Stoma Sensor Patch

The sensor patch with a chamfered edge and thickness gradient improves adhesion and detects adhesion failures in ostomy devices, reducing leakage and enhancing user confidence.

JP7701268B2Active Publication Date: 2025-07-01COLOPLAST AS
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Patent Information

Application Number
JP2021544398
Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
Priority Date
2019-01-31
Filing Date
2020-01-30
Publication Date
2025-07-01
Estimated Expiration
2040-01-30

AI Technical Summary

Technical Problem

Ostomy devices experience poor adhesion due to stoma excrement and skin moisture, leading to leakage and embarrassment, with existing solutions failing to provide reliable detection of impending defects or leaks.

Method used

A sensor patch with a chamfered edge is attached to the base plate, featuring a first adhesive sensor layer with a thickness gradient to ensure smooth transition and improved adhesion, equipped with electrodes for electronic detection of moisture and adhesion failure.

Benefits of technology

Enhances adhesion reliability by reducing crease formation and leakage risks, providing timely detection of potential defects through electronic monitoring.

✦ Generated by Eureka AI based on patent content.

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Abstract

A sensor patch (50) for attachment to a base plate for an ostomy appliance and a method for manufacturing such a sensor patch are disclosed. The sensor patch has a proximal side and a distal side. The distal side is adapted for attachment to an adhesive surface of a base plate, and the adhesive surface of the base plate is adapted for attaching the base plate to a skin surface of a user. The sensor patch includes a sensor assembly (204) including a plurality of electrodes (216) and a first adhesive sensor layer (52) forming the proximal side of the sensor patch and adapted for attaching the sensor patch to a skin surface of a user. 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 radially from a portion adjacent the first central portion to a first outer periphery of the first adhesive sensor layer.
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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 Art

[0002] Stoma excrement often contains body fluids and visceral contents, which are aggressive to both the user's skin and the ostomy device, and these have an adverse effect on the efficiency and integrity of the adhesive material used to attach the ostomy device to the user's skin surface. Generally, a safe, reliable, and efficient ostomy device is highly desirable for the user.

[0003] However, the large ostomist population continues to have particularly great and persistent concerns about the poor adhesion of the base plate adhesive that attaches the ostomy appliance to the user's skin surface. This is because such poor adhesion will almost certainly cause leakage accidents that are embarrassing and stigmatizing. Furthermore, such accidents have been found to cause a sense of reduced quality of life from interviews with several users. The poor adhesion of the base plate adhesive can be caused by various reasons. In most cases, leakage accidents are caused by stoma excrement entering between the proximal surface of the base plate and the user's skin, which results from, for example, an uneven skin surface or skin wrinkles, such as an improper attachment of the base plate to the skin. The unwanted entry of this stoma excrement "under" the adhesive leads to the deterioration and / or weakening of the adhesive material that supports the weight of the ostomy appliance and provides its seal. Such failures often occur surprisingly rapidly, and only the user knows that if leakage occurs and the failure has already become serious, the ostomy appliance and possibly the user's clothes also need to be quickly replaced.

[0004] In other examples, the main factor for poor adhesion is simply a matter of how much time has elapsed since the base plate of the ostomy appliance was first applied to the user's skin surface. In addition to excrement from the stoma itself, the skin surface around the stoma continuously secretes a certain amount of moisture (e.g., sweat). To reduce this, in most cases, the adhesive of the base plate for the ostomy device contains a hydrophilic colloid material that can absorb moisture at a high level, thereby stabilizing the polymer matrix of the adhesive material and extending the lifespan (the "wear time") of the base plate. However, ultimately, the adhesiveness of the base plate can no longer support the force applied to the base plate from the weight of the excrement collection bag, and it becomes necessary to replace the appliance.

[0005] There can be significant differences in the severity and / or rate of occurrence of poor adhesion and possible leaks, but such differences correlate to varying factors including, at least to some extent, those described above. A mere indication that a defect or leak is impending or has already occurred fails to provide a reliable and satisfactory solution to the problem of avoiding embarrassing and stigmatizing leakage incidents that can cause sudden shame in ostomy appliances. In other words, ostomy appliance users can greatly benefit from appliance solutions that provide better advice and options regarding how and - in particular - how quickly to react to a defect in the adhesive of the base plate of the appliance or the onset of a leak. More generally, ostomists and healthcare professionals also welcome improvements to ostomy devices that reduce or eliminate the occurrence of sudden leakage incidents.

Summary of the Invention

Problems to be Solved by the Invention

[0006] The object of the present disclosure is to provide a sensor patch and a base plate for promoting highly reliable detection of the risk of ostomy appliance defects, and / or improvement of detection, and / or improvement of detection of the risk of leakage. The sensor patch and base plate of the present disclosure can be provided to promote detection of the risk of defects and / or the risk of leakage related to the adhesive base plate of the ostomy appliance.

[0007] A further object of the present disclosure is a method for facilitating the attachment of a sensor patch to an ostomy appliance, such as the base plate of an ostomy appliance, thereby reducing the risk of impairing the ability of the ostomy appliance to avoid leakage, particularly between the user's skin surface and the adhesive surface of the base plate. In particular, the object of the present disclosure is to thin the edge of the sensor patch so that the transition from the adhesive surface of the base plate to the adhesive surface of the sensor patch attached to the adhesive surface of the base plate is as smooth as possible. In other words, the object of the present disclosure is to thin the edge formed between the adhesive surface of the base plate and the sensor patch attached thereto. In particular, the presence of such an edge is assumed to have an unfavorable effect on the quality of the adhesion of the base plate / sensor patch to the user's skin surface, and therefore the object is to thin such an edge.

Means for Solving the Problems

[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 has a proximal side and a distal side. The distal side is adapted to be attached to the adhesive surface of the base plate, and the adhesive surface of the base plate is adapted to attach the base plate to the user's skin surface.

[0010] The sensor patch includes a sensor assembly including a plurality of electrodes including a first electrode and a second electrode for forming a first sensor; and a first adhesive sensor layer forming a proximal side of the sensor patch and adapted to attach the sensor patch to 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 radially along a direction from a portion adjacent to the first central portion of the first adhesive sensor layer to a first outer periphery. The first outer rim thickness adjacent to the 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 the first minimum outer rim thickness.

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

[0012] Thereby, a sensor patch having a chamfered edge is provided, thereby smoothing the transition between the base plate and the sensor patch attached to the base plate. The sensor patch having a chamfered edge can reduce potentially unfavorable effects on the sensor patch attached to the adhesive surface of the base plate, such as effects that 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 as disclosed above, such as a sensor patch having a proximal side and a distal side and adapted to attach the distal side to an adhesive surface of a base plate for an ostomy appliance, wherein the adhesive surface of the base plate is adapted to attach the base plate to a skin surface of a user.

[0014] The method includes providing a first adhesive sensor material and laying out a layer of the first adhesive sensor material to form a first adhesive sensor layer of a 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 radially along a direction from a portion adjacent to the first central portion of the first adhesive sensor layer to a first outer periphery, the first outer rim thickness adjacent to the first central portion being the first central thickness, and the first outer rim thickness at the first outer periphery of the first adhesive sensor layer being the 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 for forming a first sensor.

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

[0017] Thereby, a method of manufacturing a sensor patch having a chamfered edge that facilitates smoothing a transition between a base plate and the sensor patch attached to the base plate is provided.

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

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

Brief Description of the Drawings

[0020]

Figure 1

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DETAILED DESCRIPTION OF THE INVENTION

[0021] In the following detailed description, reference is made to the accompanying drawings, which form a part hereof, and in which are shown by way of illustration specific embodiments in which the invention may be practiced. In this regard, directional terms, such as "upper", "bottom", "front", "rear", "tip", "end", etc., are used with reference to the orientation of the drawings being described. Since the components of the embodiments can be positioned in many different orientations, the directional terms are used for purposes of illustration and are in no way limiting. It is to be understood that other embodiments may be utilized and structural or logical changes may be made without departing from the scope of the present invention. Accordingly, the following detailed description should not be considered limiting, and the scope of the present invention is defined by the appended claims.

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

[0023] Throughout the present disclosure, the words "stoma" and "ostomy" are used to denote surgically created openings that bypass a person's intestine or urinary tract. These words are used interchangeably and are not intended to have a differentiated meaning. The same applies to any words or expressions derived therefrom, such as "stomal", "ostomy", etc. Also, both solid and liquid waste exiting the stoma can be interchangeably referred to as "excrement", "waste", and "fluids" of the stoma. A subject who has undergone an ostomy surgery can be referred to as an "ostomist" or "ostomate" - and also as a "patient" or "user". However, in some cases, "user" can also be related to or refer to healthcare professionals (HCPs), such as surgeons or ostomy care nurses. In such cases, it is specified or implicitly understood from the context that the "user" is not the "patient" himself / herself.

[0024] In the following, when referring to the proximal side of a device or a part of a device, it always refers to the side facing the skin when the ostomy appliance is worn by the user. Similarly, when referring to the distal side of a device or a part of a device, it always refers to the side facing outward when viewed from the skin when the ostomy appliance is worn by the user. In other words, the proximal side is the side closest to the user when the appliance is attached to the user, and the distal side refers to the opposite side - the side farthest 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. Thus, the axial direction is approximately perpendicular to the user's skin or abdominal surface.

[0026] The radial direction is defined as being perpendicular to the axial direction, i.e., perpendicular to the direction of the stoma, i.e., as "extending" to the distal / proximal surface 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 a reference to an "outer" element means that this element is farther from the central part of the ostomy appliance than the element referred to as "inner". Further, "innermost" should be construed as the part of a component that forms the center of the component and / or is adjacent to the center of the component. Similarly, "outermost" should be construed as the part of a component that forms the outer edge or outer contour of the component and / or is adjacent to the outer edge or outer contour.

[0027] The use of the word "substantially" as a modifier for some features or effects in this disclosure is merely intended to mean that any deviation is within the tolerance that would be normally expected by a person skilled in the art.

[0028] The use of the word "generally" as a modifier for some structural and functional features or effects in this disclosure is merely intended to mean that - in the case of structural features, most or the major part of such features exhibit that property, and in the case of functional features or effects, most of the results including that property result in the effect, with the exception that multiple results do not result in the effect in some cases.

[0029] The use of the word "essentially" as a modifier for some structural and functional features or effects in this disclosure is used to emphasize what the most important focus of something or the facts regarding something are (i.e., a feature may have various effects or perform various functions, but when the disclosure is described as "essentially" providing for one effect, this is the focus and the most important effect regarding the disclosure).

[0030] Throughout the present disclosure, the use of terms such as "first," "second," "third," "fourth," "primary," "secondary," "tertiary," etc. does not imply any particular order or importance and is included merely to identify individual 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. For example, for facilitating detection of moisture transmitted to an adhesive material provided for attachment of the base plate to the skin surface of a user and for detecting an increased risk of leakage. For example, the sensor patch may enable an electronic measurement of the performance of the base plate and / or facilitate detection of an increased risk of leakage and / or facilitate detection of a decrease in the adhesion of the base plate to the skin of the user.

[0032] An ostomy appliance includes a base plate and an ostomy pouch (also referred to as an ostomy bag). The ostomy appliance can be a colostomy appliance, an ileostomy appliance, or an artificial bladder appliance. The ostomy appliance can be a two-piece ostomy appliance, i.e., the base plate and the ostomy pouch can be releasably coupled, for example, by mechanical and / or adhesive coupling, such that, for example, a plurality of ostomy pouches can be utilized (exchanged) with one base plate. For example, the base plate may include a connecting ring for coupling the ostomy pouch to the base plate. Further, the two-piece ostomy appliance can facilitate proper attachment of the base plate to the skin, for example, by improving the user's view of the stoma area. Alternatively, the ostomy appliance can be a one-piece ostomy appliance, i.e., the base plate and the ostomy pouch can be fixedly attached to each other. The base plate is configured to couple to the user's stoma and / or the skin surrounding the stoma, such as the skin site around the stoma.

[0033] The base plate may include a first adhesive layer, i.e., a first layer of an adhesive material. In use, the proximal surface of the first adhesive layer adheres to the user's skin at the stoma surrounding site 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 hydrophilic colloids. The first composition may include one or more water-soluble or water-swellable hydrophilic colloids. The first composition may be a pressure-sensitive adhesive composition suitable for medical purposes, including a rubbery elastomer base and one or more water-soluble or water-swellable hydrophilic colloids. 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 user's skin. The distal surface of the first adhesive layer may be configured to face outward as seen from the user's skin.

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

[0035] The base plate may include a second adhesive layer, also referred to as the rim adhesive layer, which is a second layer of adhesive material. The second adhesive layer may be a different adhesive material from 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 hydrophilic colloids. The second composition may include one or more water-soluble or water-swellable hydrophilic colloids. The second composition may be a pressure-sensitive adhesive composition suitable for medical purposes, including a rubbery elastomer base and one or more water-soluble or water-swellable hydrophilic colloids. 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 user's skin, for example, at least in the rim portion of the second adhesive layer. The distal surface of the second adhesive layer may be configured to face outward as seen from the user's skin. The second adhesive layer may cover a larger area than the first adhesive layer. For example, the proximal surface of the second adhesive layer may form an adhesive rim surrounding the first adhesive layer.

[0036] The properties of the first adhesive layer and / or the second adhesive layer can be varied by different content ratios. 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 hydrophilic colloid. 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 can be thinner than the first adhesive layer. Alternatively or in addition, the second adhesive layer may not absorb water and / or sweat as much as 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 a part of the adhesive surface of the base plate adapted to attach the base plate to the skin surface of the user. The first adhesive layer and the second adhesive layer may form the adhesive surface of the base plate adapted to attach the base plate to the skin surface of the 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 radially along the radius from a portion adjacent to the central portion of the first adhesive layer and / or the second adhesive layer to the outer periphery. The outer rim thickness may decrease convexly, concavely, or substantially linearly along the radius from a portion adjacent to the central portion to the outer periphery. The outer rim thickness adjacent to the central portion may be the central thickness. The outer rim thickness at the outer periphery may be the minimum outer rim thickness. The central thickness may be from 0.5 mm to 1.5 mm. The minimum outer rim thickness may be less than 0.5 mm, for example 0.4 mm, for example less than 0.3 mm, for example less than 0.1 mm.

[0039] The first adhesive layer and / or the second adhesive layer may surround an opening, for example a stoma opening. The first adhesive layer and / or the second adhesive layer may have an inner rim portion surrounded by the central portion. The inner rim portion may have an inner rim thickness that increases radially along the radius from the inner periphery of the first adhesive layer and / or the second adhesive layer to the central portion. The inner rim thickness may increase convexly, concavely, or substantially linearly along the radius from the inner periphery to the central portion. The inner rim thickness adjacent to the central portion may be the central thickness. The inner rim thickness at the inner periphery may be the minimum inner rim thickness. The minimum inner 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.

[0040] By providing an adhesive, for example, a base plate in which the outer rim of the first adhesive layer and / or the second adhesive layer becomes thinner and / or the inner rim becomes thicker, the transition portion between the base plate and the user's skin at the edge of the base plate is made easier and smoother. Thereby, the risk that clothing adheres to the edge of the base plate and potentially peels the base plate from the skin can be reduced. Accordingly, the risk of leakage due to a base plate with insufficient adhesion to the user's skin is reduced.

[0041] The base plate may include a release liner that can be peeled off by the 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 to cover, for example, the proximal surface of the first adhesive layer and / or the proximal surface of the second adhesive layer, such as the proximal surface of the second adhesive layer 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 to face, for example, the proximal surface of the first adhesive layer and / or the proximal surface of the second adhesive layer, such as the proximal surface of the second adhesive layer 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, for example, the first adhesive layer and / or the second adhesive layer, from external distortion and stress during use. Further, the backing layer may also cover the adhesive layer, for example, the first adhesive layer and / or the second adhesive layer, so that the adhesive layer does not adhere to the clothing worn on the upper part 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 outward as seen 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 respectively include a stoma opening that jointly forms the stoma opening of the base plate. The stoma opening may be provided in the central portion of the base plate. The central portion of the base plate may surround the stoma opening. The stoma opening may be configured to receive the user's stoma and / or the stoma opening may be configured to allow excrement from the stoma to pass through the stoma opening and into the ostomy pouch attached to the base plate. For example, the stoma opening may be configured such that excrement can pass from the proximal side of the base plate to the distal side of the base plate. The size and / or shape of the stoma opening can generally be adjusted by the user or a caregiver to fit the user's stoma before applying the base plate.

[0044] The sensor patch according to the present disclosure is adapted to be attached to the base plate. For example, the sensor patch may be configured to be positioned between the user's skin and the proximal side of the base plate. For example, the sensor patch may be adapted to be attached to the first adhesive layer of the base plate. For example, the distal side of the sensor patch may be configured to face the proximal surface of the first adhesive layer of the base plate. For example, the sensor patch, for example the distal side of the sensor patch, may be configured to adhere to the proximal surface 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 each include a stoma opening for jointly forming the stoma opening of the sensor patch and / or may be adapted to form a stoma opening. The stoma opening of the sensor patch may be configured, for example, to be aligned with the stoma opening of the base plate to jointly form 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 a caregiver to fit the user's stoma before applying the sensor patch. The size and / or shape of the stoma opening of the sensor patch may be adjusted, for example, together with the adjustment of the stoma opening of the base plate 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 the distal surface of the sensor assembly is coupled to the 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, a second sensor may be formed by the first electrode and the third electrode, a third sensor may be formed by the first electrode and the fourth electrode, a fourth sensor may be formed by the first electrode and the fifth electrode, and / or a fifth sensor 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 the monitoring device.

[0048] The plurality of electrodes are conductive and may include one or more of a metallic material (e.g., silver, copper, gold, titanium, aluminum, stainless steel), a ceramic material (e.g., ITO), a polymeric material (e.g., PEDOT, PANI, PPy), and a carbonaceous material (e.g., carbon black, carbon nanotube, carbon fiber, graphene, graphite).

[0049] The plurality of electrodes may form loops and / or open loops. One or more open-loop electrodes enable electrode arrangement configurations in some or a single electrode layer.

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

[0051] The sensor assembly may include, for example, a masking element having a proximal surface and a distal surface. The masking element may be configured to electrically insulate at least a portion of the plurality of electrodes from a proximal layer, e.g., a first adhesive sensor layer. The masking element may, for example, cover or overlap a plurality of portions of the plurality of electrodes 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 can be disposed on the proximal side of the sensor assembly. The proximal side of the first adhesive sensor layer, for example, forms the proximal side of the sensor patch. The proximal side of the first adhesive sensor layer can be configured to adhere to the skin of the user. Thus, the combined base plate and sensor patch after being attached to the base plate can form an adhesive proximal surface configured to be attached to the skin surface of the user. The first adhesive sensor layer can be made of a first adhesive sensor material, for example, a first composition, a second composition, or a third composition. The third composition can include one or more polyisobutenes and / or styrene-isoprene-styrene. The third composition can include one or more hydrophilic colloids. The third composition can include one or more water-soluble or water-swellable hydrophilic colloids. The third 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 hydrophilic colloids.

[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 radially from a portion adjacent to the first central portion of the first adhesive sensor layer to the first outer periphery. The first outer rim thickness can decrease convexly, concavely, or substantially linearly radially from a portion adjacent to the first central portion of the first adhesive sensor layer to the first outer periphery. The first outer rim thickness adjacent to the first central portion is the first central thickness. The first outer rim thickness at the first outer periphery of the first adhesive sensor layer is the first minimum outer rim thickness. The first central thickness can be from 0.5 mm to 1.5 mm. The first minimum outer rim thickness can 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 first outer rim portion adjacent to the first central portion can be from 15 to 35 mm. The radial distance from the first outer rim portion adjacent to the first central portion of the first adhesive sensor layer to the first outer periphery can be from 0.5 to 20 mm. The radial distance from the center point of the first adhesive sensor layer to the first outer periphery can be from 15.5 to 55 mm, from 20 to 45 mm, from 25 to 40 mm, from 30 to 35 mm.

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

[0055] The first adhesive sensor layer may surround an opening, such as a stoma opening and / or an opening larger than the stoma opening. The first adhesive sensor layer may have a first inner rim portion surrounded by a first central portion. The first inner rim portion may have a first inner rim thickness that increases radially from the first inner circumference of the first adhesive sensor layer to the first central portion. The first inner rim thickness may increase convexly, concavely, or substantially linearly along the radial direction from the first inner circumference of the first adhesive sensor layer to the first central portion. The first inner rim thickness adjacent to the first central portion may be the first central thickness. The first inner rim thickness at the first inner circumference of the first adhesive sensor layer may be the 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, such as 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, the first central portion adjacent to the inner rim portion, may be 10.5 - 50 mm, such as 15 - 40 mm, such as 20 - 35 mm, such as 20 - 30 mm.

[0056] In the manufacture of the sensor patch, a first adhesive sensor material is provided, and a layer of the first adhesive sensor material for forming the first adhesive sensor layer is laid out, and the first central portion, the first outer rim portion, and / or the first inner rim portion may be formed according to the above.

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

[0058] The hydrophilic colloid may be arranged such that the first outer rim average / maximum particle size and / or the first inner rim average / maximum particle size is 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 of 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 hydrophilic colloid can be selected so that, for example, the outer and / or inner circumferences of the first adhesive sensor layer can be made thinner in order to achieve a smaller particle size. Providing the first adhesive sensor material to form the first adhesive sensor layer can include selecting the hydrophilic colloid of the first adhesive sensor material according to the particle size. For example, selecting the hydrophilic colloid of the first adhesive sensor material can include selecting the hydrophilic colloid so as to achieve an average / maximum particle size 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 hydrophilic colloid are retained despite the decrease in the thickness of the adhesive containing the hydrophilic colloid. Instead or in addition, laying out the layer of the first adhesive sensor material can include laying out the layer of the first adhesive sensor material so as to form a first central portion having a hydrophilic colloid with a first central average / maximum particle size, laying out the layer of the first adhesive sensor material so as to form a first outer rim portion having a hydrophilic colloid with a first outer rim average / maximum particle size, and / or laying out the layer of the first adhesive sensor material so as to form a first inner rim portion having a hydrophilic colloid with a first inner rim average / maximum particle size.

[0060] Laying out the layer of the first adhesive sensor material to form the first adhesive sensor layer can include extruding the first adhesive sensor layer. Instead or in addition, laying out the layer of the first adhesive sensor material to form the first adhesive sensor layer can include molding, for example injection molding, the first adhesive sensor layer. The mold can 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 according to the above. Instead or in addition, laying out the layer of the first adhesive sensor material to form the first adhesive sensor layer can include laying out the first adhesive sensor material on a non-planar surface, for example on the distal surface of the first release liner shaped to provide the outer shape of the first outer rim, the first central portion, and / or the first inner rim according to the above or on the proximal surface of the sensor assembly.

[0061] In multiple embodiments, the sensor patch includes, for example, a second adhesive sensor layer having a proximal side and a distal side. The second adhesive sensor layer can be disposed on the distal side of the sensor assembly. The distal side of the second adhesive sensor layer can be configured to adhere to the proximal surface of the base plate, such as the proximal surface of the first adhesive layer of the base plate. The second adhesive sensor layer can be made of a second adhesive sensor material, such as a first composition, a second composition, a third composition, or a fourth composition. The fourth composition can include one or more polyisobutenes and / or styrene-isoprene-styrene. The fourth composition can include one or more hydrophilic colloids. The fourth composition can include one or more water-soluble or water-swellable hydrophilic colloids. 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 hydrophilic colloids. The second adhesive sensor material can be the same as the first adhesive sensor material. When the second adhesive sensor layer is disposed on the distal side of the sensor assembly, it provides a symmetric sensor patch such that each side of the sensor patch adheres 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, for example, a second outer rim thickness that decreases radially along a radius from a portion adjacent to the second central portion of the second adhesive sensor layer to the second outer periphery. The second outer rim thickness may decrease convexly, concavely, or substantially linearly along a radius from a portion adjacent to the second central portion of the second adhesive sensor layer to the second outer periphery. The second outer rim thickness adjacent to the second central portion may be the second central thickness. The second outer rim thickness at the second outer periphery of the second adhesive sensor layer may be the second minimum outer rim thickness. The second central thickness may be from 0.5 mm to 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 to the second central portion may be from 15 to 35 mm. The radial distance from the second outer rim portion adjacent to the second central portion of the second adhesive sensor layer to the second outer periphery may be from 0.5 to 25 mm. The radial distance from the second center point of the second adhesive sensor layer to the second outer periphery may be from 15.5 to 60 mm, for example, from 20 to 50 mm, for example, from 25 to 40 mm, for example, from 30 to 35 mm.

[0063] The second adhesive sensor layer can surround an opening, for example, a stoma opening and / or an opening larger than the stoma opening. The second adhesive sensor layer can have a second inner rim portion surrounded by a second central portion. The second inner rim portion can have a second inner rim thickness that increases radially from the second inner circumference of the second adhesive sensor layer to the second central portion. The second inner rim thickness can increase radially convexly, concavely, or substantially linearly from the second inner circumference of the second adhesive sensor layer to the second central portion. The second inner rim thickness adjacent to the second central portion can be the second central thickness. The second inner rim thickness at the second inner circumference of the second adhesive sensor layer can be the second minimum inner rim thickness. The second minimum inner rim thickness can 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 inner rim portion adjacent to the second central portion can be 10 - 30 mm. The radial distance from the second inner circumference of the second adhesive sensor layer to the second central portion, for example, the second central portion adjacent to the second inner rim portion, can be 0.5 - 20 mm. The radial distance from the center point to the second central portion, for example, the second central portion adjacent to the second inner rim portion, can be 10.5 - 50 mm, for example, 15 - 40 mm, for example, 20 - 35 mm, for example, 20 - 30 mm.

[0064] In the manufacture of the sensor patch, a second adhesive sensor material is provided and a layer of the second adhesive sensor material is laid out to form the second adhesive sensor layer, which can form the second central portion, the second outer rim portion, and / or the second inner rim portion according to the above.

[0065] The second adhesive sensor layer may contain a hydrophilic colloid. The hydrophilic colloid disposed along the second outer periphery of the second adhesive sensor layer, for example, the hydrophilic colloid 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 hydrophilic colloid disposed in the second central portion may have a second central average particle size and / or a second central maximum particle size. The hydrophilic colloid disposed along the second inner periphery of the second adhesive sensor layer, for example, the hydrophilic colloid 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 hydrophilic colloid may be less than 0.2 mm, for example, less than 0.1 mm. The maximum particle size of the hydrophilic colloid may be less than 0.3 mm, for example, less than 0.2 mm, for example, less than 0.1 mm. The second outer rim average particle size may be less than 0.2 mm, for example, less than 0.1 mm. The second outer rim maximum particle size may be less than 0.3 mm, for example, less than 0.2 mm, for example, less than 0.1 mm. The second inner rim average particle size may be less than 0.2 mm, for example, less than 0.1 mm. The second inner rim maximum particle size may be less than 0.3 mm, for example, less than 0.2 mm, for example, less than 0.1 mm. The second central average particle size may be less than 0.2 mm, for example, less than 0.1 mm. The second central maximum particle size may be less than 0.3 mm, for example, less than 0.2 mm, for example, less than 0.1 mm.

[0066] The hydrophilic colloid may be arranged such that the second outer rim average / maximum particle size and / or the second inner rim average / maximum particle size is 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 of 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 a second adhesive sensor material to form a second adhesive sensor layer may include sorting the hydrophilic colloid of the second adhesive sensor material according to particle size. For example, sorting the hydrophilic colloid of the second adhesive sensor material may include sorting the hydrophilic colloid to achieve an average / maximum particle size of less than 0.3 mm, such as less than 0.2 mm, such as less than 0.1 mm. Alternatively or in addition, 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 a hydrophilic colloid 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 a hydrophilic colloid 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 a hydrophilic colloid with a second inner rim average / maximum particle size.

[0068] Laying out the 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 the layer of the second adhesive sensor material to form the second adhesive sensor layer may include molding, such as 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 according to the above. Alternatively or in addition, laying out the layer of the second adhesive sensor material to form the second adhesive sensor layer may include laying out the second adhesive sensor material on a non-planar surface, such as the proximal surface of a second release liner or the distal surface of a sensor assembly, shaped to provide the outer profile of the second outer rim, the second central portion, and / or the second inner rim according to the above.

[0069] A sensor assembly including a plurality of electrodes can 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 can be disposed with respect 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 can be disposed, for example, to measure a portion of the adhesive layer where the adhesive layer has a substantially uniform thickness. Such an arrangement can facilitate the reliability of the measurement and / or the subsequent interpretation of the measured values. The plurality of electrodes of the sensor assembly can form, for example, a loop surrounding a central point, such as an open loop or a closed loop. The first electrode can form a first loop, the second electrode can form a second loop, the third electrode can form a third loop, the fourth electrode can form a fourth loop, the fifth electrode can form a fifth loop, and / or the sixth electrode can form a sixth loop. An electrode, such as the first electrode, can form a plurality of loops. For example, the first electrode can form a plurality of first loops, including, for example, a first primary loop, a first secondary loop, a first tertiary loop, and the like.

[0070] The radial distance from the central 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 can be less than the radial distance from the central point to the first outer rim portion, such as the first outer rim portion adjacent to the first central portion. The radial distance from the central 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 can be greater than the radial distance from the central point to the first inner rim portion, such as the first inner rim portion adjacent to the first central portion.

[0071] From the center point, the radial distances 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 can be less than the radial distance from the center point to the second outer rim portion, for example, the second outer rim portion adjacent to the second central portion. From the center point, the radial distances 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 can be greater than the radial distance from the center point to the second inner rim portion, for example, the second inner rim portion adjacent to the second central portion.

[0072] The radial distance from the center point to the second loop can 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 can 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 can 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 can 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 can 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, for example, the first sensor release liner and / or the second sensor release liner.

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

[0075] The second sensor release liner may include a distal surface and a proximal surface. The second sensor release liner may be arranged to protect the second adhesive sensor layer. For example, the proximal surface of the second sensor release liner may face the distal surface of the second adhesive sensor layer. The second sensor release liner may be configured to be peeled off by a user before attaching the sensor patch to the base plate. A layer of the second adhesive sensor material may 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, such as a plurality of electrodes of the sensor patch, to a monitor device. The monitor interface may be configured to wirelessly connect the sensor patch, such as a plurality of electrodes of the sensor patch, to a monitor device. The monitor interface may be configured to electrically and / or mechanically couple the sensor patch and the monitor device.

[0077] The sensor patch of the present disclosure can be combined with a base plate, for example, to form a base plate, such as a monolithic one-piece type, that is integrated with a sensor assembly portion, such as the sensor assembly portion described above. For example, the base plate can include a sensor assembly, such as the sensor assembly described with respect to the sensor patch. For example, the sensor assembly can be positioned between a first adhesive layer and a second adhesive layer. The distal surface of the first adhesive layer can face the proximal side of the sensor assembly, and / or the distal side of the sensor assembly can face the proximal side of the second adhesive layer. For example, the first adhesive layer and / or the second adhesive layer of the base plate can be 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 can be less than the radial distance from the center point to the outer rim portion of the first adhesive layer and / or the second adhesive layer, for example, the outer rim portion adjacent to the 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 can be greater than the radial distance from the center point to the inner rim portion of the first adhesive layer and / or the second adhesive layer, for example, the inner rim portion adjacent to the central portion of the first adhesive layer and / or the second adhesive layer.

[0079] Figure 1 schematically shows 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. In use, the proximal surface 200B of the first adhesive layer 200 adheres to the user's skin. The base plate 4 includes a second adhesive layer 202 having a distal surface 202A and a proximal surface 202B. As shown, the second adhesive layer 202 extends over a larger surface area than the first adhesive layer 200 to provide a rim surrounding the proximal surface 200 of the first adhesive layer 200 on the proximal surface 202 of the second adhesive layer 202.

[0080] The base plate 4 includes a release liner 206 that can be peeled off by the user before applying the base plate 4 to the skin. The release liner 206 includes a distal surface 206A and a proximal surface 206B. The distal surface 206A of the release liner 206 covers the proximal surface of the first adhesive layer 200 and 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, such as the first adhesive layer 200 and / or the second adhesive layer 202, from external distortion and stress during use. Further, the backing layer 208 also covers the adhesive layers, such as the first adhesive layer 200 and / or the second adhesive layer 202, to prevent the adhesive layers 200, 202 from adhering to the 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 outward as seen from the user's skin. The proximal surface 208B of the backing layer 208 covers the second adhesive layer 202.

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

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

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

[0085] The sensor patch 50 includes a sensor assembly 204 that includes a plurality of electrodes 216. Each electrode 216 has a respective connection portion 217 for connecting the plurality of electrodes 216 to respective terminal elements of the 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, for example formed, on the proximal surface 214B of the support layer 214 such that the electrodes 216 can 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 a plurality of portions of the electrode 216 from an adjacent layer, such as the first adhesive sensor layer 52. The masking element 218 covers or overlaps a plurality of 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 user's skin. Thus, after being applied to the base plate, the combined base plate and sensor patch 50 form an adhesive proximal surface configured to be applied to the user's skin surface.

[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 disposed to protect the first adhesive sensor layer 52. The distal surface 54A of the first sensor release liner 54 faces the proximal surface 52B of the first adhesive sensor layer 52. The first sensor release liner 54 is configured to be peeled off by the user before applying the base plate with the attached sensor patch to the skin. The first adhesive sensor layer 52 may be laid out at 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 the base plate, such as the 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 arranged to protect the second adhesive sensor layer 56. The proximal surface 58B of the second sensor release liner 58 faces the distal surface 56A of the second adhesive sensor layer 56. The second sensor release liner 58 is configured to be peeled off by a user before applying the sensor patch to the base plate. The second adhesive sensor layer 56 can be laid out at the proximal side 58B of the second sensor release liner 58.

[0092] The exemplary sensor patch 50 described includes a second adhesive sensor layer 56 disposed on the distal side 204A of the sensor assembly 204, but it is envisioned that alternative sensor patches according to the present disclosure may be provided without such a second adhesive sensor layer 56 and its attendant second sensor release liner 58. Rather, in such alternative sensor patches, it is envisioned that the distal surface of the sensor patch is the distal surface of the sensor assembly 204, particularly the distal surface of the support layer 214. In such alternative sensor patches, the distal surface of the support layer 214 can be configured for attachment to the adhesive surface of the base plate. Thus, while the sensor patch 50 having the first adhesive sensor layer 52 and the second adhesive sensor layer 56 is shown and described, it is envisioned that similar sensor patches without the second adhesive sensor layer 56 and its attendant second sensor release liner 58 are provided in accordance with the present disclosure.

[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, can each include a stoma opening 60 for jointly forming the stoma opening of the sensor patch 50. The stoma opening of the sensor patch is configured, for example, to be aligned with the stoma opening of the base plate to jointly form the stoma opening of the combined base plate and the sensor patch 50.

[0094] FIG. 3 schematically shows an exemplary electrode configuration 220 of electrodes 216 of an exemplary sensor assembly, such as 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 can 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] FIG. 4 schematically shows a cross-sectional view of a sensor patch 50, such as sensor patch 50 described in connection with FIG. 2. For illustrative purposes, 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 can be created by a user, i.e., the sensor patch can be manufactured and / or sold having an area adapted to form a stoma opening 60 that does not have a stoma opening 60 but has a center point 19.

[0098] As similarly described with reference to FIG. 2, the sensor patch 50 includes a sensor assembly 204, a first adhesive sensor layer 52, a second adhesive sensor layer 56, a first sensor release liner 54, and a 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, the exemplary sensor patch 50 described includes a second adhesive sensor layer 56 disposed on the distal side of the sensor assembly 204, but it is contemplated that alternative sensor patches according to the present disclosure may be provided without such a second adhesive sensor layer 56 and the accompanying 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 the 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 the 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 to 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., to the first central portion 62 adjacent to the first inner rim portion 66. The radial distance D84 from the center point 19 to the first central portion 62 adjacent to the first inner rim portion 66 is also shown. The radial distance D80 from the center point 19 to the first outer rim portion 64 adjacent to the first central portion 62 is also shown.

[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 along a direction from a portion adjacent to the first central portion 62 of the first adhesive sensor layer 52 to the first outer periphery 68. The first outer rim thickness adjacent to 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 the first minimum outer rim thickness D68.

[0102] The first inner rim portion 66 has a first inner rim thickness that increases radially along a direction from the first inner periphery 69 of the first adhesive sensor layer 52 to the first central portion 62. The first inner rim thickness adjacent to the first central portion 62 is the first central thickness D62, and the first inner rim thickness at the first inner periphery 69 of the first adhesive sensor layer 52 is the 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 to 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 to the second inner rim portion 76. The radial distance D94 from the center point 19 to the second central portion 72 adjacent to the second inner rim portion 76 is also shown. The radial distance D90 from the center point 19 to the second outer rim portion 74 adjacent to the second central portion 72 is also shown.

[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 along a direction from a portion adjacent to the second central portion 72 of the second adhesive sensor layer 56 to the second outer periphery 78. The second outer rim thickness adjacent to 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 the second minimum outer rim thickness D78.

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

[0107] In the example of the description, 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 substantially linearly. 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 convexly or concavely along the radial direction.

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

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

[0110] The radial distance D14 from the center point to the third loop formed by the third electrode of the plurality of electrodes 216 is less than the radial distance D80 from the center point 19 to the first outer rim portion 64, for example, to 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 the radial distance D90 from the center point 19 to the second outer rim portion 74, for example, to 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 exemplary method 1000 for manufacturing a sensor patch, such as the sensor patch described with respect to one or more of the above figures.

[0112] Method 1000 includes providing a first adhesive sensor material 1002 and laying out a layer of the first adhesive sensor material to form a first adhesive sensor layer of the sensor patch 1004. 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 radially from a portion adjacent to the first central portion of the first adhesive sensor layer to the first outer perimeter. Further, the first adhesive sensor material is laid out 1004 such that the first outer rim thickness adjacent to the first central portion becomes the first central thickness and the first outer rim thickness at the first outer perimeter of the first adhesive sensor layer becomes the first minimum outer rim thickness. Laying out the first adhesive sensor material 1004 may further include forming a first inner rim portion surrounded by the first central portion, and the first inner rim portion has a first outer rim thickness that gradually increases radially from the first inner perimeter of the first adhesive sensor layer to the first central portion adjacent to the first inner rim portion.

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

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

[0115] Method 1000 includes placing the sensor assembly on the distal side of the first adhesive sensor layer 1008, where the proximal side of the first adhesive sensor layer is adapted to attach the sensor patch to the skin surface of the user.

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

[0117] Providing the first adhesive sensor material 1002 may optionally include sorting the hydrophilic colloid of the first adhesive sensor material according to particle size 1012. For example, sorting the hydrophilic colloid 1012 may be performed to achieve a smaller average and / or maximum particle size, for example, to provide a thinner rim portion of the first adhesive layer. Alternatively or in addition, laying out a layer of the first adhesive sensor material 1004 may include laying out a layer of the first adhesive sensor material to form a first central portion having a hydrophilic colloid with a first central average particle size and / or a first central maximum particle size, and a first outer rim portion and / or a first inner rim portion having a hydrophilic colloid with a first outer rim average particle size, and / or a first outer rim average particle size, and / or a first inner rim average particle size, and / or a first inner rim average particle size, respectively, the first outer rim average / maximum particle size and / or the first inner rim average / maximum particle size being less than the first central average / maximum particle size. Thereby, the first rim portion may achieve a thinner thickness, for example, at the periphery than the first central portion.

[0118] In a plurality of embodiments, method 1000 may include providing a second adhesive sensor material 1102 and laying out a layer of the second adhesive sensor material to form a second adhesive sensor layer of the sensor patch 1104. The described method includes providing a second adhesive sensor material 1102 to form a second adhesive sensor layer, but alternative methods may omit steps related to such a second adhesive sensor layer such that the resulting sensor patch has a distal surface that is the distal surface of the sensor assembly and such that the resulting sensor patch has only 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 radially from an adjacent portion of the second central portion of the second adhesive sensor layer to the second outer perimeter. Further, the second adhesive sensor material is laid out 1104 such that the second outer rim thickness adjacent to the second central portion is the second central thickness and the second outer rim thickness at the second outer perimeter of the second adhesive sensor layer is the second minimum outer rim thickness. 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 radially from the second inner perimeter of the second adhesive sensor layer to the second central portion adjacent to the second inner rim portion.

[0119] Laying out a layer of the second adhesive sensor material to form a second adhesive sensor layer 1104 may include extruding the second adhesive sensor layer, molding the second adhesive sensor layer, such as by injection molding, and / or leveling the second adhesive sensor layer on a defined surface. The layout 1104 of the layer of the second adhesive sensor material may include post-processing to form or improve a rim portion.

[0120] Method 1000 optionally includes providing a second sensor release liner 1110. The layout 1104 of the layer of the second adhesive sensor material can include laying out the layer of the second adhesive sensor material proximal to the second sensor release liner 1104.

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

[0122] Providing a sensor patch with a thinner outer rim and / or a thicker inner rim of the 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, the risk of potentially forming a crease between the user's skin and the adhesive surface of the sensor patch and the base plate is reduced. A crease between the adhesive surface and the user's skin can weaken the adhesion and increase the risk of leakage. Therefore, 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] While 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 made without departing from the scope of the invention and may replace the specific embodiments shown and described herein. This application is intended to cover any modifications or variations of the body side member for an ostomy appliance as described herein. Accordingly, the invention is to be limited only by the claims and their equivalents. The present disclosure further includes the following aspects: 《Aspect 1》 A sensor patch for attachment to a base plate of an ostomy appliance, having a proximal side and a distal side, the distal side being adapted to be attached to an adhesive surface of the base plate, the adhesive surface of the base plate being adapted to attach the base plate to a user's skin surface, the sensor patch comprising: - A sensor assembly including a plurality of electrodes including a first electrode and a second electrode for forming 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 user's skin surface, 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 that decreases radially along a radius from a portion adjacent to the first central portion of the first adhesive sensor layer to a first outer periphery, the first outer rim thickness adjacent to the first central portion being the first central thickness, and the first outer rim thickness at the first outer periphery of the first adhesive sensor layer being a first minimum outer rim thickness; a first adhesive sensor layer comprising; The sensor patch is adapted to form a stoma opening having a center point, the stoma opening being configured to allow excrement to pass through the stoma opening and into an ostomy pouch attached to the base plate. A sensor patch. 《Aspect 2》 The sensor patch according to Aspect 1, wherein the first central thickness is 0.5 mm to 1.5 mm. 《Aspect 3》 The sensor patch according to Aspect 1 or 2, wherein the first minimum outer rim thickness is less than 0.5 mm. 《Aspect 4》 The sensor patch according to any one of Aspects 1 to 3, wherein a radial distance from the center point to the first outer rim portion adjacent to the central portion is 15 to 35 mm. 《Aspect 5》 The sensor patch according to any one of Aspects 1 to 4, wherein a radial distance from the first outer rim portion adjacent to the central portion of the first adhesive sensor layer to the first outer periphery is 0.5 to 20 mm. 《Aspect 6》 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 the first inner circumference of the first adhesive sensor layer to the first central portion, the first inner rim thickness adjacent to 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, the sensor patch according to any one of aspects 1 to 5. 《Aspect 7》 The first minimum inner rim thickness is less than 0.5 mm, the sensor patch according to aspect 6. 《Aspect 8》 The radial distance from the central point to the first central portion adjacent to the first inner rim portion is 10 to 30 mm, the sensor patch according to any one of aspects 1 to 7. 《Aspect 9》 The radial distance of the first inner rim portion from the first inner circumference of the first adhesive sensor layer to the first central portion is 0.5 to 20 mm, the sensor patch according to any one of aspects 1 to 8. 《Aspect 10》 The first adhesive sensor layer includes a hydrophilic colloid, the sensor patch according to any one of aspects 1 to 9. 《Aspect 11》 The hydrophilic colloid is arranged such that the hydrophilic colloid arranged along the first outer circumference of the first adhesive sensor layer has a first outer rim average particle size, the hydrophilic colloid arranged at the first central portion having a first central average particle size, and the first outer rim average particle size being less than the first central average particle size, the sensor patch according to aspect 10. 《Aspect 12》 The first outer rim average particle size is less than half of the first central average particle size, the sensor patch according to aspect 11. 《Aspect 13》 The hydrophilic colloid has an average particle size of less than 0.2 mm, the sensor patch according to any one of aspects 10 to 12. 《Aspect 14》 Including a first sensor release liner arranged to protect the first adhesive sensor layer and configured to be peeled off by the user before the base plate having the attached sensor patch is applied to the skin, the sensor patch according to any one of aspects 1 to 13. 《Aspect 15》 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, the sensor patch according to any one of Aspects 1 to 14. 《Aspect 16》 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, the sensor patch according to Aspect 15. 《Aspect 17》 The first outer rim thickness decreases convexly along the radial direction from a portion adjacent to the first central portion of the first adhesive sensor layer to the first outer periphery, the sensor patch according to any one of Aspects 1 to 16. 《Aspect 18》 The first outer rim thickness decreases concavely along the radial direction from a portion adjacent to the first central portion of the first adhesive sensor layer to the first outer periphery, the sensor patch according to any one of Aspects 1 to 16. 《Aspect 19》 The first outer rim thickness decreases substantially linearly along the radial direction from a portion adjacent to the first central portion of the first adhesive sensor layer to the first outer periphery, the sensor patch according to any one of Aspects 1 to 16. 《Aspect 20》 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, wherein the adhesive surface of the base plate is adapted to attach the base plate to a user's skin surface, the method comprising: - providing a first adhesive sensor material; - Laying out the layer of the first adhesive sensor material so as to form a first adhesive sensor layer of the sensor patch, wherein the first adhesive sensor material is laid out to form a first central portion and a first outer rim portion surrounding the first central portion, the first central portion has a first central thickness, and the first outer rim portion has a first outer rim thickness that gradually decreases radially along from a portion adjacent to the first central portion of the first adhesive sensor layer to a first outer periphery, the first outer rim thickness adjacent to 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; - Providing a sensor assembly including a plurality of electrodes including a first electrode and a second electrode for forming a first sensor; - Disposing the sensor assembly on the distal side of the first adhesive sensor layer, wherein the proximal side of the first adhesive sensor layer is adapted to attach the sensor patch to the skin surface of the user; A method comprising. 《Aspect 21》 The method according to aspect 20, comprising providing a first sensor release liner, and laying out the layer of the first adhesive sensor material includes laying out the layer of the first adhesive sensor material on the distal side of the first sensor release liner. 《Aspect 22》 The method according to aspect 20 or 21, wherein providing the first adhesive sensor material includes sorting the hydrophilic colloid of the first adhesive sensor material according to particle size. 《Aspect 23》 The method according to aspect 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 hydrophilic colloid with a first central average particle size, and laying out the layer of the first adhesive sensor material to form the first outer rim portion having a hydrophilic colloid with a first outer rim average particle size, and the first outer rim average particle size is less than the first central average particle size. 《Aspect 24》 The method according to aspect 22 or 23, wherein sorting the hydrophilic colloid includes sorting the hydrophilic colloid to achieve an average particle size of the hydrophilic colloid of less than 0.2 mm. Aspect 25 The method according to any one of aspects 20 to 24, wherein laying out the layer of the first adhesive sensor material to form the first adhesive sensor layer includes extruding the first adhesive sensor layer. Aspect 26 The method according to any one of aspects 20 to 25, wherein laying out the layer of the first adhesive sensor material to form the first adhesive sensor layer includes molding, for example, injection molding the first adhesive sensor layer, and the mold has a non-planar surface shaped to provide the first outer rim thickness that gradually decreases along the radial direction from a portion adjacent to the first central portion of the first adhesive sensor layer to the first outer periphery. Aspect 27 The method according to any one of aspects 20 to 26, wherein laying out the layer of the first adhesive sensor material to form the first adhesive sensor layer includes spreading the first adhesive sensor material on a non-planar surface shaped to provide the first outer rim thickness that gradually decreases along the radial direction from a portion adjacent to the first central portion of the first adhesive sensor layer to the first outer periphery.

Claims

1. A sensor patch for attachment to a base plate for an ostomy appliance, having a proximal side and a distal side, the distal side being adapted to be attached to an adhesive surface of the base plate, the adhesive surface of the base plate being adapted to attach the base plate to a user's skin surface, the sensor patch comprising: - A sensor assembly including a plurality of electrodes including a first electrode and a second electrode for forming 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 user's skin surface, 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 that decreases radially from a portion adjacent to the first central portion of the first adhesive sensor layer to a first outer periphery, the first outer rim thickness adjacent to the first central portion being the first central thickness, and the first outer rim thickness at the first outer periphery of the first adhesive sensor layer being a first minimum outer rim thickness, the first adhesive sensor layer; and the sensor patch is adapted to form a stoma opening having a center point, the stoma opening being configured to allow excrement to pass through the stoma opening and into an ostomy pouch attached to the base plate; 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 periphery of the first adhesive sensor layer to the first central portion, the first inner rim thickness adjacent to the first central portion being the first central thickness, and the first inner rim thickness at the first inner periphery of the first adhesive sensor layer being a first minimum inner rim thickness; sensor patch.

2. The sensor patch according to claim 1, wherein the first central thickness is from 0.5 mm to 1.5 mm.

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

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

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

6. The first minimum inner rim thickness is less than 0.5 mm, the sensor patch according to any one of claims 1 to 5.

7. The radial distance from the center point to the first central portion adjacent to the first inner rim portion is 10 to 30 mm, the sensor patch according to any one of claims 1 to 6.

8. The radial distance of the first inner rim portion from the first inner periphery of the first adhesive sensor layer to the first central portion is 0.5 to 20 mm, the sensor patch according to any one of claims 1 to 7.

9. The first adhesive sensor layer includes a hydrophilic colloid, the sensor patch according to any one of claims 1 to 8.

10. The hydrophilic colloid is arranged such that the hydrophilic colloid arranged along the first outer periphery of the first adhesive sensor layer has a first outer rim average particle size, and the hydrophilic colloid arranged in the first central portion has a first central average particle size, and the first outer rim average particle size is lower than the first central average particle size, the sensor patch according to claim 9.

11. The first outer rim average particle size is lower than half of the first central average particle size, the sensor patch according to claim 10.

12. The hydrophilic colloid has an average particle size of less than 0.2 mm, the sensor patch according to any one of claims 9 to 11.

13. Including a first sensor release liner arranged to protect the first adhesive sensor layer and configured to be peeled off by the user before the base plate having the attached sensor patch is applied to the skin, the sensor patch according to any one of claims 1 to 12.

14. The first electrode forms a first loop surrounding the center point, and the radial distance from the center point to the first loop is lower than the radial distance from the center point to the first outer rim portion, the sensor patch according to any one of claims 1 to 13.

15. The second electrode forms a second loop surrounding the central point, and a radial distance from the central point to the second loop is less than the radial distance from the central point to the first loop, the sensor patch according to claim 14.

16. The first outer rim thickness is decreased such that a shape of the outer rim portion is convex along the radial direction from a portion adjacent to the first central portion of the first adhesive sensor layer to the first outer periphery, the sensor patch according to any one of claims 1 to 15.

17. The first outer rim thickness is decreased such that a shape of the outer rim portion is concave along the radial direction from a portion adjacent to the first central portion of the first adhesive sensor layer to the first outer periphery, the sensor patch according to any one of claims 1 to 15.

18. The first outer rim thickness is decreased substantially linearly along the radial direction from a portion adjacent to the first central portion of the first adhesive sensor layer to the first outer periphery, the sensor patch according to any one of claims 1 to 15.

19. 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 being 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 layer of the first adhesive sensor material so as to form a first adhesive sensor layer of the sensor patch, wherein the first adhesive sensor material is laid out so as to form a first central portion and a first outer rim portion surrounding the first central portion, the first central portion has a first central thickness, and the first outer rim portion has a first outer rim thickness that gradually decreases radially from a portion adjacent to the first central portion of the first adhesive sensor layer to a first outer periphery, the first outer rim thickness adjacent to 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, and a proximal side of the first adhesive sensor layer is adapted to attach the sensor patch to the skin surface of the user; laying out; - providing a sensor assembly including a plurality of electrodes including a first electrode and a second electrode for forming a first sensor; - disposing the sensor assembly on a distal side of the first adhesive sensor layer; A method comprising.

20. The method according to claim 19, comprising providing a first sensor release liner, and laying out the layer of the first adhesive sensor material includes laying out the layer of the first adhesive sensor material on a distal side of the first sensor release liner.

21. The method according to claim 19 or 20, wherein providing the first adhesive sensor material includes sorting a hydrophilic colloid of the first adhesive sensor material according to particle size.

22. Laying out the layer of the first adhesive sensor material includes laying out the layer of the first adhesive sensor material so as to form the first central portion having a hydrophilic colloid with a first central average particle size and laying out the layer of the first adhesive sensor material so as to form the first outer rim portion having a hydrophilic colloid with a first outer rim average particle size, and the first outer rim average particle size is less than the first central average particle size. The method according to claim 21.

23. The method according to claim 21 or 22, wherein sorting the hydrophilic colloid includes sorting the hydrophilic colloid so as to achieve an average particle size of the hydrophilic colloid of less than 0.2 mm.

24. Laying out the layer of the first adhesive sensor material so as to form the first adhesive sensor layer includes extruding the first adhesive sensor layer, the method according to any one of claims 19 to 23.

25. Laying out the layer of the first adhesive sensor material so as to form the first adhesive sensor layer includes shaping the first adhesive sensor layer, the mold having a non-planar surface shaped to provide the first outer rim thickness that gradually decreases along the radial direction from a portion adjacent to the first central portion of the first adhesive sensor layer to the first outer periphery, the method according to any one of claims 19 to 23.

26. Laying out the layer of the first adhesive sensor material so as to form the first adhesive sensor layer includes spreading the first adhesive sensor material on a non-planar surface shaped to provide the first outer rim thickness that gradually decreases along the radial direction from a portion adjacent to the first central portion of the first adhesive sensor layer to the first outer periphery, the method according to any one of claims 19 to 23.

Citation Information

Patent Citations

  • leak sensor

    JP2009528519A

  • Adhesive patch

    JP2012035111A

  • Ostomy equipment

    JP2014500128A

  • Safety device for colostomy having a wetness detector and alarm

    US6171289B1