Base plate for an ostomy appliance and sensor assembly portion for the base plate, and method for manufacturing the base plate and sensor assembly portion - Patents.com

Abstract

To disclose a base plate for an ostomy appliance and a method for manufacturing the base plate.SOLUTION: A base plate is provided, including: a top layer; a first adhesive layer; an electrode assembly including a plurality of electrodes, the electrode assembly having a first part and a second part, the first part including connection parts of the plurality of electrodes, the second part being arranged between the first adhesive layer and the top layer; and a monitor interface configured for connecting the base plate to a monitor device, the monitor interface including a plurality of terminals configured to form electrical connections with respective terminals of the monitor device. The top layer includes a top layer opening configured to allow for connection between the plurality of electrodes of the electrode assembly and terminals of the monitor device.SELECTED DRAWING: Figure 3

Description

[Technical field]

[0001] The present disclosure relates to an ostomy system, a device thereof, a method for manufacturing an ostomy appliance, and a method for monitoring an ostomy appliance. The ostomy appliance system includes an ostomy appliance and an ostomy monitor device. In particular, the present disclosure relates to classification of leaks in an ostomy appliance and / or detection and monitoring of the performance of the ostomy appliance. Summary of the Invention [Means for solving the problem]

[0002] The accompanying drawings are included to provide a further understanding of the embodiments, and are incorporated in and constitute a part of this specification. The drawings illustrate embodiments and, together with the description, serve to explain the principles of the embodiments. Other embodiments and many of the intended advantages of the embodiments will be readily appreciated as they become better understood by reference to the following detailed description. Elements of the drawings are not necessarily drawn to scale relative to each other. Like reference characters indicate corresponding like parts. [Brief description of the drawings]

[0003] [Figure 1] FIG. 1 illustrates an exemplary ostomy system. [Diagram 2] FIG. 2 illustrates an exemplary monitoring device for an ostomy system. [Diagram 3] FIG. 3 is an exploded view of the base plate of the ostomy appliance. [Figure 4] FIG. 4 is an exploded view of an exemplary electrode assembly. [Diagram 5] FIG. 5 is a proximal view of a portion of the base plate and / or a portion of the sensor assembly. [Figure 6] FIG. 6 is a distal view of an exemplary electrode configuration. [Figure 7] FIG. 7 is a distal view of an exemplary masking element. [Figure 8]FIG. 8 is a distal view of an exemplary first adhesive layer. [Figure 9] FIG. 9 is a proximal view of the first adhesive layer of FIG. [Figure 10] FIG. 10 is a distal view of the portion of the base plate including the monitor interface and / or the sensor assembly portion. [Figure 11] FIG. 11 illustrates an exploded view of an exemplary base plate. [Figure 12] FIG. 12 shows an exploded view of an exemplary electrode assembly. [Figure 13] FIG. 13 shows an exploded view of an exemplary electrode assembly. [Figure 14] FIG. 14 shows an exemplary electrode configuration. [Figure 15] FIG. 15 shows a schematic representation of a portion of the base plate and / or a portion of the sensor assembly. [Figure 16] FIG. 16 shows a schematic representation of a portion of a base plate and / or a portion of a sensor assembly. [Figure 17] FIG. 17 shows a schematic representation of a portion of a base plate and / or a portion of a sensor assembly. [Figure 18] FIG. 18 shows a flow chart of an exemplary method. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0004] Various exemplary embodiments and details are described below with reference to the figures, where relevant. It should be noted that the figures may or may not be drawn to scale, and elements of similar structure or function are represented by similar reference numerals throughout the figures. It should also be noted that the figures are intended only to facilitate the description of the embodiments. The figures are not intended as an exhaustive description of the invention or as a limitation on the scope of the invention. In addition, the illustrated embodiment does not necessarily have all of the aspects or advantages shown. An aspect or advantage described in conjunction with a particular embodiment is not necessarily limited to the embodiment, and may be implemented in any other embodiment even if not so shown or explicitly described.

[0005] Throughout this disclosure, the terms "stoma" and "ostomy" are used to indicate a surgically created opening that bypasses a person's intestinal or urinary system. These terms are used synonymously and no distinction is intended. The same applies to any term or phrase derived from these terms, such as "stoma's", "ostomies", etc. Also, the solid and liquid waste from the stoma can be referred to synonymously as both stoma "emissions", "waste" and "fluid". A subject who has undergone an ostomy operation may also be referred to as an "ostomist" or "ostomate" - or even a "patient" or "user". However, in some cases, the "user" may relate to or refer to a healthcare professional (HCP), such as a surgeon or ostomy care nurse. In those cases, it is either explicitly stated that the "user" is not the "patient" himself, or it is implicit from the context.

[0006] Hereinafter, whenever a proximal side or surface of a layer, element, device or part of a device is referred to, the reference is to the side or surface that faces the skin when a user wears the ostomy appliance. Similarly, whenever a distal side or surface of a layer, element, device or part of a device is referred to, the reference is to the side or surface that faces away from the skin when a user wears the ostomy appliance. In other words, when the appliance is worn by a user, the proximal side or surface is the side or surface that is closest to the user and the distal side is the opposite side or surface - the side or surface that is furthest away from the user during use.

[0007] The axial direction is defined as the direction of the stoma when the user is wearing the appliance, and is therefore generally perpendicular to the user's skin or abdominal surface.

[0008] The radial direction is defined as perpendicular to the axial direction. Depending on the text, the terms "inner" and "outer" may be used. These modifiers should generally be viewed with respect to the radial direction such that a reference to an "outer" element means that the element is further from a central portion of the ostomy appliance than the element referenced as "inner". Additionally, "innermost" should be interpreted as the portion of the component that forms the center of the component and / or the portion adjacent to the center of the component. Similarly, "outermost" should be interpreted as the portion of the component that forms the outer edge or contour of the component and / or the portion adjacent to that outer edge or contour.

[0009] The use of the term "substantially" as a modifier to a particular feature or advantage in the present disclosure is intended to mean merely that any deviations are within the tolerances normally expected by one of ordinary skill in the relevant art.

[0010] The use of the term "generally" as a modifier to a particular feature or effect in this disclosure is intended to mean simply that, in the case of structural features, the majority or majority of such features indicate the property in question, and in the case of functional features or effects, the majority of results associated with that feature provide that effect, but exceptional results do not provide that effect.

[0011] The present disclosure relates to an ostomy system device, such as an ostomy system and an ostomy appliance, a base plate of the ostomy appliance, a monitor device, and optionally one or more accessory devices. Additionally, methods related to the ostomy system and the ostomy system device are disclosed. The accessory device (also referred to as an external device) may be a mobile phone or other handheld device. The accessory device may be, for example, a wearable personal electronic device, such as a watch or other wrist-worn electronic device. The accessory device may be a docking station. The docking station may be configured to electrically and / or mechanically couple the monitor device to the docking station. The docking station may be configured to charge the monitor device and / or to transfer data between the monitor device and the docking station. The ostomy system may include a server device. The server device may be operated and / or controlled by an ostomy appliance manufacturer and / or a service center.

[0012] The present disclosure relates to ostomy system devices, such as ostomy systems and ostomy appliances, base plates of ostomy appliances, monitor devices and optionally one or more accessory devices that, alone or together, facilitate reliable identification of the nature, severity and rapidity of moisture propagation in an adhesive material that provides attachment of the base plate to a user's skin surface. Depending on the nature of the moisture propagation pattern in the adhesive, the ostomy system and its devices can provide the user with information about the type of obstruction and an indication of the severity and therefore the remaining time frame for replacing the ostomy appliance without experiencing severe leakage and / or skin damage.

[0013] The ostomy appliance includes a base plate and an ostomy pouch (also called an ostomy bag). The ostomy appliance may be an artificial anus appliance, an ileostomy appliance, or an artificial bladder appliance. The ostomy appliance may be a two-piece ostomy appliance, i.e., the base plate and the ostomy pouch may be releasably coupled, for example, using mechanical and / or adhesive coupling, thereby allowing, for example, multiple ostomy pouches to be utilized (interchangeable) with one base plate. Furthermore, the two-piece ostomy appliance may facilitate accurate application of the base plate to the skin, for example, to facilitate improved user vision of the stoma area. The ostomy appliance may be a single-piece ostomy appliance, i.e., the base plate and the ostomy pouch may be fixedly attached to each other. The base plate is configured to couple to the peristomal skin, such as the stoma and / or surrounding skin area of ​​the user.

[0014] The ostomy appliance includes a base plate, e.g., a monolithic one-piece base plate integrated with the sensor assembly portion, or a separate sensor assembly portion, e.g., a base plate and a sensor assembly portion subsequently applied to the base plate, so that any base plate, e.g., a conventional base plate, can achieve the features described herein. The features described herein with respect to the base plate can be provided, e.g., by the sensor assembly portion applied to the base plate by a user. The sensor assembly portion can be adapted to be attached to the ostomy plate.

[0015] The disclosed method of attaching the base plate to the peristomal skin, such as the stoma and / or surrounding skin area of ​​a user, may include attaching the sensor assembly portion to the base plate and attaching the base plate with the attached sensor assembly portion to the peristomal skin, such as the stoma and / or surrounding skin area of ​​the user. Alternatively, the method of attaching the base plate to the user's stoma and / or peristomal skin may include attaching the sensor assembly portion to the user's stoma and / or peristomal skin and attaching the base plate to the user's stoma and / or peristomal skin over the attached sensor assembly portion.

[0016] The base plate and / or the sensor assembly portion includes a first adhesive layer, also denoted as a central adhesive layer. During use, the first adhesive layer adheres to the user's skin (surrounding area) and / or additional seals such as sealing paste, sealing tape and / or sealing rings. Thus, the first adhesive layer may be configured to attach the base plate and / or the sensor assembly portion to the user's skin surface. The first adhesive layer may have a stoma opening, such as a first adhesive stoma opening, having a central point.

[0017] The first adhesive layer may be made of a first composition. The first composition may include one or more polyisobutenes and / or styrene-isoprene-styrene. The first composition may include one or more hydrocolloids.

[0018] The first composition may comprise one or more water-soluble or water-swellable hydrocolloids. The first composition may be a pressure-sensitive adhesive composition suitable for medical purposes, comprising a resilient elastomeric base and one or more water-soluble or water-swellable hydrocolloids. The first composition may comprise one or more polybutenes, one or more styrene copolymers, one or more hydrocolloids, or any combination thereof. The adhesive properties of the polybutene combined with the absorbency of the hydrocolloids makes the first composition suitable for use with ostomy appliances. The styrene copolymer may be, for example, a styrene-butadiene-styrene block copolymer or a styrene-isoprene-styrene block copolymer. Preferably, one or more styrene-isoprene-styrene (SIS) block type copolymers are utilized. The amount of styrene block copolymer may be 5% to 20% of the total adhesive composition. The butene component is suitably a conjugated butadiene polymer selected from polybutadiene, polyisoprene. The polybutene is preferably present in an amount of 35% to 50% of the total adhesive composition. Preferably, the polybutene is polyisobutylene (PIB). Hydrocolloids suitable for incorporation into the first composition are selected from hydrocolloids of natural origin, semi-synthetic hydrocolloids and synthetic hydrocolloids. The first composition may contain 20% to 60% hydrocolloid. A preferred hydrocolloid is carboxymethylcellulose (CMC). The first composition may optionally contain other components such as fillers, tackifiers, plasticizers and other additives.

[0019] The first adhesive layer may have a plurality of sensor point openings, optionally configured to overlap a portion of an electrode, for example to form a sensor point.

[0020] The sensor point openings of the first adhesive layer can include a primary sensor point opening. The primary sensor point openings can include one or more first primary sensor point openings and one or more second primary sensor point openings, where the first primary sensor point openings are configured to overlap a portion of an electrode and the second primary sensor point openings are configured to overlap a portion of another electrode different from the electrode that the first primary sensor point openings at least partially overlap.

[0021] The sensor point openings of the first adhesive layer can include secondary sensor point openings. The secondary sensor point openings can include one or more first secondary sensor point openings and one or more second secondary sensor point openings, where the first secondary sensor point openings are configured to overlap a portion of an electrode and the second secondary sensor point openings are configured to overlap a portion of another electrode different from the electrode that the first secondary sensor point openings at least partially overlap.

[0022] The sensor point openings of the first adhesive layer can include tertiary sensor point openings. The tertiary sensor point openings can include one or more first tertiary sensor point openings and one or more second tertiary sensor point openings, where the first tertiary sensor point openings are configured to overlap a portion of an electrode and the second tertiary sensor point openings are configured to overlap a portion of another electrode different from the electrode that the first tertiary sensor point openings at least partially overlap.

[0023] The first adhesive layer may have a substantially uniform thickness. The first adhesive layer may have a thickness in the range of 0.1 mm to 1.5 mm, for example, in the range of 0.2 mm to 1.2 mm.

[0024] The first adhesive layer may have a primary thickness in a primary portion of the first adhesive layer, for example a primary region within a primary radial distance or range of radial distances from a center point of the stoma opening. The primary thickness may be in the range of 0.2 mm to 1.5 mm, such as about 1.0 mm. The primary radial distance may be in the range of 20 mm to 50 mm, such as in the range of 25 mm to 35 mm, for example 30 mm.

[0025] The first adhesive layer may have a secondary thickness in a secondary portion of the first adhesive layer, e.g., a secondary region a secondary radial distance or range of radial distances away from the center point of the stoma opening. The secondary thickness may be in the range of 0.2 mm to 1.0 mm, such as about 0.5 mm. The secondary radial distance may be in the range of 20 mm to 50 mm, such as in the range of 25 mm to 35 mm, e.g., 30 mm.

[0026] The base plate and / or sensor assembly portion may include a second layer. The second layer may be a second adhesive layer, also denoted as a rim adhesive layer. The second layer may have a second radial extent, at least in a first angular range of the base plate and / or sensor assembly portion, that is greater than the first radial extent of the first adhesive layer. Thus, a portion of the proximal surface of the second layer may be configured to be attached to a skin surface of a user. The portion of the proximal surface of the second layer configured to be attached to a skin surface of a user is also denoted as a skin attachment surface of the second adhesive layer. The second layer may have a stoma opening, such as a second layer stoma opening and / or a second adhesive stoma opening, having a center point.

[0027] The second adhesive layer may be made of a second composition. The second composition may include one or more polyisobutenes and / or styrene-isoprene-styrene. The second composition may include one or more hydrocolloids.

[0028] The second composition may comprise one or more water-soluble or water-swellable hydrocolloids. The second composition may be a pressure-sensitive adhesive composition suitable for medical purposes, comprising a resilient elastomeric base and one or more water-soluble or water-swellable hydrocolloids. The second composition may comprise one or more polybutenes, one or more styrene copolymers, one or more hydrocolloids, or any combination thereof. The combination of the adhesive properties of the polybutene with the absorbency of the hydrocolloids makes the second composition suitable for use with ostomy appliances. The styrene copolymer may be, for example, a styrene-butadiene-styrene block copolymer or a styrene-isoprene-styrene block copolymer. Preferably, one or more styrene-isoprene-styrene (SIS) block type copolymers are utilized. The amount of styrene block copolymer may be 5% to 20% of the total adhesive composition. The butene component is suitably a conjugated butadiene polymer selected from polybutadiene, polyisoprene. The polybutene is preferably present in an amount of 35% to 50% of the total adhesive composition. Preferably, the polybutene is polyisobutylene (PIB). Hydrocolloids suitable for incorporation into the second composition are selected from hydrocolloids of natural origin, semi-synthetic hydrocolloids and synthetic hydrocolloids. The second composition may contain 20% to 60% hydrocolloid. A preferred hydrocolloid is carboxymethylcellulose (CMC). The second composition may optionally contain other components such as fillers, tackifiers, plasticizers and other additives.

[0029] The different ratios of content may change the properties of the first and / or second adhesive layer. The second adhesive layer and the first adhesive layer may have different properties. The second adhesive layer (second composition) and the first adhesive layer (first composition) may have different ratios of polyisobutene, styrene-isoprene-styrene and / or hydrocolloid. For example, the second adhesive layer may provide stronger adhesion to the skin compared to the attachment to the skin provided by the first adhesive layer. Alternatively or additionally, the second adhesive layer may be thinner than the first adhesive layer. Alternatively or additionally, the second adhesive layer may absorb less water and / or sweat than the first adhesive layer. Alternatively or additionally, the second adhesive layer may be less moldable than the first adhesive layer. The second adhesive layer may provide a second leak-resistant barrier.

[0030] The second layer may have a substantially uniform thickness. The second layer may have a thickness in the range of 0.1 mm to 1.5 mm, such as 0.5 mm, 0.6 mm, or 0.7 mm, for example in the range of 0.2 mm to 1.0 mm.

[0031] The base plate and / or the sensor assembly portion may include one or more electrodes, such as a plurality of electrodes, such as 2, 3, 4, 5, 6 or more electrodes. The sensor assembly portion may be applied to the base plate, thereby providing the base plate with one or more electrodes, for example.

[0032] The electrodes, e.g., some or all of the electrodes, may be disposed between the first adhesive layer and the second adhesive layer. The electrodes may be disposed in an electrode assembly, e.g., an electrode layer. The electrodes include connections connecting the electrodes to other components and / or interface terminals. The electrodes may include one or more conductor portions and / or one or more sensing portions. The electrode assembly may be disposed between the first adhesive layer and the second adhesive layer. The base plate and / or the sensor assembly portion, e.g., the electrode assembly, may include a first electrode, a second electrode, and optionally a third electrode. The base plate and / or the sensor assembly portion, e.g., the electrode assembly, may include a fourth electrode and / or a fifth electrode. The base plate and / or the sensor assembly portion, e.g., the electrode assembly, may optionally include a sixth electrode. The base plate and / or the sensor assembly portion, e.g., the electrode assembly, may include a ground electrode. The ground electrode may include a first electrode portion. The first electrode portion of the ground electrode may form the ground of the first electrode. The ground electrode may include a second electrode portion. The second electrode portion of the ground electrode may form a ground for the second electrode. The ground electrode may include a third electrode portion. The third electrode portion of the ground electrode may form a ground for the third electrode. The ground electrode may include a fourth electrode portion. The fourth electrode portion of the ground electrode may form a ground for the fourth electrode and / or the fifth electrode.

[0033] The ground electrode or an electrode portion of the ground electrode may be configured as or form a (common) reference electrode for some or all of the other electrodes of the electrode assembly. The ground electrode may also be referred to as the reference electrode.

[0034] The electrodes are electrically conductive and may include one or more of metallic materials (e.g., silver, copper, gold, titanium, aluminum, stainless steel), ceramic materials (e.g., ITO), polymeric materials (e.g., PEDOT, PANI, PPy), and carbonaceous materials (e.g., carbon black, carbon nanotubes, carbon fibers, graphene, graphite).

[0035] Two electrodes of the electrode assembly may form a sensor. The first electrode and the ground electrode (e.g., the first electrode portion of the ground electrode) may form a first sensor or a first electrode pair. The second electrode and the ground electrode (e.g., the second electrode portion of the ground electrode) may form a second sensor or a second electrode pair. The third electrode and the ground electrode (e.g., the third electrode portion of the ground electrode) may form a third sensor or a third electrode pair. The fourth electrode and the ground electrode (e.g., the fourth electrode portion of the ground electrode) may form a fourth sensor or a fourth electrode pair. The fifth electrode and the ground electrode (e.g., the fifth electrode portion of the ground electrode) may form a fifth sensor or a fifth electrode pair.

[0036] The first electrode may form an open loop. The second electrode may form an open loop, and / or the third electrode may form an open loop. The fourth electrode may form an open loop. The fifth electrode may form an open loop. Open loop electrodes allow for electrode placement into few or one electrode layers.

[0037] The electrode assembly may include a support layer, also referred to as a support membrane. One or more electrodes may be formed, e.g., printed, on a proximal side of the support layer. One or more electrodes may be formed, e.g., printed, on a distal side of the support layer. The electrode assembly, such as the support layer of the electrode assembly, may have a stoma opening, such as an electrode assembly stoma opening and / or a support layer stoma opening, having a center point.

[0038] The support layer may include a polymeric material (e.g., polyurethane, PTFE, PVDF) and / or a ceramic material (e.g., alumina, silica). In one or more exemplary base plate and / or sensor assembly parts, the support layer is made of thermoplastic polyurethane (TPU). The support layer material may be made of or include one or more of polyester, thermoplastic elastomer (TPE), polyamide, polyimide, ethylene vinyl acetate (EVA), polyurea, and silicone.

[0039] Exemplary thermoplastic elastomers for the support layer are styrene block copolymers (TPS, TPE-s), thermoplastic polyolefin elastomers (TPO, TPE-o), thermoplastic vulcanizates (TPV, TPE-v), thermoplastic polyurethanes (TPU), thermoplastic copolyesters (TPC, TPE-E) and thermoplastic polyamides (TPA, TPE-A).

[0040] The sensor assembly portion, such as the base plate and / or the electrode assembly, may include a masking element configured to insulate at least a portion of the electrode from the first adhesive layer of the base plate and / or the sensor assembly portion. The masking element may include two or more sensor point openings, such as one or more. The sensor point openings may include a primary sensor point opening and / or a secondary sensor point opening. The sensor point openings may include a tertiary sensor point opening. The sensor point openings may include a quaternary sensor point opening. The sensor point openings of the masking element overlap at least one of the electrodes of the electrode assembly when viewed in the axial direction, thereby forming, for example, a sensor point. For example, the primary sensor point opening may overlap a portion of the ground electrode and / or a portion of the fourth electrode. The secondary sensor point opening may overlap a portion of the fourth electrode and / or a portion of the fifth electrode. The tertiary sensor point opening may overlap a portion of the fifth electrode and / or a portion of the ground electrode.

[0041] The masking element may include two or more, such as one or more, terminal openings. The masking element may include a polymeric material (e.g., polyurethane, PTFE, PVDF) and / or a ceramic material (e.g., alumina, silica). In one or more exemplary base plate and / or sensor assembly parts, the masking element is made of or includes a thermoplastic polyurethane (TPU). In one or more exemplary base plate and / or sensor assembly parts, the masking element is made of or includes a polyester. The masking element material may be made of or include one or more of polyester, thermoplastic elastomer (TPE), polyamide, polyimide, ethylene vinyl acetate (EVA), polyurea, and silicone.

[0042] Exemplary thermoplastic elastomers for the masking element are styrene block copolymers (TPS, TPE-s), thermoplastic polyolefin elastomers (TPO, TPE-o), thermoplastic vulcanizates (TPV, TPE-v), thermoplastic polyurethanes (TPU), thermoplastic copolyesters (TPC, TPE-E) and thermoplastic polyamides (TPA, TPE-A).

[0043] The base plate and / or the sensor assembly portion may include a first intermediate element. The first intermediate element may be disposed between the electrode / electrode layer and the first adhesive layer and / or between the second layer and the first adhesive layer. The first intermediate layer may be made of an insulating material.

[0044] The base plate and / or sensor assembly portion may include a release liner, which is a protective layer that protects the adhesive layer during shipping and storage and is peeled off by the user before applying the base plate and / or sensor assembly portion to the skin. The release liner may have a stoma opening, such as a release liner stoma opening, with a center point.

[0045] The base plate and / or sensor assembly portion may include a top layer. The top layer is a protective layer that protects the adhesive layer from external strains and stresses when a user wears the ostomy appliance. The electrodes, e.g., some or all of the electrodes, may be disposed between the first adhesive layer and the top layer. The top layer may have a stoma opening, e.g., a top layer stoma opening, having a center point. The top layer may have a thickness in the range of 0.01 mm to 1.0 mm, e.g., 0.04 mm, e.g., 0.02 mm to 0.2 mm.

[0046] The base plate and / or sensor assembly portion may include a monitor interface. The monitor interface may be configured to electrically and / or mechanically connect the ostomy appliance (the base plate and / or sensor assembly portion) to a monitoring device. The monitor interface may be configured to wirelessly connect the ostomy appliance (the base plate and / or sensor assembly portion) to the monitoring device. Thus, the monitor interface of the base plate and / or sensor assembly portion is configured to electrically and / or mechanically couple the ostomy appliance and the monitoring device.

[0047] The monitor interface of the base plate and / or sensor assembly portion may include a coupling portion that forms a mechanical connection, such as a releasable coupling, between a monitoring device and the base plate and / or sensor assembly portion, e.g., as part of the first connector of the monitor interface. The coupling portion may be configured to engage with a monitoring device coupling portion that releasably couples the monitoring device to the base plate and / or sensor assembly portion.

[0048] The monitor interface of the base plate and / or sensor assembly portion may include a plurality of terminals, such as 2, 3, 4, 5, 6, or more than 6 terminals, forming an electrical connection with each terminal of the monitor device as part of the first connector of the monitor interface. The monitor interface may include a ground terminal element forming a ground terminal. The monitor interface may include a first terminal element forming a first terminal, a second terminal element forming a second terminal, and optionally a third terminal element forming a third terminal. The monitor interface may include a fourth terminal element forming a fourth terminal and / or a fifth terminal element forming a fifth terminal. The monitor interface may optionally include a sixth terminal element forming a sixth terminal. The terminal elements of the monitor interface may contact the respective electrodes of the base plate and / or sensor assembly portion of the sensor assembly portion, such as the electrode assembly. The first intermediate element may be disposed between the terminal element and the first adhesive layer. The first intermediate element may cover or overlap the terminal elements of the base plate and / or sensor assembly portion when viewed in the axial direction. Thus, the first adhesive layer may be protected from or receive more evenly distributed mechanical stresses from the terminal elements of the base plate and / or sensor assembly portion, thereby reducing the risk of the terminal elements penetrating or otherwise damaging the first adhesive layer. The first intermediate element may protect or mechanically and / or electrically shield the first adhesive layer from the terminal elements of the base plate and / or sensor assembly portion.

[0049] The terminal elements, such as the ground terminal element, the first terminal element, the second terminal element, the third terminal element, the fourth terminal element, the fifth terminal element, and / or the sixth terminal element, may include a distal end and a proximal end. The terminal elements, such as the ground terminal element, the first terminal element, the second terminal element, the third terminal element, the fourth terminal element, the fifth terminal element, and / or the sixth terminal element, may include a distal portion, a central portion, and / or a proximal portion. The distal portion may be between the distal portion and the central portion. The proximal portion may be between the proximal portion and the central portion. The terminal elements, such as the ground terminal element, the first terminal element, the second terminal element, the third terminal element, the fourth terminal element, the fifth terminal element, and / or the sixth terminal element, may be gold plated copper.

[0050] The base plate may include a connection ring or other connecting member that connects the ostomy pouch to the base plate (two-piece ostomy appliance). The center point may be defined as the center of the connection ring.

[0051] The base plate and / or the sensor assembly portion may have a stoma opening having, for example, a central point. The stoma opening of the base plate and / or the sensor assembly portion may be collectively formed of the stoma openings of the layers of the base plate and / or the sensor assembly portion, such as the top layer, the first adhesive layer, the second layer and / or the sensor assembly portion. The stoma openings of the layers of the base plate and / or the sensor assembly portion, such as the top layer, the first adhesive layer, the second layer and / or the sensor assembly portion, may be aligned to form the stoma opening of the base plate and / or the sensor assembly portion. The stoma opening may be a through passage of the base plate and / or the sensor assembly portion. The stoma opening may be located substantially at the center of the base plate and / or the sensor assembly portion. The stoma openings of the layers of the base plate and / or the sensor assembly portion may be located substantially at the center of each layer. The stoma opening may be configured to receive a user's stoma and / or may be configured to allow drainage from the stoma through the stoma opening and into an ostomy pouch attached to the base plate. For example, the stoma opening may be configured to allow drainage to pass from a proximal side of the base plate and / or sensor assembly portion to a distal side of the base plate and / or sensor assembly portion. The size and / or shape of the stoma opening may typically be adjusted by a user or nurse to fit the user's stoma prior to application of the ostomy appliance. In one or more exemplary base plates or sensor assembly portions, a user forms a stoma opening while preparing the base plate and / or sensor assembly portion for application.

[0052] The monitor device includes a processor and one or more interfaces, such as the first interface and / or the second interface. The monitor device may include a memory that stores the ostomy data.

[0053] In one or more exemplary monitor devices, the processor is configured to apply a processing scheme, a first interface is connected to the processor and the memory, and the first interface is configured to collect ostomy data from a base plate and / or sensor assembly portion coupled to the first interface. The ostomy data may include a plurality, such as one or all of: first ostomy data from a first electrode pair of the base plate and / or sensor assembly portion, second ostomy data from a second electrode pair of the base plate and / or sensor assembly portion, and third ostomy data from a third electrode pair of the base plate and / or sensor assembly portion. The second interface is connected to the processor. Applying the processing scheme may include one or more of obtaining first parameter data based on the first ostomy data, obtaining second parameter data based on the second ostomy data, and obtaining third parameter data based on the third ostomy data. Applying the processing modality may include determining an operational state of a base plate of the ostomy appliance based on a plurality, such as one or all of the first parameter data, the second parameter data, and the third parameter data. The operational state may be indicative of an extent of radial erosion of a portion of the base plate, such as the first adhesive layer, and / or the sensor assembly, and / or a significant leakage risk of the ostomy appliance. The monitoring device is configured to transmit a first monitoring signal including monitor data indicative of the first operational state of the base plate via the second interface in response to determining that the operational state is the first operational state, and / or transmit a second monitoring signal including monitor data indicative of the second operational state of the base plate via the second interface in response to determining that the operational state is the second operational state.

[0054] In one or more exemplary monitoring devices, the first operating state of the base plate corresponds to a situation in which a first adhesive layer of the base plate and / or sensor assembly portion has undergone a first degree of radial leakage, e.g., the first adhesive layer has eroded to a first radial distance of the first electrode pair but has not eroded to a second radial distance of the second electrode pair.

[0055] In one or more exemplary monitoring devices, the second operating state of the base plate corresponds to a situation in which the first adhesive layer of the base plate and / or sensor assembly portion has undergone a second degree of radial leakage, e.g., the first adhesive layer has eroded to a second radial distance of the second electrode pair but has not eroded to a third radial distance of the third electrode pair.

[0056] Obtaining the first parameter data based on the first ostomy data may include identifying one or more first parameters based on the first ostomy data. Obtaining the second parameter data based on the second ostomy data may include identifying one or more second parameters based on the second ostomy data. Obtaining the third parameter data based on the third ostomy data may include identifying one or more third parameters based on the third ostomy data. In one or more exemplary monitoring devices, the determination of the operating state may be based on one or more first parameters, such as a first primary parameter and / or a first secondary parameter, of the first parameter data. In one or more exemplary monitoring devices, the determination of the operating state may be based on one or more second parameters, such as a second primary parameter and / or a second secondary parameter, of the second parameter data. In one or more exemplary monitoring devices, the determination of the operating state may be based on one or more third parameters, such as a third primary parameter and / or a third secondary parameter, of the third parameter data. In one or more example monitoring devices, the determination of the operating state may be based on one or more fourth parameters, such as a fourth primary parameter and / or a fourth secondary parameter of the fourth parameter data.

[0057] The first parameter data, the second parameter data, and the third parameter data may be indicative of resistance between the first electrode pair, the second electrode pair, and the third electrode pair, respectively.

[0058] The first parameter data, the second parameter data, and the third parameter data may indicate a rate of resistance change between the first electrode pair, the second electrode pair, and the third electrode pair, respectively.

[0059] In one or more exemplary monitor devices, determining the operating state of the baseplate is based on a first set of criteria based on the first parameter data and / or the second parameter data, and if the first set of criteria is satisfied, the operating state is determined to be the first operating state. The first set of criteria may include one or more first criteria based on one or more of the first parameter data, the second parameter data, and the third parameter data. The first set of criteria may include a first primary criterion based on the first parameter data. The first set of criteria may include a first secondary criterion based on the second parameter data. The first set of criteria may include a first tertiary criterion based on the third parameter data.

[0060] In one or more exemplary monitor devices, determining the motion status of the baseplate may be based on a first threshold set including one or more of the first thresholds. The first threshold set may include, for example, one or more of the thresholds to be applied to the first set of criteria. The first threshold set may include a first primary threshold. The first threshold set may include a first secondary threshold. The first threshold set may include a first tertiary threshold.

[0061] The first set of criteria is: (P_1_1 <TH_1_1)、 (P_2_1>TH_1_2), and (P_3_1>TH_1_3) can be given by, where P_1_1 is the first primary parameter based on the first parameter data, TH_1_1 is the first primary threshold, P_2_1 is the second primary parameter based on the second parameter data, TH_1_2 is the first secondary threshold, P_3_1 is the third primary parameter based on the third parameter data, TH_1_3 is the first tertiary threshold, and the first operating state indicates low radial leakage at the base plate and / or the sensor assembly part. The first thresholds (TH_1_1, TH_1_2, and TH_1_3) can be the same or different depending on, for example, the electrode configuration of the base plate and / or the sensor assembly part. The first tertiary criterion (P_3_1 < TH_1_3) can be omitted from the first set of criteria.

[0062] The first primary parameter P_1_1 can indicate the resistance between the first pair of electrodes (the first electrode part of the first electrode and the ground electrode) of the base plate and / or the sensor assembly part.

[0063] The second primary parameter can indicate the resistance between the second pair of electrodes (the second electrode part of the second electrode and the ground electrode) of the base plate and / or the sensor assembly part.

[0064] The third primary parameter can indicate the resistance between the third pair of electrodes (the third electrode part of the third electrode and the ground electrode) of the base plate and / or the sensor assembly part.

[0065] In one or more exemplary monitor devices, determining the operating state of the base plate is based on a second set of criteria based on the second parameter data and / or the third parameter data. When the second set of criteria is met, the operating state is determined to be the second operating state. The second set of criteria can be based on the first parameter data.

[0066] The second reference set may include one or more second references based on one or more of the first parameter data, the second parameter data, and the third parameter data. The second reference set may include a second primary reference based on the first parameter data. The second reference set may include a second secondary reference based on the second parameter data. The second reference set may include a second tertiary reference based on the third parameter data.

[0067] In one or more exemplary monitor devices, determining the operating state of the base plate is based on a second set of thresholds including one or more of the second thresholds. The second set of thresholds may include, for example, one or more of the thresholds to be applied to the second reference set. The second set of thresholds may include a second primary threshold. The second set of thresholds may include a second secondary threshold. The second set of thresholds may include a second tertiary threshold.

[0068] The second reference set is (P_1_1 < TH_2_1), (P_2_1 < TH_2_2), and (P_3_1 > TH_2_3) may be given by, where P_1_1 is a first primary parameter based on the first parameter data, indicating the resistance between the first pair of electrodes, TH_2_1 is a second primary threshold, P_2_1 is a second primary parameter based on the second parameter data, indicating the resistance between the second pair of electrodes, TH_2_2 is a second secondary threshold, P_3_1 is a third primary parameter based on the third parameter data, indicating the resistance between the third pair of electrodes, TH_2_3 is a second tertiary threshold, and the second operating state indicates moderate radial leakage at the base plate and / or the sensor assembly portion. The second thresholds (TH_2_1, TH_2_2, and TH_2_3) may be the same or different, for example, depending on the electrode configuration of the base plate and / or the sensor assembly portion. The second primary reference (P_1_1 < TH_2_1) and / or the second tertiary reference (P_3_1 > TH_2_3) may be omitted from the second reference set.

[0069] In one or more exemplary monitoring devices, determining the operational state of the base plate is based on a default criterion set based on the first parameter data, and if the default criterion set is satisfied, the operational state is determined to be the default operational state, and in accordance with determining that the operational state is the default operational state, a default monitor signal is transmitted including monitor data indicative of a default operational state of the ostomy appliance.

[0070] The default criteria set is (P_1_1>TH_D_1), (P_2_1>TH_D_2), and (P_3_1>TH_D_3) where P_1_1 is a first primary parameter based on the first parameter data and indicative of a resistance between the first electrode pair, TH_D_1 is a default primary threshold, P_2_1 is a second primary parameter based on the second parameter data and indicative of a resistance between the second electrode pair, TH_D_2 is a default secondary threshold, P_3_1 is a third primary parameter based on the third parameter data and indicative of a resistance between the third electrode pair, and TH_D_3 is a default tertiary threshold, and the default operating condition is indicative of no or very low radial leakage at the base plate and / or sensor assembly portion. The default thresholds (TH_D_1, TH_D_2, and TH_D_3) may be the same or different depending on, for example, the electrode configuration of the base plate and / or sensor assembly portion.

[0071] In one or more exemplary monitoring devices, determining the operational state of the base plate is based on a third set of criteria based on the third parameter data, and if the third set of criteria is satisfied, the operational state is determined to be a third operational state, and in accordance with determining that the operational state is the third operational state, transmitting a third monitor signal including monitor data indicative of a third operational state of the ostomy appliance.

[0072] In one or more exemplary monitor devices, the third operating state of the base plate corresponds to a situation where the first adhesive layer of the base plate and / or the sensor assembly portion has received a third degree of radial leakage, for example, a situation where the first adhesive layer has leaked to the third radial distance of the third electrode pair.

[0073] The third reference set can be given by (P_1_1 < TH_3_1), (P_2_1 < TH_3_2), and (P_3_1 < TH_3_3) where P_1_1 is the first primary parameter based on the first parameter data, indicating the resistance between the first pair of electrodes, TH_3_1 is the third primary threshold, P_2_1 is the second primary parameter based on the second parameter data, indicating the resistance between the second pair of electrodes, TH_3_2 is the third secondary threshold, P_3_1 is the third primary parameter based on the third parameter data, indicating the resistance between the third pair of electrodes, TH_3_3 is the third tertiary threshold, and the third operating state indicates a high degree of radial leakage in the base plate and / or the sensor assembly portion. The third thresholds (TH_3_1, TH_3_2, and TH_3_3) can be the same or different depending on, for example, the electrode configuration of the base plate and / or the sensor assembly portion. The third primary reference (P_1_1 < TH_3_1) and / or the third secondary reference (P_2_1 < TH_3_2) can be omitted from the third reference set.

[0074] In one or more exemplary monitor devices, the ostomy data includes fourth ostomy data from the fourth electrode pair of the base plate and / or the sensor assembly portion. Applying the processing method can include obtaining fourth parameter data based on the fourth ostomy data and determining the operating state of the base plate of the ostomy appliance based on the fourth parameter data. The monitor device can be configured to transmit a fourth monitor signal including monitor data indicating the fourth operating state of the ostomy appliance according to the determination that the operating state is the fourth operating state.

[0075] In one or more exemplary monitoring devices, the fourth operating state of the base plate corresponds to a situation in which the fourth electrode pair detects fluid, such as excreta, at a fourth radial distance between the distal surface of the first adhesive layer and the user's skin, such that in the fourth operating state there is a high risk of leakage from the ostomy appliance.

[0076] The fourth set of criteria is: (P_4_1 <TH_4_4) where P_4_1 is a fourth primary parameter based on the fourth parameter data and indicative of resistance between the fourth electrode pair, and TH_4_4 is a fourth quaternary threshold value, the fourth operating state being indicative of a high risk of leakage from the ostomy appliance.

[0077] The monitoring device includes a monitoring device housing, optionally made of a plastic material. The monitoring device housing may be an elongated housing having a first end and a second end. The monitoring device housing may have a length or maximum extent along a longitudinal axis in the range of 1 cm to 15 cm. The monitoring device housing may have a width or maximum extent perpendicular to the longitudinal axis in the range of 0.5 cm to 3 cm. The monitoring device housing may be curved in shape.

[0078] The monitoring device includes a first interface. The first interface may be configured as an appliance interface that electrically and / or mechanically connects the monitoring device to the ostomy appliance. Thus, the appliance interface is configured to electrically and / or mechanically couple the monitoring device and the ostomy appliance. The first interface may be configured as an accessory device interface that electrically and / or mechanically connects the monitoring device to an accessory device, such as a docking station. The first interface may be configured to couple to a docking station of the ostomy system, for example, to charge the monitoring device and / or transfer data between the monitoring device and the docking station.

[0079] The first interface of the monitoring device may include multiple terminals, such as 2, 3, 4, 5, 6, or more than 6 terminals, that form an electrical connection with the terminals and / or electrodes of the ostomy appliance. One or more terminals of the first interface may be configured to form an electrical connection with the terminals of an accessory device, such as a docking station. The first interface may include a ground terminal. The first interface may include a first terminal, a second terminal, and optionally a third terminal. The first interface may include a fourth terminal and / or a fifth terminal. The first interface optionally includes a sixth terminal. In one or more exemplary monitoring devices, the first interface has M terminals, where M is an integer in the range of 4 to 8.

[0080] The first interface of the monitoring device may include a coupling (alternatively referred to as a device coupling or a monitor device coupling) that forms a mechanical connection, such as a releasable coupling, between the monitoring device and the base plate and / or the sensor assembly portion. The coupling and terminals of the first interface form a first connector of (at least a portion of) the monitoring device.

[0081] The monitoring device includes a power unit for powering the monitoring device. The power unit may include a battery. The power unit may include a charging circuit connected to the battery and to terminals of the first interface for charging the battery via the first interface, e.g., the first connector. The first interface may include separate charging terminals for charging the battery.

[0082] The monitor device may include a sensor unit having one or more sensors. The sensor unit is connected to the processor to provide sensor data to the processor. The sensor unit may include an accelerometer to sense acceleration and provide the acceleration data to the processor. The sensor unit may include a temperature sensor to provide temperature data to the processor.

[0083] The monitoring device includes a second interface connected to the processor. The second interface may be configured as an accessory interface for connecting, e.g., wirelessly, the monitoring device to one or more accessory devices. The second interface may include, for example, an antenna and a wireless transceiver configured for wireless communication at a frequency in the range of 2.4 GHz to 2.5 GHz. The wireless transceiver may be a Bluetooth transceiver, i.e., the wireless transceiver may be configured for wireless communication according to a Bluetooth protocol, e.g., Bluetooth Low Energy, Bluetooth 4.0, Bluetooth 5. The second interface optionally includes a loudspeaker and / or a haptic feedback element for providing audio signals and / or haptic feedback, respectively, to the user.

[0084] In one or more exemplary ostomy systems, the monitoring device forms an integral part of the ostomy appliance, for example, the monitoring device may form an integral part of the base plate and / or sensor assembly portion of the ostomy appliance.

[0085] The ostomy system may include a docking station that forms an accessory device of the ostomy system. The docking station may be configured to electrically and / or mechanically couple the monitoring device to the docking station.

[0086] The docking station may include a docking monitor interface. The docking monitor interface may be configured to electrically and / or mechanically connect the monitoring device to the docking station. The docking monitor interface may be configured to wirelessly connect the monitoring device to the docking station. The docking monitor interface of the docking station may be configured to electrically and / or mechanically couple the docking station and the monitoring device.

[0087] The docking station's docking monitor interface may include a coupling portion that forms a mechanical connection, such as a releasable coupling, between the monitor device and the docking station, e.g., as part of the first connector of the docking monitor interface. The coupling portion may be configured to engage with the coupling portion of the monitor device to releasably couple the monitor device to the docking station.

[0088] The docking monitor interface of the docking station may include multiple terminals, such as 2, 3, 4, 5, 6, or more than 6 terminals that form electrical connections with respective terminals of the monitor device as part of a first connector of the docking monitor interface. The docking monitor interface may include a ground terminal. The docking monitor interface may include a first terminal and / or a second terminal. The docking station may include a third terminal. The docking monitor interface may include a fourth terminal and / or a fifth terminal. The docking monitor interface optionally includes a sixth terminal.

[0089] A base plate for an ostomy appliance, such as the base plate described above, is disclosed. Also disclosed is a sensor assembly portion for an ostomy appliance, such as a sensor assembly portion for attaching to the base plate. The base plate and / or the sensor assembly portion can include a top layer, a first adhesive layer, an electrode assembly including a plurality of electrodes, and a monitor interface configured to connect the base plate and / or the sensor assembly portion to a monitoring device, e.g., mechanically and / or electrically connect the base plate and / or the sensor assembly portion to the monitoring device. The base plate and / or the sensor assembly portion can include additional layers and / or features described above.

[0090] The electrode assembly can have a first portion and a second portion. The first portion can include, for example, a connection portion for a plurality of electrodes configured to connect the plurality of electrodes to a terminal of a monitoring device. The second portion can include a sensing portion of the plurality of electrodes. The electrode assembly, such as the second portion of the electrode assembly, can be disposed between the first adhesive layer and the top layer.

[0091] The monitor interface may include a plurality of terminals electrically connected to the plurality of electrodes and configured to connect with respective terminals of the monitor device. The connection portion may form the plurality of terminals of the monitor interface.

[0092] The top layer can include top layer openings configured to allow connections, such as electrical connections, between the multiple electrodes of the electrode assembly and terminals of a monitoring device.

[0093] Also disclosed is a device for connecting to a base plate and / or sensor assembly portion of an ostomy appliance, such as the base plate disclosed above. The device can be, for example, a monitoring device, such as the monitoring device disclosed above. The monitoring device can be configured to measure an electrical parameter using electrodes of the base plate and / or the sensor assembly portion. The device can include electronic circuitry. The electronic circuitry can include a processor. The electronic circuitry can be encapsulated by a device housing.

[0094] The device can include, for example, an orthosis interface configured to connect the device to a base plate and / or a sensor assembly portion. The orthosis interface can include, for example, a plurality of terminals for forming electrical connections with a plurality of electrodes of the base plate and / or the sensor assembly portion. The orthosis interface can include a device interface. The device interface can provide a connection between the device and the base plate.

[0095] Also disclosed is a method for manufacturing a base plate or sensor assembly portion, such as a base plate or sensor assembly portion for an ostomy appliance, such as the base plate or sensor assembly portion disclosed above.

[0096] The method can include providing an upper layer, providing an electrode assembly including a plurality of electrodes, and providing a first adhesive layer.

[0097] The electrode assembly may have a first portion and a second portion. The first portion may include, for example, a connection portion for a plurality of electrodes configured to connect the plurality of electrodes to a terminal of a monitoring device. The second portion may include a sensing portion consisting of a plurality of electrodes.

[0098] The method may further include assembling the upper layer, the electrode assembly, and the first adhesive layer such that an electrode assembly, such as, for example, a second portion of the electrode assembly, is disposed between the first adhesive layer and the upper layer.

[0099] The method can further include providing the top layer with a top layer opening, which can be configured to provide a connection, such as an electrical connection, between the plurality of electrodes of the electrode assembly and a terminal of a monitoring device.

[0100] By providing the top layer openings in the top layer, the electrodes of the electrode assembly can be accessible to a monitoring device external to the base plate and / or sensor assembly portion to connect to the electrode assembly, for example, terminals of the monitoring device can be connected through the top layer openings to the electrodes of the electrode assembly, for example, to connections and / or terminals of the electrode assembly.

[0101] The top layer, the electrode assembly and / or the first adhesive layer may be substantially planar. The top layer, the electrode assembly and / or the first adhesive layer may extend in a base plate plane and / or in a sensor assembly part plane.

[0102] The release liner can be provided on a proximal side of the first adhesive layer. The first adhesive layer can be provided with a release liner on a proximal side of the first adhesive layer. The release liner can have a distal side facing the first adhesive layer. The first adhesive layer can be provided, such as by forming it on a release liner, such as on the distal side of the release liner, for example, by scraping off a thin layer of a first composition, such as a first adhesive composition, and forming the first adhesive layer on the release liner. The first adhesive layer can be formed on the release liner prior to assembling the top layer, electrode assembly, and first adhesive layer.

[0103] An electrode assembly, such as a second portion of the electrode assembly, can be disposed between the top layer and the first adhesive layer. The electrode assembly can include a proximal side and / or a distal side. The distal side of the electrode assembly can face the top layer. The proximal side of the electrode assembly can face the first adhesive layer.

[0104] The first portion of the electrode assembly can extend through the top layer opening. The first portion of the electrode assembly can have two substantially parallel sides, for example in the base plate plane and / or in the sensor assembly portion plane.

[0105] The plurality of electrodes can be provided and / or disposed on a proximal side of the electrode assembly. The electrode assembly can include a support layer. The plurality of electrodes can be provided and / or disposed on a proximal side of the support layer. For example, the plurality of electrodes can be printed on the proximal side of the support layer. The plurality of electrodes can face the first adhesive layer. The plurality of electrodes can contact the first adhesive layer.

[0106] The first portion of the electrode assembly can have a primary side. The first portion of the electrode assembly can have a secondary side. The primary side of the first portion of the electrode assembly can be a proximal side of the first portion of the electrode assembly. The secondary side of the first portion of the electrode assembly can be a distal side of the first portion of the electrode assembly. The primary side of the first portion of the electrode assembly can initially be a proximal side of the first portion of the electrode assembly. The secondary side of the first portion of the electrode assembly can initially be a distal side of the first portion of the electrode assembly. The first portion of the electrode assembly can be folded back, for example, to expose connections of the multiple electrodes at the distal side of the base plate and / or sensor assembly portion. For example, the first portion can be bent, for example, between 170 and 190 degrees, for example, 180 degrees, such that the primary side of the first portion of the electrode assembly faces in a distal direction. Thus, the primary side of the first portion of the electrode assembly can at least partially face in a distal direction. The first portion of the electrode assembly can be folded back through the top layer opening. Folding the first portion of the electrode assembly can be particularly suitable when multiple electrodes are provided on the proximal side of the electrode assembly.

[0107] The connection portion of each of the multiple electrodes can extend from the proximal side of the electrode assembly to the distal side of the electrode assembly, such as by penetrating a support layer of the electrode assembly. For example, the support layer can have a small hole in the first portion of the electrode assembly to connect with the connection portion on the distal side of the electrode assembly.

[0108] The monitor interface can include a coupling configured to form a mechanical connection, such as a releasable coupling, between the monitor device and the base plate and / or sensor assembly portion. For example, the coupling can be a rigid coupling. The coupling can provide an electrical connection, such as through a plurality of terminals of the monitor interface and the monitor device, between the monitor device coupled to the coupling and the plurality of electrodes of the electrode assembly.

[0109] The coupling portion can be attached to the top layer, e.g., to a distal side of the top layer. Alternatively or additionally, the coupling portion can be attached to the electrode assembly, e.g., to a distal side of the electrode assembly, e.g., to a distal side of the support layer of the electrode assembly. The coupling portion can be attached to the top layer and / or the electrode assembly by gluing or welding. The coupling portion can extend through the top layer opening.

[0110] The coupling portion can be aligned with the connection of the plurality of electrodes. The first portion of the electrode assembly can extend into the coupling portion. The coupling portion can be positioned to cover the connection of the plurality of electrodes. Alternatively or additionally, the connection of the plurality of electrodes can be positioned within a terminal interface area defined by the coupling portion. The terminal interface area can be, for example, an area where terminals of the base plate and / or the sensor assembly portion can connect, such as mechanically and / or electrically, with respective terminals of the monitoring device. The terminal interface area need not be an area with structural boundaries and / or visible. The terminal interface area can be an area adjacent to the coupling portion. Alternatively or additionally, the terminal interface area can be surrounded by the coupling portion, such as an area surrounded by the coupling portion. The terminal interface area can be within a 20 mm radius of the coupling portion, for example, within a 10 mm radius of the coupling portion, for example, within a 5 mm radius of the coupling portion, for example, within a 1 mm radius of the coupling portion. The coupling portion can surround the terminal interface area. The coupling portion can have one or more laterals, including a first lateral, and the terminal interface region can be adjacent to an lateral of the coupling portion, for example, the first lateral.

[0111] The electrode assembly may include a reinforcing element. The reinforcing element may form at least a portion of the first portion of the electrode assembly. The reinforcing element may provide and / or strengthen the first portion of the electrode assembly to, for example, better accommodate direct contact between the terminals of the monitoring device and the attachment of the plurality of electrodes. Additionally, the reinforcing element may facilitate bending of the first portion of the electrode assembly, for example, redirecting a primary side of the first portion of the electrode assembly to face in a distal direction.

[0112] The reinforcing element can include multiple conductive paths. The multiple conductive paths can be connected to multiple electrodes, for example, to form multiple electrode connections. For example, the reinforcing element can be a flex circuit. The multiple conductive paths can extend along the entire length of the reinforcing element.

[0113] And / or, the sensor assembly portion can include a second adhesive layer, such as the second adhesive layer as disclosed above. The second adhesive layer can have a proximal side and / or a distal side. The proximal side of the second adhesive layer can face the distal side of the electrode assembly. The distal side of the second adhesive layer can face the bond. The second adhesive layer can be between the top layer and the electrode assembly. The method can include providing the second adhesive layer. The method can include positioning the second adhesive layer, for example, with the proximal side facing the distal side of the electrode assembly. The second adhesive layer can be provided, such as by being formed on the proximal side of the top layer, such that, for example, the distal side of the second adhesive layer faces the proximal side of the top layer. The distal side of the second adhesive layer can face the proximal side of the top layer. The second adhesive layer can be provided on the upper layer by scraping off a thin layer of a second composition, such as a second adhesive composition, to form the second adhesive layer on the upper layer, such as on the proximal side of the upper layer.

[0114] The second adhesive layer can include, for example, a second adhesive layer opening aligned with the top layer opening. The second adhesive layer opening can be configured to provide a connection, such as an electrical connection, between the electrodes of the electrode assembly and a terminal of the monitoring device. For example, a connection, such as an electrical connection, between the electrodes of the electrode assembly and a terminal of the monitoring device can be provided through the top layer opening and the second adhesive layer opening.

[0115] The second adhesive layer can extend over a larger area in the base plate plane and / or in the sensor assembly part plane than the first adhesive layer, for example, the second adhesive layer can extend over a second area in the base plate / sensor assembly plane that is larger than the first area and / or covers the first area, for example, when the first adhesive layer extends over the first area.

[0116] The top layer opening and / or the second adhesive layer opening can be U-shaped. For example, the top layer opening and / or the second adhesive layer opening can be provided by making a U-shaped cut in the top layer and / or the second adhesive layer. For example, the top layer opening and / or the second adhesive layer opening can be provided by a U-shaped cut that redirects the top layer and / or the second adhesive layer and the electrode assembly underlying the top layer such that the electrode assembly, e.g., the first portion of the electrode assembly, extends through the top layer opening and / or the primary side of the first portion of the electrode assembly faces in a distal direction.

[0117] The top layer opening and / or the second adhesive layer opening can be provided in the top layer and / or the second adhesive layer after assembling the top layer, the electrode assembly, and the first adhesive layer, and, optionally, the second adhesive layer.

[0118] The base plate and / or the sensor assembly portion may include a back element. The back element may be provided between the first adhesive layer and the electrode assembly and / or the electrodes of the electrode assembly. The back element may be provided between the first adhesive layer and the first portion of the electrode assembly. The back element may make it difficult for a portion of the electrode assembly, such as the first portion of the electrode assembly, to adhere to the first adhesive layer, e.g., to redirect the portion, such as the first portion of the electrode assembly, e.g., to extend through the top layer opening. The back element may be used as a stop for a cut in the opening, such as a U-shaped cut.

[0119] Alternatively or additionally, the top layer opening and / or the second adhesive layer opening can be provided in the top layer and / or the second adhesive layer prior to assembling the top layer, the electrode assembly, and the first adhesive layer, and optionally the second adhesive layer, e.g., prior to assembling the top layer and / or the second adhesive layer with the electrode assembly and / or the first adhesive layer. For example, the top layer opening and / or the second adhesive layer opening can be provided by cutting or punching a hole in the top layer and / or the second adhesive layer. The top layer opening and the second adhesive layer opening can be provided simultaneously.

[0120] The base plate and / or sensor assembly portion can be cut out from the assembled layers, including, for example, the top layer, the electrode assembly, and / or the first adhesive layer. The method can include cutting out, such as by punching, the base plate and / or sensor assembly portion from the assembled top layer, the electrode assembly, and the first adhesive layer. The cutting out can provide a contour of the base plate and / or sensor assembly portion. The cutting out can be performed before folding back the first portion of the electrode assembly.

[0121] The base plate and / or the sensor assembly portion can include a stoma opening having a central point. For example, the top layer, the second adhesive, the electrode assembly, the first adhesive, and / or the release liner can include a stoma opening having a central point, for example, collectively forming a stoma opening having a central point for the base plate and / or the sensor assembly portion.

[0122] The horizontal axis of the base plate plane and / or the sensor assembly plane can intersect, for example, at the center point of the stoma opening. The horizontal axis can be oriented substantially horizontally, for example parallel to the ground, when the base plate is worn as intended. The upper half of the base plate can be defined as part of the base plate in the base plate plane above the horizontal axis, when the base plate is worn as intended. The lower half of the base plate can be defined as part of the base plate in the base plate plane below the horizontal axis, when the base plate is worn as intended.

[0123] The coupling portion and / or the first portion of the electrode assembly may be positioned on the upper half of the base plate and / or the sensor assembly portion. The coupling portion and / or the first portion of the electrode assembly may be positioned on the upper half of the base plate and / or the sensor assembly portion within an angular interval from the horizontal axis, e.g., 45°-135°, e.g., 45°-90°, or 90°-135°, relative to a center point of the base plate. Positioning the coupling portion and / or the first portion of the electrode assembly in this manner allows a device, such as a monitor device, to be coupled to the coupling portion and / or the first portion of the electrode assembly with little or no interference with the ostomy bag. This may also facilitate attachment of the device to the base plate.

[0124] FIG. 1 illustrates an exemplary ostomy system. The ostomy system 1 includes an ostomy appliance 2 including a base plate 4. The base plate 4 is adapted to support an ostomy pouch (not shown). Furthermore, the ostomy system 1 includes a monitor device 6 and an accessory device 8 (a mobile phone). The monitor device 6 is connectable to the base plate 4 via a first connector of the monitor device 6 and the base plate 4, respectively. The monitor device 6 is configured to wirelessly communicate with the accessory device 8. Optionally, the accessory device 8 is configured to communicate with a server device 10 of the ostomy system 1, for example, via a network 12. The server device 10 may be operated and / or controlled by an ostomy appliance manufacturer and / or a service center. Ostomy data or parameter data based on the ostomy data is obtained from an electrode / sensor of the ostomy appliance 2 with the monitor device 6. The monitor device 6 processes the ostomy data and / or the parameter data based on the ostomy data to identify monitor data to be transmitted to the accessory device 8. In the ostomy system shown, the accessory device 8 is a mobile phone, however, the accessory device 8 may be implemented as another handheld device, such as a tablet device or a wearable, such as a watch or other wrist-worn electronic device. The monitor device 6 is thus configured to identify and transmit monitor data to the accessory device 8. The base plate 4 includes a coupling member 14 in the form of a coupling ring 16 that couples an ostomy pouch (not shown) to the base plate (a two-piece ostomy appliance). The base plate has a stoma receiving opening 18 with a stoma center point. The size and / or shape of the stoma opening 18 is typically adjusted by the user or a nurse to fit the user's stoma prior to application of the ostomy appliance.

[0125] The ostomy system 1 optionally includes a docking station 20 forming an accessory device of the ostomy system 1. The docking station 20 includes a docking monitor interface including a first connector 22 configured to electrically and / or mechanically connect the monitor device 6 to the docking station 20. The docking monitor interface may be configured to wirelessly connect the monitor device to the docking station. The docking station 20 includes a user interface 24 to receive user input and / or provide feedback to the user about the operational status of the docking station 20. The user interface 24 may include a touch screen. The user interface 24 may include one or more physical buttons and / or one or more visual indicators, such as light emitting diodes.

[0126] 2 is a schematic block diagram of an exemplary monitor device. The monitor device 6 includes a monitor device housing 100, a processor 101, and one or more interfaces, including a first interface 102 (appliance interface) and a second interface 104 (accessory interface). The monitor device 6 includes a memory 106 that stores ostomy data and / or parameter data based on the ostomy data. The memory 106 is connected to the processor 101 and / or the first interface 102.

[0127] The first interface 102 is configured as an appliance interface that electrically and / or mechanically connects the monitoring device 6 to an ostomy appliance, such as the ostomy appliance 2. The first interface 102 includes a plurality of terminals that form an electrical connection with respective terminals of the ostomy appliance 2 (base plate 4). The first interface 102 includes a ground terminal 108, a first terminal 110, a second terminal 112, and a third terminal 114. The first interface 102 optionally includes a fourth terminal 116 and a fifth terminal 118. The first interface 102 of the monitoring device 6 includes a coupling portion 120 that forms a mechanical connection, such as a releasable coupling, between the monitoring device and the base plate. The coupling portion 120 and the terminals 108, 110, 112, 114, 116, and 118 of the first interface 102 form (at least a part of) a first connector of the monitoring device 6.

[0128] The monitoring device 6 comprises a power unit 121 for powering the monitoring device and its active components, i.e. the power unit 121 is connected to the processor 101, the first interface 102, the second interface 104 and the memory 106. The power unit comprises a battery and a charging circuit. The charging circuit is connected to the battery and to terminals of the first interface 102 for charging the battery via the terminals of the first interface, e.g. the terminals of the first connector.

[0129] The monitoring device second interface 104 is configured as an accessory interface that connects the monitoring device 6 to one or more accessory devices, such as the accessory device 8. The second interface 104 includes an antenna 122 and a wireless transceiver 124 configured to wirelessly communicate with the accessory device. Optionally, the second interface 104 includes a loudspeaker 126 and / or a haptic feedback element 128 that provide audio signals and / or haptic feedback to the user, respectively.

[0130] The monitor device 6 includes a sensor unit 140 connected to the processor 101. The sensor unit 140 includes a temperature sensor that provides temperature data to the processor and a G-sensor or accelerometer that provides acceleration data to the processor 101.

[0131] The processor 101 is configured to apply a processing scheme, and the first interface 102 is configured to collect ostomy data from a base plate coupled to the first interface, the ostomy data including first ostomy data from a first electrode pair of the base plate, second ostomy data from a second electrode pair of the base plate, and third ostomy data from a third electrode pair of the base plate. The ostomy data may be stored in the memory 106 and / or processed in the processor 101 to obtain parameter data. The parameter data may be stored in the memory 106. The processor 101 is configured to apply the processing scheme, and applying the processing scheme includes obtaining first parameter data based on the first ostomy data, obtaining second parameter data based on the second ostomy data, and obtaining third parameter data based on the third ostomy data. In other words, the processor 101 is configured to obtain first, second, and third parameter data based on the first, second, and third ostomy data, respectively. Applying the processing scheme includes determining an operational state of a base plate of the ostomy appliance based on one or more, e.g., all, of the first parameter data, the second parameter data, and the third parameter data, the operational state being indicative of an extent of radial erosion of the base plate and / or a serious leakage risk of the ostomy appliance. The monitor device 6 is configured to transmit a first monitor signal including monitor data indicative of the first operational state of the base plate via the second interface in response to determining that the operational state is the first operational state, and to transmit a second monitor signal including monitor data indicative of the second operational state of the base plate via the second interface in response to determining that the operational state is the second operational state.

[0132] FIG. 3 shows an exploded view of an exemplary base plate of an ostomy appliance. The base plate 4 includes a first adhesive layer 200. In use, a proximal surface of the first adhesive layer 200 adheres to the user's skin in the peristomal area and / or additional seals such as sealing paste, sealing tape, and / or sealing rings. The base plate 4 optionally includes a second adhesive layer 202, also referred to as a rim adhesive layer. The base plate 4 includes a plurality of electrodes disposed on an electrode assembly 204. The electrode assembly 204 is disposed between the first adhesive layer 200 and the second adhesive layer 202. The electrode assembly 204 includes a support layer having electrodes formed on a proximal surface of the support layer. The base plate 4 includes a release liner 206 that is peeled off by the user before applying the base plate 4 to the skin. The base plate 4 includes a top layer 208 and a bonding ring 209 that bonds the ostomy pouch to the base plate 4. The top layer 208 is a protective layer that protects the second adhesive layer 202 from external strains and stresses during use.

[0133] The base plate 4 includes a monitor interface. The monitor interface is configured to electrically and / or mechanically connect the ostomy appliance (base plate 4) to a monitor device. The monitor interface of the base plate includes a coupling portion 210 that forms a mechanical connection, such as a releasable coupling, between the monitor device and the base plate. The coupling portion 210 is configured to engage with the coupling portion of the monitor device to releasably couple the monitor device to the base plate 4. Furthermore, the monitor interface of the base plate 4 includes a plurality of terminals that respectively form a plurality of terminals 212 that form an electrical connection with each terminal of the monitor device. The coupling portion 210 and the terminals 212 form a first connector 211 of the base plate 4. The base plate 4 includes a first intermediate element 213 on the proximal side of the electrode assembly. The first intermediate element 213 is disposed between the terminal element that forms the terminal 212 and a first adhesive layer (not shown). The first intermediate element 213 covers, when viewed in the axial direction, the terminal elements forming the terminals 212 of the base plate 4 and protects the first adhesive layer from mechanical stresses from the terminal elements of the base plate.

[0134] As mentioned above, some parts of the base plate 4 shown may be provided as separate assemblies that are applied to an existing base plate, e.g., may include one or more of the components described above, thereby providing a base plate like the base plate 4 described above, etc. For example, a sensor assembly portion 700 may be provided that includes, e.g., the electrode assembly 204, the first connector 211, the first intermediate element 213, the first adhesive layer 200, and the release liner 206. Furthermore, the sensor assembly portion 700 may also include the second adhesive layer 202 and / or the top layer 208. It may be conceivable that a user may provide a hole in the layer of the base plate through which the sensor assembly portion 700 is applied, thereby allowing the first connector 211 of the sensor assembly portion 700 to protrude through the layer of the base plate and to which the sensor assembly portion 700 is applied. Alternatively, the sensor assembly portion 700 may be applied to the base plate such that the first connector 211 is located outside the periphery of the base plate.

[0135] 4 illustrates an exploded view of an exemplary electrode assembly 204 and / or sensor assembly portion of the base plate. The electrode assembly 204 has a distal side 204A and a proximal side 204B. The electrode assembly includes a support layer 214 having a proximal surface 214B and electrodes 216, including a ground electrode, a first electrode, a second electrode, a third electrode, a fourth electrode, and a fifth electrode, each having a respective connection portion 217 connecting the electrode 216 to a respective terminal element of the monitor interface. The electrodes 216 are provided, such as formed on the proximal side 214B of the support layer 214, e.g., the electrodes 216 may be located on the proximal side 214B of the support layer. Additionally, the electrode assembly 204 includes a masking element 218 having a proximal surface 218B and configured to insulate an electrode portion of the electrode 216 from the first adhesive layer and / or sensor assembly portion of the base plate. The masking element 218 covers or overlaps a portion of the electrode 216 when viewed in the axial direction.

[0136] 5 is a proximal view of the proximal face of the base plate portion and / or sensor assembly portion 700 of the base plate 4 without the first adhesive layer and release liner. The base plate 4 and / or sensor assembly portion 700 includes a first intermediate element 213 on the proximal side of the electrode assembly, i.e., between the electrode assembly 204 and the first adhesive layer (not shown). The first intermediate element 213 covers the terminal element of the base plate 4 when viewed in the axial direction and protects the first adhesive layer from mechanical stress from the terminal element of the base plate and / or sensor assembly portion.

[0137] 6 is a distal view of an exemplary electrode configuration 220 of the electrode 216 of the electrode assembly 204. The electrode assembly 204, such as the electrode configuration 220 of the electrode assembly 204, includes a ground electrode 222, a first electrode 224, a second electrode 226, a third electrode 228, a fourth electrode 230, and a fifth electrode 232. The ground electrode 222 includes a ground connection 222A, and the first electrode 224 includes a first connection 224A. The second electrode 226 includes a second connection 226A, and the third electrode 228 includes a third connection 228A. The fourth electrode 230 includes a fourth connection 230A, and the fifth electrode 232 includes a fifth connection 232A.

[0138] The fourth electrode 230 includes a fourth detection portion 230B. The fifth electrode 232 includes a fifth detection portion 232B.

[0139] The ground electrode 222 includes a first electrode portion 234 that forms a ground for the first electrode 224. The ground electrode 222 includes a second electrode portion 236 that forms a ground for the second electrode 226. The ground electrode 222 includes a third electrode portion 238 that forms a ground for the third electrode 228. The ground electrode 222 includes a fourth electrode portion 240 that forms a ground for the fourth electrode 230 and the fifth electrode 232. The fourth electrode portion 240 of the ground electrode 222 includes a ground detection portion 222B.

[0140] 7 is a distal view of an exemplary masking element. Masking element 218 optionally has a plurality of terminal openings, including six terminal openings. The plurality of terminal openings includes a ground terminal opening 242, a first terminal opening 244, a second terminal opening 246, a third terminal opening 248, a fourth terminal opening 250, and a fifth terminal opening 252. The terminal openings 242, 244, 246, 248, 250, 252 of masking element 218 are configured to overlap and / or align with respective connections 222A, 224A, 226A, 228A, 230A, 232A of the electrodes of the electrode assembly.

[0141] The masking element 218 has a plurality of sensor point openings. The sensor point openings include primary sensor point openings shown within dashed lines 254, each configured to overlap a portion of the ground electrode 222 and / or a portion of the fourth electrode 230. The primary sensor point openings 254, in the illustrated exemplary masking element, include five first primary sensor point openings 254A, each configured to overlap a portion of the ground electrode 222. The primary sensor point openings 254, in the illustrated exemplary masking element, include four second primary sensor point openings 254B, each configured to overlap a portion of the fourth electrode 230. The sensor point openings include secondary sensor point openings shown within dashed lines 256, each configured to overlap a portion of the fourth electrode 230 and / or a portion of the fifth electrode 232. The secondary sensor point openings 256 include five first secondary sensor point openings 256A each configured to overlap a portion of the fifth electrode 232 in the illustrated exemplary masking element. The secondary sensor point openings 256 include four second secondary sensor point openings 256B each configured to overlap a portion of the fourth electrode 230 in the illustrated exemplary masking element. The sensor point openings include tertiary sensor point openings shown within dashed lines 258, each tertiary sensor opening configured to overlap a portion of the fifth electrode 232 and / or a portion of the ground electrode 222. The tertiary sensor point openings 258 include five first tertiary sensor point openings 258A each configured to overlap a portion of the fifth electrode 232. The tertiary sensor point openings 258 include four second tertiary sensor point openings 258B each configured to overlap a portion of the ground electrode 222 in the illustrated exemplary masking element.

[0142] 8 is a distal view of an exemplary first adhesive layer. The first adhesive layer 200 has a plurality of sensor point openings. The sensor point openings of the first adhesive layer include primary sensor point openings shown within dashed lines 260, each configured to overlap a portion of the ground electrode 222 and / or a portion of the fourth electrode 230 of the electrode assembly. The primary sensor point openings 260 include five first primary sensor point openings 260A, in the exemplary first adhesive layer shown, each configured to overlap a portion of the ground electrode 222. The primary sensor point openings 260 include four second primary sensor point openings 260B, in the exemplary first adhesive layer shown, each configured to overlap a portion of the fourth electrode 230. The sensor point openings of the first adhesive layer include secondary sensor point openings shown within dashed lines 262, each configured to overlap a portion of the fourth electrode 230 and / or a portion of the fifth electrode 232 of the electrode assembly. The secondary sensor point openings 262, in the illustrated exemplary first adhesive layer, include five first secondary sensor point openings 262A each configured to overlap a portion of the fifth electrode 232. The secondary sensor point openings 262, in the illustrated exemplary first adhesive layer, include four second secondary sensor point openings 262B each configured to overlap a portion of the fourth electrode 230. The first adhesive layer sensor point openings include tertiary sensor point openings shown within dashed lines 264, each tertiary sensor opening configured to overlap a portion of the fifth electrode 232 and / or a portion of the ground electrode 222 of the electrode assembly. The tertiary sensor point openings 264, in the illustrated exemplary first adhesive layer, include five first tertiary sensor point openings 264A each configured to overlap a portion of the fifth electrode 232. The tertiary sensor point openings 264, in the example first adhesive layer shown, include four second tertiary sensor point openings 264B each configured to overlap a portion of the ground electrode 222. Figure 9 is a proximal view of the first adhesive layer of Figure 8.

[0143] 10 is a more detailed distal view of a portion of the base plate 4 and / or the sensor assembly portion 700. The base plate 4 and / or the sensor assembly portion 700 includes a monitor interface 207. The monitor interface 207 includes a first connector 211. The first connector 211 includes a coupling portion 210 configured to releasably couple a monitoring device to the base plate 4 and / or the sensor assembly portion 700, thereby forming a releasable coupling. The first connector 211 of the monitor interface 207 includes a plurality of terminals formed with respective terminal elements that form respective electrical connections with respective terminals of the monitoring device.

[0144] The plurality of terminals of the first connector 211 of the monitor interface 207 includes a ground terminal element 282 forming a ground terminal 282A, a first terminal element 284 forming a first terminal 284, a second terminal element 286 forming a second terminal 286A, and a third terminal element 288 forming a third terminal 288A. The monitor interface 207 optionally includes a fourth terminal element 290 forming a fourth terminal 290A and / or a fifth terminal element 292 forming a fifth terminal 290. The terminal elements 282, 284, 286, 288, 290, 292 contact the respective connections 222A, 224A, 226A, 228A, 230a, 232A of the electrodes 222, 224, 226, 228, 230, 232.

[0145] FIG. 11 shows an exploded view of an exemplary base plate 4 of an ostomy appliance. The base plate 4 includes a first adhesive layer 200. The base plate 4 optionally includes a second adhesive layer 202, also referred to as a rim adhesive layer. The base plate 4 includes a plurality of electrodes 216 disposed on an electrode assembly 204. The electrode assembly 204 is disposed between the first adhesive layer 200 and the second adhesive layer 202. The electrode assembly 204 optionally includes a support layer 214. The electrodes may be formed on a proximal side of the support layer 214, such as by printing a conductive ink. The electrode assembly 204 optionally includes a masking element 218, for example, covering or overlapping a portion of the electrode 216, for example, when viewed axially from a proximal side of the electrode 216. The electrode assembly includes a first portion 302 including a connection portion 217 of the plurality of electrodes 216. The electrode assembly includes a second portion 303. The base plate 4 includes a release liner 206. The base plate 4 includes a top layer 208. The base plate 4 optionally includes a coupling ring 209 that couples the ostomy pouch to the base plate 4. Alternatively, for example in the case of a single piece ostomy appliance, the ostomy pouch may be secured directly to the base plate 4.

[0146] The base plate 4 includes a monitor interface configured to connect, such as mechanically and / or electronically connect, the base plate to a monitor device. The monitor interface includes a number of terminals 212 configured to form electrical connections with respective terminals of the monitor device. For example, as shown, the connection portion 217 may form the multiple terminals 212 of the monitor interface. Alternatively, terminal elements may be provided to form multiple terminals, for example as shown in FIG. 3.

[0147] The top layer 208 includes a top layer opening 304. The second adhesive layer 202 includes a second adhesive layer opening 306. The top layer opening 304 and the second adhesive layer opening 306 are configured to allow connection between the multiple electrodes 216 of the electrode assembly 204 and terminals of a monitoring device coupled to the base plate 4. For example, the first portion 302 of the electrode assembly 216 can extend through the top layer opening 304 and the second adhesive layer opening 306.

[0148] As described with respect to FIG. 3, the portion of the illustrated base plate 4 may be provided as a separate assembly and attached to an existing base plate, e.g., a base plate including one or more of the components described above, to provide a base plate, e.g., such as the base plate 4 described above. By way of example, a sensor assembly portion 700 may be provided that includes, e.g., the electrode assembly 204, the first adhesive layer 200, and the release liner 206. In addition, the sensor assembly portion 700 may also include the second adhesive layer 202 and / or the top layer 208. It may be envisioned that the user may provide holes in the layer of the base plate to which the sensor assembly portion 700 will be attached to allow connection between the multiple electrodes 216 of the electrode assembly 204 and the terminals of the monitoring device coupled to the base plate 4.

[0149] 12 illustrates an exploded view of an exemplary electrode assembly 204 of a base plate and / or sensor assembly portion, such as the base plate 4 and / or sensor assembly portion 700 of FIG. 11. The electrode assembly has a distal side 204A and a proximal side 204B. The electrode assembly 204 includes a support layer 214 having a proximal side 214B and a distal side 214A. The electrode assembly 204 includes a plurality of electrodes 216. Each electrode of the plurality of electrodes 216 has a respective connection 217 connecting the electrode 216 to a respective terminal element of the monitor interface. The electrodes 216 are provided, such as formed on the proximal side 214B of the support layer 214; for example, the electrodes 216 can be located on the proximal side 214B of the support layer 214. Additionally, the electrode assembly 204 optionally includes a masking element 218 having a proximal side 218B and configured to insulate an electrode portion of the electrode 216 from the base plate 4 and / or the first adhesive layer 200 of the sensor assembly portion 700 (see FIG. 11 ). The masking element 218 covers or overlaps a portion of the electrode 216, for example, when viewed axially from the proximal side 204B. The masking element 218 may be configured to not cover or overlap a connection portion 217 of the multiple electrodes.

[0150] In some exemplary electrode assemblies 204, such as the electrode assembly 204 of FIG. 12, the electrode assembly 204 includes a reinforcing element 308. The reinforcing element 308 may be positioned near the electrode assembly 216, such as near the plurality of electrodes 216, such as near the plurality of connections 217 of the plurality of electrodes 216. The reinforcing element 308 may form at least a portion of a first portion of the electrode assembly 204. An opening 310 may be provided in the reinforcing element 308 to provide a conductive path between opposite sides of the reinforcing element 308, such as between a proximal side 308B and a distal side 308A of the reinforcing element 308.

[0151] 13 illustrates an alternative to FIG. 12 in which the reinforcing element 308 includes a plurality of conductive paths 311. For example, the reinforcing element 308 may be a flex circuit. The plurality of conductive paths 311 may be connected to a plurality of electrodes 216. The plurality of conductive paths 311 may thereby form connections 217 of the plurality of electrodes 216. The plurality of conductive paths 311 may provide a conductive path between a proximal side 308B and a distal side 308A of the reinforcing element 308.

[0152] FIG. 14 illustrates an exemplary electrode configuration 220 of multiple electrodes 216, similar to the electrode configuration 220 illustrated in FIG. 6, but where the connections 217, such as the ground connection 222A, the first connection 224A, the second connection 226A, the third connection 228A, the fourth connection 230A and / or the fifth connection 232A, are straight connector portions.

[0153] 15 shows a cross-sectional schematic representation of a portion of the base plate 4 and / or a sensor assembly portion 700. The base plate 4 and / or the sensor assembly portion 700 includes a first adhesive layer 200, an optional second adhesive layer 202, and a top layer 208. An electrode assembly including a plurality of electrodes 216 is disposed between the first adhesive layer 200 and the top layer 208, such as between the first adhesive layer 200 and the second adhesive layer 202. For example, a second portion of the electrode assembly is disposed between the first adhesive layer, the second adhesive layer 202, and / or the top layer 208. The electrode assembly further includes an optional stiffening element 308.

[0154] The top layer 208 and the second adhesive layer 202 include openings 304, 306. The top layer 208 includes a top layer opening 304. The second adhesive layer 202 includes a second adhesive layer opening 306. A first portion 302 of the electrode assembly extends through the top layer opening 304 and the second adhesive layer opening 306. The first portion 302 includes connection paths for the plurality of electrodes and the reinforcement element 308. The first portion 302 may include the support layer 214 or a portion of the support layer. Connections for the plurality of electrodes to the connection portions 217 may be provided through the reinforcement element 308 and / or the support layer 214.

[0155] 16 shows a cross-sectional schematic representation of the base plate portion 4 and / or sensor assembly portion 700 shown in FIG. 15 , where the base plate 4 and / or sensor assembly portion 700 includes a coupling portion 210. The coupling portion 210 is configured to form a mechanical connection between a monitoring device and the base plate 4 and / or sensor assembly portion 700. The electrode assembly first portion 302 extends into the coupling portion 210 and allows a monitoring device, such as a terminal of the monitoring device, to be connected to an electrode 216 of the base plate 4 and / or sensor assembly portion 700.

[0156] In the example shown, the bonding portion 210 is attached to the top layer 208. However, in alternative examples, the bonding portion 210 is attached to the electrode assembly, and in such circumstances, the bonding portion 210 may extend through the top layer opening 304 and the second adhesive layer opening 306.

[0157] 17 shows a cross-sectional schematic representation of a portion of a base plate 4 and / or a sensor assembly portion 700. The base plate 4 and / or the sensor assembly portion 700 includes a first adhesive layer 200, an optional second adhesive layer 202, and a top layer 208. An electrode assembly including a plurality of electrodes 216 is disposed between the first adhesive layer 200 and the top layer 208, such as between the first adhesive layer 200 and the second adhesive layer 202. For example, a second portion of the electrode assembly is disposed between the first adhesive layer, the second adhesive layer 202, and / or the top layer 208.

[0158] The top layer 208 includes a top layer opening 304. The second adhesive layer 202 includes a second adhesive layer opening 306. The top layer opening 304 and the second adhesive layer opening 306 are provided by a U-shaped cut. The first portion 302 of the electrode assembly is folded back inside the U-shaped cut together with the top layer 208 and a portion of the second adhesive layer 202 to expose the connections 217 of the plurality of electrodes 216 distal to the base plate 4 and / or the sensor assembly portion 700. The first portion 302 includes the connections 217 of the plurality of electrodes and extends through the top layer opening 304 and the second adhesive layer opening 306. A monitoring device may thereby be connected to the connections 217. Although not shown in FIG. 17, the electrode assembly may further include an optional reinforcing element 308, for example as shown in FIGS. 15 and 16, and / or the base plate 4 and / or the sensor assembly portion 700 may be provided with a coupling portion 210, for example as shown in FIG. 16.

[0159] The base plate 4 and / or sensor assembly portion 700 includes a back element 312. The back element 312 is provided between the first adhesive layer 200 and the electrode assembly and / or the plurality of electrodes 216 of the electrode assembly, such as between the first adhesive layer 200 and the first portion 302 of the electrode assembly. The back element 312 may facilitate the first portion 302 of the electrode assembly not adhering to the first adhesive layer, thereby allowing the first portion 302 of the electrode assembly to be turned, etc. The back element 312 may also be applied to the exemplary base plate and / or sensor assembly portion as described in connection with FIG. 15 and / or FIG. 16.

[0160] 18 shows a flow chart of an exemplary method 1000, for example, a method for manufacturing a base plate or sensor assembly portion for an ostomy appliance. The method includes providing 1002 an upper layer, optionally providing 1004 a second adhesive layer, and providing 1006 an electrode assembly including a plurality of electrodes, the electrode assembly having a first portion, the first portion including connections for the plurality of electrodes, and a second portion. The method further includes providing 1008 the first adhesive layer, assembling 1010 the upper layer, the optional second adhesive layer, the electrode assembly, and the first adhesive layer, and providing 1012 an upper layer opening in the upper layer and, optionally, a second adhesive layer opening in the second adhesive layer.

[0161] Assembling 1010 the top layer, optional second adhesive layer, electrode assembly, and first adhesive layer may include assembling such that the electrode assembly is disposed between the first adhesive layer and the top layer and / or between the first adhesive layer and the optional second adhesive layer. For example, assembling 1010 the top layer, optional second adhesive layer, electrode assembly, and first adhesive layer may include assembling such that a second portion of the electrode assembly, including a sensing portion of, for example, a plurality of electrodes, is disposed between the first adhesive layer and the second adhesive layer / top layer.

[0162] Providing 1012 the top layer opening, and optional second adhesive layer opening, includes providing 1012 the top layer opening, and optional second adhesive layer opening, such that the top layer opening, and optional second adhesive layer opening are configured to provide a connection between the multiple electrodes of the electrode assembly and a terminal of the monitoring device.

[0163] Method 1000 further optionally includes orienting 1014 a first portion of the electrode assembly through the top layer opening and the optional second adhesive layer opening. Orienting 1014 a first portion of the electrode assembly through the top layer opening and the optional second adhesive layer can include folding back the first portion of the electrode assembly to expose connections of the plurality of electrodes, for example, distal to the base plate and / or sensor assembly portion.

[0164] The method 1000 further optionally includes providing 1016 a coupling portion on the base plate and / or the sensor assembly portion. The coupling portion can be provided 1016 to align with the top layer opening and the optional second adhesive layer opening. The coupling portion can be provided 1016 to align with a first portion of the electrode assembly.

[0165] As shown, the top layer opening, and optional second adhesive layer opening, can be provided 1010 after assembling 1008. Alternatively, the top layer opening, and optional second adhesive layer opening, can be provided 1010 before assembling 1008.

[0166] For example, the top layer opening, and the optional second adhesive layer opening, can be provided prior to providing the electrode assembly. The top layer opening, and the optional second adhesive layer opening, can be provided simultaneously, for example, by cutting through both the top layer and the second adhesive layer.

[0167] The position of the first connector on the base plate and / or sensor assembly portion, the number of terminals, and the position of the terminals of the coupling portion may be adapted to the electrode configuration used in the electrode assembly of the base plate and / or sensor assembly portion.

[0168] The use of terms such as "first", "second", "third" and "fourth", "primary", "secondary", "tertiary", etc. does not imply any particular order, but is included to identify individual elements. Furthermore, the use of terms such as "first", "second", "third" and "fourth", "primary", "secondary", "tertiary", etc. does not imply any order or importance, but rather terms such as "first", "second", "third" and "fourth", "primary", "secondary", "tertiary", etc. are used to distinguish one element from another. It is noted that terms such as "first", "second", "third" and "fourth", "primary", "secondary", "tertiary", etc. are used herein and elsewhere for labeling purposes only, and are not intended to indicate any particular spatial or temporal order. Furthermore, the label of a first element does not imply the presence of a second element, and vice versa.

[0169] While certain features have been illustrated and described, it will be understood that these features are not intended to limit the invention as claimed. Moreover, it will be apparent to those skilled in the art that various changes and modifications can be made without departing from the spirit and scope of the invention as claimed. Accordingly, the specification and drawings are to be regarded in an illustrative rather than a restrictive sense. The invention as claimed is intended to embrace all alternatives, modifications, and equivalents.

[0170] Exemplary embodiments of the present disclosure are described in the following sections.

[0171] 1. A base plate for an ostomy appliance, comprising: -The upper layer, a first adhesive layer, an electrode assembly including a plurality of electrodes, the electrode assembly having a first portion including a connection portion of the plurality of electrodes and a second portion disposed between the first adhesive layer and the upper layer; a monitor interface configured to connect the base plate to a monitor device, the monitor interface including a plurality of terminals configured to form electrical connections with respective terminals of the monitor device; Including, A base plate, the top layer including top layer openings configured to allow connections between the plurality of electrodes of the electrode assembly and terminals of the monitoring device.

[0172] 2. The base plate according to item 1, wherein the connection portion forms a plurality of terminals of a monitor interface.

[0173] 3. The base plate of any of items 1 or 2, wherein the first portion of the electrode assembly extends through the top layer opening.

[0174] 4. A base plate as described in item 3, wherein the electrode assembly includes a proximal side and a distal side, the multiple electrodes are disposed on the proximal side, and a first portion of the electrode assembly is folded back to expose connections of the multiple electrodes on the distal side of the base plate.

[0175] 5. A base plate described in any of items 1 to 3, wherein the electrode assembly includes a proximal side and a distal side, a plurality of electrodes are arranged on the proximal side, and each connection portion of the plurality of electrodes extends from the proximal side of the electrode assembly, for example, through a support layer of the electrode assembly, to the distal side of the electrode assembly.

[0176] 6. The base plate according to any one of items 1 to 5, wherein the upper opening is U-shaped.

[0177] 7. A base plate described in any of items 1 to 6, wherein the monitor interface includes a coupling portion configured to form a mechanical connection, such as a releasable coupling, between the monitor device and the base plate.

[0178] 8. The base plate of item 7, wherein the coupling portion is attached to the electrode assembly, such as to a distal side of the electrode assembly, and the coupling portion extends through the top layer opening.

[0179] 9. The base plate of item 7, wherein the coupling portion is attached to an upper layer, such as to a distal side of the upper layer.

[0180] 10. A base plate according to any one of items 7 to 9, wherein the first portion of the electrode assembly extends into the joint.

[0181] 11. A base plate according to any of items 1 to 10, wherein the electrode assembly includes a reinforcing element, the reinforcing element forming at least a part of the first portion of the electrode assembly.

[0182] 12. The base plate according to item 11, wherein the reinforcing element comprises a plurality of conductive paths connected to a plurality of electrodes to form a connection of the plurality of electrodes.

[0183] 13. The base plate according to any of items 11 or 12, wherein the reinforcement element is a flex circuit.

[0184] 14. A base plate described in any of items 1 to 13, comprising a second adhesive layer between the upper layer and the electrode assembly, the second adhesive layer comprising a second adhesive layer opening aligned with the upper layer opening, and configured to provide an electrical connection between multiple electrodes of the electrode assembly and terminals of a monitoring device.

[0185] 15. A method for manufacturing a base plate or sensor assembly portion for an ostomy appliance, comprising: providing an upper layer; - providing an electrode assembly including a plurality of electrodes, the electrode assembly having a first portion including a connection portion of the plurality of electrodes and a second portion; providing a first adhesive layer; - assembling the top layer, the electrode assembly, and the first adhesive layer such that a second portion of the electrode assembly is disposed between the first adhesive layer and the top layer; The method includes: - providing top layer openings in the top layer, the top layer openings configured to allow connections between the plurality of electrodes of the electrode assembly and terminals of the monitoring device.

[0186] 16. The method of claim 15, wherein the top layer opening is provided in the top layer after assembling the top layer, the electrode assembly, and the first adhesive layer.

[0187] 17. The method of claim 15, wherein the top layer opening is provided in the top layer prior to assembling the top layer, the electrode assembly, and the first adhesive layer.

[0188] 18. The method according to any of items 15 to 17, wherein the upper layer opening is provided by making a U-shaped cut in the upper layer.

[0189] 19. A sensor assembly portion for an ostomy appliance, comprising: -The upper layer, a first adhesive layer, an electrode assembly including a plurality of electrodes, the electrode assembly having a first portion including a connection portion of the plurality of electrodes and a second portion disposed between the first adhesive layer and the upper layer; a monitor interface configured to connect the sensor assembly portion to a monitoring device, the monitor interface including a plurality of terminals configured to form electrical connections with respective terminals of the monitoring device; Including, A sensor assembly portion, the top layer including top layer openings configured to provide connections between a plurality of electrodes of the electrode assembly and terminals of a monitoring device.

[0190] 20. The sensor assembly portion of item 19, wherein the connection portion forms a plurality of terminals of the monitor interface.

[0191] 21. The sensor assembly portion of either item 19 or 20, wherein the first portion of the electrode assembly extends through the top layer opening.

[0192] 22. A sensor assembly portion as described in item 21, wherein the electrode assembly includes a proximal side and a distal side, a plurality of electrodes are disposed on the proximal side, and a first portion of the electrode assembly is folded back to expose connections of the plurality of electrodes on the distal side of the sensor assembly portion.

[0193] 23. A sensor assembly portion described in any of items 19 to 21, wherein the electrode assembly includes a proximal side and a distal side, a plurality of electrodes are arranged on the proximal side, and each connection portion of the plurality of electrodes extends from the proximal side of the electrode assembly, for example, through a support layer of the electrode assembly, to the distal side of the electrode assembly.

[0194] 24. The sensor assembly portion of any of items 19 to 23, wherein the upper opening is U-shaped.

[0195] 25. A sensor assembly portion of any of items 19 to 24, wherein the monitor interface includes a coupling portion configured to form a mechanical connection, such as a releasable coupling, between the monitor device and the sensor assembly portion.

[0196] 26. The sensor assembly portion of item 25, wherein the coupling portion is attached to the electrode assembly, such as to a distal side of the electrode assembly, and the coupling portion extends through the top layer opening.

[0197] 27. The sensor assembly portion of item 25, wherein the coupling portion is attached to an upper layer, such as a distal side of the upper layer.

[0198] 28. A sensor assembly portion according to any of items 25 to 27, wherein a first portion of the electrode assembly extends into the coupling portion.

[0199] 29. A sensor assembly portion according to any of items 19 to 28, wherein the electrode assembly includes a reinforcing element, the reinforcing element forming at least a part of the first portion of the electrode assembly.

[0200] 30. The sensor assembly portion of item 29, wherein the reinforcing element includes a plurality of conductive paths connected to the plurality of electrodes to form a plurality of electrode connections.

[0201] 31. The sensor assembly portion of either item 29 or 30, wherein the stiffening element is a flex circuit.

[0202] 32. A sensor assembly portion of any of items 19 to 31, comprising a second adhesive layer between the top layer and the electrode assembly, the second adhesive layer including a second adhesive layer opening aligned with the top layer opening, and configured to provide an electrical connection between multiple electrodes of the electrode assembly and terminals of a monitoring device. The present disclosure further includes the following aspects: Aspect 1 1. A method for manufacturing a base plate for an ostomy appliance, comprising: providing an upper layer; - providing an electrode assembly including a plurality of electrodes, the electrode assembly having a first portion including connections of the plurality of electrodes configured to connect the plurality of electrodes to terminals of a monitoring device, and a second portion; - providing a first adhesive layer comprising one or more water-soluble or water-swellable hydrocolloids; - assembling the top layer, the electrode assembly, and the first adhesive layer such that the second portion of the electrode assembly is disposed between the first adhesive layer and the top layer; The method further comprising: - providing an upper layer opening in the upper layer, the upper layer opening configured to allow connection between the connection portions of the plurality of electrodes and terminals of the monitoring device. Aspect 2 The method of embodiment 1, wherein the upper layer includes an upper layer stoma opening and the first adhesive layer includes a first adhesive stoma opening, and assembling the upper layer, the electrode assembly, and the first adhesive layer includes aligning the upper layer stoma opening and the first adhesive stoma opening to form a stoma opening in the base plate configured to pass waste from a user's stoma. Aspect 3 3. The method of claim 1 or 2, wherein the top layer opening is provided in the top layer after assembling the top layer, the electrode assembly, and the first adhesive layer. Aspect 4 3. The method of claim 1 or 2, wherein the top layer opening is provided in the top layer prior to assembling the top layer, the electrode assembly, and the first adhesive layer. Aspect 5 A method according to any one of aspects 1 to 4, wherein the upper layer opening is provided by making a U-shaped cut in the upper layer. Aspect 6 A base plate for an ostomy appliance, comprising: -The upper layer, a first adhesive layer comprising one or more water-soluble or water-swellable hydrocolloids; an electrode assembly including a plurality of electrodes, the electrode assembly having a first portion including connections of the plurality of electrodes configured to connect the plurality of electrodes to terminals of a monitoring device, and a second portion disposed between the first adhesive layer and the top layer; a monitor interface configured to connect the base plate to a monitor device, the monitor interface including a plurality of terminals configured to form electrical connections with respective terminals of the monitor device; Including, The base plate, the top layer including top layer openings configured to allow connections between the plurality of electrodes of the electrode assembly and terminals of the monitoring device. Aspect 7 A base plate as described in aspect 6, comprising a stoma opening at least partially formed by an upper layer stoma opening of the upper layer and a first adhesive stoma opening of the first adhesive layer, the stoma opening of the base plate being configured to allow waste from a user's stoma to pass therethrough. Aspect 8 A base plate as described in any one of claims 6 to 7, wherein the connection portion forms the multiple terminals of the monitor interface. Aspect 9: Aspects 9. The base plate of any one of aspects 6 to 8, wherein the first portion of the electrode assembly extends through the top layer opening. Aspect 10 A base plate as described in aspect 9, wherein the electrode assembly includes a proximal side and a distal side, the multiple electrodes are arranged on the proximal side, and the first portion of the electrode assembly is folded back to expose the connection portions of the multiple electrodes on the distal side of the base plate. Aspect 11 A base plate described in any one of aspects 6 to 9, wherein the electrode assembly includes a proximal side and a distal side, the plurality of electrodes are arranged on the proximal side, and the connection portions of each of the plurality of electrodes extend from the proximal side of the electrode assembly, for example, through a support layer of the electrode assembly, to the distal side of the electrode assembly. Aspect 12 12. The base plate according to any one of aspects 6 to 11, wherein the upper layer opening is U-shaped. Aspect 13 A base plate described in any one of aspects 6 to 12, wherein the monitor interface includes a coupling portion configured to form a mechanical connection, such as a releasable coupling, between the monitor device and the base plate. Aspect 14 A base plate as described in embodiment 13, wherein the coupling portion is attached to the electrode assembly, such as the distal side of the electrode assembly, and the coupling portion extends through the upper layer opening. Aspect 15 14. The base plate of claim 13, wherein the coupling portion is attached to the upper layer, such as to the distal side of the upper layer. Aspect 16 14. The base plate according to any one of aspects 11 to 13, wherein the first portion of the electrode assembly extends into the coupling portion. Aspect 17 17. The base plate of any one of aspects 6 to 16, wherein the electrode assembly includes a reinforcing element, the reinforcing element forming at least a part of the first portion of the electrode assembly. Aspect 18 A base plate as described in embodiment 17, wherein the reinforcing element includes a plurality of conductive paths connected to the plurality of electrodes to form the connection portions of the plurality of electrodes. Aspect 19 19. The base plate of any one of claims 17 to 18, wherein the stiffening element is a flex circuit. Aspect 20 A base plate described in any one of aspects 6 to 19, comprising a second adhesive layer between the upper layer and the electrode assembly, the second adhesive layer comprising a second adhesive layer opening aligned with the upper layer opening, and configured to electrically connect between the multiple electrodes of the electrode assembly and terminals of the monitoring device, the second adhesive layer comprising one or more water-soluble or water-swellable hydrocolloids. Aspect 21 A base plate for an ostomy appliance obtainable by the method according to any one of aspects 1 to 5. [Explanation of symbols]

[0203] 1 Ostomy system 2 Ostomy appliance 4 Base plate 6 Monitor Devices 8 Attached Devices 10 Server Devices 12 Network 14 Connecting members 16 Connecting Ring 18 Stoma receiving opening 100 monitor device case 101 Processor 102 First Interface 104 Second Interface 106 Memory 108 Ground terminal of the monitoring device 110 First terminal of the monitor device 112 Second terminal of monitor device 114 The third terminal of the monitor device 116 4th terminal of monitor device 118 5th terminal of monitor device 120 Joint 122 Antenna 124 Radio Transceiver 126 Loudspeaker 128 Haptic Feedback Elements 200 First adhesive layer 200A Distal side / distal surface of first adhesive layer 200B Proximal side / proximal surface of first adhesive layer 202 Second adhesive layer 202A Distal side / distal surface of second adhesive layer 202B Proximal side / proximal surface of second adhesive layer 204 Electrode assembly 204A Distal side / distal surface of electrode assembly 204B Proximal side / proximal surface of electrode assembly 206 Release Liner 206A Distal side / distal surface of release liner 206B Proximal side / proximal surface of release liner 207 Monitor Interface 208 Upper layer 208A Upper layer distal side / distal surface 208B Upper proximal side / proximal surface 209 Connecting Ring 210 First connector coupling portion 211 First Connector 212 Terminal of the first connector 213 First intermediate element 213A Distal side / distal surface of first intermediate element 213B Proximal side / proximal surface of first intermediate element 214 Support layer for electrode assembly 214A Distal side / distal surface of support layer 214B Proximal side / proximal surface of support layer 216 Electrode of electrode assembly 217 Connection 218 Masking Elements Distal side / distal surface of 218A masking element 218B Proximal side / proximal face of masking element 220 Electrode configuration 222 Ground electrode 222A Ground Connection 222B Ground detection unit 224 First electrode 224A 1st Connection 226 Second Electrode 226A Second Connection 228 Third Electrode 228A 3rd Connection 230 Fourth Electrode 230A 4th Connection 230B Fourth detector 232 Fifth Electrode 232A 5th Connection 232B 5th detector 234 First electrode portion of ground electrode 236 Second electrode portion of ground electrode 238 Third electrode part of ground electrode 240 Fourth electrode part of the ground electrode 242 Ground terminal opening 244 First terminal opening 246 Second terminal opening 248 Third terminal opening 250 4th terminal opening 252 5th terminal opening 254 Primary Sensor Point Aperture of Masking Element 254A Single sensor point opening 254B Single-sided two-sensor opening 256 Secondary Sensor Point Aperture of Masking Element 256A Secondary First Sensor Point Aperture 256B Secondary 2nd sensor point opening 258 Masking element tertiary sensor point opening 258A Three-way 1-sensor opening 258B Three-way two-sensor opening 260 Primary sensor point opening of first adhesive layer 260A Single sensor point opening 260B Single-sided two-sensor opening 262 Secondary sensor point opening of first adhesive layer 262A Secondary First Sensor Point Aperture 262B Secondary 2nd sensor point opening 264 Tertiary sensor point opening of first adhesive layer 264A Three-way 1-sensor opening 264B Three-way two-sensor opening 270 Terminal Interface Area 272 Terminal Elements 272A Distal end of terminal element 272B Proximal end of terminal element 274A Distal portion of terminal element 274B Proximal portion of terminal element 276A Distal Terminal Element Bend 276B Bend of proximal terminal element 278 Guide hole 282 Ground Terminal Element 282A ground terminal 284 First Terminal Element 284A 1st Terminal 286 Second Terminal Element 286A 2nd Terminal 288 Third Terminal Element 288A 3rd Terminal 290 Fourth Terminal Element 290A 4th Terminal 292 Fifth Terminal Element 292A 5th Terminal 302 First part of electrode assembly 303 Second part of electrode assembly 304 Upper Opening 306 Second adhesive layer opening 308 Reinforcing Elements 308A Distal side of stiffening element 308B Proximal side of stiffening element 310 Opening 311 Conductive Path 312 Back element 700 Sensor assembly part 1000 ways 1002 Providing an upper layer 1004 Providing a second adhesive layer 1006 Providing an electrode assembly 1008 Providing a first adhesive layer Assembling 1010 layers 1012 Providing a layer opening 1014 Orienting a portion of the electrode assembly 1016 Providing a joint M Number of terminals on the first interface of the monitor device

Claims

1. 1. A method for manufacturing a base plate for an ostomy appliance, comprising: - providing a top layer; providing an electrode assembly including a plurality of electrodes, the electrode assembly having a first portion including a connection portion of the plurality of electrodes configured to connect the plurality of electrodes to terminals of a monitoring device, and a second portion including a detection portion of the plurality of electrodes, the electrode assembly including a support layer; - providing and / or arranging said plurality of electrodes on the proximal side of said support layer; - providing a first adhesive layer comprising one or more water-soluble or water-swellable hydrocolloids; - assembling the top layer, the electrode assembly and the first adhesive layer such that the second portion of the electrode assembly is disposed between the first adhesive layer and the top layer; The method further comprising: providing top layer openings in the top layer, the top layer openings being configured to allow connections between the connections of the plurality of electrodes and terminals of the monitoring device; the electrodes of the electrode assembly are in physical contact with the first adhesive layer; the upper layer includes an upper layer stoma opening, the first adhesive layer includes a stoma opening disposed in the first adhesive layer, and assembling the upper layer, the electrode assembly, and the first adhesive layer includes aligning the upper layer stoma opening and the stoma opening disposed in the first adhesive layer to form a stoma opening in the base plate configured to pass waste from a user's stoma; The plurality of electrodes form an electrode pair and are configured to detect a resistance or a rate of resistance change between the electrode pair. The method.

2. The method of claim 1 , wherein the top layer opening is provided in the top layer after assembling the top layer, the electrode assembly, and the first adhesive layer.

3. The method of claim 1 or 2, wherein the top layer opening is provided in the top layer prior to assembling the top layer, the electrode assembly, and the first adhesive layer.

4. The method according to any one of claims 1 to 3, wherein the top layer opening is provided by making a U-shaped cut in the top layer.

5. A base plate for an ostomy appliance, comprising: -The upper layer, - a first adhesive layer comprising one or more water-soluble or water-swellable hydrocolloids; - an electrode assembly including a plurality of electrodes, the electrode assembly having: a first part including a connection portion of the plurality of electrodes configured to connect the plurality of electrodes to terminals of a monitoring device; and a second part including a detection portion of the plurality of electrodes, the second part being disposed between the first adhesive layer and the upper layer; the electrode assembly comprising a support layer, the electrodes being provided and / or positioned proximal to the support layer; a monitor interface configured to connect the base plate to a monitor device, the monitor interface including a plurality of terminals configured to form electrical connections with respective terminals of the monitor device; Including, the top layer includes top layer openings configured to allow connections between the electrodes of the electrode assembly and terminals of the monitoring device; the electrodes of the electrode assembly are in physical contact with the first adhesive layer; the base plate includes a stoma opening at least partially formed by an upper layer stoma opening of the upper layer and a stoma opening in the first adhesive layer, the stoma opening of the base plate being configured to pass waste from the stoma of a user; The plurality of electrodes form an electrode pair and are configured to detect a resistance or a resistance change rate between the electrode pair. The base plate.

6. The base plate of claim 5 , wherein the plurality of electrodes are printed on the proximal side of the support layer.

7. The base plate according to claim 5 or 6, wherein the connection portion forms the plurality of terminals of the monitor interface.

8. The base plate according to any one of claims 5 to 7, wherein the first portion of the electrode assembly extends through the top layer opening.

9. 9. The base plate of claim 8, wherein the electrode assembly includes a proximal side and a distal side, the plurality of electrodes are disposed on the proximal side, and the first portion of the electrode assembly is folded back to expose the connection portions of the plurality of electrodes on the distal side of the base plate.

10. A base plate according to any one of claims 5 to 8, wherein the electrode assembly includes a proximal side and a distal side, the plurality of electrodes are arranged on the proximal side, and the connection portions of each of the plurality of electrodes extend from the proximal side of the electrode assembly to the distal side of the electrode assembly.

11. The base plate according to any one of claims 5 to 10, wherein the upper layer opening is U-shaped.

12. The base plate of any one of claims 5 to 11, wherein the monitor interface comprises a coupling configured to form a mechanical connection between the monitor device and the base plate.

13. The base plate of claim 12 , wherein the coupling portion is attached to the electrode assembly and the coupling portion extends through the top layer opening.

14. The base plate of claim 12 , wherein the coupling portion is attached to the upper layer.

15. The base plate of claim 12 , wherein the first portion of the electrode assembly extends into the joint.

16. A base plate according to any one of claims 5 to 15, wherein the electrode assembly includes a reinforcing element, the reinforcing element forming at least a part of the first portion of the electrode assembly.

17. The base plate of claim 16 , wherein the stiffening element includes a plurality of conductive paths connected to the plurality of electrodes to form the connections of the plurality of electrodes.

18. 18. The base plate according to claim 16 or 17, wherein the stiffening element is a flex circuit.

19. A base plate as described in any one of claims 5 to 18, comprising a second adhesive layer between the upper layer and the electrode assembly, the second adhesive layer including a second adhesive layer opening aligned with the upper layer opening, and configured to electrically connect between the multiple electrodes of the electrode assembly and terminals of the monitoring device, the second adhesive layer including one or more water-soluble or water-swellable hydrocolloids.

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