Hinged connector for ostomy base plate and sensor assembly

Abstract

To disclose a coupling part and a base plate including the coupling part.SOLUTION: A base plate for an ostomy appliance is provided, the base plate including: a top layer; a first adhesive layer; an electrode assembly including a plurality of electrodes; and a monitor interface configured for connecting the base plate to a monitor device, the monitor interface including a plurality of terminals electrically connected to the plurality of electrodes and configured to connect with respective terminals of the monitor device and including a coupling part configured for coupling between the monitor device and the base plate. The plurality of terminals may be provided on the coupling part. The coupling part may include a locking section, e.g. configured to lock the monitor device in the coupling part of the base plate.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present disclosure relates to an ostomy system, its devices, a method of manufacturing an ostomy appliance, and a method of monitoring an ostomy appliance. The ostomy appliance system includes an ostomy appliance and an ostomy monitoring device. In particular, the present disclosure relates to leakage classification and / or detection of an ostomy appliance and monitoring of its operation.

Summary of the Invention

Means for Solving the Problems

[0002] The accompanying drawings are included to provide a further understanding of the embodiments and are incorporated herein and constitute a part of this specification. The drawings illustrate the embodiments and serve to explain the principles of the embodiments together with the description. Many other embodiments and intended advantages of the embodiments will be readily recognized as the more detailed description below is referred to and better understood. The elements of the drawings are not necessarily drawn to scale relative to each other. Like reference numerals denote corresponding like parts.

Brief Description of the Drawings

[0003] [Figure 1] FIG. 1 shows an exemplary ostomy system. [Figure 2] FIG. 2 shows an exemplary monitoring device of an ostomy system. [Figure 3] FIG. 3 is an exploded assembly view of the base plate of an ostomy appliance. [Figure 4] FIG. 4 is an exploded assembly view of an exemplary electrode assembly. [Figure 5] [[ID=三十五]]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] Figure 9 is a proximal view of the first adhesive layer in Figure 8. [Figure 10] Figure 10 is a distal view of the base plate portion and / or sensor assembly portion, including the monitor interface. [Figure 11a] Figure 11a shows an exploded view of an exemplary base plate. [Figure 11b] Figure 11b shows an exploded view of an exemplary base plate. [Figure 12] Figure 12 shows an exploded view of an exemplary electrode assembly. [Figure 13] Figure 13 shows an exploded view of an exemplary electrode assembly. [Figure 14] Figure 14 shows an exemplary electrode configuration. [Figure 15] Figure 15 shows a schematic representation of the base plate and / or sensor assembly. [Figure 16] Figure 16 shows a schematic representation of the base plate and / or sensor assembly. [Figure 17] Figure 17 shows a schematic representation of the base plate and / or sensor assembly. [Figure 18] Figure 18 shows a schematic representation of the base plate and / or sensor assembly. [Figure 19] Figure 19 shows a schematic representation of the base plate and / or sensor assembly. [Figure 20] Figure 20 shows a schematic representation of the base plate and / or sensor assembly. [Figure 21] Figure 21 shows a schematic representation of the base plate portion and / or the sensor assembly portion. [Figure 22] Figure 22 schematically shows an exemplary base plate and monitor device. [Figure 23] Figure 23 schematically shows the base plate and monitor device components as an example. [Figure 24] Figure 24 schematically shows an exemplary monitoring device. [Figure 25] Figure 25 schematically shows an exemplary base plate and a monitor device. [Figure 26] Figure 26 schematically shows a portion of an exemplary base plate and a monitor device. [Figure 27] Figure 27 schematically shows an exemplary base plate. [Figure 28] Figure 28 schematically shows an exemplary base plate and a monitor device. [Figure 29] Figure 29 schematically shows an exemplary joint. [Figure 30] Figure 30 schematically shows an exemplary joint. [Figure 31] Figure 31 schematically shows an exemplary joint. [Figure 32] Figure 32 schematically shows an exemplary joint. [Figure 33] Figure 33 schematically shows an exploded view of an exemplary base plate. [Figure 34] Figure 34 schematically shows a portion of an exemplary joint and an electrode assembly.

MODE FOR CARRYING OUT THE INVENTION

[0004] Various exemplary embodiments and details will be described below with reference to the figures where relevant. Note that the figures may or may not be drawn to scale, and elements of similar structure or function are represented by like reference numerals throughout the figures. Also note that the figures are intended only to facilitate the description of the embodiments. The figures are not intended as an exhaustive description of the present invention or as a limitation on the scope of the present invention. In addition, the embodiments shown need not have all of the aspects or advantages shown. The aspects or advantages described in conjunction with a particular embodiment are not necessarily limited to that embodiment and may be implemented in any other embodiment even if not shown or explicitly described as such.

[0005] Throughout this disclosure, the terms "stoma" and "ostomy" are used to denote surgically created openings that bypass a person's intestinal or urinary tract. These terms are used synonymously and are not intended to have distinct meanings. The same applies to any terms or phrases derived from these terms, such as "stomal", "multiple ostomies", etc. Also, solid and liquid waste exiting the stoma can both be referred to synonymously as stoma "effluent", "waste", and "fluid". A subject who has undergone an ostomy surgery can be referred to as an "ostomist" or "ostomate" - and also as a "patient" or "user". However, in some cases, "user" may also relate to or refer to a healthcare provider (HCP) such as a surgeon or an 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, when referring to the proximal side or proximal surface of a layer, element, device, or part of a device, the reference is always to the side or surface facing the skin when the user wears the ostomy appliance. Similarly, when referring to the distal side or distal surface of a layer, element, device, or part of a device, the reference is always to the side or surface facing away from the skin when the user wears the ostomy appliance. In other words, when the appliance is worn by the user, the proximal side or proximal surface is the side or surface closest to the user, and the distal side is the opposite side or surface - the side or surface farthest from the user during use.

[0007] The axial direction is defined as the direction of the stoma when the user wears the appliance. Thus, the axial direction is generally orthogonal to the user's skin or abdominal surface.

[0008] The radial direction is defined as being perpendicular to the axial direction. The terms “internal” and “external” may be used in the text. These modifiers should generally be understood in relation to the radial direction such that the “external” element is further away from the central part of the ostomy appliance than the element referred to as “internal.” In addition, “innermost” should be interpreted as the part of the component that forms the center of the component and / or the part adjacent to the center of the component. Similarly, “outermost” should be interpreted as the part of the component that forms the outer edge or outer contour of the component and / or the part adjacent to that outer edge or outer contour.

[0009] The use of the term “substantially” as a modifier of any particular feature or effect in this disclosure is intended to mean simply that any deviation is within the tolerances typically expected by those skilled in the art in the relevant field.

[0010] The use of the term “generally” as a modifier to a particular feature or effect in this disclosure is intended to mean, in the case of a structural feature, that the majority or most of such feature is the characteristic in question, and in the case of a functional feature or effect, that the majority of the results relating to that characteristic provide that effect, but exceptional results do not.

[0011] This disclosure relates to devices of an ostomy system, such as an ostomy system and an ostomy appliance, a base plate for an ostomy appliance, a monitoring device, and optionally one or more accessory devices. Furthermore, methods relating to an ostomy system and devices of an ostomy system are disclosed. Accessory devices (also called external devices) may be a mobile phone or other handheld device. Accessory devices may be wearable personal electronic devices, such as a wristwatch or other wrist-worn electronic device. Accessory devices may be a docking station. A docking station may be configured to electrically and / or mechanically couple a monitoring device to the docking station. A docking station may be configured to charge the monitoring device and / or to transfer data between the monitoring device and the docking station. An ostomy system may include a server device. A server device may be operated and / or controlled by an ostomy appliance manufacturer and / or a service center.

[0012] This disclosure relates to devices of an ostomy system, such as an ostomy system and an ostomy appliance, a base plate of an ostomy appliance, a monitoring device, and optionally one or more accessory devices, which facilitate, alone or together, reliable identification of the nature, severity, and speed of moisture propagation in an adhesive material that provides attachment of a base plate to the 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 failure and also provide the user with indication of the severity, and therefore the remaining time frame for replacing the ostomy appliance, without experiencing a significant leak and / or without skin damage.

[0013] An ostomy appliance includes a base plate and an ostomy pouch (also called an ostomy bag). An ostomy appliance may be a colostomy appliance, an ileostomy appliance, or a bladder appliance. An ostomy appliance may be a two-piece appliance, where the base plate and ostomy pouch may be releasably connected, for example, using mechanical and / or adhesive bonding, thereby allowing, for example, multiple ostomy pouches to be used (replaced) with a single base plate. Furthermore, a two-piece ostomy appliance may facilitate the precise application of the base plate to the skin, for example, improving user visibility of the stoma area. An ostomy appliance may also be a single-piece appliance, where the base plate and ostomy pouch may be fixedly attached to each other. The base plate is configured to bond to the skin surrounding the stoma, such as the user's stoma and / or surrounding skin area.

[0014] The ostomy appliance includes, for example, a base plate such as a monolithic one-piece base plate integrated with a sensor assembly, or a separate sensor assembly such as a base plate and a sensor assembly applied subsequently to the base plate. For example, this is to enable any base plate, such as a conventional base plate, to achieve the features described herein. The features described herein with respect to the base plate may be provided, for example, by a sensor assembly applied to the base plate by the user. The sensor assembly may be adapted to adhere to the ostomy plate.

[0015] A disclosed method for attaching a base plate to the skin around a stoma, such as the user's stoma and / or surrounding skin area, may include attaching a sensor assembly portion to the base plate and, for example, attaching the base plate together with the attached sensor assembly portion to the skin around the stoma, such as the user's stoma and / or surrounding skin area. Alternatively, a method for attaching a base plate to the skin around a stoma, such as the user's stoma and / or surrounding skin, may include attaching a sensor assembly portion to the user's stoma and / or surrounding skin and attaching the base plate to the skin around the stoma on the user's stoma and / or the attached sensor assembly portion.

[0016] The base plate and / or sensor assembly portion may include a first adhesive layer, also referred to as a central adhesive layer. During use, the first adhesive layer adheres to the user's skin (surrounding area) and / or to additional sealing such as sealing paste, sealing tape and / or sealing ring. Thus, the first adhesive layer may be configured to attach the base plate and / or 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, which has a central point.

[0017] The first adhesive layer may be made of the first composition. The first composition may contain one or more polyisobutenes and / or styrene-isoprene-styrenes. The first composition may contain one or more hydrophilic colloids. The first composition may contain one or more water-soluble or water-swellable hydrophilic colloids.

[0018] The first composition may be a pressure-sensitive adhesive composition suitable for medical purposes, comprising an elastic elastomer base and one or more water-soluble or water-swellable hydrophilic colloids. The first composition may comprise one or more polybutenes, one or more styrene copolymers, one or more hydrophilic colloids, or any combination thereof. The combination of the adhesive properties of polybutene and the absorbency of the hydrophilic colloids makes the first composition suitable for use in 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 copolymers are used. The amount of styrene block copolymer may be 5% to 20% of the total adhesive composition. The butene component is a conjugated butadiene polymer, optionally selected from polybutadiene and polyisoprene. The polybutene is preferably present in an amount of 35% to 50% of the total adhesive composition. Preferably, the polybutene is polyisobutylene (PIB). Hydrophilic colloids suitable for incorporation into the first composition are selected from naturally occurring hydrophilic colloids, semi-synthetic hydrophilic colloids, and synthetic hydrophilic colloids. The first composition may contain 20% to 60% hydrophilic colloid. A preferred hydrophilic colloid 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. The sensor point openings of the first adhesive layer are optionally configured to overlap a portion of an electrode, for example, to form a sensor point.

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

[0021] The sensor point opening of the first adhesive layer may include secondary sensor point openings. The secondary sensor point openings may include one or more first secondary sensor point openings and one or more second secondary sensor point openings, wherein 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 that is different from the electrode over which the first secondary sensor point openings at least partially overlap.

[0022] The sensor point opening of the first adhesive layer may include a tertiary sensor point opening. The tertiary sensor point opening may include one or more first tertiary sensor point openings and one or more second tertiary sensor point openings, wherein the first tertiary sensor point opening is configured to overlap a portion of an electrode, and the second tertiary sensor point opening is configured to overlap a portion of another electrode that is different from the electrode over which the first tertiary sensor point opening at least partially overlaps.

[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 the primary portion of the first adhesive layer, for example, in the primary radial distance from the center point of the stoma opening or in the primary region within the primary radial distance range. 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, and may be 30 mm, for example.

[0025] The first adhesive layer may have a secondary thickness in the secondary portion of the first adhesive layer, for example, in a secondary region that is a distance from the center point of the stoma opening by a distance in the secondary radial direction or a range in the secondary radial direction. 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, and may be 30 mm, for example.

[0026] The base plate and / or sensor assembly portion may include a second layer. The second layer may be a second adhesive layer also referred to as a rim adhesive layer. The second layer may have a second radial spread that is greater than the first radial spread of the first adhesive layer, at least within a first angular range of the base plate and / or sensor assembly portion. Thus, the proximal portion of the second layer may be configured to attach to the user's skin surface. The proximal portion of the second layer configured to attach to the user's skin surface is also referred to as the skin attachment surface of the second adhesive layer. The second layer may have stoma openings, such as a stoma opening of the second layer and / or a second adhesive stoma opening, which have a center point.

[0027] A second adhesive layer may be made from a second composition. The second composition may contain one or more polyisobutenes and / or styrene-isoprene-styrenes. The second composition may contain one or more hydrophilic colloids. The second composition may contain one or more water-soluble or water-swellable hydrophilic colloids.

[0028] The second composition may be a pressure-sensitive adhesive composition suitable for medical purposes, comprising an elastic elastomer base and one or more water-soluble or water-swellable hydrophilic colloids. The second composition may comprise one or more polybutenes, one or more styrene copolymers, one or more hydrophilic colloids, or any combination thereof. The combination of the adhesive properties of polybutene and the absorbency of the hydrophilic colloids makes the second composition suitable for use in 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 copolymers are used. The amount of styrene block copolymer may be 5% to 20% of the total adhesive composition. The butene component is a conjugated butadiene polymer, optionally selected from polybutadiene and polyisoprene. The polybutene is preferably present in an amount of 35% to 50% of the total adhesive composition. Preferably, the polybutene is polyisobutylene (PIB). Hydrophilic colloids suitable for incorporation into the second composition are selected from naturally occurring hydrophilic colloids, semi-synthetic hydrophilic colloids, and synthetic hydrophilic colloids. The second composition may contain 20% to 60% hydrophilic colloid. A preferred hydrophilic colloid is carboxymethylcellulose (CMC). The second composition may optionally contain other components such as fillers, tackifiers, plasticizers, and other additives.

[0029] Different proportions of content can alter the properties of the first and / or second adhesive layers. 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 contain different proportions of polyisobutene, styrene-isoprene-styrene, and / or hydrophilic colloids. 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 have lower moldability than the first adhesive layer. The second adhesive layer may provide a second leak-proof 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 sensor assembly portion may include one or more electrodes, such as two, three, four, five, six, or seven or more electrodes. The sensor assembly portion may be applied to the base plate, thereby providing, for example, one or more electrodes to the base plate.

[0032] Electrodes, for example, some or all of them, may be placed between the first adhesive layer and the second adhesive layer. Electrodes may be placed in an electrode assembly, for example, an electrode layer. Electrodes include connectors that connect the electrodes to other components and / or interface terminals. Electrodes may include one or more conductive portions and / or one or more sensing portions. Electrode assemblies may be placed between the first adhesive layer and the second adhesive layer. Base plate and / or sensor assembly portions, for example, an electrode assembly, may include a first electrode, a second electrode, and optionally a third electrode. Base plate and / or sensor assembly portions, for example, an electrode assembly, may include a fourth electrode and / or a fifth electrode. Base plate and / or sensor assembly portions, for example, an electrode assembly, may optionally include a sixth electrode. Base plate and / or sensor assembly portions, for example, an 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 the ground of the second electrode. The ground electrode may include a third electrode portion. The third electrode portion of the ground electrode may form the ground of the third electrode. The ground electrode may include a fourth electrode portion. The fourth electrode portion of the ground electrode may form the ground of the fourth electrode and / or the fifth electrode. The ground electrode or an electrode portion of the ground electrode may be configured as a (common) reference electrode of some or all of the other electrodes of the electrode assembly, or may form a (common) reference electrode. The ground electrode may also be referred to as a reference electrode.

[0033] The electrodes are conductive and may include one or more of the following materials: metallic materials (e.g., silver, copper, gold, titanium, aluminum, stainless steel), ceramic materials (e.g., ITO), polymer materials (e.g., PEDOT, PANI, PPy), and carbonaceous materials (e.g., carbon black, carbon nanotubes, carbon fibers, graphene, graphite).

[0034] Two electrodes of an electrode assembly can form a sensor. A first electrode and a ground electrode (e.g., the first electrode portion of the ground electrode) can form a first sensor or a first electrode pair. A second electrode and a ground electrode (e.g., the second electrode portion of the ground electrode) can form a second sensor or a second electrode pair. A third electrode and a ground electrode (e.g., the third electrode portion of the ground electrode) can form a third sensor or a third electrode pair. A fourth electrode and a ground electrode (e.g., the fourth electrode portion of the ground electrode) can form a fourth sensor or a fourth electrode pair. A fifth electrode and a ground electrode (e.g., the fifth electrode portion of the ground electrode) can form a fifth sensor or a fifth electrode pair.

[0035] 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 on a few or one electrode layer.

[0036] The electrode assembly may include a support layer, also referred to as a support membrane. One or more electrodes may be formed, for example, printed, on the proximal side of the support layer. One or more electrodes may be formed, for example, printed, on the distal side of the support layer. The electrode assembly, including the support layer of the electrode assembly, may have stoma openings, such as an electrode assembly stoma opening and / or a support layer stoma opening, which have a center point.

[0037] The support layer may include polymer materials (e.g., polyurethane, PTFE, PVDF) and / or ceramic materials (e.g., alumina, silica). In one or more exemplary baseplate and / or sensor assembly parts, the support layer is made of thermoplastic polyurethane (TPU). The support layer material may be made of one or more of polyester, thermoplastic elastomer (TPE), polyamide, polyimide, ethylene vinyl acetate (EVA), polyurea, and silicone, or may include one or more of these.

[0038] Examples of thermoplastic elastomers for the support layer include styrene block copolymer (TPS, TPE-s), thermoplastic polyolefin elastomer (TPO, TPE-o), thermoplastic vulcanized rubber (TPV, TPE-v), thermoplastic polyurethane (TPU), thermoplastic copolyester (TPC, TPE-E), and thermoplastic polyamide (TPA, TPE-A).

[0039] The sensor assembly portion, such as the base plate and / or electrode assembly, may include a masking element configured to insulate at least a portion of the electrodes from the first adhesive layer of the base plate and / or sensor assembly portion. The masking element may include one or more sensor point openings. 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. When viewed in the axial direction, the sensor point openings of the masking element overlap with at least one of the electrodes of the electrode assembly, thereby forming, for example, a sensor point. For example, the primary sensor point opening may overlap with the portion of the ground electrode and / or the portion of the fourth electrode. The secondary sensor point opening may overlap with the portion of the fourth electrode and / or the portion of the fifth electrode. The tertiary sensor point opening may overlap with the portion of the fifth electrode and / or the portion of the ground electrode.

[0040] The masking element may include one or more terminal openings. The masking element may include polymer materials (e.g., polyurethane, PTFE, PVDF) and / or ceramic materials (e.g., alumina, silica). In one or more exemplary baseplate and / or sensor assembly parts, the masking element is made of or includes thermoplastic polyurethane (TPU). In one or more exemplary baseplate and / or sensor assembly parts, the masking element is made of or includes 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.

[0041] Examples of thermoplastic elastomers that serve as masking elements include styrene block copolymers (TPS, TPE-s), thermoplastic polyolefin elastomers (TPO, TPE-o), thermoplastic vulcanized rubber (TPV, TPE-v), thermoplastic polyurethane (TPU), thermoplastic copolyesters (TPC, TPE-E), and thermoplastic polyamides (TPA, TPE-A).

[0042] The base plate and / or sensor assembly portion may include a first intermediate element. The first intermediate element may be positioned 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.

[0043] The base plate and / or sensor assembly portion may include a release liner. The release liner is a protective layer that protects the adhesive layer during transport 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, which has a center point.

[0044] The base plate and / or sensor assembly portion may include an upper layer. The upper layer is a protective layer that protects the adhesive layer from external strain and stress when the user wears the ostomy appliance. Electrodes, for example, some or all of the electrodes, may be placed between the first adhesive layer and the upper layer. The upper layer may have a stoma opening, such as an upper stoma opening, with a center point. The upper layer may have a thickness in the range of 0.01 mm to 1.0 mm, such as 0.04 mm, for example, in the range of 0.02 mm to 0.2 mm.

[0045] The base plate and / or sensor assembly portion includes a monitor interface. The monitor interface may be configured to electrically and / or mechanically connect the ostomy appliance (base plate / sensor assembly portion) to a monitoring device. The monitor interface may be configured to wirelessly connect the ostomy appliance (base plate / sensor assembly portion) to the monitoring device. Therefore, 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.

[0046] The monitor interface of the base plate and / or sensor assembly portion may include, for example, a coupling portion that forms a mechanical connection, such as a releasable coupling, between the monitor device and the base plate and / or sensor assembly portion, as part of a first connector of the monitor interface. The coupling portion may be configured to engage with a monitor device coupling portion that releasably couples the monitor device to the base plate and / or sensor assembly portion.

[0047] The monitor interface of the base plate and / or sensor assembly portion may include a plurality of terminals, such as two, three, four, five, six, or seven or more terminals, which form electrical connections to each terminal of the monitor device, for example, as part of a first connector of the monitor interface. The monitor interface may include a ground terminal element that forms a ground terminal. The monitor interface may include a first terminal element that forms a first terminal, a second terminal element that forms a second terminal, and optionally a third terminal element that forms a third terminal. The monitor interface may include a fourth terminal element that forms a fourth terminal and / or a fifth terminal element that forms a fifth terminal. The monitor interface may optionally include a sixth terminal element that forms a sixth terminal. The terminal elements of the monitor interface may contact each electrode of the sensor assembly portion, such as the base plate and / or electrode assembly. A first intermediate element may be positioned between the terminal elements and the first adhesive layer. When viewed in the axial direction, the first intermediate element may cover or overlap the terminal elements of the base plate and / or sensor assembly portion. Therefore, the first adhesive layer may be protected from the terminal elements of the base plate and / or sensor assembly portion, or subjected to more evenly distributed mechanical stress from the terminal elements, thereby reducing the risk of the terminal elements penetrating the first adhesive layer or damaging the first adhesive layer in other ways. The first intermediate element may protect the first adhesive layer from the terminal elements of the base plate and / or sensor assembly portion, or provide mechanical and / or electrical shielding.

[0048] Terminal elements such as the grounding 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 tip and a base. Terminal elements such as the grounding 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 tip and the central portion. The proximal portion may be between the base and the central portion. Terminal elements such as the grounding 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 made of gold-plated copper.

[0049] The base plate may include a connecting 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 connecting ring.

[0050] The base plate and / or sensor assembly portion may have, for example, a stoma opening with a center point. The stoma opening of the base plate and / or sensor assembly portion may be collectively formed by the stoma openings of the layers of the base plate and / or sensor assembly portion, such as the upper 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 sensor assembly portion, such as the upper 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 sensor assembly portion.

[0051] The stoma opening may be a through-passage for the baseplate and / or sensor assembly portion. The stoma opening may be located substantially in the center of the baseplate and / or sensor assembly portion. The stoma openings of the layers of the baseplate and / or sensor assembly portion may be located substantially in the center of each layer. The stoma opening may be configured to receive the user's stoma and / or to allow discharge from the stoma through the stoma opening into an ostomy pouch attached to the baseplate. For example, the stoma opening may be configured to allow discharge to pass from the proximal side of the baseplate and / or sensor assembly portion to the distal side of the baseplate and / or sensor assembly portion. The size and / or shape of the stoma opening is usually adjusted by the user or nurse to fit the user's stoma before applying the ostomy appliance. In one or more exemplary baseplate and / or sensor assembly portions, the user forms the stoma opening while preparing the baseplate and / or sensor assembly portion for application.

[0052] The monitoring device includes a processor and one or more interfaces, such as a first interface and / or a second interface. The monitoring device may include memory for storing ostomy data.

[0053] In one or more exemplary monitoring devices, a processor is configured to apply a processing scheme, a first interface is connected to the processor and memory, and the first interface is configured to collect ostomy data from a baseplate and / or sensor assembly portion coupled to the first interface. The ostomy data may include one or more, such as first ostomy data from a first electrode pair of the baseplate and / or sensor assembly portion, second ostomy data from a second electrode pair of the baseplate and / or sensor assembly portion, and third ostomy data from a third electrode pair of the baseplate 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 a processing method may include determining the operational state of the ostomy appliance base plate based on a plurality of parameters, such as one or all of the first, second, and third parameter data. The operational state may indicate the degree of radial erosion of the base plate, such as the first adhesive layer, and / or the sensor assembly portion, and / or the risk of serious leakage of the ostomy appliance. The monitoring device is configured to transmit a first monitoring signal via a second interface, containing monitoring data indicating the first operational state of the base plate, in accordance with the determination that the operational state is a first operational state, and / or to transmit a second monitoring signal via the second interface, containing monitoring data indicating the second operational state of the base plate, in accordance with the determination that the operational state is a second operational state.

[0054] In one or more exemplary monitoring devices, a first 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 first degree of radial leakage, for example, the first adhesive layer has been eroded to a first radial distance of the first electrode pair but not to a second radial distance of the second electrode pair.

[0055] In one or more exemplary monitoring devices, a 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, for example, the first adhesive layer has been eroded to a second radial distance of the second electrode pair, but not to a third radial distance of the third electrode pair.

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

[0057] The first parameter data, the second parameter data, and the third parameter data may represent the 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 represent the rate of change in resistance between the first electrode pair, the second electrode pair, and the third electrode pair, respectively.

[0059] In one or more exemplary monitoring devices, the operating state of the baseplate is determined based on a first set of criteria based on first parameter data and / or second parameter data. If the first set of criteria is satisfied, the operating state is determined to be a 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, second parameter data, and 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 monitoring devices, determining the operating state of the baseplate may be based on a first threshold set, which includes one or more first thresholds. The first threshold set may include, for example, one or more thresholds to be applied to a first reference set. 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 represent the resistance between the first electrode pair (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 represent the resistance between the second electrode pair (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 represent the resistance between the third electrode pair (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 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) and 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 the 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 the 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 the 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 depending on, for example, 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 operating state of the baseplate is based on a default criterion set based on first parameter data. If the default criterion set is met, the operating state is determined to be the default operating state, and in accordance with the determination that the operating state is the default operating state, a default monitor signal is transmitted, which includes monitor data indicating the default operating 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) The default threshold can be given by the formula, where P_1_1 is a first-order parameter based on first parameter data, representing the resistance between first electrode pairs, TH_D_1 is the default first-order threshold, P_2_1 is a second-order parameter based on second parameter data, representing the resistance between second electrode pairs, TH_D_2 is the default second-order threshold, P_3_1 is a third-order parameter based on third parameter data, representing the resistance between third electrode pairs, TH_D_3 is the default third-order threshold, and the default operating state indicates that there is no or very low radial leakage in 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, for example, on the electrode configuration of the base plate and / or sensor assembly portion.

[0071] In one or more exemplary monitoring devices, determining the operating state of the baseplate is based on a third set of criteria that includes third parameter data. If the third set of criteria is met, the operating state is determined to be a third operating state, and in accordance with the determination that the operating state is a third operating state, a third monitoring signal is transmitted that includes monitoring data indicating the third operating 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 may 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 a first primary parameter based on first parameter data, indicating the resistance between the first electrode pair, TH_3_1 is a third primary threshold, P_2_1 is a second primary parameter based on second parameter data, indicating the resistance between the second electrode pair, TH_3_2 is a third secondary threshold, P_3_1 is a third primary parameter based on third parameter data, indicating the resistance between the third electrode pair, TH_3_3 is a 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) may be the same or different, for example, depending on 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) may 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 a processing method may 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 may be configured to transmit a fourth monitor signal including monitor data indicating the fourth operating state of the ostomy appliance according to a 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 discharge at a fourth radial distance between the distal surface of the first adhesive layer and the user's skin, and therefore the fourth operating state presents a high risk of leakage from the ostomy appliance.

[0076] The fourth set of criteria is, (P_4_1 <TH_4_4) The fourth parameter is a fourth-order parameter based on the fourth parameter data, representing the resistance between the fourth electrode pair, and the fourth operating state is a high risk of leakage from the ostomy appliance.

[0077] The monitoring device includes a monitoring device housing optionally made of 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 width along its longitudinal axis in the range of 1 cm to 15 cm. The monitoring device housing may have a width or maximum width perpendicular to its 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 for electrically and / or mechanically connecting the monitoring device to an 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 also be configured as an accessory device interface for electrically and / or mechanically connecting the monitoring device to an accessory device such as a docking station. The first interface may be coupled to the docking station of the ostomy system and configured, for example, to charge the monitoring device and / or to transfer data between the monitoring device and the docking station.

[0079] The first interface of the monitoring device may include a plurality of terminals, such as 2, 3, 4, 5, 6, or 7 or more, which form electrical connections with each terminal and / or electrode of the ostomy appliance. One or more terminals of the first interface may be configured to form electrical connections with each terminal 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 may optionally include a sixth terminal. In one or more exemplary monitoring devices, the first interface has M terminals, where M is an integer between 4 and 8.

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

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

[0082] The monitoring device may include a sensor unit having one or more sensors. The sensor unit is connected to a processor and supplies sensor data to the processor. The sensor unit may include an accelerometer that detects acceleration and provides acceleration data to the processor. The sensor unit may include a temperature sensor that provides 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 auxiliary interface for connecting the monitoring device to one or more auxiliary devices, for example, wirelessly. The second interface may include, for example, an antenna and a wireless transceiver configured for wireless communication in the frequency 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 using the Bluetooth® protocol, such as Bluetooth® Low Energy, Bluetooth® 4.0, or Bluetooth® 5. The second interface optionally includes a loudspeaker and / or haptic feedback elements that provide audio signals and / or haptic feedback to the user, respectively.

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

[0085] An 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 connect a monitoring device to the docking station.

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

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

[0088] The docking monitor interface of a docking station may include multiple terminals, such as 2, 3, 4, 5, 6, or 7 or more terminals, which form electrical connections to each terminal of a monitor device, for example, as part of the 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 may optionally include a sixth terminal.

[0089] Disclosed is a base plate for an ostomy appliance, such as the base plate described above. Also disclosed is a sensor assembly portion for an ostomy appliance, such as a sensor assembly portion applied to the base plate. The base plate and / or sensor assembly portion may include an upper layer, a first adhesive layer, an electrode assembly including multiple electrodes, and a monitor interface configured to connect the base plate and / or sensor assembly portion to a monitoring device. The base plate and / or sensor assembly portion may include the additional layers and / or features described above.

[0090] The monitor interface may include multiple terminals that are electrically connected to multiple electrodes and configured to connect to each terminal of the monitor device.

[0091] The monitor interface may include a coupling configured to connect the monitor device to the base plate and / or sensor assembly portion. Multiple terminals may be provided on the coupling. The coupling may include, for example, a locking section configured to lock the monitor device in the coupling position with the base plate and / or sensor assembly portion.

[0092] Furthermore, monitoring devices such as the monitoring device described above, which connects to the base plate and / or sensor assembly portion of the ostomy appliance, are also disclosed. The monitoring device may include a monitoring device housing, an electronic circuit, and an appliance interface configured to connect the monitoring device to the base plate and / or sensor assembly portion. The monitoring device may include additional features such as those described above.

[0093] The orthotic interface may include multiple terminals that connect to multiple electrodes on the base plate and / or sensor assembly portion. The orthotic interface may also include a monitor device coupling portion configured to connect the monitor device to the base plate and / or sensor assembly portion.

[0094] A monitoring device, such as an orthotic interface for a monitoring device, may include, for example, a locking mechanism configured to engage with a locking section of a base plate and / or sensor assembly portion, thereby locking the monitoring device in a coupled position with, for example, the base plate and / or sensor assembly portion.

[0095] The monitoring device may include electronic circuits, such as those that receive, process, store, and / or transmit signals and / or data. These electronic circuits may include, for example, a processor, a wireless communication unit, and memory. The electronic circuits may be enclosed by a monitoring device housing.

[0096] Also disclosed are ostomy systems including the base plate and / or sensor assembly portion and the monitoring device described above. The ostomy system may further include an ostomy pouch.

[0097] Base plates and / or sensor assembly portions, such as monitor interfaces and coupling parts, may include locking sections. Alternatively or additionally, monitor devices, such as monitor device coupling parts, may include locking sections. Locking sections may be configured to cooperate with each locking mechanism. For example, the locking section of a base plate and / or sensor assembly portion may be configured to cooperate with the locking mechanism of a monitor device, and / or the locking section of a monitor device may be configured to cooperate with the locking mechanism of a base plate and / or sensor assembly portion.

[0098] The locking section may include a hole that penetrates a joint, such as the joint of the base plate and / or the sensor assembly portion and / or the monitor device joint of the monitor device. Alternatively or additionally, the locking section may include a projection protruding from a surface, such as the first surface of the base plate and / or the sensor assembly portion. Alternatively or additionally, the locking section may include a recess on the edge of the joint and / or the monitor device joint. Alternatively or additionally, the locking section may include a first recess on the first edge of the joint and / or the monitor device joint, and a second recess on the second edge of the joint and / or the monitor device joint. The first edge may be the inverse of the second edge. Alternatively or additionally, the locking section may include a recess on the surface of the joint and / or the monitor device joint.

[0099] The coupling portion may include a snap fastener, such as a first snap fastener. The monitor device coupling portion may include a snap fastener, such as a second snap fastener. The first snap fastener may be configured to cooperate with the second snap fastener.

[0100] The coupling portion may include a projection. The projection may have a concave side. The projection, such as the concave side of the projection, may, for example, form a locking section of the coupling portion. The monitor device coupling portion may include a cavity. The cavity may be configured, for example, to receive the projection along the projection direction of the projection, for example, in the engagement direction. The projection may be configured, for example, to engage with the cavity in the engagement direction. The monitor device coupling portion may include one or more deflectable elements positioned in the cavity, such as on the side of the cavity. The deflectable elements may, for example, form part of the locking mechanism of the monitor device. The deflectable elements may be configured to engage with the concave side of the projection, thereby holding the projection in the cavity, for example. The deflectable elements, such as spring elements, may be elastically deformable. Alternatively, the monitor device coupling portion may include a projection, and the coupling portion may include a cavity and optionally one or more deflectable elements positioned in the cavity.

[0101] The monitor device coupling and / or coupling may include a projection element positioned within the cavity, such as substantially at the center of the cavity. The projection of the coupling and / or monitor device coupling may include, for example, a socket configured to receive the projection element positioned in the cavity. The projection element and socket may be shaped to engage together. The projection element and socket may be shaped to limit possible orientations, thereby ensuring correct coupling of the monitor device to, for example, the base plate and / or sensor assembly portion. For example, the projection element and socket may have a triangular cross-section. Multiple terminals of the monitor device and / or the base plate and / or sensor assembly portion may be provided on the projection element, such as at the ends of the projection element. Multiple terminals of the base plate and / or sensor assembly portion and / or monitor device may be provided on the socket, such as at the bottom of the socket.

[0102] The projections of the joint may project substantially perpendicular to the projection direction, for example, the plane of the base plate and / or sensor assembly portion, and may project, for example, axially. The upper layer and / or first adhesive layer may extend in the plane of the base plate and / or sensor assembly portion.

[0103] The monitoring device may be curved, for example, in the base plate and / or sensor assembly portion, to indicate to the user the correct way to orient the monitoring device.

[0104] The coupling portion may include a first alignment element. The monitor device, such as the monitor device coupling portion, may include a second alignment element. The second alignment element may be configured to engage with the first alignment element. The first alignment element may have a first alignment edge configured to be received by the second alignment element, which together forms a recess with the second alignment edge. The second alignment element may have an open end toward the rim surface of the monitor device. Thereafter, the monitor device may be aligned appropriately, i.e., the coupling of the monitor device may be prevented if the first and second alignment elements are not properly oriented.

[0105] The aforementioned projection can be positioned on the upper part of the first alignment element, substantially axially or otherwise, relative to the first alignment element. For example, the first alignment edge can surround the projection.

[0106] The coupling portion may be configured to engage with the monitor device by linear motion in the engagement direction of the monitor device with respect to the base plate and / or sensor assembly portion. The monitor device coupling portion may be configured to engage with the base plate and / or sensor assembly portion, such as the coupling portion of the base plate and / or sensor assembly portion, by linear motion in the engagement direction of the monitor device with respect to the base plate and / or sensor assembly portion. For example, the monitor device, such as the monitor device coupling portion, and the base plate and / or sensor assembly portion, such as the coupling portion of the base plate and / or sensor assembly portion, can transition from separation to coupling by linear motion, such as a single linear motion in the engagement direction of the monitor device with respect to the base plate and / or sensor assembly portion.

[0107] The coupling portion may be configured to disengage from the monitor device by linear motion in the disengagement direction of the monitor device relative to the base plate and / or sensor assembly portion. The monitor device coupling portion may be configured to disengage from the base plate and / or sensor assembly portion, such as the coupling portion of the base plate and / or sensor assembly portion, by linear motion in the disengagement direction of the monitor device relative to the base plate and / or sensor assembly portion. For example, the monitor device, such as the monitor device coupling portion, and the base plate and / or sensor assembly portion, such as the coupling portion of the base plate and / or sensor assembly portion, can move from coupling to separation by linear motion, such as a single linear motion in the disengagement direction of the monitor device relative to the base plate and / or sensor assembly portion. The disengagement direction may be the opposite of the engagement direction. Alternatively, the disengagement direction may be perpendicular to the engagement direction.

[0108] The upper layer and / or first adhesive layer may be substantially flat before application, for example. The upper layer and / or first adhesive layer may extend to the base plate and / or sensor assembly portion. The engagement direction and / or disengagement direction may be substantially parallel to and / or perpendicular to the plane of the base plate and / or sensor assembly portion.

[0109] The engagement direction and / or disengagement direction may be directed toward the stoma opening of the base plate and / or sensor assembly portion. For example, the engagement direction and / or disengagement direction may originate from an edge of the base plate and / or sensor assembly portion, such as the edge of the upper layer and / or first adhesive layer. The engagement direction and / or disengagement direction may be radial to the base plate and / or sensor assembly portion. Alternatively, the engagement direction and / or disengagement direction may be substantially perpendicular to the radial direction of the base plate and / or sensor assembly portion.

[0110] The joint may be substantially flat. For example, the joint may substantially extend onto a plane such as the base plate and / or the plane of the sensor assembly portion.

[0111] The joint may include a first surface and a second surface. The second surface may be the inverse of the first surface. The second surface may face an upper layer, such as in the proximal direction; for example, the second surface may face the user's skin. The first surface may face away from the upper layer, such as in the distal direction; for example, the first surface may face away from the user's skin.

[0112] The electrode assembly may be provided between the upper layer and the first adhesive layer. The distal side of the electrode assembly may face the upper layer. The proximal side of the electrode assembly may face the first adhesive layer.

[0113] The electrode assembly may include a support layer. Multiple electrodes may be provided proximal to the support layer. Multiple electrodes may face a first adhesive layer. Multiple electrodes may be in contact with the first adhesive layer.

[0114] The joint may be formed at least partially by the first electrode assembly portion of the electrode assembly and / or the first upper layer portion of the upper layer.

[0115] The first electrode assembly portion may extend through an opening in the upper layer to form at least a portion of the joint. Each of the first electrode assembly and / or the first upper layer portion may be cut from the electrode assembly and / or the upper layer, for example, by a U-shaped cut, thereby enabling the formation of at least a portion of the joint. The first electrode assembly portion and / or the first upper layer portion may be a portion near the respective edges of the first electrode assembly and the upper layer, thereby enabling the formation of at least a portion of the joint.

[0116] Multiple terminals may be provided on the second surface of the coupling. Alternatively or additionally, multiple terminals may be provided on the first side of the coupling.

[0117] The second surface and upper layer of the joint can be separated, thereby allowing at least a portion of the monitor device to be positioned between the second surface and upper layer of the joint, for example, when the monitor device is connected to the base plate and / or sensor assembly portion.

[0118] The coupling may include a first coupling section and a second coupling section. The coupling may be configured to receive at least a portion of a monitoring device between the first coupling section and the second coupling section. The first coupling section and the second coupling section may be biased toward each other. For example, the first coupling section may be biased toward the second coupling section, and / or the second coupling section may be biased toward the first coupling section. The first coupling section may be deflectable toward the second coupling section. Alternatively or additionally, the second coupling section may be deflectable toward the first coupling section.

[0119] The coupling portion may be positioned so that the monitor device is coupled to the base plate at the distal end of the upper layer. The coupling portion may be positioned distal to the upper layer. The coupling portion may be positioned so that when the monitor device is coupled to the base plate and / or sensor assembly portion, the upper layer of the base plate and / or sensor assembly portion is positioned between the monitor device and the user's skin. The monitor device may be configured so that when the monitor device is coupled to the base plate and / or sensor assembly portion, the upper layer of the base plate and / or sensor assembly portion is positioned between the monitor device and the user's skin.

[0120] A monitoring device can cause skin irritation, for example, if the skin touches the monitoring device and / or if the monitoring device moves while in contact with the skin. Therefore, it may be an advantage of this disclosure that the base plate and / or sensor assembly portion can be positioned to provide a protective layer between the skin and the monitoring device. Thus, skin irritation caused by the monitoring device can be reduced or avoided.

[0121] A monitor device, such as a monitor device housing, may have a first surface and a second surface. The first surface may be the inverse of the second surface. The first surface and / or the second surface may be substantially flat. The monitor device may include a rim surface between the first surface and the second surface. The rim surface may be substantially perpendicular to the first surface and / or the second surface.

[0122] The monitor device coupling portion may be provided on the rim surface, such as a first portion of the rim surface. For example, the monitor device coupling portion may be provided by an opening on the rim surface, such as a first portion of the rim surface. Alternatively, the monitor device coupling portion may be provided on the first surface and / or the second surface, such as an opening or groove on the first surface and / or the second surface.

[0123] Multiple terminals of the monitoring device may be configured to be electrically connected to multiple electrodes of the base plate and / or sensor assembly, such as through electrical connections to multiple terminals of the base plate and / or sensor assembly.

[0124] The base plate and / or sensor assembly portion, such as the coupling portion or monitor interface, may include a locking mechanism. Alternatively or additionally, the monitor device may include a locking mechanism. The locking mechanism may be configured to lock the monitor device in the coupling position with the base plate and / or sensor assembly portion. For example, the locking mechanism may provide that the monitor device is maintained in the coupling position with the base plate and / or sensor assembly portion. The locking mechanism may be configured to automatically lock the monitor device in the coupling position with the base plate and / or sensor assembly portion. For example, the locking mechanism may be biased toward the lock, for example, by a spring bias. For example, the locking mechanism may include biasing means, for example, a spring, for biasing the locking mechanism toward the locked position. The locking mechanism may be configured to unlock the monitor device from the coupling position with the base plate and / or sensor assembly portion when interacting with a user. Alternatively or additionally, the locking mechanism may be configured to lock the monitor device in the coupling position with the base plate and / or sensor assembly portion when interacting with a user.

[0125] The monitoring device may include an opening that receives a connection to the base plate and / or a sensor assembly portion. For example, the monitoring device connection may be provided by an opening that receives a connection to the base plate and / or a sensor assembly portion. The locking mechanism may include a locking component located inside the opening, such as a pin configured to engage with a hole in the locking section. Alternatively or additionally, the monitoring device may include a groove that receives a connection to the base plate and / or a sensor assembly portion. For example, the monitoring device connection may be provided by a groove that receives a connection to the base plate and / or a sensor assembly portion. The locking mechanism may include a locking component located inside the groove, such as a pin configured to engage with a hole in the locking section.

[0126] The base plate, and / or the sensor assembly portion, and / or the monitoring device may include a locking element (which may alternatively be indicated as an unlocking element). The locking element may form part of a locking mechanism. The locking element may be configured to unlock and / or lock the locking mechanism when, for example, a user interacts with the locking element. For example, the locking element may include a button for user interaction. For example, the locking element may engage to lock the locking mechanism, and / or the locking element may engage to unlock the locking mechanism. User interaction with the locking element may include deflecting one or more buttons or sliding a slider, etc.

[0127] Each of the locking elements may include a first button. The first button may be deflectable in a first direction.

[0128] The first direction may be substantially perpendicular to the engagement direction and / or substantially perpendicular to the disengagement direction. Alternatively, the first direction may be substantially parallel to the engagement direction and / or substantially parallel to the disengagement direction. For example, the first direction may be substantially the same as the engagement direction and / or the disengagement direction. Alternatively, the first direction may be substantially opposite to the engagement direction and / or the disengagement direction.

[0129] The locking element may include a first button and a second button, such as a second button. The second button may be deflectable in a second direction.

[0130] The first direction may be substantially opposite to the second direction. The first direction and the opposite second direction may provide the first and second buttons to be deflected, for example, engaged simultaneously by the user pinching the monitoring device.

[0131] The first direction and / or the second direction may be substantially perpendicular to the engagement direction, and / or the first direction may be substantially parallel to the disengagement direction. This allows the user to pinch the monitoring device and push / pull it in the engagement direction and / or disengagement direction.

[0132] The locking element may include a slider. The slider may be slidable in a first slider direction. The slider may be a spring that is loaded and biased toward a second slider direction. The first slider direction may be the opposite of the second slider direction. The first slider direction and / or the second slider direction may be substantially orthogonal to the engagement direction and / or disengagement direction. Alternatively, the first slider direction and / or the second slider direction may be substantially parallel to the engagement direction and / or disengagement direction, such as the opposite of the engagement direction and / or disengagement direction.

[0133] The monitoring device may include clamps, such as clamps configured to grip the joint of a base plate and / or a sensor assembly portion between a first clamp surface and a second clamp surface. The locking mechanism may include a locking component positioned between the first clamp surface and the second clamp surface. For example, the locking component may be configured to engage with a locking section. For example, the locking component may be a pin that engages with a hole in the locking section.

[0134] The first and second clamp surfaces may be biased toward each other by, for example, a spring and / or magnetic element provided to the first and / or second clamp surfaces. The monitoring device may include, for example, a clamp lock configured to lock the first and second clamp surfaces in a closed clamp position. The clamp lock may be configured to be locked and / or unlocked by user interaction. The locking element may function to lock and / or unlock the clamp lock as described above.

[0135] Multiple terminals may be provided on the first clamp surface. Alternatively or additionally, multiple terminals may be provided on the second clamp surface. The first clamp surface and / or the second clamp surface may be formed by the monitor device housing.

[0136] Also disclosed are connectors for the base plate and / or sensor assembly portion of an ostomy appliance, such as connectors configured to connect a monitoring device to the base plate and / or sensor assembly portion. The connectors may be those of any disclosed base plate and / or sensor assembly portion.

[0137] The joint may include a first joint section and a second joint section. The first joint section may be substantially flat in the first joint plane, and the second joint section may be substantially flat in the second joint plane.

[0138] The first coupling section may be configured to be attached to the distal side of the first part of the base plate and / or sensor assembly, such as the distal side of the first part of the electrode assembly of the base plate and / or sensor assembly and / or the distal side of the first part of the upper layer of the base plate and / or sensor assembly. The first part of the electrode assembly and / or the first part of the upper layer may be the first part of the base plate and / or sensor assembly that includes a connection point for multiple electrodes.

[0139] The second coupling section may be configured to be attached to the distal side of the second part of the base plate and / or sensor assembly, such as the distal side of the upper layer of the base plate and / or sensor assembly and / or the distal side of the upper layer of the second part of the base plate and / or sensor assembly.

[0140] For example, a base plate and sensor assembly portion by any disclosed base plate and sensor assembly portion is also disclosed, including a coupling portion configured to connect a monitor device to the base plate and / or sensor assembly portion. For example, a base plate and / or sensor assembly portion of an ostomy appliance including an upper layer, a first adhesive layer, an electrode assembly including a plurality of electrodes having a connecting portion and a sensing portion, and a monitor interface configured to connect the base plate and / or sensor assembly portion to a monitor device. The monitor interface may include a coupling portion configured to connect the monitor device to the base plate and / or sensor assembly portion.

[0141] The coupling portion may include a first coupling section and a second coupling section. The first coupling section may be substantially flat in the first coupling plane, and the second coupling section may be substantially flat in the second coupling plane. The first coupling section may be attached to a first part of an electrode assembly including a coupling, such as overlapping a first part of an electrode assembly, and / or a first part of an upper layer including a coupling, such as overlapping a first part of an electrode assembly. The first coupling section may be attached to a first part of an electrode assembly with a first part of another layer in between. The proximal side of the first coupling section may be attached to the distal side of an upper layer, such as the distal side of a first part of an upper layer. Alternatively, the proximal side of the first coupling section may be attached to the distal side of an electrode assembly, such as the distal side of a first part of an electrode assembly.

[0142] The second coupling section can be attached to the second part of the base plate and / or sensor assembly, such as the distal side of the second part of the upper layer, for example, the distal side of the second part of the upper layer of the base plate and / or sensor assembly. The proximal side of the second coupling section can be attached to the distal side of the upper layer, such as the distal side of the second part of the upper layer. The second coupling section can be attached, at least partially, to the second part of the electrode assembly, such as the distal side of the second part of the electrode assembly of the base plate and / or sensor assembly. The proximal side of the second coupling section can be attached, at least partially, to the distal side of the second part of the electrode assembly.

[0143] An advantage of the disclosed connector and the associated base plate and / or sensor assembly is that the connection of the monitoring device to the base plate and / or sensor assembly can be made easier and more convenient for the user. Furthermore, the connection of the monitoring device to the base plate and / or sensor assembly can be made more durable using the disclosed connector.

[0144] The first joint section may be hinged to the second joint section, allowing rotational motion of the first joint section relative to the second joint section around a hinge axis. The hinge axis may be parallel to the planes of the first and second joint sections. The resulting rotational motion may include positions where the first and second joint sections are substantially parallel and / or substantially continuous.

[0145] The rotational motion of the first joint section around the hinge axis relative to the second joint section may be limited. For example, the possible rotation may be between the first joint angle and the second joint angle. The first joint angle may be between 0 and 10 degrees, such as 0 to 5 degrees or 0 degrees. The second joint angle may be between 10 and 90 degrees, such as 15 to 45 degrees, 25 to 40 degrees, 30 degrees, or 35 degrees.

[0146] In a stationary state, the first and second coupling sections and / or the upper layer may form a stationary angle. The stationary state may be a state in which no force is applied to the first and / or second coupling sections. For example, the base plate and / or sensor assembly section may be unpacked and laid flat. Providing a stationary angle to the coupling section may assist the user in mounting the monitoring device because the coupling section, e.g., the first coupling section, is lifted away from the distal side of the upper layer, thus facilitating access to the coupling section, e.g., the first coupling section. The stationary angle may be greater than 0 degrees, such as greater than 1 degree, greater than 5 degrees, greater than 10 degrees, greater than 15 degrees, greater than 20 degrees, etc. The stationary angle may be less than 80 degrees, such as less than 70 degrees, less than 60 degrees, less than 50 degrees, etc. A larger stationary angle may facilitate the coupling of the monitoring device, while a smaller stationary angle may provide a flatter base plate and / or sensor assembly section, thus optimizing the storage of the base plate and / or sensor assembly section.

[0147] The angles between the first joint section and the second joint section, such as the first joint angle, the second joint angle, and / or the stationary angle, may be measured relative to a position where the first joint section and the second joint section are substantially parallel and / or substantially continuous.

[0148] The second coupling section may include, for example, a second primary coupling section and one or more second secondary coupling sections, including a first second secondary coupling section and / or a second second secondary coupling section. The second primary coupling section may be located on the primary side of the hinge axis. One or more second secondary coupling sections may be located on the secondary side of the hinge axis. The secondary side of the hinge axis may be the opposite side of the primary side of the hinge axis. The second coupling sections extending on both sides of the hinge axis help to increase the stability of the coupling, for example, when rotating the first coupling section around the hinge axis. Furthermore, they may provide a reduced risk of damaging the electrode assembly during use of the base plate and / or sensor assembly portion.

[0149] The first coupling section may include, for example, a locking section and / or a plurality of locking sections configured to lock the monitor device in a coupling position with the base plate and / or sensor assembly portion. The locking sections may be configured to cooperate with each locking mechanism, for example, the locking mechanism of the monitor device.

[0150] The locking section may include a hole extending through the joint, such as the first joint section. Alternatively or additionally, the locking section may include a projection protruding from a surface, such as the first surface of the joint, such as the first joint section. Alternatively or additionally, the locking section may include a recess on the edge of the joint, such as the first joint section. Alternatively or additionally, the locking section may include a first recess on the first edge of the joint, such as the first joint section, and a second recess on the second edge of the joint, such as the first joint section. The first edge may be the inverse of the second edge. Alternatively or additionally, the locking section may include a groove in the section of the joint, such as the first joint section.

[0151] The joints of the joint sections, such as the first joint section and / or the second joint section, can be attached to the electrode assembly and / or upper layer by adhesive and / or welding. For example, the first joint section can be attached to the first part of the base plate and / or sensor assembly portion, such as the first part of the electrode assembly and / or the first part of the upper layer, by adhesive. Alternatively or additionally, the first joint section can be attached to the first part of the base plate and / or sensor assembly portion, such as the first part of the electrode assembly and / or the first part of the upper layer, by welding the first joint section and the first part of the base plate and / or sensor assembly portion together. The second joint section can be attached to the second part of the base plate and / or sensor assembly portion, such as the second part of the upper layer, by adhesive. Alternatively or as an addition, the second joint section may be attached to the second part of the base plate and / or sensor assembly, such as the upper second part, by welding the second joint section and the second part of the base plate and / or sensor assembly together.

[0152] The first joint section may include a first joint section adhesive configured to be attached to a base plate and / or a first part of a sensor assembly, such as a first part of an electrode assembly and / or a first part of an upper layer. The second joint section may include a second joint section adhesive configured to be attached to a base plate and / or a second part of a sensor assembly, such as a second part of an upper layer.

[0153] The joint may have one or more thicknesses. The thickness of the first joint section may be substantially uniform. The thickness of the second joint section may be substantially uniform. The first joint section may have the first joint thickness. The second joint section may have the second joint thickness. The first joint thickness may be less than 2 mm, such as less than 1 mm, less than 0.6 mm, etc. The second joint thickness may be less than 2 mm, such as less than 1 mm, less than 0.6 mm, or less than 0.3 mm. The first joint thickness may exceed the second joint thickness.

[0154] The joint may have one or more lines of reduced thickness along the hinge axis, allowing, for example, rotational motion of the first joint section relative to the second joint section around the hinge axis. The thinner thickness along the hinge axis may facilitate rotational motion between the first and second joint sections. One or more lines of reduced thickness may be provided on the distal side of the joint, thereby providing, for example, rotational motion in one direction, e.g., distally of the first joint section, and / or restricting rotational motion in the opposite direction, e.g., proximal of the first joint section. One or more lines of reduced thickness may include multiple lines of reduced thickness, such as two lines of reduced thickness, three lines of reduced thickness, or four or more lines of reduced thickness. One or more lines of reduced thickness may be provided, for example, by kiss-cutting or laser engraving.

[0155] As an addition or alternative, the joint may include one or more holes along the hinge axis, for example, to allow rotational movement of the first joint section relative to the second joint section around the hinge axis. One or more holes along the hinge axis may facilitate rotational movement between the first joint section and the second joint section. One or more holes may include multiple holes such as two, three, four, or five or more holes. One or more holes may be provided, for example, by laser cutting or punching.

[0156] The base plate and / or sensor assembly portion may include a backing element. The backing element may be provided between the electrode assembly and / or multiple electrodes of the electrode assembly and the first adhesive layer. The backing element may be provided between the first adhesive layer and the first portion of the electrode assembly. The backing element may prevent a portion of the electrode assembly, such as the first portion of the electrode assembly, from adhering to the first adhesive layer, thereby facilitating the turning of the portion, such as the first portion of the electrode assembly (e.g., together with the first joint section of the joint). Alternatively or additionally, the backing element may be used as a stop for opening cuts, such as U-shaped cuts.

[0157] Figure 1 shows an exemplary ostomy system. The ostomy system 1 includes an ostomy appliance 2, which includes a base plate 4. The base plate 4 is fitted to support an ostomy pouch (not shown). Furthermore, the ostomy system 1 includes a monitoring device 6 and an accessory device 8 (mobile phone). The monitoring device 6 is connectable to the base plate 4 via first connectors on both the monitoring device 6 and the base plate 4. The monitoring device 6 is configured to communicate wirelessly 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 service center. Ostomy data or parameter data based on ostomy data is acquired from electrodes / sensors of the ostomy appliance 2 having the monitoring device 6. The monitoring device 6 processes the ostomy data and / or parameter data based on ostomy data to identify the monitoring data to be sent to the accessory device 8. In the ostomy system shown, the accessory device 8 is a mobile phone, but the accessory device 8 may be implemented as another handheld device such as a tablet device or a wearable such as a wristwatch or other wrist-worn electronic device. Accordingly, the monitoring device 6 is configured to identify monitoring data and transmit it to the accessory device 8. The base plate 4 includes a connecting member 14 in the form of a connecting ring 16 that connects an ostomy pouch (not shown) to the base plate (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 usually adjusted by the user or nurse to fit the user's stoma before application of the ostomy appliance.

[0158] The ostomy system 1 optionally includes a docking station 20 which forms an accessory device of the ostomy system 1. The docking station 20 includes a docking monitor interface which includes a first connector 22 configured to electrically and / or mechanically connect a 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 which receives user input and / or provides the user with feedback on the operating status of the docking station 20. The user interface 24 may include a touchscreen. The user interface 24 may include one or more physical buttons and / or one or more visual indicators such as light-emitting diodes.

[0159] Figure 2 is a schematic block diagram of an exemplary monitoring device. The monitoring device 6 includes a monitoring device housing 100, a processor 101, and one or more interfaces, one or more of which include a first interface 102 (orthotic interface) and a second interface 104 (accessory interface). The monitoring device 6 includes a memory 106 for storing ostomy data and / or parameter data based on ostomy data. The memory 106 is connected to the processor 101 and / or the first interface 102.

[0160] The first interface 102 is configured as an appliance interface that electrically and / or mechanically connects the monitor device 6 to an ostomy appliance, for example, an ostomy appliance 2. The first interface 102 includes a plurality of terminals that form electrical connections with each terminal 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 monitor device 6 includes a coupling portion 120 that forms a mechanical connection, such as a releasable coupling, between the monitor 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 the first connector (at least a portion of it) of the monitor device 6.

[0161] The monitor device 6 includes a power unit 121 that supplies power to the monitor device and its active components, namely the power unit 121 which is connected to the processor 101, the first interface 102, the second interface 104, and the memory 106. The power unit includes a battery and a charging circuit. The charging circuit is connected to the battery and the terminals of the first interface 102 and charges the battery via the terminals of the first interface, for example, the terminals of the first connector.

[0162] The second interface 104 of the monitoring device is configured as an accessory interface for connecting the monitoring device 6 to one or more accessory devices, such as accessory device 8. The second interface 104 includes an antenna 122 and a wireless transceiver 124 configured to communicate wirelessly with the accessory devices. 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.

[0163] The monitoring device 6 includes a sensor unit 140 connected to the processor 101. The sensor unit 140 includes a temperature sensor that supplies temperature data to the processor and a G sensor or accelerometer that supplies acceleration data to the processor 101.

[0164] 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 memory 106 and / or processed by the processor 101 to obtain parameter data. The parameter data may be stored in memory 106. The processor 101 is configured to apply a processing scheme, and applying the processing scheme includes obtaining first parameter data based on first ostomy data, obtaining second parameter data based on second ostomy data, and obtaining third parameter data based on third ostomy data. In other words, the processor 101 is configured to obtain first, second, and third parameter data based on first, second, and third ostomy data, respectively. Applying the processing method involves determining the operational state of the ostomy appliance base plate based on one or more, for example, all, of the first, second, and third parameter data, the operational state indicating the degree of radial erosion of the base plate and / or the risk of serious leakage of the ostomy appliance. The monitoring device 6 is configured to transmit a first monitoring signal via a second interface, containing monitoring data indicating the first operational state of the base plate, in accordance with the determination that the operational state is a first operational state, and to transmit a second monitoring signal via a second interface, containing monitoring data indicating the second operational state of the base plate, in accordance with the determination that the operational state is a second operational state.

[0165] Figure 3 shows an exploded view of an exemplary base plate of an ostomy appliance. The base plate 4 includes a first adhesive layer 200. During use, the proximal surface of the first adhesive layer 200 adheres to the user's skin in the peri-stoma area and / or to additional sealing such as sealing paste, sealing tape, and / or sealing ring. 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 arranged in an electrode assembly 204. The electrode assembly 204 is positioned between the first adhesive layer 200 and the second adhesive layer 202. The electrode assembly 204 includes a support layer having electrodes formed on the 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 an upper layer 208 and a connecting ring 209 that connects the ostomy pouch to the base plate 4. The upper layer 208 is a protective layer that protects the second adhesive layer 202 from external strain and stress during use.

[0166] 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, each forming 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 positioned between the terminal elements that form the terminals 212 and a first adhesive layer (not shown). The first intermediate element 213, when viewed in the axial direction, covers the terminal elements forming the terminals 212 of the base plate 4, protecting the first adhesive layer from mechanical stress from the terminal elements of the base plate.

[0167] As described above, some parts of the base plate 4 shown may be provided as separate assemblies to be applied to an existing base plate, for example, including one or more of the components described above, thereby providing a base plate such as the base plate 4 described above. For example, a sensor assembly portion 700 may be provided, for example, including an electrode assembly 204, a first connector 211, a first intermediate element 213, a first adhesive layer 200, and a release liner 206. Furthermore, the sensor assembly portion 700 may also include a second adhesive layer 202 and / or an upper layer 208. It is conceivable that a user may provide a hole in the layers of the base plate to which the sensor assembly portion 700 is applied, thereby allowing the first connector 211 of the sensor assembly portion 700 to protrude through the layers of the base plate and be applied thereto. 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.

[0168] Figure 4 shows an exploded view of an exemplary electrode assembly 204 of the base plate and / or sensor assembly portion. 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, the electrodes 216 including a ground electrode, a first electrode, a second electrode, a third electrode, a fourth electrode and a fifth electrode, each electrode having a connection portion 217 that connects the electrode 216 to each terminal element of the monitor interface. The electrodes 216 are provided such as being formed on the proximal side 214B of the support layer 214, for example, the electrodes 216 may be located on the proximal side 214B of the support layer. Furthermore, the electrode assembly 204 includes a masking element 218 having a proximal surface 218B and configured to insulate the electrode portion of the electrode 216 from the first adhesive layer of the base plate and / or sensor assembly portion. When viewed in the axial direction, the masking element 218 covers or overlaps with the portion of the electrode 216.

[0169] Figure 5 is a proximal view of the proximal surface of the portion of the base plate and / or sensor assembly portion without the first adhesive layer and release liner. The base plate 4 and / or sensor assembly portion 700 includes a first intermediate element 213 between the electrode assembly 204 and the first adhesive layer (not shown) on the proximal side of the electrode assembly. When viewed in the axial direction, the first intermediate element 213 covers the terminal elements of the base plate 4 and / or sensor assembly portion 700 and protects the first adhesive layer from mechanical stress from the terminal elements of the base plate and / or sensor assembly portion.

[0170] Figure 6 is a distal view of an exemplary electrode configuration 220 of electrode 216 of electrode assembly 204. Electrode assembly 204, including electrode configuration 220 of 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 portion 222A, the first electrode 224 includes a first connection portion 224A, the second electrode 226 includes a second connection portion 226A, the third electrode 228 includes a third connection portion 228A, the fourth electrode 230 includes a fourth connection portion 230A, and the fifth electrode 232 includes a fifth connection portion 232A.

[0171] The fourth electrode 230 includes a fourth detection unit 230B. The fifth electrode 232 includes a fifth detection unit 232B.

[0172] The grounding electrode 222 includes a first electrode portion 234 that forms the ground for the first electrode 224. The grounding electrode 222 includes a second electrode portion 236 that forms the ground for the second electrode 226. The grounding electrode 222 includes a third electrode portion 238 that forms the ground for the third electrode 228. The grounding electrode 222 includes a fourth electrode portion 240 that forms the ground for the fourth electrode 230 and the fifth electrode 232. The fourth electrode portion 240 of the grounding electrode 222 includes a ground detection portion 222B.

[0173] Figure 7 is a distal view of an exemplary masking element. The masking element 218 optionally has a plurality of terminal openings, including six terminal openings. The plurality of terminal openings include 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, and 252 of the masking element 218 are configured to overlap and / or align with the respective connection portions 222A, 224A, 226A, 228A, 230A, and 232A of the electrodes of the electrode assembly.

[0174] The masking element 218 has a plurality of sensor point openings. The sensor point openings include primary sensor point openings shown within the dotted line 254, each primary sensor point opening 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 include five first primary sensor point openings 254A, each configured to overlap a portion of the ground electrode 222 in the illustrated masking element shown. The primary sensor point openings 254 include four second primary sensor point openings 254B, each configured to overlap a portion of the fourth electrode 230 in the illustrated masking element shown. The sensor point openings include secondary sensor point openings shown within the dotted line 256, each secondary sensor point opening configured to overlap a portion of the fourth electrode 230 and / or a portion of the fifth electrode 232. The secondary sensor point opening 256 includes five first secondary sensor point openings 256A, each configured to overlap the portion of the fifth electrode 232 in the illustrated masking element. The secondary sensor point opening 256 includes four second secondary sensor point openings 256B, each configured to overlap the portion of the fourth electrode 230 in the illustrated masking element. The sensor point opening includes a tertiary sensor point opening shown within the dotted line 258, each configured to overlap the portion of the fifth electrode 232 and / or the ground electrode 222. The tertiary sensor point opening 258 includes five first tertiary sensor point openings 258A, each configured to overlap the portion of the fifth electrode 232 in the illustrated masking element. The tertiary sensor point opening 258 includes four second tertiary sensor point openings 258B, each configured to overlap the portion of the ground electrode 222 in the illustrated masking element.

[0175] Figure 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 the dotted line 260, each primary sensor point opening configured to overlap the portion of the ground electrode 222 and / or the portion of the fourth electrode 230 of the electrode assembly. The primary sensor point openings 260 in the exemplary first adhesive layer shown include five primary sensor point openings 260A, each configured to overlap the portion of the ground electrode 222. The primary sensor point openings 260 in the exemplary first adhesive layer shown include four secondary primary sensor point openings 260B, each configured to overlap the portion of the fourth electrode 230. The sensor point openings of the first adhesive layer include secondary sensor point openings shown within the dotted line 262, each secondary sensor point opening configured to overlap the portion of the fourth electrode 230 and / or the portion of the fifth electrode 232 of the electrode assembly. The secondary sensor point openings 262 include five first secondary sensor point openings 262A, each configured to overlap the portion of the fifth electrode 232 in the illustrated exemplary first adhesive layer. The secondary sensor point openings 262 also include four second secondary sensor point openings 262B, each configured to overlap the portion of the fourth electrode 230 in the illustrated exemplary first adhesive layer. The sensor point openings of the first adhesive layer include tertiary sensor point openings shown within the dotted line 264, each configured to overlap the portion of the fifth electrode 232 and / or the ground electrode 222 of the electrode assembly. The tertiary sensor point openings 264 include five first tertiary sensor point openings 264A, each configured to overlap the portion of the fifth electrode 232 in the illustrated exemplary first adhesive layer. The tertiary sensor point aperture 264 includes four second tertiary sensor point apertures 264B, each configured to overlap the portion of the ground electrode 222 in the illustrated exemplary first adhesive layer. Figure 9 is a proximal view of the first adhesive layer in Figure 8.

[0176] Figure 10 is a more detailed distal view 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 of the base plate includes a first connector 211. The first connector 211 includes a coupling portion 210 configured to releasably couple a monitor device to the base plate and / or the sensor assembly portion, thereby forming a releasable coupling. The first connector 211 of the monitor interface 207 includes a plurality of terminals formed by terminal elements that form each electrical connection to each terminal of the monitor device.

[0177] The terminals of the first connector 211 of the monitor interface 207 include a grounding terminal element 282 forming a grounding terminal 282A, a first terminal element 284 forming a first terminal 284A, a second terminal element 286 forming a second terminal 286A, and a third terminal element 288 forming a third terminal 288A. The monitor interface optionally includes a fourth terminal element 290 forming a fourth terminal 290A and / or a fifth terminal element 292 forming a fifth terminal 292A. The terminal elements 282, 284, 286, 288, 290, and 292 contact the respective connection points 222A, 224A, 226A, 228A, 230a, and 232A of electrodes 222, 224, 226, 228, 230, and 232A.

[0178] Figure 11a 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 that are arranged in an electrode assembly 204. The electrode assembly 204 is arranged 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 the proximal side of the support layer 214 by printing conductive ink or the like. The electrode assembly 204 optionally includes a masking element 218 that covers or overlaps, for example, a portion of the electrode 216 when viewed axially from the proximal side of the electrode 216. The electrode assembly has a first portion 302 that includes a connection portion 217 for the plurality of electrodes 216. The electrode assembly has a second portion 303. The base plate 4 includes a release liner 206. The base plate 4 includes an upper layer 208. The base plate 4 optionally includes a connecting ring 209 for connecting an ostomy pouch to the base plate 4. Alternatively, for example in the case of a single-piece ostomy appliance, the ostomy pouch may be directly fixed to the base plate 4.

[0179] The base plate 4 includes a monitor interface configured to connect, such as by mechanically and / or electronically connecting the base plate to a monitor device. The monitor interface includes a plurality of terminals 212 configured to form electrical connections with each terminal of the monitor device. For example, as shown, a connection portion 217 may form a plurality of terminals 212 of the monitor interface. Alternatively, as shown, for example, in Figure 3, terminal elements may be provided to form a plurality of terminals.

[0180] The upper layer 208 includes an upper layer opening 304. The second adhesive layer 202 includes a second adhesive layer opening 306. The upper layer opening 304 and the second adhesive layer opening 306 are configured to allow connection between the electrodes 216 of the electrode assembly 204 and the terminals of a monitoring device coupled to the base plate 4. For example, a first portion 302 of the electrode assembly 216 may extend through the upper layer opening 304 and the second adhesive layer opening 306.

[0181] Figure 11b 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 that are arranged in an electrode assembly 204. The electrode assembly 204 is positioned between the first adhesive layer 200 and the second adhesive layer 202. The electrode assembly 204 optionally includes a support layer 214. The electrodes 216 may be formed on the proximal side of the support layer 214 by printing conductive ink on the proximal side of the support layer 214, etc. The electrode assembly 204 optionally includes a masking element 218 that covers or overlaps, for example, a portion of the electrode 216 when viewed axially from the proximal side of the electrode 216. The electrode assembly 204 has a first portion 302 that includes a connection portion 217 for the plurality of electrodes 216. The electrode assembly 204 has a second portion 303, which includes sensing portions for a plurality of electrodes 216. The base plate 4 includes a release liner 206. The base plate 4 includes an upper layer 208. The base plate 4 optionally includes a connecting ring 209 for connecting an ostomy pouch to the base plate 4. Alternatively, for example in the case of a single-piece ostomy appliance, the ostomy pouch may be directly fixed to the base plate 4.

[0182] The base plate 4 includes a monitor interface configured to connect, such as by mechanically and / or electronically connecting the base plate 4 to a monitor device. The monitor interface includes a plurality of terminals 212 configured to form electrical connections with each terminal of the monitor device. For example, as shown, a connection portion 217 may form a plurality of terminals 212 of the monitor interface. Alternatively, as shown, for example, in Figure 3, terminal elements may be provided to form a plurality of terminals 212.

[0183] As shown by the dashed line, the layers are positioned such that the first adhesive layer 200 does not cover the primary side, such as the distal side of the first portion 302 of the electrode assembly 204.

[0184] The release liner 206 includes a first raised portion 314 and a plurality of protrusions 316. The first adhesive layer 200 can be provided by rubbing a layer of the first composition, such as the first adhesive composition, onto the release liner 206. The increasing height of the protrusions 316 and the raised portion 314 minimizes the distance between the scraping device and the release liner 206 so that the first composition does not accumulate in these areas. Thereafter, the protrusions 316 describe sensor point openings of the first adhesive layer 200 (e.g., sensor point openings 260, 262, 264 in Figure 8), and the first raised portion 314 describes the first portion 302, such as the primary side of the first portion 302 of the electrode assembly 204 that is not covered by the first adhesive layer 200.

[0185] Furthermore, the first adhesive layer 200 may normally exhibit viscosity, and the release liner 206 having protrusions 316 and first raised portions 314 provides that the shape of the first adhesive layer 200, including the sensor point opening, is maintained while the release liner 206 is maintained.

[0186] Optional masking elements 218 may be provided to insulate a plurality of electrodes 216 or a portion of a plurality of electrodes 216. The masking element 218 has a plurality of terminal openings 318 to allow connection from the proximal side of the electrode assembly 204 to the connection portion 217 of the plurality of electrodes 216.

[0187] As explained with respect to Figure 3, similarly, some parts of the base plate 4 shown in Figures 11a and 11b may be provided as separate assemblies, such as sensor assembly parts 700 applied to an existing base plate, which include one or more of the components described above, thereby providing a base plate like the base plate 4 described above.

[0188] Figure 12 shows an exploded view of an exemplary electrode assembly 204 of a base plate, such as the base plate 4 in Figure 11a or Figure 11b. The electrode assembly 204 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 connection portion 217 that connects the electrode 216 to each terminal element of the monitor interface. The electrodes 216 are provided such as being formed on the proximal side 214B of the support layer 214, for example, the electrode 216 may be located on the proximal side 214B of the support layer 214. Furthermore, the electrode assembly 204 optionally includes a masking element 218 having a proximal side 218B and configured to insulate the electrode portion of the electrode 216 from the first adhesive layer 200 of the base plate 4 (see Figure 11a or Figure 11b). The masking element 218 covers or overlaps with a portion of the electrode 216 when viewed axially from the proximal side 204B, for example. The masking element 218 may be configured not to cover or overlap the connection portions 217 of multiple electrodes.

[0189] In some exemplary electrode assemblies 204, such as the electrode assembly 204 in Figure 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 a plurality of electrodes 216, such as near a plurality of connection points 217 of a plurality of electrodes 216. The reinforcing element 308 may form at least a portion of the first part of the electrode assembly 204. An opening 310 may be provided in the reinforcing element 308, thereby providing a conductive path between both sides of the reinforcing element 308, such as between the proximal side 308B and the distal side 308A of the reinforcing element 308.

[0190] Figure 13 shows an alternative to Figure 12 in which the reinforcing element 308 includes multiple conductive paths 311. For example, the reinforcing element 308 may be a flexible circuit. The multiple conductive paths 311 may be connected to multiple electrodes 216. Thus, the multiple conductive paths 311 may form a connection point 217 of the multiple electrodes 216. The multiple conductive paths 311 may provide a conductive path between the proximal side 308B and the distal side 308A of the reinforcing element 308.

[0191] Figure 14 shows an exemplary electrode configuration 220 of multiple electrodes 216, similar to the electrode configuration 220 shown in Figure 6, but with connection parts 217 such as the ground connection part 222A, the first connection part 224A, the second connection part 226A, the third connection part 228A, the fourth connection part 230A and / or the fifth connection part 232A being linear connector parts.

[0192] Figure 15 shows a schematic cross-sectional representation of a portion of the base plate 4 and / or a sensor assembly portion 700. The base plate 4 and / or sensor assembly portion 700 includes a first adhesive layer 200, an optional second adhesive layer 202, and an upper layer 208. An electrode assembly containing multiple electrodes 216 is positioned between the first adhesive layer 200 and the upper 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 positioned between the first adhesive layer and the second adhesive layer and / or the upper layer 208. The electrode assembly further includes an optional reinforcing element 308.

[0193] The upper layer 208 and the second adhesive layer 202 include openings 304 and 306. The upper layer 208 includes the upper layer opening 304. The second adhesive layer 202 includes the second adhesive layer opening 306. The first portion 302 of the electrode assembly extends through the upper layer opening 304 and the second adhesive layer opening 306. The first portion 302 includes connection paths for the multiple electrodes and reinforcing elements 308. The first portion 302 may include the support layer 214 or a portion of the support layer. Connections to the connection portions 217 of the multiple electrodes may be provided through the reinforcing elements 308 and / or the support layer 214.

[0194] Figure 16 shows a schematic cross-sectional representation of the base plate portion 4 and / or sensor assembly portion 700 shown in Figure 15, the base plate 4 and sensor assembly portion 700 including a coupling portion 210. The coupling portion 210 is configured to form a mechanical connection between the monitoring device and the base plate 4 and / or sensor assembly portion 700. The first portion 302 of the electrode assembly extends into the coupling portion 210, allowing a monitoring device, such as the terminals of the monitoring device, to be connected to the electrodes 216 of the base plate 4 and / or sensor assembly portion 700.

[0195] In the example shown, the coupling portion 210 is attached to the upper layer 208. However, in an alternative example, the coupling portion 210 is attached to the electrode assembly, in which case the coupling portion 210 may extend through the upper layer opening 304 and the second adhesive layer opening 306.

[0196] Figure 17 shows a schematic cross-sectional representation 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 first adhesive layer 200, an optional second adhesive layer 202, and an upper layer 208. An electrode assembly containing multiple electrodes 216 is placed between the first adhesive layer 200 and the upper 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 placed between the first adhesive layer, the second adhesive layer 202, and / or the upper layer 208.

[0197] The upper layer 208 includes an upper layer opening 304. The second adhesive layer 202 includes a second adhesive layer opening 306. The upper 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, together with the portions of the upper layer 208 and the second adhesive layer 202, is folded back into the U-shaped cut to expose the connection portion 217 of the multiple electrodes 216 on the distal side of the base plate 4 and / or sensor assembly portion 700. The first portion 302 includes the connection portion 217 of the multiple electrodes and extends through the upper layer opening 304 and the second adhesive layer opening 306. Thereafter, the monitoring device can be connected to the multiple connection portion 217. Although not shown in Figure 17, the electrode assembly may further include optional reinforcing elements 308, for example, as shown in Figures 15 and 16, and / or the base plate 4 and / or sensor assembly portion 700 may be provided with a coupling portion 210, for example, as shown in Figure 16.

[0198] 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 a 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 can 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 turn, etc. The back element 312 may also be applied to exemplary base plate and / or sensor assembly portions, as described in relation to Figures 15 and / or 16.

[0199] Figure 18 shows a schematic cross-sectional representation of a portion of the base plate 4 and / or a sensor assembly portion 700. The base plate 4 and / or sensor assembly portion 700 include a first adhesive layer 200, an optional second adhesive layer 202, and an upper layer 208. An electrode assembly containing multiple electrodes 216 is positioned between the first adhesive layer 200 and the upper layer 208, such as between the first adhesive layer 200 and the second adhesive layer 202. For example, a second portion of an electrode assembly 204 is positioned between the first adhesive layer 200 and the second adhesive layer 202 and / or the upper layer 208. The electrode assembly 204 further includes an optional reinforcing element 308 and an optional release liner 206.

[0200] The first adhesive layer 200 is provided so as not to cover the primary side of the first portion 302 of the electrode assembly 204. For example, the release liner 206 includes a first raised portion 314, which facilitates the formation of the first adhesive layer 202 so as not to cover the primary side of the first portion 302 of the electrode assembly 204. The primary side of the first portion 302 may be the proximal side of the first portion 302. The first portion 302 includes connections between a plurality of electrodes 216 and a reinforcing element 308 or a portion of the reinforcing element 308. The first portion 302 may include a portion of the support layer 214.

[0201] Figure 19 shows a schematic cross-sectional representation of the portion of the base plate 4 and / or the sensor assembly portion 700 shown in Figure 18, further illustrating that the connection portion 217 may be accessible by, for example, slightly bending the first portion 302 of the electrode assembly 204 distally. Alternatively, the release liner 206 may be removed, thereby allowing access to the first portion 302 of the electrode assembly 204 from the proximal side.

[0202] Since the first adhesive layer 200 does not cover the first portion 302 of the electrode assembly 204, the first portion 302 does not adhere to the release liner or any other nearby layer. Therefore, the connection portion 217 may be accessible, for example, for connection to a monitoring device. Connections of multiple electrodes 216 to the connection portion 217 may be provided through the reinforcing element 308, or the connection portion 217 may be formed by the conductive path of the reinforcing element 308.

[0203] Figure 20 shows a schematic cross-sectional representation 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 first adhesive layer 200, an optional second adhesive layer 202, and an upper layer 208. An electrode assembly 204, including multiple electrodes 216, is positioned between the first adhesive layer 200 and the upper 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 204 is positioned between the first adhesive layer and the second adhesive layer 202 / upper layer 208. Although not shown, the electrode assembly 204 may include reinforcing elements 308, for example, as shown in Figures 18 and 19. Thus, the base plate 4 and / or sensor assembly portion 700 in Figure 20 may correspond to the base plate 4 and / or sensor assembly portion 700 in Figures 18 and 19.

[0204] The first portion 302 of the electrode assembly 204 is folded back together with the upper layer 208 and the second adhesive layer to expose the connection portion 217 of the multiple electrodes 216 on the distal side of the base plate 4 and / or sensor assembly portion 700. Thus, the primary side of the first portion 302, which is initially on the proximal side (as shown in Figure 18), faces distally after the first portion 302 has turned.

[0205] Figure 21 shows a schematic cross-sectional representation of the portion of the base plate 4 and / or the sensor assembly portion 700 shown in Figure 20, including the coupling portion 210. The coupling portion 210 is configured to form a mechanical connection between the monitoring device and the base plate 4 and / or the sensor assembly portion 700. The first portion 302 of the electrode assembly 204 extends into the coupling portion 210, thereby enabling the monitoring device, such as the terminals of the monitoring device, to be connected to the electrodes 216 of the base plate 4 and / or the sensor assembly portion 700. The coupling portion 210 is positioned to cover the connection portions 217 of the multiple electrodes 216. The coupling portion 210 may be attached to the upper layer 208 and / or the coupling portion 210 may be attached to the electrode assembly 204.

[0206] Figure 22 schematically shows an exemplary base plate 4, such as the base plate shown in Figure 11a or Figure 11b, and a monitor device 6, such as the monitor device shown in Figure 2.

[0207] The base plate includes a coupling portion 210 configured to connect the monitor device 6 to the base plate 4. The coupling portion 210 is configured to engage with the monitor device 6 by linear motion in the engagement direction 412 of the monitor device 6 relative to the base plate 4. The monitor device 6 includes, for example, an opening 424 on the rim surface of the monitor device 6. The opening 424 may form the monitor device coupling portion. The opening 424 is configured to receive the coupling portion 210 of the base plate 4. The monitor device 6 is configured to engage with the coupling portion 210 of the base plate 4 by linear motion in the engagement direction 412 of the monitor device 6 relative to the base plate 4. The engagement direction 412 may be toward the stoma opening 18 of the base plate 4.

[0208] Multiple terminals 212 of the base plate are provided to the coupling portion 210. Multiple terminals of the monitor device 6 may be provided inside the opening 424, so that when the monitor device 6 is coupled to the base plate 4, it can be connected to the multiple terminals 212 of the base plate 4.

[0209] The coupling portion 210 is configured to disengage from the monitor device 6 by linear motion in the disengagement direction 413 of the monitor device relative to the base plate 4. The monitor device 6 is configured to disengage from the coupling portion 210 of the base plate 4 by linear motion of the monitor device 6 relative to the base plate 4 in the disengagement direction 413 of the monitor device 6 relative to the base plate 4. The disengagement direction 413 may be the opposite of the stoma opening 18 of the base plate 4.

[0210] The upper layer 208 and the first adhesive layer 200 are substantially flat before being applied to the user's skin, for example, and extend along the base plate plane. The engagement direction 412 and the disengagement direction 413 are substantially parallel to the base plate plane.

[0211] The monitor device 6 and / or base plate 4 include a locking mechanism configured to lock the monitor device 6 in the coupled position with the base plate 4. The locking mechanism includes a locking element 430, which includes a first button 430a and a second button 430b.

[0212] The first button 430a is deflectable in a first direction 432, and the second button 430b is deflectable in a second direction 433. The first direction 432 is substantially the opposite of the second direction 433. The first direction 432 and the second direction 433 are substantially orthogonal to the engagement direction 412 and the disengagement direction 413, thereby allowing the user to grasp the first button 430a and the second button 430b while, for example, engaging or disengaging the monitor device 6 to the base plate 4.

[0213] The locking element 430 is configured to unlock and / or lock the locking mechanism, such as unlocking the monitor device 6 in the position where it is coupled to the base plate 4, and / or locking the monitor device 6 in the position where it is coupled to the base plate 4. For example, the first button 430a and the second button 430b should be pressed simultaneously to lock and / or unlock the monitor device 6 in the position where it is coupled to the base plate 4. For example, the first button 430a and the second button 430b may be pressed to lock the monitor device 6 in the position where it is coupled to the base plate 4, and then the first button 430a and the second button 430b may be pressed again to unlock the monitor device 6 in the position where it is coupled to the base plate 4. Alternatively, the locking mechanism may be biased, for example, by a spring bias toward locking the monitor device 6 in the coupled position with the base plate 4, and the monitor device 6 may be unlocked in the coupled position with the base plate 4 by pressing the first button 430a and the second button 430b. In the shown example, the locking element 430 is provided on the monitor device 6. However, in another exemplary monitor device and / or base plate, the locking element 430 may be provided on the base plate 4, such as at the coupling portion 210 of the base plate 4.

[0214] The locking mechanism of the monitor device 6 is configured to cooperate with a locking section 428 of the base plate 4. In the example shown, the locking section 428 includes a hole 428a extending through the coupling 210, a first recess 428b at the first edge of the coupling 210, and a second recess 428c at the second edge of the coupling 210. For example, the locking mechanism of the monitor device 6 may include a locking component, such as a pin, positioned inside the opening 424 and configured to protrude through the hole 428a. Thus, for example, the locking mechanism of the monitor device 6 may include a pin that engages with the hole 428a of the coupling 210 of the base plate 4, and / or the locking mechanism of the monitor device 6 may include an element that can deflect perpendicular to the engagement direction 412, thereby engaging with, for example, the first recess 428b and / or the second recess 428c.

[0215] The coupling portion 210 is substantially flat and includes a first surface 460 and a second surface 462 (see Figure 23). The second surface 462 faces the top surface 208, and the first surface faces the opposite side of the top layer 208. The second surface 462 may face substantially proximal, and the first surface 460 may face substantially distal. A plurality of terminals 212 may be provided on the first surface 460 and / or the second surface 462 of the coupling portion 210.

[0216] The second surface of the coupling portion 210 and the upper layer 208 are separated, thereby allowing, for example, at least a portion of the monitor device 6 to be positioned between the second surface of the coupling portion 210 and the upper layer 208, thereby allowing, for example, the coupling portion 210 to be received by the opening 424 of the monitor device 6.

[0217] Figure 23 schematically shows an exemplary base plate 4, such as the base plate shown in Figure 11a or Figure 11b, and a portion of the monitor device 6, such as the monitor device shown in Figure 2. The base plate 4 in Figure 23 is the same as the base plate 4 shown in relation to Figure 22.

[0218] The monitor device 6 shown in Figure 23 includes, for example, an opening 424 on the rim surface of the monitor device 6. The opening 424 is configured to receive the coupling portion 210 of the base plate 4. The monitor device 6 is configured to engage with the coupling portion 210 of the base plate 4 by linear motion of the monitor device 6 in the engagement direction 412 of the monitor device 6 relative to the base plate 4. The monitor device 6 is configured to disengage the coupling portion 210 of the base plate 4 by linear motion of the monitor device 6 in the disengagement direction 413 of the monitor device 6 relative to the base plate 4.

[0219] Multiple terminals 212 of the base plate are provided to the coupling portion 210. Multiple terminals of the monitor device 6 may be provided inside the opening 424, thereby connecting to the multiple terminals 212 of the base plate 4 when, for example, the monitor device 6 is coupled to the base plate 4.

[0220] The monitor device 6 includes a locking mechanism configured to lock the monitor device 6 in the coupled position with the base plate 4. The locking mechanism of the monitor device 6 is configured to cooperate with a locking section 428 of the base plate 4. In the example shown, the locking section 428 includes a hole 428a extending through the coupling portion 210. For example, the locking mechanism of the monitor device 6 may include a locking component, such as a pin, configured to be located inside the opening 424 and protrude through the hole 428a. In contrast to the example shown in Figure 22, the locking section 428 in Figure 23 does not include recesses 428b, 428c. However, it should be noted that, as shown in Figure 22, the locking section 428 in Figure 22 may optionally include recesses 428b, 428c.

[0221] The locking mechanism includes a locking element 430, which includes a first button 430a. The locking element 430, such as the first button 430a, further includes a locking element projection 431. The button 430a is deflectable in a first direction 432, and the locking element projection 431 is configured to allow the user to pull / push the first button 430a in a second direction 433 opposite to the first direction 432. The locking element 430 may be configured to rotate around an axis that is substantially perpendicular to the engagement direction 412 and the disengagement direction 413 and substantially parallel to the base plate plane.

[0222] The locking element 430 is configured to unlock and / or lock the locking mechanism, thereby unlocking the monitor device 6 in the position where it is coupled to the base plate 4, and / or locking the monitor device 6 in the position where it is coupled to the base plate 4. For example, a user may press the first button 430a in a first direction, thereby locking the locking mechanism, and then the user may push / pull the first button 430a in a second direction using the locking element projection 431, thereby unlocking the locking mechanism.

[0223] Therefore, the user can linearly move the monitor device 6 in the engagement direction 412 so that the coupling portion 210 is received by the opening 424, and then the user can lock the locking mechanism by pressing the first button 430a in the first direction, and the monitor device is locked, such as being held in the coupled position with the base plate. Subsequently, in order to remove the monitor device 6 from the base plate 4, the user can unlock the locking mechanism by pushing / pulling the locking element projection 431 in the second direction 433, and the user can disengage the monitor device 6 from the base plate 4 by moving the monitor device 6 in the disengagement direction 413.

[0224] The locking element 430 may be configured to be positioned in a plurality of predefined positions, including, for example, a locked position and a first unlocked position. The predefined positions may be positions in which a greater force is required to change the position of the locking element 430. The plurality of predefined positions may include a second unlocked position, such as a cleaning position, in which the locking element 430 is opened, allowing cleaning of the inside of the opening 424. The locking element may move from the locked position to the first unlocked position by movement in a second direction 433, for example, angular motion of the locking element 430 between 10 and 75 degrees. The locking element may move from the first unlocked position to the second unlocked position by (further) movement in the second direction 433, for example, angular motion of the locking element 430 between 90 and 170 degrees. The locking element 430 may move from the second unlocked position to the first unlocked position by movement in a first direction 432, for example, angular motion of the locking element 430 between 90 and 170 degrees. The locking element 430 can move from a first unlocked position to a locked position by (further) motion in the first direction 432, for example, angular motion of the locking element 430 of 10 to 75 degrees. The angular distance between the locked position and the second unlocked position can be between 100 and 200 degrees.

[0225] Figure 24 schematically shows an exemplary monitor device 6, such as the monitor device shown in Figure 2. The monitor device 6 includes a monitor device housing 100 and a plurality of terminals 600 that connect to a plurality of electrodes on a base plate. The monitor device 6 further includes a monitor device coupling portion configured to connect the monitor device to the base plate. The monitor device coupling portion and the plurality of terminals 600 (one or more of terminals 108, 110, 112, 114, 116, 118 in Figure 2) may form part of the appliance interface of the monitor device 6.

[0226] The monitor device 6 includes a locking mechanism configured to engage with the locking section of the base plate to lock the monitor device 6 in the coupled position with the base plate. The monitor device 6 includes a clamp 470 configured to grip the coupled portion of the base plate between a first clamp surface 472 and a second clamp surface 474. The locking mechanism may include a locking component (not shown) positioned between the first clamp surface 472 and the second clamp surface 474. The locking component may be configured to engage with the locking section of the base plate. For example, the locking component may be a pin configured to engage with a hole in the locking section of the base plate.

[0227] Multiple terminals 600 are provided on the first clamp surface 472. Alternatively or additionally, multiple terminals 600 may be provided on the second clamp surface 472.

[0228] The first clamp surface 472 and the second clamp surface 474 may be biased toward each other, for example, by spring bias or magnetic bias. Alternatively, the first clamp surface 472 and the second clamp surface 474 may be biased toward each other, for example, by spring bias or magnetic bias. The monitoring device 6 includes a clamp lock 476 configured to lock the first clamp surface 472 and the second clamp surface 474 in the closed clamp position. The clamp lock 476 may be configured to be unlocked by user interaction.

[0229] Figures 25 and 26 schematically show an exemplary base plate 4, such as the base plate shown in Figure 11a or Figure 11b, and a monitor device 6, such as the monitor device shown in Figure 2. Figure 26 shows only a portion of the exemplary base plate 4.

[0230] The base plate 4 includes a joint 210. The joint 210 includes a projection 480. The projection 480 has a concave side 482, and for example, the projection 480 may be a cylindrical body having substantially a concave side wall. The projection 480 and / or the concave side 482 form a locking section 428 of the joint 210.

[0231] The monitor device coupling portion 120 includes a cavity 484. The cavity 484 is configured to receive a projection 480, and the projection 480 is configured to engage with the cavity 484. The monitor device coupling portion 120 includes one or more deflectable elements 486 positioned on the side of the cavity 484. The deflectable elements 486 form part of the locking mechanism of the monitor device 6 and are configured to engage with the recessed side 482 of the projection 480. This allows the projection 480 to be held within the cavity 484.

[0232] Furthermore, the monitor device coupling portion 120 includes a projection element 488 positioned substantially at the center of the cavity 484. The projection 480 of the coupling portion 210 includes a corresponding socket 490 configured to receive the projection element 488. The projection element 488 and the socket 490 have a triangular cross-section, limiting the possible orientations for engagement and ensuring the correct coupling of the monitor device 6 to the base plate 4.

[0233] Multiple terminals 600 of the monitor device 6 are provided at the ends of the protruding elements 488, and multiple terminals 212 of the base plate 4 are provided at the bottom of the socket 490.

[0234] The monitoring device 6 is further shown to be curved to indicate to the user the precise way in which to orient the monitoring device 6. The curvature of the monitoring device 6 is such that it has a concave side configured to face the ostomy opening 18 of the base plate 4.

[0235] The coupling portion 210 further includes a first alignment element 492, and the monitor device coupling portion 120 includes a second alignment element 494. The projection 480 is positioned on top of the first alignment element 492. The first alignment element 492 and the second alignment element 494 are configured to engage to further ensure the correct alignment of the monitor device 6 with respect to the base plate 4. The first alignment element 492 forms a first alignment edge which is configured to be received by the second alignment element 494, which forms a recess having a second alignment edge. The second alignment element 494 has an open end facing the rim surface of the monitor device 6 and an opposing closed end to ensure that the first alignment element 492 can be received by the second alignment element 494 only when the monitor device 6 is correctly oriented, for example, when the recessed side of the monitor device 6 faces the stoma opening 18.

[0236] Figures 27 and 28 schematically show an exemplary base plate 4, such as the base plate shown in Figure 11a or Figure 11b. The base plate 4 includes a coupling 210 which includes a first coupling section 496 and a second coupling section 498. The coupling 210 is configured to receive at least a portion of the monitoring device 6 between the first coupling section 496 and the second coupling section 498, as shown in Figure 28. The first coupling section 496 and the second coupling section 498 are biased toward each other, for example, by the elasticity of the coupling 210 and / or by spring means. In the example shown, the first coupling section 496 is deflectable away from the second coupling section 498. The first coupling section 496 includes a lever 499 which allows a user to bend the first coupling section 496 away from the second coupling section 498, thereby releasing, for example, the monitoring device 6 from the coupling 210. The monitor device 6 is wedge-shaped to allow for easy insertion between the first coupling section 496 and the second coupling section 498.

[0237] The coupling portion 210 includes a locking section 428 which includes a first projection 428d protruding from the first coupling portion section 496 and a second projection 428e protruding from the second coupling portion section 498. The monitoring device 6 may include corresponding recesses 602, such as a first recess 602a that receives the first projection 428d and a second recess 602b that receives the second projection 428e.

[0238] Multiple terminals 212 of the base plate 4 are provided to the joint 210, such as between the first joint section 496 and the second joint section 498.

[0239] Figure 29 schematically shows an exemplary coupling 210, for example, the distal side 210A of the coupling 210, including a first coupling section 496 and a second coupling section 498. As can be seen, the first coupling section 496 and the second coupling section are substantially flat. The first coupling section 496 is configured to be attached to a first portion of a base plate, such as a first portion 302 of an electrode assembly, as described in relation to Figures 15 to 21, for example. The second coupling section 496 is configured to be attached to a second portion of a base plate, such as a second portion of the upper layer of the base plate.

[0240] The first joint section 496 is hinged to the second joint section 498, thereby allowing rotational movement of the first joint section 496 around the hinge axis 702 relative to the second joint section 498. The hinge axis 702 is parallel to both the first joint section 496 and the second joint section 498.

[0241] For example, referring to Figure 17, the coupling section 210 in Figure 29 can be attached to the upper layer 208 before the first portion 302 of the electrode assembly is turned, such that the first coupling section 496 is attached to the first portion of the upper layer 208 on the first portion 302 of the electrode assembly, and the second coupling section 498 is attached to the second portion of the upper layer 208 that has not been turned. The hinged attachment of the first coupling section 496 and the second coupling section 498 lifts the first portion 302 of the electrode assembly together with the first coupling section 496, allowing access to the distal side of the electrode assembly having the connector 217.

[0242] The joint 210 includes a reduced-thickness line 720 along the hinge axis, allowing rotational movement of the first joint section 496 relative to the second joint section 498 around the hinge axis. The reduced-thickness line 720 is provided on the distal side of the joint 210, allowing rotation of the first joint section, for example, in the distal direction. The flexibility that provides hinge mounting of the first joint section 496 and the second joint section 498 may be provided by other means, such as those described with reference to Figures 30 and 31.

[0243] The second joint section 498 includes a second primary joint section 708 and two second secondary joint sections 710A and 710B. In another exemplary joint (not shown), the second joint section 498 includes, for example, one second secondary joint section extending along the entire circumference of the first joint section 496.

[0244] The second primary coupling section 708 is located on the primary side of the hinge axis. The second secondary coupling sections 710A and 710B are located on the secondary side of the hinge axis 754, opposite to the proximal side of the hinge axis 754. Thereafter, the second coupling section 498 provides increased stability of the coupling 210 as the first coupling section 496 rotates around the hinge axis 754.

[0245] The coupling portion 210, such as the first coupling portion section 496 of the coupling portion 210, includes a locking section with a hole 428a. The locking section 428a is configured to lock the monitor device in the coupling position with the base plate. The hole 428a extends through the coupling portion 210, for example, through the first coupling portion section 496. The locking mechanism of the monitor device may include a locking component, such as a pin, positioned inside the opening that receives the coupling portion 210 and configured to protrude through the hole 428a.

[0246] Figure 30 schematically shows an exemplary joint 210 similar to the exemplary joint 210 in Figure 29. However, the hinge attachment of the first joint section 496 and the second joint section 498 is provided by providing a hole 722 in the joint 210 along the hinge axis 754. The hole 722 along the hinge axis 754 allows for rotational movement of the first joint section 496 relative to the second joint section 498 around the hinge axis 754.

[0247] Figures 31a and 31b schematically show exemplary joints 210 similar to the exemplary joint 210 in Figure 29. However, the joints 210 in Figures 31a and 31b are made by laminating multiple laminates 724, 726, and 728, and the hinge attachment between the first joint section 496 and the second joint section 498 is provided by the laminate layers 724, 726, and 728.

[0248] Figure 31a shows an exploded view of an exemplary joint 210, showing the laminate layers that make up the joint 210. The joint 210 is made of a first laminate 724 laminated with a second laminate 726, and a third laminate 728 laminated with the second laminate 726 and the first laminate 724. The lamination process may be provided in several steps, for example, in the first step, the first laminate 724 may be laminated with the second laminate 726, optionally cut into a specific shape, and then laminated with the third laminate 728. After laminating the laminates 724, 726, and 728, the joint 210 may be cut or punched out.

[0249] Figure 31b shows an exemplary joint 210. As can be seen, the hinged attachment of the first joint section 496 and the second joint section 498 is provided by extending only the third laminate 728 across the hinge axis. The third laminate 728 may be selected to have a thickness thin enough to rotate the first joint section 496 relative to the second joint section 498. The material of the third laminate may also be selected to be a non-rigid material. The first laminate 724 and the second laminate 726 may provide increased strength to the first joint section 496.

[0250] Figure 32 schematically shows an exemplary joint 210, such as one of the joints 210 in Figures 29 to 31, viewed from the side. As shown, the first joint section 496 is substantially flat in the first joint plane 750, and the second joint section 498 is substantially flat in the second joint plane 752. Thus, the hinge axis 754 (see Figures 29 to 31) is parallel to the first joint plane 750 and the second joint plane 752.

[0251] To facilitate easier coupling of the monitoring device to the coupling 210, the coupling 210 may be configured such that the first coupling section 496 is biased toward a position where it is lifted slightly from the base plate. Thus, in a stationary state, i.e., when no force is applied to the first coupling, for example, when no pressure is applied to the distal side of the coupling section 496, the first coupling section and the second coupling section form a stationary angle 756. The stationary angle may be greater than 5 degrees, for example, greater than 10 degrees, for example, greater than 15 degrees, for example, greater than 20 degrees.

[0252] Figure 32 also shows that the joint 210 may include adhesives 712, 714 that are attached to layers of the base plate, such as the upper layer of the base plate. For example, the first joint section 496 includes a first joint section adhesive 712 configured to be attached to a first part of the base plate, such as a first part of an electrode assembly. The second joint section 498 includes a second joint section adhesive 714 configured to be attached to a second part of the base plate, such as a second part of the upper layer. Alternatively, the first joint section 496 and / or the second joint section 498 may be welded to each part of the base plate.

[0253] The first joint section 496 has a first joint thickness 716, and the second joint section has a second joint thickness 718. The first joint thickness 716 and the second joint thickness 718 may be the same. Alternatively, the first joint thickness may be greater than the second joint thickness 718, for example, as in the exemplary joint 210 shown in Figure 31b. For example, the first joint thickness may be 0.6 mm and the second joint thickness may be 0.3 mm.

[0254] Figure 33 schematically shows an exploded assembly of an exemplary base plate 4 and / or sensor assembly portion 700 of an ostomy appliance, as also described in relation to the previous figure. The base plate 4 and / or sensor assembly portion 700 includes an upper layer 208, a first adhesive layer 200, and an electrode assembly 204. The electrode assembly 204 includes a plurality of electrodes having connectors and sensing portions. However, as can be seen in Figure 33, it is understood that the electrodes of the electrode assembly 204 are positioned on the proximal side of the electrode assembly 204, i.e., facing the first adhesive layer 200. The first adhesive layer 200 is closest to the skin, i.e., the most proximal layer of the layers shown. The upper layer 208 is the most distal layer of the layers shown.

[0255] The base plate 4 and / or sensor assembly portion 700 also includes a monitor interface configured to connect the base plate 4 and / or sensor assembly portion 700 to a monitoring device (see, for example, Figures 22 and 23). The monitor interface includes a coupling portion 210, as illustrated and described in relation to any of Figures 29 to 32. The coupling portion 210 is configured to connect the monitoring device to the base plate 4 and / or sensor assembly portion 700.

[0256] The first coupling section 496 of the coupling 210 is attached to the first part of the base plate and / or sensor assembly portion, which includes connections for multiple electrodes such as the first portion 302 of the electrode assembly 204 and / or the first portion 730 of the upper layer 208. Holes may be provided in the upper layer 208 and, if a second adhesive layer is present, in the second adhesive layer, thereby allowing direct attachment, for example, between the first coupling section 496 and the first portion 302 of the electrode assembly 204. Alternatively, a U-shaped contour may be cut around the first portion 730 of the upper layer 208 so that the attached first coupling section 496, the first portion 730 of the upper layer 208 and the first portion 302 of the electrode assembly may be rotatable around a hinge axis. The first joint section 496 can be attached to the first portion 730 of the upper layer 208 and / or the first portion 302 of the electrode assembly 204 by first joint section adhesive or by welding the first joint section 496 together with the first portion 730 of the upper layer 208 and / or the first portion 302 of the electrode assembly 204.

[0257] The backing element 312 is provided between the first portion 302 of the electrode assembly 204 and the first adhesive layer 200, such as between the proximal side of the first portion 302 of the electrode assembly 204 and the energetic side of the first adhesive layer 200. The backing element 312 prevents the first portion 302 of the electrode assembly from adhering to the first adhesive layer 200, thereby facilitating the turning of the first portion 302 of the electrode assembly 204 (for example, together with the first joint section). The backing element 312 may further provide a stop for the punching process that provides a hole or U-shaped cut in the upper layer 208.

[0258] The second joint section 498 is attached to the second part of the base plate and / or sensor assembly, such as the second part 732 of the upper layer 208. The second joint section 498 may be attached to the second part 732 of the upper layer 208 by adhesive or by welding the second joint section 498 and the second part 732 of the upper layer 208 together.

[0259] When attached to the upper layer 208, the second coupling section 498 may be parallel to the upper layer 208. Thus, the stationary angle 756 described in relation to Figure 32 may be formed between the first coupling section 496 and the upper layer 208.

[0260] Although not specifically shown in Figure 33, the base plate 4 and / or sensor assembly portion 700 may include additional layers, such as those shown in Figure 11a.

[0261] Figure 34 schematically shows an exemplary coupling 210, for example, the proximal side 210B of the coupling 210 and an exemplary first portion 302 of the electrode assembly, as described in relation to the previous Figure 33. Figure 34 shows a first coupling section adhesive 712 positioned between the first coupling section 496 and the first portion 302 of the electrode assembly. The first coupling section adhesive 712 is provided between the proximal side 496B of the first coupling section 496 and the distal side of the first portion 302 of the electrode assembly, thereby attaching, for example, the proximal side 496B of the first coupling section 496 to the distal side of the first portion 302 of the electrode assembly.

[0262] The position of the first connector in the base plate and / or sensor assembly portion, and the number and position of terminals in the coupling portion, may be adapted to the electrode configuration used in the electrode assembly of the base plate and / or sensor assembly portion.

[0263] The use of terms such as "first", "second", "third", and "fourth", "primary", "secondary", "tertiary", etc. does not imply any particular order and is included for the purpose of identifying individual elements. Further, the use of terms such as "first", "second", "third", and "fourth", "primary", "secondary", "tertiary", etc. does not indicate any order or importance. Rather, the terms "first", "second", "third", and "fourth", "primary", "secondary", "tertiary", etc. are used to distinguish one element from another. Note that the words "first", "second", "third", and "fourth", "primary", "secondary", "tertiary", etc. are used only for labeling purposes in this specification and elsewhere and are not intended to indicate any particular spatial or temporal order. Further, the label of the first element does not imply the presence of the second element, and vice versa.

[0264] Although specific features have been shown and described, it is understood that they are not intended to limit the invention as claimed, and it will be apparent to those skilled in the art that various modifications and variations can be made without departing from the spirit and scope of the invention as claimed. Accordingly, this specification and the drawings are to be regarded in an illustrative rather than a limiting sense. The invention as claimed is intended to embrace all alternatives, modifications, and equivalents.

[0265] Exemplary base plate and monitor device are described in the following items.

[0266] Item 1. A base plate for an ostomy appliance, - an upper layer, - a first adhesive layer, - an electrode assembly including a plurality of electrodes, - a monitor interface configured to connect the base plate to a monitor device, including a plurality of terminals electrically connected to the plurality of electrodes and configured to connect to each terminal of the monitor device, and including a coupling portion configured to couple the monitor device and the base plate, the monitor interface comprising, A plurality of terminals are provided at a coupling portion, and the coupling portion includes a lock section configured to lock a monitor device at the coupling portion of the base plate, the base plate.

[0267] Item 2. The base plate according to item 1, wherein the lock section includes a hole extending through the coupling portion.

[0268] Item 3. The base plate according to item 1 or 2, wherein the lock section includes a protrusion protruding from the surface of the coupling portion.

[0269] Item 4. The base plate according to any one of items 1 to 3, wherein the lock section includes a depression at the edge of the coupling portion and / or a groove on the surface of the coupling portion.

[0270] Item 5. The base plate according to any one of items 1 to 4, wherein the coupling portion includes a first surface and a second surface, the second surface is opposite to the first surface, and the second surface faces the upper layer.

[0271] Item 6. The base plate according to item 5, wherein the plurality of terminals are provided on the second surface of the coupling portion.

[0272] Item 7. The base plate according to item 5 or 6, wherein the second surface of the coupling portion and the upper layer are separated so that at least a part of the monitor device can be positioned between the second surface of the coupling portion and the upper layer when the monitor device is connected to the base plate.

[0273] Item 8. The base plate according to any one of items 1 to 7, wherein the coupling portion is substantially flat.

[0274] Item 9. The base plate according to any one of items 1 to 8, wherein the coupling portion includes a first coupling section and a second coupling section, and the coupling portion is configured to receive at least a part of the monitor device between the first coupling section and the second coupling section.

[0275] Item 10. The base plate as described in Item 9, wherein the first joint section and the second joint section are biased toward each other.

[0276] Item 11. A base plate according to any one of items 1 to 10, wherein the coupling portion includes a projection that protrudes in a projection direction substantially perpendicular to the plane of the base plate, the projection having a recess that forms a locking section of the coupling portion, and the projection is configured to engage with a cavity of a monitor device.

[0277] Item 12. The base plate as described in Item 11, comprising a socket configured to receive a protruding element positioned in the cavity of a monitor device.

[0278] Item 13. The socket is a base plate as described in Item 12, having a triangular cross-section.

[0279] Item 14. A monitoring device for connecting to the base plate of an ostomy appliance, - Monitor device enclosure, - Electronic circuits and, - An orthotic device interface configured to connect a monitor device to a base plate, comprising a plurality of terminals for connecting to a plurality of electrodes on the base plate, and a monitor device coupling portion configured to couple the monitor device and the base plate, and Includes, A monitor device including a locking mechanism configured to engage with a locking section of a base plate to lock the monitor device in a coupled position with the base plate.

[0280] Item 15. The monitor device according to Item 14, wherein the monitor device coupling is configured to engage with the base plate by linear motion in the engagement direction of the monitor device with respect to the base plate.

[0281] Item 16. The locking mechanism is the monitor device according to item 14 or 15, which is biased towards the locking of the locking mechanism.

[0282] Item 17. The monitor device according to any one of items 14 to 16, including a locking element configured to unlock or lock the locking mechanism when the user interacts with the locking element.

[0283] Item 18. Dependent on item 15. The locking element includes a first button that can be deflected in a first direction, and the first direction is substantially parallel to or substantially orthogonal to the engagement direction. The monitor device described in item 17.

[0284] Item 19. The locking element includes a first button and a second button. The first button can be deflected in a first direction, and the second button can be deflected in a second direction. The first direction is substantially opposite to the second direction. The monitor device described in item 17.

[0285] Item 20. Dependent on item 15. The first direction and the second direction are substantially orthogonal to the engagement direction. The monitor device described in item 19.

[0286] Item 21. The locking element includes a slider that can slide in a first slider direction. The slider is spring-loaded and biased towards a second slider direction, and the first slider direction is opposite to the second slider direction. The monitor device described in any one of items 17 to 20.

[0287] Item 22. Dependent on item 15. The first slider direction and the second slider direction are substantially orthogonal to the engagement direction. The monitor device described in item 21.

[0288] Item 23. The monitor device according to any one of items 14 to 22, including an opening for receiving the coupling part of the base plate, and the locking mechanism includes a locking component positioned inside the opening.

[0289] Item 24. A monitoring device according to any one of items 14 to 22, comprising a clamp configured to grip a joint of a base plate between a first clamp surface and a second clamp surface, wherein the locking mechanism comprises a locking component positioned between the first clamp surface and the second clamp surface.

[0290] Item 25. Multiple terminals are provided on the first clamp surface of the monitoring device as described in Item 24.

[0291] Item 26. The monitoring device according to item 24 or 25, wherein the first clamp surface and the second clamp surface are biased toward each other.

[0292] Item 27. A monitoring device according to any one of items 24-26, including a clamp lock configured to lock a first clamp surface and a second clamp surface into a closed clamp position.

[0293] Item 28. A clamp lock is configured to be unlocked by user interaction, as described in Item 27 of the monitoring device.

[0294] Item 29. A monitor device according to any one of items 11 to 28, wherein the monitor device coupling comprises a cavity and one or more deflectable elements positioned in the cavity, the cavity being configured to receive a projection of a base plate, and the deflectable elements forming a portion of a locking mechanism configured to engage with the recessed side of the projection.

[0295] Item 30. The monitor device coupling portion includes a projection positioned in the cavity, as described in Item 29.

[0296] Item 31. The protruding element has a triangular cross-section, as described in Item 30 of the monitoring device.

[0297] Item 32. A monitoring device according to item 30 or 31, wherein multiple terminals are provided on a protruding element.

[0298] Further exemplary embodiments of this disclosure are described in Section 2 below.

[0299] Item 2, part 1. A connector for a base plate and / or sensor assembly portion for an ostomy appliance, the connector comprising a first connector section and a second connector section, the first connector section being substantially flat in the first connector plane, and the second connector section being substantially flat in the second connector plane. The first coupling section is configured to be attached to the first portion of the base plate and / or sensor assembly portion, The second coupling section is configured to be attached to the second portion of the base plate and / or sensor assembly portion, The first joint section is hinged to the second joint section, allowing rotational movement of the first joint section relative to the second joint section around the hinge axis. The hinge axis is parallel to the first joint plane and the second joint plane of the joint.

[0300] Item 2 of the second section. The joint according to item 1 of the second section, wherein in a stationary state, the first joint section and the second joint section form a stationary angle, and the stationary state is a state in which no force is applied to the first joint.

[0301] Item 3 of the second section, the joint described in Item 2 of the second section, where the stationary angle is greater than 5 degrees, for example, greater than 10 degrees, for example, greater than 15 degrees, for example, greater than 20 degrees.

[0302] Item 4 of Item 2. The joint section of any one of Items 1 to 3 of Item 2 comprises a second primary joint section and one or more second secondary joint sections, wherein the second primary joint section is located on the primary side of the hinge axis and one or more second secondary joint sections are located on the secondary side of the hinge axis, with the secondary side of the hinge axis being the opposite of the primary side of the hinge axis.

[0303] Item 5 of Item 2. The coupling section according to any one of Items 1 to 4 of Item 2, wherein the first coupling section includes a locking section configured to lock the monitoring device in a coupling position with the base plate and / or sensor assembly portion.

[0304] Item 6 of the second section: The lock section is the joint described in Item 5 of the second section, which includes a hole that penetrates the first joint section.

[0305] Item 7 of the second section. The first coupling section is a coupling according to any one of items 1 to 6 of the second section, configured to be attached to the distal side of the first portion of the base plate and / or sensor assembly.

[0306] Item 8 of the second section, the second coupling section is configured to be attached distal to the second portion of the base plate and / or sensor assembly portion, as described in any one of items 1 to 7 of the second section.

[0307] Item 9 of Item 2. The joint according to any one of Items 1 to 8 of Item 2, comprising a first joint section adhesive configured to be attached to a first portion of the base plate and / or sensor assembly portion.

[0308] Item 10 of Item 2. The joint section according to any one of Items 1 to 9 of Item 2, comprising a second joint section adhesive configured to be attached to the second portion of the base plate and / or sensor assembly portion.

[0309] Item 11 of the second section: A joint according to any one of items 1 to 10 of the second section, wherein the first joint section has a first joint thickness, and the second joint section has a second joint thickness, and the first joint thickness and / or the second joint thickness is less than 2 mm, for example less than 1 mm, for example 0.6 mm.

[0310] Item 12 of the second section: The joint described in Item 11 of the second section, wherein the thickness of the first joint exceeds the thickness of the second joint.

[0311] Item 13 of the second section, a joint according to any one of items 1 to 12 of the second section, comprising one or more lines of reduced thickness along the hinge axis, and enabling rotational movement of the first joint section relative to the second joint section about the hinge axis.

[0312] Item 14 of the second section, the joint according to item 13 of the second section, wherein one or more lines of reduced thickness are provided on the distal side of the joint.

[0313] Item 15 of the second section, a coupling as described in any one of items 1 to 14 of the second section, comprising one or more holes along the hinge axis, allowing rotational movement of the first coupling section relative to the second coupling section about the hinge axis.

[0314] Item 2, 16. Base plate for ostomy appliance, - Upper levels, - The first adhesive layer, - An electrode assembly including a plurality of electrodes having connection parts and detection parts, - A monitor interface configured to connect a base plate to a monitor device, and including a coupling portion configured to connect the monitor device and the base plate, and Includes, The joint includes a first joint section and a second joint section, the first joint section being substantially flat in the first joint plane, and the second joint section being substantially flat in the second joint plane. The first coupling section is attached to a first portion of a base plate which includes a connection section for multiple electrodes. The second joint section is attached to the second part of the base plate. The first joint section is hinged to the second joint section, allowing rotational movement of the first joint section relative to the second joint section around the hinge axis. The hinge axis is parallel to the first and second joint planes of the base plate.

[0315] Item 17 of the second section, the proximal side of the second joint section, is attached to the distal side of the second portion of the upper layer, the base plate as described in Item 16 of the second section.

[0316] Item 18 of the second section: The proximal side of the first joint section is attached to the distal side of the first portion of the upper layer, the base plate as described in Item 16 or 17 of the second section.

[0317] Item 19 of the second section: The proximal side of the first coupling section is attached to the distal side of the first part of the electrode assembly, as described in item 16 or 17 of the second section.

[0318] Item 20 of Item 2. The base plate as described in any one of Items 16-19 of Item 2, wherein the first joint section is attached to the first part of the base plate by adhesive for the first joint section.

[0319] Item 21 of Item 2. The first joint section is attached to the first part of the base plate by welding the first joint section and the first part of the base plate together, as described in any one of Items 16-20 of Item 2.

[0320] Item 22 of Item 2. The second joint section is attached to the second part of the base plate by the second joint section adhesive, as described in any one of Items 16-21 of Item 2.

[0321] Item 23 of Item 2. The second joint section is attached to the second part of the base plate by welding the second joint section and the second part of the base plate together, as described in any one of Items 16-22 of Item 2.

[0322] Item 24 of Item 2: A base plate as described in any one of Items 16-23 of Item 2, in a stationary state, the first joint section and the upper layer form a stationary angle, and the stationary state is a state in which no force is applied to the first joint.

[0323] Item 25 of the second section: The stationary angle is greater than 5 degrees, e.g., greater than 10 degrees, e.g., greater than 15 degrees, e.g., greater than 20 degrees, as described in Item 24 of the second section.

[0324] Item 26 of Item 2. A base plate as described in any one of Items 16-25 of Item 2, including a backing element between the first adhesive layer and the electrode assembly.

[0325] Item 27. Sensor assembly part for ostomy appliance, - Upper levels, - The first adhesive layer, - An electrode assembly including a plurality of electrodes having connection parts and detection parts, - A monitor interface configured to connect a sensor assembly to a monitor device, and including a coupling portion configured to connect the monitor device and the sensor assembly; Includes, The joint includes a first joint section and a second joint section, the first joint section being substantially flat in the first joint plane, and the second joint section being substantially flat in the second joint plane. The first coupling section is attached to the first part of the sensor assembly, which includes the connection of multiple electrodes. The second coupling section is attached to the second part of the sensor assembly. The first joint section is hinged to the second joint section, allowing rotational movement of the first joint section relative to the second joint section around the hinge axis. The hinge axis is parallel to the first and second coupling planes, respectively, in the sensor assembly portion.

[0326] Item 28 of the second section, the proximal side of the second joint section, is attached to the distal side of the second part of the upper layer, the sensor assembly portion as described in Item 27 of the second section.

[0327] Item 29 of the second section: The sensor assembly according to item 27 or 28, wherein the proximal side of the first joint section is attached to the distal side of the first portion of the upper layer.

[0328] Item 30 of the second section, the sensor assembly portion according to item 27 or 28, wherein the proximal side of the first coupling section is attached to the distal side of the first portion of the electrode assembly.

[0329] Item 31 of Item 2. The first joint section is attached to the first part of the sensor assembly part by adhesive of the first joint section, as described in any one of Items 27-30 of Item 2.

[0330] Item 32 of the second section, the first joint section is attached to the first part of the sensor assembly by welding the first joint section and the first part of the sensor assembly together, as described in any one of items 27 to 31 of the second section.

[0331] Item 33 of the second section, the sensor assembly part as described in any one of items 27-32 of the second section, wherein the second joint section is attached to the second part of the sensor assembly part by adhesive of the second joint section.

[0332] Item 34 of the second section, the sensor assembly part described in any one of items 27-33 of the second section, wherein the second joint section is attached to the second part of the sensor assembly part by welding the second joint section and the second part of the sensor assembly part together.

[0333] Item 35 of the second section: A sensor assembly part as described in any one of items 27-34 of the second section, in which, in a stationary state, the first joint section and the upper layer form a stationary angle, and the stationary state is a state in which no force is applied to the first joint.

[0334] Item 36 of the second section: The stationary angle is greater than 5 degrees, for example, greater than 10 degrees, for example, greater than 15 degrees, for example, greater than 20 degrees, the sensor assembly part as described in Item 35 of the second section.

[0335] Section 37 of the second item. A sensor assembly portion according to Section 37 or 36 of the second item, comprising a backing element between the first adhesive layer and the electrode assembly. [Explanation of Symbols]

[0336] 1. Ostomy System 2. Ostomy appliance 4 Base Plate 6. Monitor Devices 8. Included Devices 10 Server Devices 12 Networks 14 Connecting member 16 Connecting rings 18 Stoma receptacle opening 100 Monitor Device Enclosures 101 Processors 102 First Interface 104 Second Interface 106 memory 108 Grounding terminal for monitor devices 110 First terminal of the monitor device 112 Second terminal of the monitor device 114 Third terminal of the monitor device 116. Fourth terminal of the monitor device 118 Fifth terminal of the monitor device 120 Joint 122 Antenna 124 Wireless Transceiver 200 First adhesive layer 200A Distal side / face of the first adhesive layer 200B Proximal side / face of the first adhesive layer 202 Second adhesive layer 202A Distal side / face of the second adhesive layer 202B Proximal side / face of the second adhesive layer 204 Electrode assembly Distal side / face of electrode assembly 204A 204B Proximal side / face of electrode assembly 206 Release Liner 206A Distal side / face of the peel-off liner 206B Proximal side / face of the release liner 208 Upper layer 208A Distal side / plane of the upper layer 208B Upper layer, proximal side / face 209 Connecting ring 210 Connection part of the first connector 210A Distal side / face of the joint 210B Proximal side / face of the joint 211 First connector 212 Terminals of the first connector 213 First intermediate element 213A Distal side / face of the first intermediate element 213B Proximal side / face of the first intermediate element 214 Support layer for electrode assembly 214A Distal side / face of the support layer 214B Proximal side / face of the supporting layer 216 Electrodes of the electrode assembly 217 Connection part 218 Masking Elements 218A Distal side / face of the masking element 218B Proximal side / face of masking element 220 Electrode configuration 222 Ground electrode 222A Grounding connection 222B Grounding detection unit 224 First electrode 224A First connection 226 Second electrode 226A Second connection section 228 Third electrode 228A Third connection 230 Fourth electrode 230A Fourth connection 230B Fourth detection unit 232 Fifth electrode 232A Fifth connection section 232B Fifth detection unit 234 First electrode portion of the ground electrode 236 Second electrode portion of the ground electrode 238 Third electrode portion of the grounding electrode 240 Fourth electrode portion of the ground electrode 242 Ground terminal opening 244 First terminal opening 246 Second terminal opening 248 Third terminal opening 250 Fourth terminal opening 252 Fifth terminal opening 254 Primary sensor point aperture of masking element 254A First primary sensor point aperture 254B Second primary sensor point aperture 256 Secondary sensor point aperture of masking element 256A First secondary sensor point aperture 256B Second secondary sensor point aperture 258 Third-order sensor point aperture of masking element 258A First tertiary sensor point aperture 258B Second tertiary sensor point aperture 260 Primary sensor point opening of the first adhesive layer 260A First primary sensor point aperture 260B Second primary sensor point aperture 262 Secondary sensor point opening of the first adhesive layer 262A First secondary sensor point aperture 262B Second secondary sensor point aperture 264 Tertiary sensor point opening of the first adhesive layer 264A First tertiary sensor point aperture 264B Second tertiary sensor point aperture 272 terminal elements 272A Distal end of monople element 272B Proximal end of terminal element 274A Distal portion of terminal element 274B Proximal portion of terminal element 276A Distal terminal element curvature 276B Proximal terminal element curvature 278 Guide hole 282 Ground Terminal Element 282A ground terminal 284 First terminal element 284A First terminal 286 Second terminal element 286A Second terminal 288 Third terminal element 288A Third terminal 290 Fourth terminal element 290A Fourth terminal 292 Fifth terminal element 292A Fifth terminal 302 First part of electrode assembly 303 Second part of the electrode assembly 304 Upper opening 306 Second adhesive layer opening 308 Reinforcement elements 308A Distal side of the reinforcing element 308B Proximal side of the reinforcing element 310 Opening 311 Conductor Road 312 Backing element 314 First raised section 412 Engagement direction 413 Disengagement direction 424 Opening 428 Rock Section 430 Lock elements 431 Locking element protrusion 432 First direction 433 Second direction 434 First slider direction 436 Second slider direction 460 First surface of the joint 462 Second surface of the joint 470 Clamp 472 First clamp surface 474 Second clamp surface 480 Protrusion 482 Concave side 484 Cavity 486 Deflectable Element 488 Projection element 490 sockets 492 First alignment element 494 Second alignment element 496 First joint section 498 Second joint section 499 Lever 600 Monitor Devices with Multiple Ports 602 Indentation 708 Second primary joint section 710, 710A, 710B Second secondary coupling section 712 First joint section adhesive 714 Second joint section adhesive 716 Thickness of the first joint 718 Second joint thickness 720 Line with reduced thickness 722 holes 724 First Lamination 726 Second Lamination 728 Third Lamination 730 The first part of the upper layer 732 The second part of the upper layer 750 First joint plane 752 Second joint plane 754 Hinge shaft 756 rest angle Number of terminals in the first interface of the M monitor device

Claims

1. A base plate for an ostomy appliance, - Upper levels, - The first adhesive layer, - An electrode assembly containing multiple electrodes, - A monitor interface configured to connect the base plate to a monitor device, comprising a plurality of terminals electrically connected to the plurality of electrodes and configured to connect to each terminal of the monitor device, and comprising a coupling portion configured to connect the monitor device and the base plate, Includes, The plurality of terminals are provided in the coupling portion, and The coupling portion includes a locking section configured to lock the monitor device at the coupling portion of the base plate, and The coupling portion includes a projection that protrudes in a projection direction substantially perpendicular to the base plate plane, the projection having a recess that forms the locking section of the coupling portion, and the projection is configured to engage with the cavity of the monitor device. Base plate.

2. The base plate according to claim 1, wherein the projection includes a socket configured to receive a projection element positioned in the cavity of the monitor device.

3. The socket is a base plate according to claim 1 or 2, having a triangular cross-section.

4. A monitor device for connecting to a base plate according to any one of claims 1 to 3, - Monitor device enclosure, - Electronic circuits and, - An orthotic device interface configured to connect the monitoring device to the base plate, comprising a plurality of terminals for connecting to a plurality of electrodes of the base plate, and a monitor device coupling portion configured to couple the monitoring device and the base plate, and Includes, A monitor device including a locking mechanism configured to engage with a locking section of the base plate to lock the monitor device in a coupled position with the base plate.

5. The monitor device according to claim 4, wherein the monitor device coupling portion includes a cavity and one or more deflectable elements positioned in the cavity, the cavity being configured to receive a projection of the base plate, and the deflectable elements forming a portion of a locking mechanism configured to engage with the recessed side of the projection.

6. The monitor device according to claim 5, wherein the monitor device coupling portion includes a protruding element positioned in the cavity.

7. The monitor device according to claim 6, wherein the projection element has a triangular cross-section.

8. The monitor device according to claim 6 or 7, wherein the plurality of terminals are provided on the protruding element.

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