outer rim thickness, the first inner rim thickness, the second outer rim thickness, and the second inner rim thickness are shown to decrease / increase in a substantially linear manner. Alternatively, one or more of the first outer rim thickness, the first inner rim thickness, the second outer rim thickness, and the second inner rim thickness may decrease / increase in a convex or concave manner along the radial direction.

[0108] A radial distance D10 from the center point to a first loop formed by a first electrode of the plurality of electrodes 216 is less than a radial distance D80 from the center point 19 to the first outer rim portion 64, e.g., the first outer rim portion 64 adjacent to the first central portion 62. A radial distance D10 from the center point to the first loop is less than a radial distance D90 from the center point 19 to the second outer rim portion 74, e.g., the second outer rim portion 74 adjacent to the second central portion 72.

[0109] A radial distance D12 from the center point to a second loop formed by a second electrode of the plurality of electrodes 216 is less than a radial distance D80 from the center point 19 to the first outer rim portion 64, e.g., the first outer rim portion 64 adjacent to the first central portion 62. A radial distance D12 from the center point to the second loop is less than a radial distance D90 from the center point 19 to the second outer rim portion 74, e.g., the second outer rim portion 74 adjacent to the second central portion 72. A radial distance D12 from the center point to the second loop is less than a radial distance D10 from the center point to the first loop.

[0110] A radial distance D14 from the center point to a third loop 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 rim portion 64, e.g., the first outer rim portion 64 adjacent to the first central portion 62. The radial distance D14 from the center point to the third loop is less than a radial distance D90 from the center point 19 to the second outer rim portion 74, e.g., the second outer rim portion 74 adjacent to the second central portion 72. The radial distance D14 from the center point to the third loop is less than the radial distance D12 from the center point to the second loop.

[0111] FIG. 5 is a schematic block diagram of an example method 1000 for manufacturing a sensor patch, such as a sensor patch as described with respect to one or more of the figures above.

[0112] The method 1000 includes providing 1002 a first adhesive sensor material and laying out 1004 a layer of the first adhesive sensor material to form a first adhesive sensor layer of the sensor patch. The first adhesive sensor material is laid out 1004 to form a first central portion and a first outer rim portion surrounding the first central portion, where the first central portion has a first central thickness and the first outer rim portion has a first outer rim thickness that gradually decreases along a radial direction from adjacent the first central portion to a first outer periphery of the first adhesive sensor layer. Further, the first adhesive sensor material is laid out 1004 such that the first outer rim thickness adjacent the first central portion is the first central thickness and the first outer rim thickness at the first outer periphery of the first adhesive sensor layer is a first minimum outer rim thickness. Laying out the first adhesive sensor material 1004 may further include forming a first inner rim portion surrounded by a first central portion, and the first inner rim portion having a first outer rim thickness that gradually increases along a radial direction from a first inner circumference of the first adhesive sensor layer to the first central portion adjacent the first inner rim portion.

[0113] Laying out 1004 a first layer of adhesive sensor material to form a first adhesive sensor layer may include extruding the first adhesive sensor layer, molding, e.g., injection molding, the first adhesive sensor layer, and / or smoothing the first adhesive sensor layer on a defined surface. Laying out 1004 a first layer of adhesive sensor material may include post-processing to form or improve a rim portion.

[0114] The method 1000 includes providing 1006 a sensor assembly including a plurality of electrodes, such as a sensor assembly as described with respect to the figures above. The electrodes include at least a first electrode and a second electrode to form a first sensor.

[0115] The method 1000 includes disposing 1008 a sensor assembly on a distal side of a first adhesive sensor layer, a proximal side of the first adhesive sensor layer adapted to attach the sensor patch to a skin surface of a user.

[0116] Method 1000 optionally includes providing 1010 a first sensor release liner. Laying out 1004 a layer of a first adhesive sensor material may include laying out 1004 a layer of a first adhesive sensor material on a distal side of the first sensor release liner.

[0117] Providing 1002 the first adhesive sensor material may optionally include sorting the hydrocolloid of the first adhesive sensor material according to particle size 1012. For example, sorting 1012 the hydrocolloid may be performed to achieve a smaller average and / or maximum particle size, e.g., to provide a thinner rim portion of the first adhesive layer. Alternatively or additionally, laying out the layer of the first adhesive sensor material 1004 may include laying out the layer of the first adhesive sensor material to form a first central portion having hydrocolloids with a first central average grain size and / or a first central maximum grain size, and laying out the layer of the first adhesive sensor material to form a first outer rim portion and / or a first inner rim portion having hydrocolloids with a first outer rim average grain size and / or a first outer rim average grain size and / or a first inner rim average grain size and / or a first inner rim average grain size, respectively, where the first outer rim average / maximum grain size and / or the first inner rim average / maximum grain size are less than the first central average / maximum grain size, whereby the first rim portion may achieve a thinner thickness at the periphery than the first central portion, for example.

[0118] In some embodiments, the method 1000 may include providing 1102 a second adhesive sensor material and laying out 1104 a layer of the second adhesive sensor material to form a second adhesive sensor layer of the sensor patch. While the described / disclosed method includes providing 1102 a second adhesive sensor material to form a second adhesive sensor layer, it is envisioned that an alternative method omits the steps associated with 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 only has the first adhesive sensor layer. The second adhesive sensor material is laid out 1104 to form a second central portion and a second outer rim portion surrounding the second central portion, where the second central portion has a second central thickness, and the second outer rim portion has a second outer rim thickness that gradually decreases along a radial direction from adjacent the second central portion to the second outer periphery of the second adhesive sensor layer. Additionally, the second adhesive sensor material is laid out such that a second outer rim thickness adjacent the second central portion is a second central thickness, and a second outer rim thickness at a second outer periphery of the second adhesive sensor layer is a second minimum outer rim thickness 1104. The layout 1104 of the second adhesive sensor material may further include forming a second inner rim portion surrounded by the second central portion, and the second inner rim portion has a second outer rim thickness that gradually increases along a radial direction from the second inner periphery of the second adhesive sensor layer to the second central portion adjacent the second inner rim portion.

[0119] Laying out 1104 the layer of the second adhesive sensor material to form the second adhesive sensor layer may include extruding the second adhesive sensor layer, molding, e.g., injection molding, the second adhesive sensor layer, and / or smoothing the second adhesive sensor layer on the defined surface. Laying out 1104 the layer of the second adhesive sensor material may include post-processing to form or improve a rim portion.

[0120] The method 1000 optionally includes providing 1110 a second sensor release liner. Laying out 1104 the layer of second adhesive sensor material may include laying out 1104 the layer of second adhesive sensor material on a proximal side of the second sensor release liner.

[0121] Providing 1102 the second adhesive sensor material may optionally include sorting 1112 the hydrocolloids of the second adhesive sensor material according to grain size. For example, sorting 1112 the hydrocolloids may be performed to achieve a smaller average and / or maximum grain size, for example, to provide a thinner rim portion of the second adhesive layer. Alternatively or additionally, laying out 1104 the layer of the second adhesive sensor material may include laying out the layer of the second adhesive sensor material to form a second central portion having hydrocolloids with a second central average / maximum grain size, and laying out the layer of the second adhesive sensor material to form a second outer rim portion and / or a second inner rim portion having hydrocolloids with a second outer rim average / maximum grain size and / or a second inner rim average / maximum grain size, respectively, where the second outer rim average / maximum grain size and / or the second inner rim average / maximum grain size are less than the second central average / maximum grain size. Thereby, the second rim portion may, for example, achieve a thinner thickness at the periphery than the second central portion.

[0122] Providing a sensor patch with a thinner outer rim and / or thicker inner rim of adhesive 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 reducing the risk of potential creases between the user's skin and the adhesive surfaces of the sensor patch and base plate. Creases between the adhesive surfaces and the user's skin can weaken the adhesion and increase the risk of leakage. Thus, by providing a thinner outer rim and / or a thicker inner rim, the risk of leakage due to the sensor patch can be reduced.

[0123] Although specific embodiments have been shown and described herein, it will be understood by those skilled in the art that various alternative and / or equivalent implementations may be substituted for the specific embodiments shown and described without departing from the scope of the present invention. This application is intended to cover any modifications or variations of the body-side members for ostomy appliances as described herein. Accordingly, the present invention is to be limited only by the claims and their equivalents.

Claims

1. 1. A sensor patch for attachment to a base plate for an ostomy appliance, the sensor patch having a proximal side and a distal side, the distal side adapted for attachment to an adhesive surface of the base plate, the adhesive surface of the base plate adapted for attachment of the base plate to a skin surface of a user, the sensor patch comprising: a sensor assembly including a plurality of electrodes, including a first electrode and a second electrode, to form a first sensor; a 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 including a first central portion having a first central thickness and a first outer rim portion surrounding the first central portion, the first outer rim portion having a first outer rim thickness decreasing radially from a portion adjacent the first central portion to a first outer rim thickness of the first adhesive sensor layer, the first outer rim thickness adjacent the first central portion being the first central thickness, and the first outer rim thickness at the first outer rim thickness of the first adhesive sensor layer being a first minimum outer rim thickness; Including, The sensor patch is adapted to form a stoma opening having a central point, the stoma opening being configured to allow waste material to pass through the stoma opening and into an ostomy pouch attached to the base plate.

2. The sensor patch of claim 1 , wherein the first center thickness is between 0.5 mm and 1.5 mm.

3. The sensor patch of claim 1 or 2, wherein the first minimum outer rim thickness is less than 0.5 mm.

4. The sensor patch of any one of claims 1 to 3, wherein a radial distance from the centre point to the first outer rim portion adjacent the central portion is between 15 and 35 mm.

5. The sensor patch of any one of claims 1 to 4, wherein a radial distance from the first outer rim portion adjacent the central portion of the first adhesive sensor layer to the first outer periphery is between 0.5 and 20 mm.

6. 6. The sensor patch of claim 1, wherein the first adhesive sensor layer has a first inner rim portion surrounded by the first central portion, the first inner rim portion having a first inner rim thickness that increases radially from a first inner circumference of the first adhesive sensor layer to the first central portion, the first inner rim thickness adjacent the first central portion being the first central thickness, and the first inner rim thickness at the first inner circumference of the first adhesive sensor layer being a first minimum inner rim thickness.

7. The sensor patch of claim 6 , wherein the first minimum inner rim thickness is less than 0.5 mm.

8. The sensor patch of any preceding claim, wherein a radial distance from the centre point to the first central portion adjacent the first inner rim portion is between 10 and 30 mm.

9. The sensor patch of any one of claims 1 to 8, wherein a radial distance of the first inner rim portion from the first inner circumference to the first central portion of the first adhesive sensor layer is between 0.5 and 20 mm.

10. The sensor patch of any one of claims 1 to 9, wherein the first adhesive sensor layer comprises a hydrocolloid.

11. 11. The sensor patch of claim 10, wherein the hydrocolloid is arranged such that the hydrocolloid disposed along the first periphery of the first adhesive sensor layer has a first outer rim average grain size and the hydrocolloid disposed in the first central portion has a first central average grain size, the first outer rim average grain size being less than the first central average grain size.

12. The sensor patch of claim 11 , wherein the first outer rim average grain size is less than half of the first central average grain size.

13. The sensor patch of any one of claims 10 to 12, wherein the hydrocolloid has an average particle size of less than 0.2 mm.

14. 14. The sensor patch of claim 1, further comprising a first sensor release liner disposed to protect the first adhesive sensor layer and configured to be peeled off by the user prior to application of the base plate with the attached sensor patch to skin.

15. 15. A sensor patch as described in any one of claims 1 to 14, wherein the first electrode forms a first loop surrounding the center point, and a radial distance from the center point to the first loop is less than the radial distance from the center point to the first outer rim portion.

16. 16. The sensor patch of claim 15, wherein the second electrode forms a second loop surrounding the center point, and a radial distance from the center point to the second loop is less than the radial distance from the center point to the first loop.

17. 17. The sensor patch of claim 1, wherein the first outer rim thickness decreases convexly along the radial direction from adjacent the first central portion of the first adhesive sensor layer to the first outer periphery.

18. 17. The sensor patch of claim 1, wherein the first outer rim thickness decreases concavely along the radial direction from adjacent the first central portion of the first adhesive sensor layer to the first outer periphery.

19. 17. The sensor patch of claim 1, wherein the first outer rim thickness decreases substantially linearly along the radial direction from adjacent the first central portion of the first adhesive sensor layer to the first outer periphery.

20. 1. A method of manufacturing 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 for an ostomy appliance, the adhesive surface of the base plate adapted to attach the base plate to a skin surface of a user, the method comprising: - providing a first adhesive sensor material; - laying out the first layer of adhesive sensor material to form a first adhesive sensor layer of the sensor patch, the first adhesive sensor material being laid out to form a first central portion and a first outer rim portion surrounding the first central portion, the first central portion having a first central thickness, and the first outer rim portion having a first outer rim thickness that gradually decreases along a radial direction from adjacent the first central portion to a first outer rim thickness of the first adhesive sensor layer, the first outer rim thickness adjacent the first central portion being the first central thickness, and the first outer rim thickness at the first outer rim thickness of the first adhesive sensor layer being a first minimum outer rim thickness; providing a sensor assembly including a plurality of electrodes, including a first electrode and a second electrode, to form a first sensor; - disposing the sensor assembly on a distal side of the first adhesive sensor layer, a proximal side of the first adhesive sensor layer adapted to attach the sensor patch to the skin surface of the user; A method comprising:

21. 21. The method of claim 20, comprising providing a first sensor release liner, and wherein laying out the layer of the first adhesive sensor material comprises laying out the layer of the first adhesive sensor material on a distal side of the first sensor release liner.

22. 22. The method of claim 20 or 21, wherein providing the first adhesive sensor material comprises sorting hydrocolloids of the first adhesive sensor material according to particle size.

23. 23. The method of claim 22, wherein laying out the layer of the first adhesive sensor material includes laying out the layer of the first adhesive sensor material to form the first central portion having a hydrocolloid having a first central average grain size, and laying out the layer of the first adhesive sensor material to form the first outer rim portion having a hydrocolloid having a first outer rim average grain size, the first outer rim average grain size being less than the first central average grain size.

24. 24. The method of claim 22 or 23, wherein screening the hydrocolloid comprises screening the hydrocolloid to achieve an average particle size of the hydrocolloid of less than 0.2 mm.

25. 25. The method of any one of claims 20 to 24, wherein laying out the layer of the first adhesive sensor material to form the first adhesive sensor layer comprises extruding the first adhesive sensor layer.

26. 26. The method of any one of claims 20 to 25, wherein laying out the layer of the first adhesive sensor material to form the first adhesive sensor layer comprises moulding, e.g. injection moulding, the first adhesive sensor layer, wherein a mould has a non-planar surface shaped to provide the first outer rim thickness that gradually decreases along the radial direction from adjacent the first central portion of the first adhesive sensor layer to the first outer periphery.

27. 27. The method of any one of claims 20 to 26, wherein laying out the layer of first adhesive sensor material to form the first adhesive sensor layer comprises smoothing the first adhesive sensor material over a non-planar surface shaped to provide the first outer rim thickness that gradually decreases along the radial direction from adjacent the first central portion of the first adhesive sensor layer to the first outer periphery.

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