Accelerometer in the monitor device

Abstract

Disclosed is a monitor device (6) for coupling to a sensor assembly for a stoma appliance. The monitor device includes a housing, a processor disposed in the housing, and an appliance interface configured to couple the monitor device to the sensor assembly. The appliance interface may include a plurality of terminals for connection to a plurality of electrodes of the sensor assembly. Further, the monitor device includes a triaxial accelerometer (540) configured to generate a position signal. Further disclosed is a method for determining a rotational offset of the sensor assembly relative to the stoma, and a system including the monitor device and the sensor assembly.

Description

Technical Field

[0001] This disclosure relates to a monitor device for a sensor assembly that includes an accelerometer for determining spatial orientation. Further, this disclosure relates to a method for determining a rotational offset of the sensor assembly relative to a stoma. Brief Description of the Drawings

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

[0003] Figure 1 An exemplary stoma system is shown,

[0004] Figure 2 An exemplary monitor device of the stoma system is shown,

[0005] Figure 3 An exploded view of a baseplate of a stoma appliance is shown,

[0006] Figure 4 An exploded view of an exemplary electrode assembly is shown,

[0007] Figure 5 A proximal view of multiple portions of the baseplate and / or a sensing patch is shown,

[0008] Figure 6 A distal view of an exemplary electrode configuration is shown,

[0009] Figure 7 A distal view of an exemplary masking element is shown,

[0010] Figure 8 A distal view of an exemplary first adhesive layer is shown,

[0011] Figure 9 Shown is Figure 8 a proximal view of the first adhesive layer of

[0012] Figure 10 A distal view of a portion of the baseplate and / or the sensing patch including a monitor interface is shown,

[0013] Figure 11 Shown is Figure 6 a distal view of the electrode configuration of

[0014] Figure 12Shows a distal view of an exemplary electrode configuration,

[0015] Figure 13 Shows a distal view of an exemplary masking element,

[0016] Figure 14 Shows a distal view of an exemplary first adhesive layer,

[0017] Figure 15 Shows a distal view of an exemplary electrode configuration,

[0018] Figure 16 Shows an embodiment of a schematic monitor device including a 3-axis accelerometer coupled to a schematic baseplate and / or sensing patch,

[0019] Figure 17 Shows an embodiment of a rotating baseplate and / or sensing patch coupled to a monitor device,

[0020] Figure 18A Shows an embodiment of a person wearing a baseplate and / or sensing patch coupled to a monitor device,

[0021] Figure 18B Shows an embodiment of an accessory device including a visual representation,

[0022] Figure 19A Shows an embodiment of a person wearing a baseplate and / or sensing patch coupled to a monitor device,

[0023] Figure 19B Shows an embodiment of an accessory device including a visual representation,

[0024] Figure 20 Shows eight exemplary orientations of a schematic monitor device including a 3-axis accelerometer,

[0025] Figure 21 Shows a graph of an experimental data set derived from an accelerometer, and

[0026] Figure 22 Shows an embodiment of a monitor device including a 3-axis accelerometer. Detailed Description

[0027] In the following, when relevant, multiple different exemplary embodiments and details are described with reference to the accompanying drawings. It should be noted that the drawings may or may not be drawn to scale, and throughout all the drawings, elements having similar structures or functions are denoted by the same reference numerals. It should also be noted that the drawings are only intended to facilitate the description of the embodiments. They are not intended as an exhaustive description of the present invention or a limitation on the scope of the present invention. Additionally, the embodiments shown need not have all the aspects or advantages shown. Aspects or advantages described in connection with a particular embodiment need not be limited to that embodiment and may be practiced in any other embodiment even if not so shown or not so explicitly described.

[0028] Throughout this disclosure, the terms "stoma" and "stomata" are used to denote an opening surgically formed that bypasses a person's intestinal or urinary tract system. These terms are used interchangeably and do not have distinct meanings. The same applies to any words or phrases derived from these terms, such as "stomal", "stomata", etc. Also, solid and liquid waste exiting the stoma can be interchangeably referred to as stoma "effluent", "waste", "liquid", and "fluid". A subject who has undergone a stomata surgery can be referred to as a "stomate" or "stomata person", and in addition, also as a "patient" or "user". However, in some cases, "user" can also refer to or denote a healthcare professional (HCP), such as a surgeon or a stomata care nurse or other personnel. In these cases, it will be explicitly stated or implied from the context that the "user" is not the "patient" himself or herself.

[0029] In the following, whenever reference is made to the proximal or surface of a layer, element, device, or part of a device, it refers to the side or surface facing the skin when the user wears the stomata appliance. Similarly, whenever reference is made to the distal or surface of a layer, element, device, or part of a device, it refers to the side or surface facing away from the skin when the user wears the stomata appliance. In other words, the proximal or surface is the side or surface closest to the user when the appliance is fitted to the user, and the distal is the opposite side or surface, i.e., the side or surface farthest from the user in use.

[0030] When the user wears the appliance, the axial direction is defined as the direction of the stoma. Thus, the axial direction is generally perpendicular to the user's skin or abdominal surface.

[0031] The radial direction is defined as perpendicular to the axial direction. In some statements, the terms "inner" and "outer" may be used. These qualifiers should generally be understood with reference to the radial direction such that reference to an "outer" element means that the element is further from the central portion of the ostomy appliance than the element referred to as "inner". Further, "innermost" should be construed as that part of the component that forms the center of the component and / or is adjacent to the center of the component. Similarly, "outermost" should be construed as that part of the component that forms the outer edge or outer contour of the component and / or is adjacent to that outer edge or outer contour.

[0032] In the present disclosure, the term "substantially" is used as a modifier of certain features or effects and is intended simply to indicate that any deviation is within the tolerances typically expected by a person skilled in the relevant art.

[0033] In the present disclosure, the term "substantially" is used as a modifier of certain features or effects and is intended simply to indicate that for a structural feature, most or the main part of this feature exhibits the property under discussion, and for a functional feature or effect is intended to indicate that most of the results involving that property provide that effect, but exceptional results do not provide that effect.

[0034] The present disclosure provides a monitor device for a sensor assembly coupled to an ostomy appliance, a method for determining a rotational offset of the sensor assembly relative to the ostomy, and an ostomy system including the sensor assembly and the monitor device.

[0035] In a first aspect of the present invention, a monitor device for a sensor assembly attachable to an ostomy appliance is disclosed. The monitor device includes a housing, a processor disposed within the housing, and an appliance interface configured to couple the monitor device to the sensor assembly. The appliance interface may include a plurality of terminals for connection to a plurality of electrodes of the sensor assembly. Further, the monitor device includes a triaxial accelerometer configured to generate a position signal. The triaxial accelerometer is capable of evaluating / measuring acceleration in a three-dimensional space spanned by mutually orthogonal x, y, and z axes. Hereinafter, the accelerometer is considered to include the x, y, and z axes. Thus, the axes of the accelerometer span a Cartesian coordinate system. In an embodiment, the accelerometer is a biaxial accelerometer.

[0036] This disclosure relates to a stoma system and its devices, such as a stoma appliance, a baseplate of the stoma appliance, a sensing patch applied to the baseplate, a monitor device, and optionally one or more accessory devices. Further, methods related to the stoma system and its devices are disclosed. The accessory device (also referred to as an external device) can be a mobile phone or other handheld device. In an embodiment, the accessory device is a personal electronic device, such as a wearable device, like a watch or other wrist-worn electronic device. The accessory device can be a docking station. In an embodiment, the docking station can be configured to electrically couple and / or mechanically couple the monitor device to the docking station. In an embodiment, the docking station can be configured to charge the battery of the monitor device and / or be configured to transfer data between the monitor device and the docking station. The stoma system can include a server device. In an embodiment, the server device can be operated and / or controlled by the stoma appliance manufacturer and / or a service center.

[0037] This disclosure provides a stoma system and its devices, such as a stoma appliance, a baseplate of the stoma appliance, a sensing patch for applying to the baseplate, a monitor device, and optionally one or more accessory devices, which alone or together facilitate a reliable determination of the nature, severity, and rapidity of moisture spread in an adhesive material provided for attaching the baseplate and / or the sensing patch to the skin surface of a user. Depending on the nature of the moisture spread pattern in the adhesive, the stoma system and its devices are capable of providing the user with information about the type of failure and, in turn, being able to provide the user with an indication of the severity and thus the remaining time range for replacing the stoma appliance without significant leakage and / or skin damage.

[0038] In an embodiment, the stoma appliance includes a baseplate and a stoma pouch (also referred to as a stoma pocket). The stoma appliance can be a colostomy appliance, an ileostomy appliance, or a urostomy appliance. In an embodiment, the stoma appliance can be a two-piece stoma appliance, i.e., the baseplate and the stoma pouch are releasably coupled, for example, by mechanical and / or adhesive coupling, such as to allow one baseplate to be used (exchanged) with multiple stoma pouches. Further, the two-piece stoma appliance can facilitate the correct application of the baseplate to the skin, for example, to obtain an improved view of the stoma area by the user. In an embodiment, the stoma appliance can be a one-piece stoma appliance, i.e., the baseplate and the stoma pouch can be fixedly attached to each other. The baseplate is configured to be coupled to the user's stoma and / or the skin around the stoma, such as the peristomal skin area.

[0039] In an embodiment, the ostomy appliance includes: a baseplate, for example, integrated with the sensing assembly portion, such as a unitary one-piece baseplate; or a separate sensing patch, such as a sensor assembly portion subsequently applied to the baseplate. In an embodiment, the sensor assembly portion is a sensing patch adapted to be applied to the baseplate, such as the proximal surface of the baseplate. Thus, any baseplate, such as a conventional baseplate, can implement the features described herein. The sensor assembly of the sensing patch can be applied to the baseplate, for example, by the user to provide the features described herein regarding the sensing / monitoring capabilities of the baseplate, and vice versa. In an embodiment, the sensing patch is adapted to adhere to the baseplate.

[0040] In an embodiment, a method for attaching a baseplate having sensing capabilities (e.g., by providing a sensing patch) to the skin of a user around and / or at the stoma, such as to a peristomal skin region, includes: attaching the sensing patch to the baseplate and attaching the baseplate, together with the attached sensing patch, to the skin of the user around and / or at the stoma, such as to a peristomal skin region. Alternatively, a method for attaching a baseplate to the skin of a user around and / or at the stoma includes: attaching the sensing patch to the skin of the user around and / or at the stoma and attaching the baseplate to the skin of the user around and / or at the stoma above the attached sensing patch, i.e., on the distal surface of the sensing patch.

[0041] In an embodiment, the baseplate and / or the sensing patch includes a first adhesive layer having a proximal side, the proximal side of the first adhesive layer being configured to attach the baseplate and / or the sensing patch to the skin surface of the user. In an embodiment, the first adhesive layer has a stoma opening with a center point, such as a first adhesive stoma opening.

[0042] In an embodiment, the base plate and / or the sensing patch includes a plurality of electrodes, the plurality of electrodes including a first leakage electrode, a second leakage electrode, and a third leakage electrode disposed in an electrode assembly of the sensor assembly. In an embodiment, the plurality of electrodes are configured to detect the presence of a liquid (such as an exudate) on the proximal side of the first adhesive layer and / or the moisture content in the first adhesive layer. In an embodiment, the electrode assembly of the sensor assembly is configured to detect the presence of a liquid (such as an exudate) on the proximal side of the first adhesive layer and / or to detect the moisture content in the first adhesive layer in a primary sensing zone and a secondary sensing zone separated from the primary sensing zone. In an embodiment, the primary sensing zone is disposed in a primary angular space relative to the center point of the first adhesive layer, and / or the secondary sensing zone is disposed in a secondary angular space separated from the primary angular space relative to the center point of the first adhesive layer. Alternatively or additionally, the primary sensing zone may be disposed in a primary radial space relative to the center point of the first adhesive layer, and the secondary sensing zone may be disposed in a secondary radial space relative to the center point of the first adhesive layer. In an embodiment, the electrode assembly of the sensor assembly is configured to detect the presence of a liquid (such as an exudate) on the proximal side of the first adhesive layer and / or to detect the moisture content in the first adhesive layer in three or more sensing zones.

[0043] In an embodiment, the monitor device includes: a housing; a processor; a memory; a first interface (also referred to as an appliance interface) connected to the processor and the memory; and a second interface connected to the processor. The first interface is configured to obtain ostomy data from a baseplate and / or a sensing patch coupled to the first interface. The ostomy data includes primary ostomy data from a primary electrode set of the baseplate and / or the sensing patch, and secondary ostomy data from a secondary electrode set of the baseplate and / or the sensing patch. In an embodiment, the processor is configured to: obtain primary parameter data based on the primary ostomy data; obtain secondary parameter data based on the secondary ostomy data; and detect the presence of liquid on the proximal side of the first adhesive layer and / or the presence of moisture in the first adhesive layer in a primary sensing area based on the primary parameter data. In an embodiment, the primary sensing area is arranged in a primary angular space relative to the center point of the first adhesive layer and / or in a primary radial space relative to the center point of the first adhesive layer. Further, in an embodiment, the processor is configured to detect the presence of liquid on the proximal side of the first adhesive layer and / or the presence of moisture in the first adhesive layer in a secondary sensing area based on the secondary parameter data. In an embodiment, the secondary sensing area is arranged in a secondary angular space relative to the center point of the first adhesive layer, and / or in a secondary radial space relative to the center point of the first adhesive layer. In an embodiment, according to detecting the presence of fluid in the primary sensing area, the processor is configured to send a primary monitor signal via the second interface, the primary monitor signal including monitor data indicating the presence of liquid and / or moisture in the primary sensing area; and according to detecting the presence of fluid in the secondary sensing area, send a secondary monitor signal via the second interface, the secondary monitor signal including monitor data indicating the presence of liquid and / or moisture in the secondary sensing area.

[0044] The baseplate and / or the sensing patch includes a first adhesive layer. During use, the first adhesive layer adheres to the skin of the user (peristomal area) and / or adheres to an additional seal, such as a sealant paste, a seal tape, and / or a seal ring. Thus, in an embodiment, the first adhesive layer may be configured to attach the baseplate and / or the sensing patch to the skin surface of the user. In an embodiment, the first adhesive layer has a stoma opening with a center point, such as a first adhesive stoma opening, or is at least prepared to form a stoma opening with a center point. The baseplate and / or the sensing patch according to the present disclosure is capable of detecting the presence of liquid or exudate on the proximal side of the first adhesive layer (between the skin surface of the user (such as the peristomal skin area) and the proximal surface of the first adhesive layer).

[0045] In an embodiment, the first adhesive layer is made of a first composition. In an embodiment, the first composition comprises one or more polyisobutenes and / or styrene-isoprene-styrene. In an embodiment, the first composition comprises one or more hydrocolloids. In an embodiment, the first composition comprises one or more water-soluble or water-swellable hydrocolloids. In an embodiment, the first composition is a pressure-sensitive adhesive composition suitable for medical purposes, comprising a rubbery elastomeric substrate and one or more water-soluble or water-swellable hydrocolloids. In an embodiment, the first composition comprises one or more polybutenes, one or more styrene copolymers, one or more hydrocolloids, or any combination thereof. The combination of the adhesive properties of polybutene and the absorption characteristics of the hydrocolloid makes the first composition suitable for use in ostomy appliances. For example, the styrene copolymer can be a styrene-butadiene-styrene block copolymer or a styrene-isoprene-styrene block copolymer. Preferably, one or more styrene-isoprene-styrene (SIS) block copolymers are employed. The amount of the styrene block copolymer can be 5% to 20% of the total adhesive composition. The butene component is suitably a conjugated butadiene polymer selected from polybutadiene and polyisoprene. The polybutene is preferably present in an amount of 35 - 50% of the total adhesive composition. Preferably, the polybutene is polyisobutene (PIB). The hydrocolloids suitable for incorporation into the first composition are selected from natural hydrocolloids, semi-synthetic hydrocolloids, and synthetic hydrocolloids. The first composition can comprise 20 - 60% of the hydrocolloid. A preferred hydrocolloid is carboxymethyl cellulose (CMC). Optionally, the first composition can comprise other components such as fillers, tackifiers, plasticizers, and / or other additives.

[0046] The first adhesive layer can have a substantially uniform thickness. The thickness of the first adhesive layer can be in the range of 0.1 mm to 1.5 mm, for example, in the range of 0.2 mm to 1.2 mm, such as 0.8 mm or 1.0 mm. The first adhesive layer can have a main thickness in a main portion of the first adhesive layer, for example, in a main region within or within a main radial distance from the center point of the stoma opening. The main thickness can be in the range of 0.2 mm to 1.5 mm, such as about 1.0 mm. The main radial distance can be in the range of 20 mm to 50 mm, such as in the range of 25 mm to 35 mm, for example 30 mm. The first adhesive layer can have a secondary thickness in a secondary portion of the first adhesive layer, for example, in a secondary region outside or within a secondary radial distance from the center point of the stoma opening. The secondary thickness can be in the range of 0.2 mm to 1.0 mm, such as about 0.5 mm. The secondary radial distance can be in the range of 20 mm to 50 mm, such as in the range of 25 mm to 35 mm, for example 30 mm.

[0047] In an embodiment, the base plate and / or the sensing patch includes a second layer. In an embodiment, the second layer is an adhesive layer. In an embodiment, the second layer has a second radially extending range that is greater than the first radially extending range of the first adhesive layer at least within the first angular range of the base plate and / or the sensing patch. Accordingly, a portion of the proximal surface of the second layer can be configured to adhere to the skin surface of the user. This portion of the proximal surface of the second layer that is configured to attach to the skin surface of the user is also referred to as the skin attachment surface of the second adhesive layer. The second layer can have a stoma opening with a center point, such as a second layer stoma opening and / or a second adhesive stoma opening.

[0048] In an embodiment, the second adhesive layer is made of a second composition. In an embodiment, the second composition comprises one or more polyisobutenes and / or styrene-isoprene-styrene. In an embodiment, the second composition comprises one or more hydrocolloids. In an embodiment, the second composition comprises one or more water-soluble or water-swellable hydrocolloids. In an embodiment, the second composition is a pressure-sensitive adhesive composition suitable for medical purposes, comprising a rubbery elastomeric substrate and one or more water-soluble or water-swellable hydrocolloids. In an embodiment, the second composition comprises one or more polybutenes, one or more styrene copolymers, one or more hydrocolloids, or any combination thereof. The combination of the tacky properties of polybutene and the absorbent properties of hydrocolloid makes the second composition suitable for use in ostomy appliances. For example, the styrene copolymer can be a styrene-butadiene-styrene block copolymer, or a styrene-isoprene-styrene block copolymer. Preferably, one or more styrene-isoprene-styrene (SIS) block copolymers are employed. The amount of the styrene block copolymer can be 5% to 20% of the total adhesive composition. The butene component is suitably a conjugated butadiene polymer selected from polybutadiene and polyisoprene. Polybutene is preferably present in an amount of 35 - 50% of the total adhesive composition. Preferably, polybutene is polyisobutene (PIB). The hydrocolloids suitable for incorporation into the second composition are selected from natural hydrocolloids, semi-synthetic hydrocolloids, and synthetic hydrocolloids. The second composition can comprise 20 - 60% of hydrocolloid. A preferred hydrocolloid is carboxymethyl cellulose (CMC). Optionally, the second composition can comprise other components, such as fillers, tackifiers, plasticizers, and / or other additives.

[0049] The different ratios of the inclusions can change the properties of the first and / or second adhesive layers. In embodiments, the second adhesive layer and the first adhesive layer have different properties. In embodiments, the second adhesive layer (second composition) and the first adhesive layer (first composition) have different ratios of polyisobutene, styrene-isoprene-styrene, and / or hydrocolloid. For example, the second adhesive layer can provide stronger adhesion to the skin compared to the adhesion to the skin provided by the first adhesive layer. Alternatively or additionally, the second adhesive layer can be thinner than the first adhesive layer. Alternatively or additionally, the second adhesive layer can have less water absorption and / or sweat absorption than the first adhesive layer. Alternatively or additionally, the second adhesive layer can have lower moldability than the first adhesive layer. In embodiments, the second adhesive layer provides a second leak barrier.

[0050] The second layer can have a substantially uniform thickness. The thickness of the second layer can be in the range of 0.1 mm to 1.5 mm, for example in the range of 0.2 mm to 1.0 mm, such as 0.5 mm, 0.6 mm, or 0.7 mm.

[0051] A baseplate with sensing capabilities is provided, for example, by a combined sensor assembly or by a sensing patch including a sensor assembly, to provide optimal or improved use of the ostomy appliance. In particular, it is promoted that the baseplate is not replaced too late (resulting in adhesive failure, leakage, and / or skin damage), or at least it is promoted that the user is informed that leakage will occur, is occurring, or has occurred. Accordingly, the user or healthcare professional can monitor and plan the use of the ostomy appliance.

[0052] In embodiments, the baseplate and / or the sensing patch includes one or more electrodes, such as a plurality of electrodes, such as two, three, four, five, six, seven or more electrodes. The sensing patch can be applied to the baseplate, such as providing one or more electrodes for the baseplate. In embodiments, the electrodes are provided in an electrode assembly. In embodiments, the electrode assembly is provided in the sensor assembly.

[0053] In an embodiment, the electrodes, such as some or all of the electrodes, are disposed between a first adhesive layer and a second adhesive layer. In an embodiment, the electrodes are disposed in an electrode assembly, such as an electrode layer of a sensor assembly. In an embodiment, the electrodes include connections for connecting the electrodes to other components and / or interface terminals / terminal elements, such as for connecting the electrodes to a monitor device. In an embodiment, the electrodes include one or more conductor portions and / or one or more sensing portions. The conductor portion can be considered as the part of the electrode that connects two or more sensing portions and / or connects the sensing portion of the corresponding electrode to the connection. The sensing portion can be considered as the part of the electrode that is suitable for sensing, for example, a liquid (such as a liquid inclusion) and / or an effluent (such as an effluent generated by a leak or an impending leak). The sensing portion can be suitable for sensing, for example, by its shape, which can potentially be circular, oval, or rectangular. Thus, the conductor portion can conduct the signal generated by the sensing portion. In an embodiment, the electrodes include alternating conductor portions and sensing portions. In an embodiment, the electrode assembly is disposed between a first adhesive layer and a second adhesive layer. The base plate and / or the sensing patch, such as the electrode assembly, can include a first electrode, a second electrode, and optionally a third electrode. The base plate and / or the sensing patch, such as the electrode assembly, can include a fourth electrode and / or a fifth electrode. The base plate and / or the sensing patch, such as the electrode assembly, optionally includes a sixth electrode. In an embodiment, the base plate and / or the sensing patch, such as the electrode assembly, includes a ground electrode. The ground electrode can include a first electrode portion. In an embodiment, the first electrode portion of the ground electrode forms the ground or reference of the first electrode. In an embodiment, the first electrode portion forms a closed loop. The ground electrode can include a second electrode portion. In an embodiment, the second electrode portion of the ground electrode forms the ground or reference of the second electrode. The ground electrode can include a third electrode portion. In an embodiment, the third electrode portion of the ground electrode forms the ground or reference of the third electrode. The ground electrode can include a fourth electrode portion. In an embodiment, the fourth electrode portion of the ground electrode forms the ground or reference of the fourth electrode and / or the fifth electrode. In an embodiment, the ground electrode is configured to be or form a (common) reference electrode for some or all of the other electrodes in the electrode assembly.

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

[0055] In an embodiment, the electrode assembly includes a support layer, also referred to as a support film. In an embodiment, the sensor assembly includes the electrode assembly and the support layer. One or more electrodes may be formed, such as printed, on the proximal side of the support layer. One or more electrodes may be formed, such as printed, on the distal side of the support layer. Thus, one or more electrodes may be disposed between the support layer and the first adhesive layer. The electrode assembly, such as the support layer of the electrode assembly, may have a stoma opening with a center point, such as an electrode assembly stoma opening and / or a support layer stoma opening. In an embodiment, the support layer comprises a polymeric material (e.g., polyurethane, PTFE, PVDF), and / or a ceramic material (e.g., alumina, silica). In one or more exemplary backing plates and / or sensing patches, the support layer is made of thermoplastic polyurethane (TPU). The support layer material may include one or more of the following: polyester, thermoplastic elastomer (TPE), polyamide, polyimide, ethylene-vinyl acetate (EVA), polyurea, and silicone, or be made thereof. Exemplary thermoplastic elastomers of the support layer are styrene block copolymers (TPS, TPE-s), thermoplastic polyolefin elastomers (TPO, TPE-o), thermoplastic vulcanizates (TPV, TPE-v), thermoplastic polyurethanes (TPU), thermoplastic copolyesters (TPC, TPE-E), and thermoplastic polyamides (TPA, TPE-A).

[0056] Determining the type of moisture pattern or the angular leak pattern can be used to help reduce the risk that a user experiences leakage of the ostomy appliance. Further, determining the type of moisture pattern and the operational state classification and / or leak pattern of the ostomy appliance can further be used to help reduce the risk of damage to the user's skin.

[0057] In an embodiment, the primary sensing area of the backing plate and / or the sensing patch is disposed in a primary angular space relative to the center point of the first adhesive layer. In an embodiment, the primary angular space spans a primary angle in the range of 45° to 315°, such as in the range of 45° to 135°. In an embodiment, the primary angle depends on the number of angular sensing areas on the backing plate and / or the sensing patch. For example, for a backing plate and / or a sensing patch having two or more sensing areas, the primary angle may be about 180° ± 15°. For example, for a backing plate and / or a sensing patch having two, three, or more sensing areas, the primary angle may be about 120° ± 15°. For example, for a backing plate and / or a sensing patch having two, three, four, or more sensing areas, the primary angle may be about 90° ± 15°. The sensing areas are separate and non-overlapping.

[0058] Alternatively or additionally, the primary sensing region may be disposed in a primary radial space relative to the center point of the first adhesive layer. In an embodiment, the primary radial space may span a primary radius in the range of 10 - 50 mm, such as in the range of 10 - 25 mm, such as in the range of 19 - 20 mm. In an embodiment, the primary radius depends on the number of radial sensing regions on the base plate and / or the sensing patch.

[0059] In an embodiment, the secondary sensing region is disposed in a secondary angular space relative to the center point of the first adhesive layer. In an embodiment, the secondary angular space may span a secondary angle in the range of 45° to 315°, such as in the range of 45° to 135°. In an embodiment, the secondary angle depends on the number of angular sensing regions on the base plate and / or the sensing patch. For example, for a base plate and / or a sensing patch having two or more sensing regions, the secondary angle may be about 180° ± 15°. For a base plate and / or a sensing patch having two, three, or more sensing regions, the secondary angle may be about 120° ± 15°. For a base plate and / or a sensing patch having two, three, four, or more sensing regions, the secondary angle may be about 90° ± 15°.

[0060] Alternatively or additionally, the secondary sensing region may be disposed in a secondary radial space relative to the center point of the first adhesive layer. In an embodiment, the secondary radial space spans a secondary radius in the range of 15 - 50 mm, such as in the range of 20 - 30 mm, such as in the range of 25 - 26 mm. In an embodiment, the secondary radius depends on the number of radial sensing regions on the base plate and / or the sensing patch. In an embodiment, the secondary radius is greater than the primary radius.

[0061] In an embodiment, a plurality of electrodes are configured to detect the presence of liquid on the proximal side in a tertiary sensing region. In an embodiment, the tertiary sensing region is disposed in a tertiary angular space relative to the center point of the first adhesive layer. In an embodiment, the tertiary angular space may span a tertiary angle in the range of 45° to 315°, such as in the range of 45° to 180°, for example in the range of 45° to 135°. In an embodiment, the tertiary angle depends on the number of angular sensing regions on the base plate and / or the sensing patch. For example, for a base plate and / or a sensing patch having three or more sensing regions, the tertiary angle may be about 180° ± 15°. For a base plate and / or a sensing patch having three or more sensing regions, the tertiary angle may be about 120° ± 15°. For a base plate and / or a sensing patch having three, four, or more sensing regions, the tertiary angle may be about 90° ± 15°.

[0062] Alternatively or additionally, the tertiary sensing zone may be arranged in a tertiary radial space relative to the center point of the first adhesive layer. In an embodiment, the tertiary radial space spans a tertiary radius in the range of 15 - 50 mm, such as in the range of 25 - 50, such as in the range of 29 - 30 mm. In an embodiment, the tertiary radius depends on the number of radial sensing zones on the base plate and / or the sensing patch. In an embodiment, the tertiary radius may be greater than the secondary radius and / or the primary radius.

[0063] In an embodiment, the primary sensing zone and the secondary sensing zone may be separate sensing zones, i.e., non - overlapping. The primary sensing zone and the tertiary sensing zone may be separate sensing zones, i.e., non - overlapping. The secondary sensing zone and the tertiary sensing zone may be separate sensing zones, i.e., non - overlapping.

[0064] In an embodiment, the primary sensing zone, the secondary sensing zone, and / or the tertiary sensing zone cover electrodes embedded in or in contact with the first adhesive layer, as well as leakage electrodes exposed to the surrounding environment. Thereby, the spread or absorption of moisture in the first adhesive layer can be detected in one or more sensing zones, thereby providing determination of the direction of moisture spread in the first adhesive layer. Similarly, exudates spreading between the wearer's skin and the first adhesive layer can be determined by the exposed leakage electrodes. The leakage electrodes may be exposed through sensing point openings. The sensing point openings of the first adhesive layer are configured to overlap a part (sensing portion) of the leakage electrode, for example to form a sensing point. In an embodiment, the sensing point openings of the first adhesive layer have a suitable shape and size to facilitate access to the leakage electrode from the proximal side of the first adhesive layer.

[0065] In an embodiment, two electrodes of the electrode assembly may form a sensor. In an embodiment, the first leakage electrode and the second leakage electrode form a primary leakage sensor or a primary leakage electrode pair for detecting the presence of liquid on the proximal side of the first adhesive layer in the primary sensing zone. In an embodiment, the second leakage electrode and the third leakage electrode form a secondary leakage sensor or a secondary leakage electrode pair for detecting the presence of liquid on the proximal side of the first adhesive layer in the secondary sensing zone. In an embodiment, the first leakage electrode and the third leakage electrode form a tertiary leakage sensor or a tertiary leakage electrode pair for detecting the presence of liquid on the proximal side of the first adhesive layer in the tertiary sensing zone.

[0066] In an embodiment, the baseplate and / or the sensing patch includes a monitor interface (also referred to as a component interface). In an embodiment, the monitor interface is configured to electrically and / or mechanically connect the ostomy appliance (baseplate and / or sensing patch) to a monitor device. In an embodiment, the monitor interface is configured to wirelessly connect the ostomy appliance (baseplate and / or sensing patch) to a monitor device. Thus, the monitor interface of the baseplate and / or the sensing patch can be configured to electrically and / or mechanically couple the ostomy appliance and the monitor device.

[0067] In an embodiment, the monitor interface of the baseplate and / or the sensing patch includes a coupling portion, such as part of a first connector that serves as the monitor interface, for forming a mechanical connection, such as a releasable coupling, between the monitor device and the baseplate and / or the sensing patch. In an embodiment, the coupling portion is configured to engage a coupling portion of the monitor device to releasably couple the monitor device to the baseplate and / or the sensing patch.

[0068] This disclosure provides a monitor device that includes a triaxial accelerometer configured to generate a position signal. The triaxial accelerometer is configured to evaluate / measure (relative) acceleration, the direction of gravity, and gravity along mutually orthogonal x, y, and z axes, i.e., across a (three-dimensional) Cartesian coordinate system. In an embodiment, the accelerometer is configured to detect movement of the monitor device. The triaxial accelerometer may be referred to as a triaxial accelerometer. In an embodiment, the evaluated / measured acceleration, direction of gravity, and / or force of gravity are included in the position signal. Thereby, the monitor device is capable of measuring relative acceleration (movement) and gravity in a three-dimensional space (i.e., the space spanned by the Cartesian coordinate system). In particular, the monitor device is capable of measuring relative acceleration and gravity along each of the x, y, and z axes of such a three-dimensional space. In an embodiment, the position signal is transmitted to a processor and / or a memory of the monitor device. In an embodiment, the position signal forms a basis for determining the spatial orientation, such as the tilt, of the monitor device.

[0069] In an embodiment, the accelerometer is configured to generate one or more position signals proportional to the acceleration of the monitor device relative to one or more axes of a three-dimensional coordinate system, and the position signals may represent movement of the monitor device (by wearing the monitor device) or user input (by tapping the monitor device). In an embodiment, a tap or a sequence of taps is a process by which a user uses his / her finger or an equivalent to generate a specific position signal, such as a position signal related to a specific tap pattern (task profile). Thus, generally, a tap is related to a brief but significant movement of the monitor device. In other words, since the monitor device moves for a short time during each tap, the tap causes the monitor device to move with a relatively high acceleration.

[0070] In the following, whenever a particular axis of the accelerometer is mentioned, such as the x-axis, y-axis, or z-axis, it refers to the axis along which acceleration can be measured / sensed by such a 3-axis accelerometer. In an embodiment, the accelerometer measures simultaneously along all three axes. Thus, the concept of sensing, measuring, or generating a position signal proportional to the acceleration along a particular axis is referred to, rather than the physical shape of the accelerometer. It should be understood that by applying a rotation of the reference frame / coordinate system, a reference to a particular axis (such as the x-axis) can also be replaced by a reference to any other axis (such as the y-axis and z-axis). The reference frame / coordinate system can be rotated by applying a rotation matrix according to linear algebra. Thus, in an embodiment, a reference to a specific axis is for illustrative purposes only. The same reasoning applies to any reference to the geometric plane spanned by the axes.

[0071] In an embodiment, the accelerometer includes certain processing capabilities such that the accelerometer can be turned on regardless of the power state of the processor of the monitor device. For example, the processing capabilities of the accelerometer include analyzing the position signal and sending relevant instructions to the processor. In an embodiment, as part of a power management system, the accelerometer is capable of turning on / off the processor of the monitor device.

[0072] In an embodiment, the accelerometer is a capacitive MEMS accelerometer. In an embodiment, the accelerometer is a piezoelectric accelerometer. In an embodiment, the accelerometer is a piezoresistive accelerometer. In an embodiment, the accelerometer has an analog output. In an embodiment, the accelerometer has a digital output. In an embodiment, the accelerometer is capable of measuring at least + / -2g. In an embodiment, the accelerometer can measure accelerations between -50g and 50g, such as between -20g and 20g, or such as between -10g and 10g. In an embodiment, the accelerometer has a bandwidth of at least 10Hz, such as 50Hz.

[0073] The present disclosure provides for the use of a baseplate and / or a sensing patch that includes a plurality of sensing zones, such as the angularly distributed sensing zones as described above. In an embodiment, the present disclosure provides for communicating to a user the zone where a leak has occurred. In an embodiment, a user may apply any rotational angle around his / her stoma to the baseplate and / or the sensing patch. For example, the presence of scars and / or wrinkles on the skin may cause the user to rotate the baseplate and / or the sensor by a certain angle, e.g., based on personal experience and / or comfort. In an embodiment, although the sensing zones are arranged in a particular array in the sensor assembly of the baseplate and / or the sensing patch, the baseplate and / or the sensing patch appears rotationally symmetric to the user. In one embodiment, data from the sensing zones is collected by a monitor device through a physical connection to the electrodes of the electrode / sensor assembly. In an embodiment, such physical connection is provided by a neck attached to and / or integral with the baseplate and / or the sensing patch, whereby the electrodes of the electrode assembly may extend into the neck and connect with the coupled monitor device at the assembly interface. Thus, in an embodiment, the baseplate and / or the sensing patch includes a neck extending radially away from the user's stoma, the neck including an assembly interface that allows the monitor device to be coupled to the baseplate and / or the sensing patch and through which to reach the electrode / sensor assembly. In an embodiment, the monitor device is configured to be coupled to the baseplate and / or the sensing patch and thus be worn closely against the user's skin. Thus, the monitor device is configured to be coupled to the baseplate and / or the sensing patch at its designated portion and to remain in such a fixed position relative to the baseplate and / or the sensing patch during the use of the baseplate and / or the sensing patch, i.e., during monitoring (such as leak monitoring). By being coupled to the baseplate and / or the sensing patch in a fixed position, the spatial orientation of the monitor device, such as the tilt relative to the natural orientation, indicates the equivalent tilt / rotation of the baseplate and / or the sensing patch. In other words, the (coupled) monitor device is fixed relative to the sensing zones provided in the sensor assembly of the baseplate and / or the sensing patch. In other words, the spatial orientation of the monitor device coupled to the baseplate and / or the sensing patch is equally applicable to the baseplate and / or the sensing patch by their fixed relative positions.

[0074] By providing an accelerometer for the monitor device, the spatial orientation of such monitor device can be determined. Thereby, since the monitor device is configured to be coupled to the baseplate and / or the sensing patch in a fixed position, the spatial orientation of the baseplate and / or the sensing patch relative to the stoma, such as the rotational offset, and the spatial orientation of the sensing zones provided in the baseplate and / or the sensing patch can be determined. Thereby, the location (in which sensing zone) where a leak may occur and / or the location where the moisture content absorbed in the adhesive is high / increasing can be communicated to the user.

[0075] In an embodiment, the position signal includes gravity values along the x-axis, along the y-axis, and along the z-axis, these axes being mutually orthogonal, and / or includes values of a first-order angular offset of the x-axis relative to a predefined orientation, a second-order angular offset of the y-axis relative to the predefined orientation, and a third-order angular offset of the z-axis relative to the predefined orientation.

[0076] In an embodiment, the x-axis, y-axis, and z-axis are mutually orthogonal according to the Cartesian coordinate system covered by a 3-axis accelerometer as described above.

[0077] In an embodiment, the position signal is mathematically represented as a vector or a matrix. In an embodiment, the position signal further includes a timestamp. By applying trigonometric functions, the total gravity can be calculated. Hereinafter, the gravity g is measured in Newtons ([N]), and for a freely falling object, 1g = 9.8 N = 9.8 m / s 2 。

[0078] In an embodiment, the position signal includes information about the gravity along the x-axis, the gravity along the y-axis, and the gravity along the z-axis.

[0079] In an embodiment, additionally or alternatively, the position signal includes information about a first-order angular offset of the x-axis relative to a predefined orientation, a second-order angular offset of the y-axis relative to the predefined orientation, and a third-order angular offset of the z-axis relative to the predefined orientation.

[0080] In an embodiment, the angular offset refers to the angular deviation between a predefined orientation and a given axial component (such as the x-axis, y-axis, or z-axis). In an embodiment, the predefined orientation is such an orientation in which one axis (such as the x-axis, or y-axis, or z-axis) is aligned with the direction of gravity, while the remaining group of axes (such as the y-axis and z-axis, or y-axis and x-axis, or z-axis and x-axis) spans a geometric (horizontal) plane normal / perpendicular to the direction of gravity. For example, the angular offset of the axis can be measured relative to the direction of gravity or relative to the horizontal plane.

[0081] In an embodiment, the position signal includes the values of the relative acceleration of the monitor device along the x-axis, y-axis, and z-axis. Thus, information related to the movement of the monitor device can be directly read from this position signal or from two or more position signals. In an embodiment, the relative acceleration indicates the movement of the monitor device. In an embodiment, the relative acceleration can be calculated based on the information related to the gravity along the x-axis, along the y-axis, and along the z-axis.

[0082] In an embodiment, the predefined orientation is the predefined natural orientation of the accelerometer. In an embodiment, the angular offset represents the deviation from the natural orientation. Thus, in an embodiment, the angular offset indicates the tilt of the accelerometer and thus the tilt of the monitor device including the accelerometer. In an embodiment where the monitor device is coupled to a baseplate and / or a sensing patch including a sensor assembly (in particular a sensor assembly including two or more sensing zones), the indication of the tilt of the monitor device is also the tilt / rotation offset of the baseplate and / or the sensing patch. In an embodiment, the processor generates an offset parameter based on one or more position signals. In an embodiment, the offset parameter is used to compensate for the tilt of the monitor device / baseplate / sensing patch when communicating the presence of a possible leak and its position relative to the stoma.

[0083] In an embodiment, the position signal is sampled at a rate of at least 0.1 Hz. In other words, in an embodiment, the sampling rate of the position signal is at least 0.1 Hz. Further in other words, a position signal is obtained at least every ten seconds. Sampling the position signal means that the accelerometer obtains a position signal at least every ten seconds. Thereby, every ten seconds, the spatial orientation of the accelerometer and thus the monitor device is evaluated. In an embodiment, the position signal is sampled at a rate of at least 1 Hz (i.e., once per second). In an embodiment, the sampling rate is at least 100 Hz, or at least 200 Hz, or at least 2000 Hz. By increasing the sampling rate, a more accurate evaluation of the spatial orientation of the monitor device is obtained. In an embodiment, this more accurate evaluation is useful for the registration of the tap sequence as described above. In addition, this more accurate evaluation provides the possibility of using the monitor device to track activities and / or physiological changes, such as the number of steps taken by the user, the time spent in bed, the breathing rhythm, or the heart rate.

[0084] In an embodiment, the monitor device is capable of tracking the activities of a user wearing the monitor device, i.e., monitoring the movement and possibly the intensity of such movement. In other words, in an embodiment, the monitor device tracks the user's activities by generating position signals related to the movement of the monitor device and thus to the user's movement. In an embodiment, during activity tracking, the sampling rate is at least 100 Hz, or at least 200 Hz, or at least 2000 Hz. In an embodiment, the monitor device is capable of distinguishing between different activities, including walking, running, cycling, tennis, etc. In an embodiment, such different activities produce different movements and thus different (distinguishable) position signals, which can be assigned to different activities. In an embodiment, data related to activity tracking can be transmitted to a system capable of determining or predicting the future operating state of a stoma appliance. In other words, in an embodiment, the system is capable of determining or predicting the likelihood of leakage or deterioration of the adhesive properties of the stoma appliance. In an embodiment, such a system can warn the user (e.g., via an accessory device) of the likelihood of leakage, e.g., due to a specific activity tracked and determined by the monitor device. In an embodiment, data related to activity tracking, such as the type of activity determined, is used to predict the amount of sweat produced. In an embodiment, the predicted amount of sweat is used to determine the future operating state of the stoma appliance.

[0085] In an embodiment, the sampling rate is adjustable, e.g., according to the power management system of the monitor device. In an embodiment, the sampling rate depends on the power management mode of the monitor device. In an embodiment, when the monitor device determines that the user is at rest, e.g., at night or when he / she is sitting or lying down, the sampling rate is low, such as less than 1 Hz, such as 0.1 Hz. In an embodiment, when the monitor device determines that the user is active, e.g., during the day, or when he / she is walking / exercising, the sampling rate is high, such as greater than 1 Hz or greater than 100 Hz, such as 2000 Hz.

[0086] In an embodiment, the monitor device includes a power management mode, wherein unless a significant acceleration is measured / detected by the accelerometer, the monitor device or at least the processor remains in a power saving mode (e.g., when the processor is turned off or remains in a sleep mode with certain functions turned off). In an embodiment, the significant acceleration is an acceleration associated with an intentional tap on the monitor device. The significant acceleration refers to an acceleration greater than + / - 0.2g, such as greater than + / - 0.5g, or such as greater than + / - 1g, such as + / - 2g. Thus, the significant acceleration can be defined as a threshold, for example, a threshold in combination with one of the exemplary accelerations. Thereby, as long as the monitor device is only exposed to a small acceleration, i.e., an acceleration less than the threshold defining the significant acceleration as described above, the battery can be saved. Therefore, in an embodiment of the power management mode, the accelerometer does not respond to small accelerations, but is configured to respond to the significant acceleration as defined above. Thus, in an embodiment, once exposed to the significant acceleration, the accelerometer instructs the processor to exit the power saving mode.

[0087] In an embodiment, the position signal indicates the spatial orientation of the monitor device. In an embodiment, the position signal indicates the spatial orientation of the monitor device relative to a predefined natural orientation. Since the position signal includes information about relative acceleration, gravity, and / or angular offset / tilt, and since the accelerometer is fixed inside the monitor device, the spatial orientation of the monitor device can be determined. In an embodiment, the movement of the monitor device is determined by calculating the difference between two position signals separated in time. Thereby, the (relative) movement of the monitor device can be tracked. In an embodiment where the monitor device is coupled to a baseplate and / or a sensing patch including a sensor assembly (in particular a sensor assembly including two or more sensing zones), the indication of the tilt of the monitor device is likewise the tilt / rotation offset of the baseplate and / or the sensing patch. Thus, the position signal can be used to generate an offset parameter that is used to compensate for such tilt when, for example, the presence of a possible leak and its position relative to the stoma are communicated to the user via a graphical user interface (GUI), such as a GUI included in an accessory device (such as a smartphone).

[0088] In an embodiment, the accelerometer includes a predefined natural orientation, wherein the primary angular offset of the x-axis relative to the direction of gravity is zero, or the secondary angular offset of the y-axis relative to the direction of gravity is zero, or the tertiary angular offset of the z-axis relative to the direction of gravity is zero.

[0089] By introducing / defining a natural orientation, this natural orientation forms a reference for any inclination / rotation offset. In an embodiment, the natural orientation is the orientation of the accelerometer and thus of the monitor device, wherein one of the axes (x, y, z) of the Cartesian coordinate system is aligned with the direction of gravity, and wherein the remaining group of axes spans a geometric (horizontal) plane perpendicular / norm to the direction of gravity. In an embodiment, the natural orientation is defined as the case where the y-axis is aligned with the direction of gravity and the x-axis and z-axis span the geometric plane and are thus horizontal. In an embodiment, the natural orientation is defined as the case where the x-axis is aligned with the direction of gravity and the y-axis and z-axis span the geometric plane and are thus horizontal. In an embodiment, the natural orientation is defined as the case where the z-axis is aligned with the direction of gravity and the x-axis and y-axis span the geometric plane and are thus horizontal. In an embodiment, alignment means that the corresponding axis is parallel to the direction of gravity, but the direction of the axis can be positive or negative in the direction of gravity. In an embodiment, the natural orientation is predefined by the manufacturer, thereby allowing the manufacturer or service provider to know how to communicate the leakage status (where the leakage occurs). In an embodiment, the natural orientation is, for example, resetable or redefinable by the user.

[0090] In other words, the natural orientation can be expressed as a neutral orientation or a default direction.

[0091] In an embodiment, the accelerometer includes a predefined natural orientation, wherein the gravity along the x-axis of the accelerometer is 0g, and wherein the gravity along the y-axis of the accelerometer is -1g.

[0092] This provides a specific embodiment of the natural orientation, wherein the y-axis of the accelerometer is parallel to the direction of gravity, and wherein the positive direction of the y-axis is opposite to the direction of gravity, i.e., the gravity along the y-axis in the direction of gravity is -1g. Similarly, since according to the Cartesian coordinate system, the x-axis is orthogonal to the y-axis, the gravity along such x-axis is 0g. Therefore, the gravity along the z-axis is also 0g. In an embodiment, the gravity along the y-axis is +1g. Therefore, according to the embodiment, the x-axis and z-axis span a horizontal geometric plane (i.e., perpendicular to the direction of gravity and the y-axis). Therefore, the direction of gravity is normal to the geometric plane spanned by the x-axis and z-axis.

[0093] In an embodiment, the accelerometer includes a predefined natural orientation, wherein the gravity along the y-axis is + / -1g. In an embodiment, the accelerometer includes a predefined natural orientation, wherein the gravity along the x-axis is + / -1g. In an embodiment, the accelerometer includes a predefined natural orientation, wherein the gravity along the z-axis is + / -1g.

[0094] In an embodiment, the accelerometer is configured to determine its spatial orientation relative to the user's stoma based on a motion pattern generated by the user. In an embodiment, the motion pattern is generated by the user wearing the monitor device. When the user has attached the baseplate and / or the sensing patch to the skin area around the stoma, i.e., when the sensor assembly at least partially surrounds the stoma, it is a challenge to understand how the possible sensing area of the sensor assembly is arranged relative to the stoma. For most users, "upward" is naturally considered as the direction pointing to the head, while "downward" is considered as the direction pointing to the lower body / feet. However, these terms can be considered ambiguous in a general sense when the user is exercising, lying down, sitting, upside down, etc. Therefore, there is a need for a monitor device that can determine its spatial orientation relative to the stoma and thus the spatial orientation of the sensor assembly relative to the stoma. As previously disclosed, in an embodiment, by knowing the spatial orientation of the monitor device, any rotation of the sensor assembly (which may include the sensing area) can be inferred.

[0095] In an embodiment, such as when the monitor device is coupled to the baseplate and / or the sensing patch, and the baseplate and / or the sensing patch are attached to the skin area around the stoma, i.e., the sensor assembly of the baseplate and / or the sensing patch surrounds the stoma, the accelerometer is configured to generate position signals at a specific sampling rate (such as 0.1 Hz or 1 Hz, or greater than 1 Hz). Each position signal includes information related to the spatial orientation of the monitor device when the specific position signal is generated. Therefore, in an embodiment, by sampling over a specific time interval, a trend of the position signals is formed. For example, if the user walks back and forth / stands up after connecting the baseplate and / or the sensing patch to the monitor device, the trend can reveal the average angular offset of the monitor device relative to a predefined natural orientation. In an embodiment, the average angular offset indicates the rotational offset of the sensor assembly of the baseplate and / or the sensing patch relative to the natural orientation. In an embodiment, the motion pattern / position signals generated by a standing / walking user are different from those of a bedridden user and a sitting user. Therefore, in an embodiment, the monitor device is configured to distinguish different body positions.

[0096] In an embodiment, the average angular offset is transmitted to an accessory device, such as a smartphone. In an embodiment, the accessory device includes a GUI configured to display a visual representation of at least two sensing zones of the sensor assembly. In an embodiment, the visual representation includes information related to the state of the area covered by the respective sensing zone, wherein the state can be an indication of the presence of liquid (e.g., leakage). In an embodiment, the average angular offset is applied to the visual representation in a manner that reflects the physical orientation of the sensor assembly relative to the user's stoma in the visual representation, e.g., applied to a mathematical model for generating the visual representation. For example, if the user prefers to wear his / her baseplate and / or sensing patch that is slightly rotated due to the presence of scars or wrinkles, such rotation is reflected in the visual representation in the GUI. In particular, the presence of a neck integral with the baseplate and / or sensing patch may cause the user to rotate his / her baseplate and / or sensing patch to avoid attaching the adhesive surface of such neck to the scars and / or wrinkles.

[0097] In an embodiment, the motion pattern includes a plurality of position signals sampled during a predefined amount of time. In an embodiment, the predefined amount of time depends on the sampling rate of the plurality of position signals. In an embodiment, the predefined amount of time is between 1 minute and 60 minutes, such as between 1 minute and 30 minutes, such as between 5 minutes and 20 minutes, such as 10 minutes. In an embodiment, the motion pattern is continuously generated by the user's motion. In an embodiment, the motion pattern includes a plurality of position signals sampled during a floating amount of time, such as the previous 10 minutes, or any previous amount of time selected between 1 minute and 60 minutes, such as the previous 30 minutes.

[0098] In an embodiment, the average angular offset is based on the calculated average / mean of at least 10 position signals, or at least 100 position signals, or at least 500 position signals. In an embodiment, the average angular offset indicates the rotational offset of the baseplate and / or sensing patch relative to a predefined natural orientation.

[0099] In an embodiment, the spatial orientation of the accelerometer indicates the rotational offset of the sensor assembly when the monitor device is coupled to the sensor assembly. In an embodiment, the monitor device is coupled to the sensor assembly of the baseplate or the sensing patch. Thus, the spatial orientation of the accelerometer, such as the tilt and thus the spatial orientation of the monitor device, indicates / corresponds to the rotational offset of the sensor assembly. In an embodiment, the rotational offset is relative to a natural orientation, such as the natural orientation previously disclosed. In an embodiment, the spatial orientation of the accelerometer indicates the position of one or more (such as two or more) sensing zones relative to the stoma. In an embodiment, the spatial orientation of the accelerometer is the average angular offset of the accelerometer and is thus the average value obtained from the plurality of position signals as described above.

[0100] In an embodiment, the processor is configured to generate an offset parameter based on an angular offset of the accelerometer relative to its natural orientation. In an embodiment, the processor is configured to transmit the position signal and / or the offset parameter to an accessory device.

[0101] In an embodiment, the accelerometer is configured to generate an offset parameter based on an angular offset of the accelerometer relative to its natural orientation. In an embodiment, the monitor device is coupled to a sensor assembly of a base plate or a sensing patch. Thus, in an embodiment, the offset parameter is a parameter indicating a rotational offset of the sensor assembly relative to the natural orientation. In an embodiment, the angular offset can be considered to be related to a two-dimensional plane, such as a geometric plane spanned by two axes of the accelerometer, which geometric plane is selected to be substantially parallel to the plane in which the base plate and / or the sensing patch is located.

[0102] In an embodiment, the offset parameter is transmitted to an accessory device. In an embodiment, the monitor device includes a transceiver for wireless communication with the accessory device. In an embodiment, the monitor device is configured to send a signal indicating the offset parameter to the accessory device. In an embodiment, communication, such as transmitting the parameter from the monitor device to the accessory device, means sending a signal indicating the parameter, for example, according to a wireless protocol, such as via a Bluetooth connection. In an embodiment, the accessory device includes a graphical user interface. In an embodiment, the offset parameter is used to generate a visual representation of the sensor assembly such that the visual representation incorporates the rotational offset of the physical sensor assembly applied to the skin area around the stoma, such as via the base plate or the sensing patch.

[0103] In an embodiment, the housing includes a skin-facing surface, and the x-axis and y-axis of the accelerometer span a geometric plane that is substantially parallel to the skin-facing surface of the housing, and the z-axis of the accelerometer extends in a direction normal to the geometric plane. In an embodiment, the housing defines the spatial extent of the monitor device, i.e., the outer shape of the monitor device. In an embodiment, the monitor device and thus its housing are configured to be worn by a user under his / her clothing, near the stoma, such that the monitor device can obtain data related to the sensor assembly disposed in the skin area around the stoma. Thus, in an embodiment, the housing is small and / or compact. In an embodiment, the housing includes a skin-facing surface that is substantially planar to be flush with the skin, or the neck of the base plate and / or the sensing patch. In an embodiment, the substantially flat skin-facing surface is parallel to the geometric plane spanned by the x-axis and y-axis of the accelerometer, whereby the z-axis of the accelerometer is normal to the geometric plane. In an embodiment, the substantially flat skin-facing surface of the housing is adapted to be arranged parallel to the geometric plane spanned by the base plate and / or the sensing patch. Thus, thereby, the geometric plane spanned by the x-axis and y-axis of the accelerometer is adapted to be arranged parallel to the geometric plane spanned by the base plate and / or the sensing patch.

[0104] Thus, the accelerometer and the housing share a certain geometry that is useful for providing the user with a sense of the orientation of the monitor device. Moreover, the inclination of the accelerometer in the geometric plane spanned by its x-axis and y-axis corresponds to the inclination of the base plate and / or the sensing patch because the geometric plane spanned by the base plate and / or the sensing patch is parallel to the geometric plane spanned by the x-axis and y-axis of the accelerometer and because the accelerometer (fixed in the housing of the monitor device) is fixed relative to the base plate and / or the sensing patch.

[0105] In an embodiment, the x-axis and z-axis of the accelerometer span a geometric plane that is substantially parallel to the skin-facing surface of the housing, and the y-axis of the accelerometer extends in a direction normal to the geometric plane.

[0106] In an embodiment, the y-axis and z-axis of the accelerometer span a geometric plane that is substantially parallel to the skin-facing surface of the housing, and the x-axis of the accelerometer extends in a direction normal to the geometric plane.

[0107] In an embodiment, two axes selected from the x-axis, y-axis, and z-axis of the accelerometer span a geometric plane that is substantially parallel to the skin-facing surface of the housing, and the unselected accelerometer axis extends in a direction normal to the geometric plane.

[0108] In an embodiment, the appliance interface is configured to be coupled to a plurality of electrodes forming at least two sensors, the at least two sensors being arranged in at least two separate sensing zones configured to monitor the skin surface around a stoma. In an embodiment, monitoring means that the sensors are configured to detect the presence of liquid (effluent) in the skin area around the stoma or the (increased) moisture content in the adhesive layer of the base plate and / or the sensing patch. In an embodiment, the appliance interface includes a number of terminals required to connect to a corresponding number of electrodes. In an embodiment, two electrodes form a sensor. In an embodiment, four electrodes are required for two sensors. In an embodiment, the first and second electrodes share a common ground, such that three electrodes are sufficient to form two sensors. Thus, in an embodiment where one of the electrodes is a common ground, the appliance interface includes at least three terminals configured to be coupled to three electrodes. At least two sensors are arranged in at least two sensing zones. The sensing zones may be primary and secondary sensing zones arranged in primary and secondary angular spaces around a stoma.

[0109] In an embodiment, the processor is configured to determine a spatial distribution of at least two sensing zones based on one or more position signals. In an embodiment, the processor is configured to determine a spatial distribution of at least two sensors, such as relative to a stoma, when the monitor device is attached to a base plate or a sensing patch adhered to the peristomal skin surface. As previously disclosed, by knowing the angular offset of the monitor device relative to the natural orientation, and thus the angular offset of the sensor assembly when the monitor device is coupled to the sensor assembly, it is possible to determine how the at least two sensing zones are distributed around the stoma. In particular, by knowing how the sensor assembly as a whole rotates around the stoma relative to the natural orientation, and by knowing how the sensing zones are arranged in the sensor assembly, the actual spatial distribution applied to the peristomal skin can be determined. In an embodiment, the arrangement of the sensing zones in the sensor assembly is predefined. In an embodiment, the arrangement of the sensing zones in the sensor assembly is predefined by the manufacturer.

[0110] In an embodiment, one or more task profiles are stored on the memory of the monitor device, and the monitor device is configured to detect one or more tap sequences included in the one or more position signals. In an embodiment, the memory is a non-transitory memory. The one or more task profiles may correspond to one or more tap sequences generated by the user and included in the one or more position signals. A tap sequence included in the one or more position signals means that the position signal includes information related to any movement of the monitor device (accelerometer), such as a tap applied by the user. Thus, the movement of the monitor device (accelerometer) caused by such a tap is included in the one or more position signals. In an embodiment, the sampling rate of the position signal is at least 1 Hz, or at least 10 Hz, or at least 2000 Hz in order to resolve the tap sequence.

[0111] For example, a tap sequence may be two short and substantially identical taps of a finger on the monitor device. Such a tap sequence may be compared with a certain task profile stored on the memory of the monitor device, i.e., a certain task profile may correspond to two short and substantially identical taps of a finger on the monitor device. By comparing the detected tap sequence (i.e., by comparing the one or more position signals) with the one or more task profiles stored on the memory of the monitor device, an output / action can be assigned to each tap sequence. Thus, in an embodiment, the user can control certain aspects of the monitor device only by tapping on the monitor device.

[0112] In an embodiment, the processor is configured to compare a given tap sequence among one or more tap sequences with one or more task profiles and generate an output associated with the given tap sequence. In an embodiment, the output is configured to affect the function of the monitor device. The output refers to an action that affects the function of the monitor device. In an embodiment, when the monitor device is tapped, the induced motion is detected by an accelerometer and included in one or more position signals. In an embodiment, the position signals, i.e., the tap sequence, are compared with one or more task profiles. In an embodiment, the comparison is performed by the processor. In an embodiment, the comparison is performed by the accelerometer. In an embodiment, a certain output is generated based on the compliance finding between the stored task profile and the detected tap sequence. In an embodiment, the output and thus the subsequent function of the monitor device depend on the specific tap order.

[0113] In an embodiment, the output is selected from waking up the monitor device from the sleep mode, starting the pairing mode, or entering the sleep mode. In an embodiment, the output depends on the given tap sequence. In an embodiment, the output affects the function of the monitor device, for example, by sending appropriate instructions to the processor, the accelerometer, or other components included in the monitor device. In an embodiment, the functions of the monitor device include exiting / entering the sleep mode and starting the pairing mode. In an embodiment, when implemented by generating an output, the task profile that prompts the monitor device to wake up from the sleep mode is stored in the memory of the monitor device. Thus, in an embodiment, by tapping the monitor device in a first specific mode / by a specific first tap sequence, the monitor device wakes up from the sleep mode. In an embodiment, by tapping the monitor device in a second specific mode / by a specific second tap sequence, the monitor device enters / starts the pairing mode. In an embodiment, the pairing mode is a mode of the monitor device in which the transceiver included in the monitor device is active for wireless pairing with an accessory device including another transceiver. Thereby, the user can connect the monitor device to the accessory device through a wireless connection by tapping in a specific second mode. In an embodiment, by tapping the monitor device in a third specific mode / by a specific third tap sequence, the monitor device enters the sleep mode. In an embodiment, the sleep mode is a state in which the monitor device saves battery / power by turning off certain pre-selected functions.

[0114] In an embodiment, in response to a certain tap sequence, the monitor device can enter the flight mode in which the wireless connection is turned off. Thus, by tapping the monitor device according to a certain task profile, the wireless connection can be turned off, for example, to comply with regulations related to such a wireless connection. In an embodiment, the monitor device can exit the flight mode by tapping the monitor device according to a second task profile. In an embodiment, the functions of the monitor device include entering / exiting the flight mode.

[0115] In an embodiment, obtaining ostomy data as described above is a default function of the monitor device that is automatically initiated by coupling the monitor device to the sensor assembly. In an embodiment, obtaining ostomy data is a function of the monitor device that is controllable by a tap sequence.

[0116] Thereby, a user can control different functions of the monitor device by simply tapping anywhere on the monitor device. The tap causes movement of the monitor device and thus, in the position signal generated by the accelerometer, includes information regarding / indicating the movement.

[0117] In an embodiment, the monitor device is configured to turn off or enter a sleep mode if no movement is detected within a predefined amount of time. In an embodiment, the monitor device is configured to turn off or enter a sleep mode if multiple consecutive position signals are the same. In an embodiment, if the position signals obtained within a specific time period, such as within 10 minutes, are the same, the monitor device is configured to turn off or enter a sleep mode. In practice, it is generally impossible for a living person to wear a monitor device including an accelerometer for a long time (e.g., 10 minutes) without making a detectable movement, i.e., without movement detected / sensed by the accelerometer and information regarding the movement being included in the position signal. Thus, in an embodiment, if multiple position signals are the same (or; if multiple consecutive position signals sampled within a predefined amount of time are the same), it indicates that the monitor device is not being worn. In an embodiment, the number of consecutive identical position signals before the monitor device is turned off or enters a sleep mode (i.e., the predefined amount of time) can be specified by the user or the manufacturer. In an embodiment, the number of consecutive identical position signals before the monitor device turns off or enters a sleep mode depends on the sampling rate such that the monitor device can turn off after 1 minute regardless of the sampling rate. In other words, for a sampling rate of 0.1 Hz, 6 position signals are generated in one minute, while for a sampling rate of 1 Hz, 60 position signals are generated in one minute. Thus, in an embodiment, the monitor device is turned off depending on the elapsed time including identical position signals. In an embodiment, if no movement (i.e., identical position signals) is detected for at least 1 minute, such as 1 minute, or such as 5 minutes, or such as 10 minutes, the monitor device turns off or enters a sleep mode.

[0118] In an embodiment, the monitor device remains turned off or in a sleep state until, for example, the user manually turns the monitor device back on. In an embodiment, when the monitor device is turned off or in a sleep state, the accelerometer can be periodically awakened and check for movement. Thereby, in an embodiment, when the accelerometer senses movement, such as by generating two different position signals, the monitor device can be automatically turned back on.

[0119] According to a second aspect of the present invention, a method for determining a rotational offset of a sensor assembly of a stoma appliance relative to a stoma is disclosed. The sensor assembly may be coupled to a monitor device such that the position of the monitor device relative to the sensor assembly is fixed. The monitor device includes a housing, a processor disposed in the housing, and an appliance interface configured to couple the monitor device to the sensor assembly, the appliance interface including a plurality of terminals for connection to a plurality of electrodes of the sensor assembly. Further, the monitor device includes a (3-axis) accelerometer configured to generate a position signal. The sensor assembly includes a plurality of electrodes forming two or more sensors, such as two or more sensors configured to determine the presence of liquid in the skin area around the stoma. The two or more sensors are arranged in at least two separate sensing zones, such as for monitoring the skin area around the stoma. Further, the sensor assembly includes a component interface configured to couple to the appliance interface of the monitor device. The method includes the steps of obtaining one or more position signals from the accelerometer (e.g., when the stoma appliance including the sensor assembly has been arranged in the skin area around the stoma and the monitor device is coupled to the sensor assembly) and determining a rotational offset of the sensor assembly based on the one or more position signals. The rotational offset may be relative to the natural orientation of the accelerometer. The one or more position signals indicate (i.e., include information about) the spatial orientation of the accelerometer and thus the spatial orientation of the monitor device itself.

[0120] In an embodiment, the stoma appliance is the baseplate and / or the sensing patch as described above. Thus, the stoma appliance is provided with an adhesive, such as a first adhesive layer, to provide attachment to the skin area around the stoma.

[0121] There is thus provided a method for determining a rotational offset of a sensor assembly relative to a stoma, in particular where the rotational offset is determined relative to a predefined natural orientation. The method utilizes the monitor device as disclosed previously with respect to the first aspect of the present invention. Thus, the above-disclosed embodiments of the monitor device are equally applicable to the monitor device used in the method for determining a rotational offset of a sensor assembly relative to a stoma as disclosed herein.

[0122] In an embodiment, the method includes an initial step of defining the natural orientation of the monitor device / the accelerometer of the monitor device. In an embodiment, the natural orientation is defined according to the embodiments of the monitor device disclosed above. In an embodiment, the natural orientation of the monitor device is defined by the user, for example by arranging the monitor device on a flat / horizontal surface according to a predefined procedure. In an embodiment, the natural orientation of the monitor device is predefined by the manufacturer.

[0123] In an embodiment, the monitor interface communicates with an accessory device that includes a graphical user interface, and the method further includes the steps of transmitting a rotational offset to the accessory device and generating (e.g., by a processor of the accessory device) a visual representation in the graphical user interface. The visual representation incorporates the rotational offset and shows the positions of at least two sensing zones relative to the stoma. In an embodiment, the accessory device (also referred to as an external device) is a mobile phone, such as a smart phone, or another handheld device. In an embodiment, the accessory device can be a personal electronic device, such as a wearable device, like a watch or other wrist-worn electronic device. In an embodiment, the accessory device is a docking station. In an embodiment, the docking station can be configured to electrically couple and / or mechanically couple the monitor device to the docking station.

[0124] In an embodiment, the graphical user interface (GUI) includes a screen configured to display a visual representation of at least two sensing zones relative to the stoma. In an embodiment, the visual representation is included in an application (app) of the accessory device. In an embodiment, the visual representation visualizes the positions of at least two sensing zones relative to the stoma, including the sensor assembly arrangement in the baseplate and / or the sensing patch around the stoma. Thus, the visual representation provides an easy-to-use way to convey to the user the status of his / her baseplate and / or sensing patch, e.g., by conveying that there may be a leak, i.e., the presence of liquid (such as effluent), in the skin area around the stoma. The visual representation incorporating the rotational offset means that the rotational offset is implemented in the visual representation such that the visual representation visualizes the sensor assembly, including any possible rotational offset. Thus, an easy-to-understand visualization of his / her baseplate and / or sensing patch including the sensing patch is provided to the user, and he / she can clearly see and understand where a possible leak is occurring (in which sensing zone), or where the adhesive has become weak due to increased / large moisture absorption in the adhesive layer.

[0125] In an embodiment, a plurality of sensing zones are provided, each sensing zone spanning a (separate) angular space. In an embodiment, the rotational offset is used as a correction factor such that the visualization of the sensor assembly / sensing zones is corrected by the rotational offset. In an embodiment, the position of each sensing zone is floating, meaning that the position of each sensing zone is defined by a mathematical model that uses the rotational offset as an input parameter. For example, the visual representation is static (always looks the same on the screen, as opposed to the above example where the visual representation reflects the physically adhered baseplate and / or sensing patch), but the data used to illustrate a possible leak is corrected by the rotational offset such that the visual representation shows the leak as occurring at a position relative to, e.g., the neck of the baseplate and / or the sensing patch and / or the monitor device rather than relative to, e.g., the user's body features ("up", "down"). In this embodiment, a large number of sensing zones (e.g., three or more, e.g., four or five) enhance the visualization because more sensing zones provide better sensitivity.

[0126] In a third aspect of the present invention, there is provided a stoma system comprising a sensor assembly and a monitor device. The monitor device includes a housing, a processor disposed in the housing, an appliance interface including a plurality of terminals for connection to a plurality of electrodes of the sensor assembly, and an (e.g., triaxial) accelerometer configured to generate a position signal. The sensor assembly includes a plurality of electrodes forming two or more sensors, such as configured to determine the presence of liquid / moisture in the skin area around the stoma. The two or more sensors are arranged in at least two separate sensing zones. Further, the sensor assembly includes a component interface configured to couple to the appliance interface of the monitor device. The monitor device is configured to couple to the sensor assembly. The monitor device can thus be fixed relative to the sensor assembly such that the spatial orientation of the monitor device is translated to the corresponding orientation of the sensor assembly. There is thus provided a stoma system utilizing the monitor device disclosed above, which stoma system is capable of determining the rotational offset of the sensor assembly by providing a (triaxial) accelerometer in the monitor device.

[0127] In an embodiment, the appliance interface is configured to couple to the component interface. In an embodiment, the coupling is a mechanical coupling. In an embodiment, the coupling is a wireless coupling. In an embodiment of the wireless coupling, the monitor device is configured to attach to the user or the stoma appliance of the sensor assembly at a predefined and fixed position relative to the sensor assembly.

[0128] In an embodiment, the sensor assembly is provided in the stoma appliance. In an embodiment, the stoma appliance is the baseplate or the sensing patch as previously disclosed. There is thus provided a device for attaching (e.g., adhering) the sensor assembly to the skin area around the stoma of the user.

[0129] In an embodiment, the accelerometer of the monitor device includes a predefined natural orientation, and the monitor device is configured to determine the rotational offset of the sensor assembly relative to the predefined natural orientation.

[0130] There is thus provided a stoma system capable of determining the rotational offset of the sensor assembly and thus for positioning the two or more sensing zones provided in the sensor assembly. Description of the Drawings

[0132] Figure 1Shows an exemplary ostomy system. The ostomy system 1 includes an ostomy appliance 2 having a baseplate 4. The baseplate 4 is adapted to support an ostomy pouch (not shown). Further, the ostomy system 1 includes a monitor device 6 and an accessory device 8 (mobile phone / smartphone). The monitor device 6 can be connected to the baseplate 4 via corresponding first connectors of the monitor device 6 and the baseplate 4. The monitor device 6 is configured to communicate wirelessly with the accessory device 8. Optionally, the accessory device 8 is configured to communicate with the server device 10 of the ostomy system 1, for example, via a network 12. The server device 10 can be operated and / or controlled by the ostomy appliance manufacturer and / or a service center. Ostomy data or parameter data based on the ostomy data is obtained from the electrodes / sensors of the ostomy appliance 2 having the monitor device 6. The monitor device 6 processes the ostomy data and / or the parameter data based on the ostomy data. Based on the processed ostomy data, the monitor device 6 can determine what monitor data is 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 can be implemented as another handheld device, such as a tablet device, or a wearable device, such as a watch or other wrist-worn electronic device. Accordingly, the monitor device 6 is configured to determine the monitor data and send it to the accessory device 8. The baseplate 4 includes a coupling member 14 in the form of a coupling ring 16 for coupling an ostomy pouch (not shown) to the baseplate (two-piece ostomy appliance). The baseplate 4 has an ostomy opening 18 with a center point 19. The size and / or shape of the ostomy opening 18 is typically adjusted by the user or a nurse before applying the ostomy appliance to fit the user's stoma.

[0133] The ostomy system 1 optionally includes a docking station 20 that forms an alternative / additional accessory device of the ostomy system 1. The docking station 20 includes a monitor expansion interface that includes a first connector 22 configured to electrically and / or mechanically connect the monitor device 6 to the docking station 20. The monitor expansion interface can be configured to wirelessly connect the monitor device to the docking station. The docking station 20 includes a user interface 24 for receiving user input and / or providing feedback to the user regarding the operating state of the docking station 20. The user interface 24 can include a touch screen. The user interface 24 can include one or more physical buttons and / or one or more visual indicators, such as light-emitting diodes.

[0134] Figure 2It is a schematic block diagram of an exemplary monitor device. The monitor device 6 includes a monitor device housing 100, a processor 101, and one or more interfaces, and the one or more interfaces include a first interface 102 (appliance interface) and a second interface 104 (accessory interface). The monitor device 6 includes a memory 106 for storing ostomy data and / or parameter data based on the ostomy data. The memory 106 is connected to the processor 101 and / or the first interface 102.

[0135] The first interface 102 is configured to electrically and / or mechanically connect the monitor device 6 to an ostomy appliance, such as the appliance interface of the ostomy appliance 2. The first interface 102 includes a plurality of terminals to form electrical connections with corresponding terminals of the ostomy appliance 2 (baseplate 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 for forming a mechanical connection, such as a releasable coupling, between the monitor device and the baseplate. The coupling portion 120 and the terminals 108, 110, 112, 114, 116, and 118 of the first interface 102 form at least a part of the first connector of the monitor device 6.

[0136] The monitor device 6 includes a power supply unit 121 for powering the monitor device and its active components, that is, the power supply unit 121 is connected to the processor 101, the first interface 102, the second interface 104, and the memory 106. The power supply unit includes a battery and a charging circuit system. The charging circuit system is connected to the battery and the terminals of the first interface 102 to charge the battery via the terminals of the first interface, such as the terminals of the first connector.

[0137] The second interface 104 of the monitor device is configured as an accessory interface for connecting the monitor device 6 to one or more accessory devices, such as the accessory device 8. The second interface 104 includes an antenna 122 and a wireless transceiver 124 configured for wireless communication with the (multiple) accessory devices. Optionally, the second interface 104 includes a speaker 126 and / or a tactile feedback element 128 for providing corresponding audio signals and / or tactile feedback to the user.

[0138] The monitor device 6 includes a 3-axis accelerometer 540 connected to the processor 101.

[0139] The processor 101 is configured to apply a processing solution, and the first interface 102 (appliance interface) is configured to collect ostomy data from a baseplate and / or a sensing patch coupled to the first interface, the ostomy data including leakage ostomy data from a leakage electrode of an ostomy appliance. The ostomy data optionally includes: first ostomy data from a first electrode pair of the baseplate and / or the sensing patch, second ostomy data from a second electrode pair of the baseplate and / or the sensing patch, and / or third ostomy data from a third electrode pair of the baseplate and / or the sensing patch. The ostomy data can be stored in the memory 106 and / or processed in the processor 101 to obtain parameter data. The parameter data can be stored in the memory 106. The processor 101 is configured to apply a processing solution, wherein applying the processing solution includes obtaining first-level leakage parameter data based on first-level leakage ostomy data; obtaining second-level leakage parameter data based on second-level leakage ostomy data; and obtaining third-level leakage parameter data based on third-level leakage ostomy data. Optionally, the processing solution includes obtaining first parameter data based on the first ostomy data; obtaining second parameter data based on the second ostomy data; obtaining third parameter data based on the third ostomy data. In other words, the processor 101 can be configured to obtain first, second, and third parameter data based on the corresponding first, second, and third ostomy data. Applying the processing solution includes determining an operating state of the baseplate and / or the sensing patch of the ostomy appliance based on one or more, such as all, of the first-level leakage parameter data, the second-level leakage parameter data, and the third-level leakage parameter data, wherein the operating state indicates a severe leakage risk in the sensing area of the ostomy appliance. The monitor device 6 is configured to send a first-level leakage monitor signal via the second interface according to determining that the operating state is a first-level leakage operating state, the first-level leakage monitor signal including monitor data indicating the first-level leakage operating state of the baseplate and / or the sensing patch; and send a second-level leakage monitor signal via the second interface according to determining that the operating state is a second-level operating state, the second-level leakage monitor signal including monitor data indicating the second-level operating state of the baseplate and / or the sensing patch. The monitor device 6 can be configured to send a third-level leakage monitor signal via the second interface according to determining that the operating state is a third-level leakage operating state, the third-level leakage monitor signal including monitor data indicating the third-level leakage operating state of the baseplate and / or the sensing patch.

[0140] Figure 3Shows an exploded view of an exemplary baseplate of a stoma appliance. The baseplate 4 includes a first adhesive layer 200 having a stoma opening 18A. During use, the proximal surface of the first adhesive layer 200 adheres to the peristomal area of the user's skin and / or to an additional seal, such as a sealant paste, a seal tape, and / or a seal ring. The baseplate 4 optionally includes a second adhesive layer 202 having a stoma opening 18B, also referred to as a rim adhesive layer. The baseplate 4 includes a plurality of electrodes disposed in an electrode assembly 204. The electrode assembly 204 is disposed between the first adhesive layer 200 and the second adhesive layer 202. The electrode assembly 204 includes a support layer having a stoma opening 18C and electrodes formed on the proximal surface of the support layer. The baseplate 4 includes a release liner 206 that the user peels off before applying the baseplate 4 to the skin. The baseplate 4 includes a top layer 208 having a stoma opening 18D and a coupling ring 209 for coupling a stoma pouch to the baseplate 4. The top layer 208 is a protective layer that protects the second adhesive layer 202 from external strain and stress during use.

[0141] The baseplate 4 includes a monitor interface. The monitor interface is configured to electrically and / or mechanically connect the stoma appliance (baseplate 4) to a monitor device. The monitor interface of the baseplate includes a coupling portion 210 for forming a mechanical connection, such as a releasable coupling, between the monitor device and the baseplate. The coupling portion 210 is configured to engage with a coupling portion of the monitor device to releasably couple the monitor device to the baseplate 4. Further, the monitor interface of the baseplate 4 includes a plurality of terminal elements that respectively form a plurality of terminals 212 for forming electrical connections with corresponding terminals of the monitor device. The coupling portion 210 and the terminals 212 form a first connector 211 of the baseplate 4. The baseplate 4 includes a first intermediate element 213 on the proximal side of the electrode assembly. The first intermediate element 213 is disposed between the terminal elements forming the terminals 212 of the baseplate 4 and the first adhesive layer (not shown). When viewed in the axial direction, the first intermediate element 213 covers the terminal elements forming the terminals 212 of the baseplate 4 and protects the first adhesive layer from the mechanical stress of the terminal elements of the baseplate.

[0142] As described above, some portions of the shown base plate 4 can be provided as separate patches to be applied to an existing base plate, for example, including one or more of the components described, to provide a base plate similar to the described base plate 4. For example, a sensing patch 700 can be provided, which, for example, includes an electrode assembly 204, a first connector 211, a first intermediate element 213, a first adhesive layer 200, and a release liner 206. Additionally, the sensing patch 700 can further include a second adhesive layer 202 and / or a top layer 208. It is contemplated that the user can set holes in the layer of the base plate to which the sensing patch 700 is to be applied to allow the first connector 211 of the sensing patch 700 to protrude through the layer of the base plate to which the sensing patch 700 is to be applied. Alternatively, the sensing patch 700 can be applied to the base plate such that the first connector 211 is positioned outside the outer periphery of the base plate.

[0143] Figure 4 An exploded view of an exemplary electrode assembly 204 of the base plate and / or the sensing patch is shown. 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 surface 214B and a plurality of electrodes 216 disposed on the proximal side of the support layer 214 and including a ground electrode, a first electrode, a second electrode, a third electrode, a fourth electrode, and a fifth electrode, wherein each electrode has a corresponding connection portion 217 for connecting the electrode 216 to a corresponding terminal element of the monitor interface. The electrodes 216 are positioned and / or formed on the proximal side 214B of the support layer 214. Further, the electrode assembly 204 includes a masking element 218 having a proximal surface 218B and configured to insulate the electrode portions of the electrodes 216 from the first adhesive layer of the base plate and / or the sensing patch. When viewed in the axial direction, the masking element 218 covers or overlaps portions of the electrodes 216.

[0144] Figure 5 Is a proximal view of the proximal surface of the base plate portion of the base plate and / or the sensing patch without the first adhesive layer and the release liner. The base plate 4 and / or the sensing patch 700 includes a first intermediate element 213 on the proximal side of the electrode assembly, i.e., between the electrode assembly 204 and the first adhesive layer (not shown). When viewed in the axial direction, the first intermediate element 213 covers the terminal elements of the base plate 4 and protects the first adhesive layer from mechanical stress from the terminal elements of the base plate and / or the sensing patch.

[0145] Figure 6Is a distal view of an exemplary electrode configuration 220 of electrode 216 of electrode assembly 204. Electrode assembly 204, such as 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, and the first electrode 224 includes a first connection portion 224A. The second electrode 226 includes a second connection portion 226A, and 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.

[0146] The fourth electrode (second leakage electrode) 230 includes a fourth sensing portion 230B. The fifth electrode (third leakage electrode) 232 includes a fifth sensing portion 232B.

[0147] The ground electrode 222 includes a first electrode portion 234 for forming the ground or reference of the first electrode 224. The ground electrode 222 includes a second electrode portion 236 for forming the ground or reference of the second electrode 226. The ground electrode 222 includes a third electrode portion 238 for forming the ground or reference of the third electrode 228. The masking element 218 is disposed proximal to the electrodes 222, 224, 226, 228 so as to cover a portion of these electrodes and insulate them from the first adhesive, and to form corresponding conductor portions of the electrodes 222, 224, 226, 228. The portions of the electrodes 222, 224, 226, 228 not covered by the masking element 219 contact the first adhesive layer and respectively form the sensing portions 224B, 226B, 228B of the electrodes 224, 226, 228. Further, the electrode portions 234, 236, 238 form the sensing portion of the ground electrode 222.

[0148] The first sensing portion 224B extends circularly around the stoma opening at least 330 degrees at a first radial distance R1 from the center point 19, also see Figure 11 . The first radial distance R1 is 14 mm. The first electrode portion 234 is disposed on the inner side of the first sensing portion (i.e., closer to the center point) and extends circularly around the stoma opening at least 330 degrees at a first ground distance RG1 from the first sensing portion (radially from the center point). The first ground distance RG1 is about 1 mm.

[0149] The second sensing portion 226B extends circularly around the stoma opening at least 330 degrees at a second radial distance R2 from the center point 19, also see Figure 11The second radial distance R2 is 18 mm. The second electrode portion 236 is disposed on the inner side of the second sensing portion 226B (i.e., closer to the center point), and extends circularly around the stoma opening at least 330 degrees at a second ground distance RG2 from the second sensing portion 226B (radially from the center point). The second ground distance RG2 is about 1 mm.

[0150] The third sensing portion 228B extends circularly around the stoma opening at least 330 degrees at a third radial distance R3 of 19 from the center point, see also Figure 11 The third radial distance R3 is about 26 mm. The third electrode portion 238 is disposed on the inner side of the third sensing portion 228B (i.e., closer to the center point), and extends circularly around the stoma opening at least 330 degrees at a third ground distance RG3 from the third sensing portion 228B (radially from the center point). The third ground distance RG3 is about 1 mm.

[0151] The ground electrode 222 includes a fourth electrode portion 240 for forming the ground or reference of the fourth electrode 230 and the fifth electrode 232. The fourth electrode portion 240 of the ground electrode forms a first leakage electrode. The fourth electrode portion 240 of the ground electrode 222 extends around the stoma opening at least 300 degrees and includes a ground sensing portion 222B. The fourth sensing portion 230B, the fifth sensing portion 232B, and the ground sensing portion of the fourth electrode portion 240 are circularly distributed around the center point at a leakage radius of 19 from the center point. The fourth sensing portion 230B, the fifth sensing portion 232B, and the ground sensing portion of the fourth electrode portion may have a radial extension range greater than 1.0 mm, such as in the range of 1.5 mm to 3.0 mm, for example about 2.0 mm. The fourth sensing portion 230B, the fifth sensing portion 232B, and the ground sensing portion of the fourth electrode portion 240 may have a circumferential extension range (perpendicular to the radial extension range) greater than 1.0 mm, such as in the range of 2.5 mm to 5.0 mm, for example about 3.5 mm. In one or more exemplary backing plates and / or sensor patches, the electrodes 224, 226, 228 and the electrode portions 234, 236, 238 may be omitted from the electrode configuration / electrode assembly.

[0152] 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, 252 of the masking element 218 are configured to overlap and / or align with the corresponding connection portions 222A, 224A, 226A, 228A, 230A, 232A of the electrodes of the electrode assembly.

[0153] The masking element 218 has a plurality of sensing point openings. These sensing point openings include primary sensing point openings shown within the dashed line 254, each primary sensing point opening being configured to overlap with a portion of the ground electrode (first leakage electrode) 222 and / or a portion of the fourth electrode (second leakage electrode) 230. In the exemplary masking element shown, the primary sensing point openings 254 include five primary sensing point openings 254A, each primary sensing point opening being configured to overlap with a corresponding sensing portion of the ground electrode (first leakage electrode) 222. In the exemplary masking element shown, the primary sensing point openings 254 include four primary sensing point openings 254B, each primary sensing point opening being configured to overlap with a corresponding sensing portion of the fourth electrode (second leakage electrode) 230. These sensing point openings include secondary sensing point openings shown within the dashed line 256, each secondary sensing point opening being configured to overlap with a portion of the fourth electrode (second leakage electrode) 230 and / or a portion of the fifth electrode (third leakage electrode) 232. In the exemplary masking element shown, the secondary sensing point openings 256 include five secondary sensing point openings 256A, each secondary sensing point opening being configured to overlap with a corresponding sensing portion of the fifth electrode (third leakage electrode) 232. In the exemplary masking element shown, the secondary sensing point openings 256 include four secondary sensing point openings 256B, each secondary sensing point opening being configured to overlap with a corresponding sensing portion of the fourth electrode (second leakage electrode) 230. These sensing point openings include tertiary sensing point openings shown within the dashed line 258, each tertiary sensor opening being configured to overlap with a portion of the fifth electrode (third leakage electrode) 232 and / or a portion of the ground electrode (first leakage electrode) 222. In the exemplary masking element shown, the tertiary sensing point openings 258 include five tertiary sensing point openings 258A, each tertiary sensing point opening being configured to overlap with a corresponding sensing portion of the fifth electrode (third leakage electrode) 232. In the exemplary masking element shown, the tertiary sensing point openings 258 include four tertiary sensing point openings 258B, each tertiary sensing point opening being configured to overlap with a corresponding sensing portion of the ground electrode (first leakage electrode) 222. The sensing point openings 254A, 254B, 256A, 256B, 258A, 258B are circularly arranged at a leakage radius of approximately 30 mm from the center point 19.

[0154] Figure 8It is a distal view of an exemplary first adhesive layer. The first adhesive layer 200 has a plurality of sensing point openings. The sensing point openings of the first adhesive layer include primary sensing point openings shown within the dashed line 260, each primary sensing point opening being configured to overlap with a portion of the ground electrode 222 of the electrode assembly and / or a portion of the fourth electrode 230. In the illustrated exemplary first adhesive layer, the primary sensing point openings include five primary sensing point openings 260A, each primary sensing point opening being configured to overlap with a corresponding sensing portion of the ground electrode 222. In the illustrated exemplary first adhesive layer, the primary sensing point openings include four primary sensing point openings 260B, each primary sensing point opening being configured to overlap with a corresponding sensing portion of the fourth electrode 230. The sensing point openings of the first adhesive layer include secondary sensing point openings shown within the dashed line 262, each second sensing point opening being configured to overlap with a portion of the fourth electrode 230 of the electrode assembly and / or a portion of the fifth electrode 232. In the illustrated exemplary first adhesive layer, the secondary sensing point openings include five secondary sensing point openings 262A, each secondary sensing point opening being configured to overlap with a corresponding sensing portion of the fifth electrode 232. In the illustrated exemplary first adhesive layer, the secondary sensing point openings include four secondary sensing point openings 262B, each secondary sensing point opening being configured to overlap with a corresponding sensing portion of the fourth electrode 230. The sensing point openings of the first adhesive layer include tertiary sensing point openings shown within the dashed line 264, each tertiary sensing point opening being configured to overlap with a portion of the fifth electrode 232 of the electrode assembly and / or a portion of the ground electrode 222. In the illustrated exemplary first adhesive layer, the tertiary sensing point openings include five tertiary sensing point openings 264A, each tertiary sensing point opening being configured to overlap with a corresponding sensing portion of the fifth electrode 232. In the illustrated exemplary first adhesive layer, the tertiary sensing point openings include four tertiary sensing point openings 264B, each tertiary sensing point opening being configured to overlap with a corresponding sensing portion of the ground electrode 222.

[0155] Figure 9 is Figure 8 a proximal view of the first adhesive layer. The sensing point openings 260A, 260B, 262A, 262B, 264A, 264B are circularly arranged at a leakage radius of approximately 30 mm from the center point.

[0156] Figure 10A more detailed distal view of a portion of the base plate 4 and / or the sensing patch 700. The base plate 4 and / or the sensing patch 700 includes a monitor interface. The monitor interface 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 sensing patch and thereby form a releasable connection. The first connector 211 of the monitor interface includes a plurality of terminals formed by respective terminal elements for forming respective electrical connections with corresponding terminals of the monitor device.

[0157] The plurality of terminals of the first connector 211 of the monitor interface include a ground terminal element 282 forming a ground terminal 282A, a first terminal element 284 forming a first terminal 284, a second terminal element 286 forming a second terminal 286A, and optionally 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, 292 contact respective connection portions 222A, 224A, 226A, 228A, 230a, 232A of the electrodes 222, 224, 226, 228, 230, 232.

[0158] The position of the first connector on the base plate and / or the sensing patch, the number of terminals, and the position of the terminals in the coupling portion can be adapted to the electrode configuration used in the electrode assembly of the base plate and / or the sensing patch. For example, the first connector for a base plate and / or a sensing patch having the Figure 11 shown electrode configuration 220A includes four terminals respectively connected to the connection portions 222A, 224A, 226A, 228A of these electrodes, and the first connector for a base plate and / or a sensing patch having the Figure 12 shown electrode configuration 220B includes three terminals respectively connected to the connection portions 222A, 224A, 226A of these electrodes.

[0159] The first connector can be arranged at the neck of the base plate and / or the sensing patch. The neck can be part of the first and / or second adhesive layer and extend radially away from the stoma opening. Thus, the neck is adapted to adhere to the skin of the user.

[0160] Figure 11 is Figure 6Distal view of an exemplary electrode configuration 220 of a baseplate and / or a sensing patch. The electrode configuration 220 includes a first leakage electrode 222, a second leakage electrode 230, and a third leakage electrode 232. The leakage electrodes 222, 230, 232 are configured to detect the presence of fluid in three sensing zones (in the illustrated example, three angular sensing zones), namely a primary sensing zone 400, a secondary sensing zone 402, and a tertiary sensing zone 404, on the proximal side of the first adhesive layer. The primary sensing zone 400 is arranged in a primary angular space between a first direction 406 and a second direction 408 relative to the center point 19, wherein the primary angular space spans a primary angle V1 of 120°. The secondary sensing zone 402 is arranged in a secondary angular space between the second direction 408 and a third direction 410 relative to the center point 19, wherein the secondary angular space spans a secondary angle V2 of 120°. The tertiary sensing zone 404 is arranged in a tertiary angular space between the third direction 410 and the first direction 406 relative to the center point 19, wherein the tertiary angular space spans a tertiary angle V3 of 120°.

[0161] The first leakage electrode 222 includes five primary sensing portions 222D arranged in the primary sensing zone 400 and four tertiary sensing portions 222E arranged in the tertiary sensing zone 404. Each primary sensing portion 222D is aligned with a corresponding primary sensing point opening 254A of the masking element 218 (see Figure 7 ). Further, each primary sensing portion 222D is aligned with a corresponding primary sensing point opening 260A of the first adhesive layer 200 (see Figure 8 ). Each tertiary sensing portion 222E of the first leakage electrode 222 is aligned with a corresponding tertiary sensing point opening 258B of the masking element 218 (see Figure 7 ). Further, each tertiary first sensing portion 222E is aligned with a corresponding tertiary sensing point opening 264B of the first adhesive layer 200 (see Figure 8 ).

[0162] The second leakage electrode 230 includes four primary sensing portions 230D arranged in the primary sensing zone 400 and four secondary sensing portions 230E arranged in the secondary sensing zone 402. Each primary sensing portion 230D is aligned with a corresponding primary sensing point opening 254B of the masking element 218 (see Figure 7 ). Further, each primary sensing portion 230D is aligned with a corresponding primary sensing point opening 260B of the first adhesive layer 200 (see Figure 8 ). Each secondary sensing portion 230E is aligned with a corresponding secondary sensing point opening 256B of the masking element 218 (see Figure 7 ). Further, each secondary sensing portion 230E is aligned with a corresponding secondary sensing point opening 262B of the first adhesive layer 200 (see Figure 8)Alignment.

[0163] The third leakage electrode 232 includes five secondary sensing portions 232D arranged in the secondary sensing area 402 and five tertiary sensing portions 232E arranged in the tertiary sensing area 404. Each secondary sensing portion 232D is aligned with a corresponding secondary sensing point opening 256A of the masking element 218 (see Figure 7 ). Further, each secondary sensing portion 232D is aligned with a corresponding secondary sensing point opening 262A of the first adhesive layer 200 (see Figure 8 ). Each tertiary sensing portion 232E is aligned with a corresponding tertiary sensing point opening 258A of the masking element 218 (see Figure 7 ). Further, each tertiary sensing portion 232E is aligned with a corresponding tertiary sensing point opening 264A of the first adhesive layer 200 (see Figure 8 ).

[0164] The sensing portions 222D, 222E, 230D, 230E, 232D, 232E are circularly arranged at a leakage radius RL of about 30 mm from the center point.

[0165] Figure 12 is a distal view of an exemplary electrode configuration 220A of the bottom plate and / or the sensing patch. The electrode configuration 220 includes a first leakage electrode 222, a second leakage electrode 230, and a third leakage electrode 232. The leakage electrodes 222, 230, 232 are configured to detect the presence of fluid on the proximal side of the first adhesive layer in two angular sensing areas, namely the primary sensing area 400 and the secondary sensing area 402. The primary sensing area 400 is arranged in a primary angular space between the first direction 406 and the second direction 408 with respect to the center point 19, wherein the primary angular space spans a primary angle V1 of about 185°. The secondary sensing area 402 is arranged in a secondary angular space between the second direction 408 and the first direction 406 with respect to the center point 19, wherein the secondary angular space spans a secondary angle V2 of about 175°.

[0166] The first leakage electrode 222 includes a primary sensing portion 222D arranged in the primary sensing area 400 and a secondary sensing portion 222F arranged in the secondary sensing area 402. The second leakage electrode 230 includes a primary sensing portion 230D arranged in the primary sensing area 400. The third leakage electrode 232 includes a secondary sensing portion 232D arranged in the secondary sensing area 402. Each primary sensing portion 222D, 230D is aligned with a corresponding primary sensing point opening of the masking element 219 (see Figure 13 ) and a corresponding primary sensing point opening of the first adhesive layer 201 (see Figure 14)Alignment. The sensing parts 222D, 222F, 230D, and 232D are circularly arranged at a leakage radius RL of approximately 30 mm from the center point.

[0167] Figure 13 is for Figure 12 The distal view of the masking layer 219 of the electrode configuration 220A for. The masking layer 219 includes a primary sensing point opening 254 and a secondary sensing point opening 256. Figure 14 is for Figure 12 The distal view of the first adhesive layer 201 of the electrode configuration 220A for, implementing a base plate and / or a sensing patch having two sensing zones arranged in separate angular spaces. The masking layer 201 includes a primary sensing point opening 260 and a secondary sensing point opening 262.

[0168] Figure 15 The distal view of an exemplary electrode configuration 220B of the base plate and / or the sensing patch. The electrode configuration 220B includes a first leakage electrode 222, a second leakage electrode 230, a third leakage electrode 232, a fourth leakage electrode 412, and a fifth leakage electrode 414. The leakage electrodes 222, 230, 232, 412, 414 are configured to detect the presence of fluid on the proximal side of the first adhesive layer in four angular sensing zones 400, 402, 404, 416. The primary sensing zone 400 is arranged in a primary angular space of a primary angle V1 spanning approximately 85°. The secondary sensing zone 402 is arranged in a secondary angular space of a secondary angle V2 spanning approximately 95°. The tertiary sensing zone 404 is arranged in a tertiary angular space of a tertiary angle V3 spanning approximately 95°. The quaternary sensing zone 416 is arranged in a quaternary angular space of a quaternary angle V4 spanning approximately 85°.

[0169] Although the exemplary base plate and / or sensing patch having two, three, and four sensing zones have been described in more detail, the base plate and / or sensing patch may include one or a greater number of sensing zones, such as five, six, seven, eight, or more sensing zones.

[0170] Figure 16Shows a schematic monitor device 6 including a 3-axis accelerometer 540 coupled to a schematic base plate 4 and / or a sensing patch 700, the sensing patch including a neck 510 extending radially away from a stoma opening 18 configured to surround a stoma. The 3-axis accelerometer 540 spans a three-dimensional space (Cartesian coordinate system) as shown by mutually orthogonal x, y, and z axes. The z-axis direction is normal to the geometric plane spanned by the x-axis and y-axis. In other words, the accelerometer is capable of measuring motion, such as acceleration, in the three-dimensional space spanned by the x, y, and z axes. In particular, the accelerometer is configured to generate a position signal. The position signal includes information related to the spatial orientation of the accelerometer 540 and information related to the spatial orientation of the monitor device 6. The direction of gravity g is shown as pointing "downward". In an embodiment, the x, y, and z axes form / spans a local coordinate system relative to the base plate 4 and / or the sensing patch 700. In these cases, the x, y, and z axes are fixed relative to the base plate 4 and / or the sensing patch 700, and rotation of the base plate 4 and / or the sensing patch 700 corresponds to rotation of the x, y, and z axes. Accordingly, the direction of gravity g changes relative to the x, y, and z axes in response to a change in the orientation of the base plate 4 and / or the sensing patch 700 (e.g., Figure 17 as shown). In certain configurations, the base plate 4 and / or the sensing patch 700 generally spans a geometric plane parallel to the geometric plane spanned by the x-axis and y-axis of the accelerometer. Alternatively, the base plate 4 and / or the sensing patch 700 generally spans a geometric plane parallel to the geometric plane spanned by two axes of the accelerometer.

[0171] The monitor device 6 is coupled to a base plate 4 and / or a sensing patch 700 including three sensing zones 500, 502, 504. The sensing zones are provided by an appropriate arrangement of electrodes as disclosed above and Figure 11 , Figure 12 and Figure 15 as shown. Since the user freely applies the base plate 4 and / or the sensing patch 700, taking into account any personal preferences and / or the presence of skin folds / scars, for example, the neck 510 can take any position around the stoma (i.e., along a 360° circle), and the base plate 4 and / or the sensing patch 700 is configured to be arranged around the stoma. In the present illustration, the neck 510 extends from the base plate 4 and / or the sensing patch 700 in a direction opposite and parallel to the direction of gravity g.

[0172] According to an embodiment of the present invention, the monitor device 6 is arranged to convey in which zone of a sensor assembly comprising two or more sensing zones (such as sensing zones 500, 502, 504) a possible leak has occurred. According to an embodiment of the present invention, the monitor device 6 comprises a 3-axis accelerometer 540 configured to generate a position signal. By providing the monitor device 6 with the accelerometer 540, the spatial orientation of the monitor device 6 and thus the spatial orientation of the base plate 4 and / or the sensing patch 700 can be determined, since the base plate 4 and / or the sensing patch 700 are coupled to the monitor device 6. In other words, by coupling the base plate 4 and / or the sensing patch 700 to the monitor device 6, any rotation or spatial orientation of the monitor device 6 is reflected in a similar rotation / spatial orientation of the base plate 4 and / or the sensing patch 700.

[0173] By defining a natural orientation N of the accelerometer 540, any deviation / angular offset from this natural orientation can be determined. In an embodiment, the natural orientation N can be defined with respect to an overall coordinate system comprising an overall x'-axis, y'-axis and z'-axis. In these cases, the rotation of the x'-axis, y'-axis and z'-axis with respect to the base plate 4 and / or the sensing patch 700 is fixed. Additionally, for example, the natural orientation N can be such an orientation where the gravity along the y'-axis is -1g, and where the gravity along the x'-axis and z'-axis is 0g. According to such a definition, when the y-axis (of the local coordinate system of the accelerometer) is parallel to the y'-axis and the direction of the gravity g, the accelerometer 540 is in the natural orientation, and thus is arranged parallel to the x'-axis and perpendicular to the direction of the gravity g, and thus is horizontal. The gravity of -1g along the y'-axis is a result of the direction of the y'-axis, and if the direction of the y'-axis is flipped, then, for example, by definition, this can be positive (+1g). Alternatively, the natural orientation N can be defined as an orientation where the angular offset of the x'-axis with respect to the direction of the gravity g is zero, or where the angular offset of the y'-axis with respect to the direction of the gravity g is zero, or where the angular offset of the z'-axis with respect to the direction of the gravity g is zero. In Figure 16 the figure, the natural orientation N is represented by a set of intersecting dashed lines, one dashed line parallel to the y'-axis and the direction of the gravity g, and one dashed line parallel to the x'-axis and perpendicular to the direction of the gravity g.

[0174] In Figure 16In this case, the orientation of the accelerometer 540 and thus the local coordinate system (i.e., the x-axis, y-axis, and z-axis), as well as the orientation of the monitor device and the attached base plate 4 and / or the sensing patch 700, are considered to be aligned with a predefined natural orientation N (e.g., the y-axis is parallel to the direction of the gravitational force g and the y'-axis of the global coordinate system. Thus, the gravitational force along the y-axis is -1g). Therefore, the angular offset or rotational offset of the base plate 4 and / or the sensing patch 700 can be considered zero. In an embodiment, such a rotational offset can be transmitted (e.g., by sending a signal indicating the rotational offset according to a wireless protocol) to an attached device, such as a smartphone, in a manner that visually displays / reflects the physical base plate and / or the sensing patch in a graphical user interface, such as in an application (app) of the smartphone. In particular, the visual representation of the physical base plate and / or the sensing patch helps to convey the location (in which sensing area) where a possible leak has occurred.

[0175] Figure 17 Shows the base plate 4 and / or the sensing patch 700 after rotation (relative to the natural orientation N) attached to the monitor device 6 discussed above with respect to Figure 16 The axes of the accelerometer 540 are shown as being deviated from the natural orientation N and the global coordinate system. To emphasize this, the x-axis and y-axis of the accelerometer 540 have been translated onto the representation of the natural orientation N. Here, it is easy to see how the y-axis of the now-rotated accelerometer 540 rotates by an angle W1 (angular offset) from the direction parallel to the gravitational force g (i.e., the y'-axis), and how the x-axis of the now-rotated accelerometer 540 rotates by the same angle W1 (angular offset) from the direction perpendicular to the gravitational force g (i.e., the x'-axis).

[0176] In an embodiment, once the sum of the accelerations measured on the x-axis, y-axis, and z-axis is equal to 1g, the monitor device 6 calculates W1 based on the measurements from the accelerometer 540 in order to determine that the base plate 4 and / or the sensing patch 700 has stopped moving. Otherwise, in some cases, the acceleration generated due to the movement of the base plate 4 and / or the sensing patch 700 and the corresponding measurements sensed by the accelerometer 540 may result in an incorrect calculation of W1. Additionally or alternatively, the measurements from the accelerometer 540 are sent by the monitor device 6 to the attached device 8 and the attached device 8 calculates W1.

[0177] In certain embodiments, W1 is the rotation angle in the xy plane. Even if the z-axis is not zero relative to the z'-axis of the natural orientation, in order to calculate W1 in the xy plane, the angle of the z-axis relative to the z'-axis is ignored by subtracting the acceleration measured on the z-axis from 1g.

[0178] In other words, Figure 17Shows the orientation of the accelerometer 540 and thus the orientation of the monitor device 6 and the coupled base plate 4 and / or the sensing patch 700 is tilted / offset by an angle W1 relative to the predefined natural orientation N / global coordinate system. Thus, the angular offset or rotational offset of the base plate 4 and / or the sensing patch 700 can be considered as W1. In an embodiment, such a rotational offset can be transmitted to an accessory device, such as a smartphone, in a manner of visually presenting / reflecting the physical base plate and / or the sensing patch in a GUI, such as in an app of the smartphone. In particular, the visual representation of the physical base plate and / or the sensing patch helps to convey to the user the location (in which sensing zone) where a possible leak may occur.

[0179] When or if it is detected that the base plate 4 and / or the sensing patch 700 is rotated by an angle W1 relative to the predefined natural orientation N, then such an angle W1 is incorporated in the visual representation. Since the base plate 4 and / or the sensing patch 700 is provided with a neck 510, the user can easily translate the visual representation onto his / her body and vice versa. In other words, the neck 510 breaks the symmetry of the possibly substantially circular base plate 4 and / or the sensing patch 700. By breaking the symmetry, the neck 510 can constitute a reference point for the user when he / she wants to locate the place (in which sensing zone) where a possible leak has occurred. When the visual representation in the GUI of the accessory device incorporates the rotational offset here as W1, he / she can better understand spatially his / her base plate and / or the sensing patch and the place where a possible leak has occurred.

[0180] Figure 18A Shows a person 499 wearing the base plate 4 and / or the sensing patch 700 coupled to the monitor device 6 as described above. The base plate 4 and / or the sensing patch 700 includes three angularly spaced sensing zones 500, 502, and 504. Note that the separation of the sensing zones is shown by dashed lines, but in reality, the sensing zones are separated due to a certain arrangement of electrodes as shown, for example, Figure 11 , Figure 12 and Figure 15 shown. The neck 510 of the base plate and / or the sensing patch is seen to extend radially away from the stoma opening 18 in a direction parallel to the direction of the gravitational force g. The monitor device 6 includes an accelerometer 540. The natural orientation N of the accelerometer 540 has been defined according to the previously disclosed definition. According to this definition of the natural orientation N, the monitor device 6 as shown and thus the base plate 4 and / or the sensing patch 700 do not include a rotational offset because the y-axis of the accelerometer is parallel to the direction of the gravitational force g (in other words, the gravitational force along the y-axis is -1g), and the x-axis is perpendicular to the direction of the gravitational force g (in other words, the gravitational force along the x-axis is 0g).

[0181] Thus, according to an embodiment, the visual representation of the base plate 4 and / or the sensing patch 700 does not include any rotational offset, asFigure 18B as shown

[0182] Figure 18B shows an accessory device 8 (smartphone) including a GUI 8a (such as a screen). The GUI 8a is configured to show a visual representation 8b of the base plate 4 and / or the sensing patch 700 applied to the user's body (see Figure 18A ). In particular, the visual representation shows the sensing areas of the base plate 4 and / or the sensing patch 700 ( Figure 18A reference numerals 500, 502, and 504 in the figures). The sensing areas can be shown by the annular segments 500a, 502a, 504a. As shown, the sensing areas 500, 502, 504 of the base plate 4 and / or the sensing patch 700 are directly translated onto the visual representation 8b. In particular, the visual representation 8b is oriented such that "up" and "down" are according to the natural orientation of the accessory device 8, or the common understanding of the orientation of the accessory device 8 in use. In other words, the orientation of the visual representation 8b conforms to the normal understanding of the accessory device 8. In other words, the orientation of the visual representation 8b is consistent with the orientation of the accessory device 8. For example, in the case where the accessory device 8 is a smartphone, in the vertical orientation, the direction of gravity can be considered parallel to the longitudinal direction of the smartphone, such as the long side. Similarly, in the horizontal direction of the smartphone, the direction of gravity can be considered parallel to the short side of the smartphone. This orientation conforms to the normal understanding of the function of the smartphone. Although a certain visual representation has been described, it should be understood that other visual representations can be employed, including other visual representations capable of providing a representation of the leakage state, such as equivalent visual representations.

[0183] Figure 19A shows a person 499 wearing the base plate 4 and / or the sensing patch 700 coupled to the monitor device 6 as described above. The base plate 4 and / or the sensing patch 700 include three angularly spaced sensing areas 500, 502, and 504. The neck 510 of the base plate and / or the sensing patch is seen to extend radially away from the stoma opening 18 in a direction inclined / offset relative to the direction of gravity g. The monitor device 6 includes an accelerometer 540. The natural orientation N of the accelerometer 540 has been defined according to the previously disclosed definition. According to this definition of the natural orientation N, the monitor device 6 and thus the base plate 4 and / or the sensing patch 700 include an angular / rotational offset W2, as highlighted by the translation of the x-axis and y-axis of the accelerometer 540 onto the natural orientation N.

[0184] Figure 19B shows an accessory device 8 (smartphone) including a GUI 8a (such as a screen). The GUI 8a is configured to show a visual representation 8b of the base plate 4 and / or the sensing patch 700 applied to the user's body (see Figure 19A)。As shown in the figure, the sensing areas 500, 502, 504 of the bottom plate 4 and / or the sensing patch 700 are directly translated onto the visual representation 8b such that the annular segments 500b, 502b, 504b showing the sensing areas 500, 502, 504 respectively are rotated according to Figure 19A the rotational offset W2. The dashed line / drawn angle in the visual representation 8b is for illustrative purposes only here and shows how the annular segments 500b, 502b, 504b have been rotated by the rotational offset of W2.

[0185] Figure 20 Eight exemplary orientations of the monitor device 6 including the 3-axis accelerometer 540 are shown. In particular, Figure 20 eight exemplary rotations are shown by which a user can select to orient his / her bottom plate and / or sensing patch including a plurality of sensing areas. In the clockwise direction, the first position is the position where the y-axis of the accelerometer is aligned / parallel with the direction of gravity g and the gravity along the y-axis is -1g, such that the angular offset of the y-axis with respect to the natural orientation N is zero degrees. The second position is the position where the y-axis of the accelerometer is rotated by an angle of 45° from the y-component Ny of the natural orientation N, i.e., this component is aligned / parallel with the direction of gravity. Continuing in the clockwise direction, the orientations of the monitor device are positions where the y-axis of the accelerometer is rotated in increments of 45°. At each position, the angular offset can be defined as the angle between the y-axis of the accelerometer and the y-component Ny of the natural orientation N.

[0186] Figure 21 A graph of an experimental data set (position signal) originating from the accelerometer is shown. The accelerometer has been arranged in the monitor device and worn by a person. The graph shows a plurality of position signals obtained from the accelerometer over time, each position signal including information about the spatial orientation / angular offset of the accelerometer with respect to the natural orientation. The concentric circles show the gravity measured in m / s 2 units such that 9.8 m / s 2 = 1g. The (angular) distribution of the data points / position signals indicates that the wearer has been moving around, e.g., walking around. Over time, due to the continuous upright position of the walking person, the data points form a trend. In this case, the data points cluster around an average angular offset A of 106°. In other words, 106° represents the (average) direction of gravity. Thus, the data shows that the monitor device has been worn such that the y-axis and x-axis of the accelerometer have been tilted by 106° with respect to the natural orientations of the corresponding y-axis and x-axis.

[0187] Since the monitor device is intended to be worn by a person, a method for determining the actual rotational offset of the (adhesive) base plate and / or the sensing patch is required. A single assessment of the spatial orientation of the accelerometer relative to its natural orientation can vary significantly because the wearer may move around, shift his / her weight between legs, jump, bend over, etc. Thus, if the spatial orientation of the accelerometer and hence the rotational offset of the base plate and / or the sensing patch are to be determined based on a single reading / single position signal of the accelerometer, the wearer must stand in a fully predefined (e.g., upright) position, which is practically impossible. In other words, a single assessment of the spatial orientation only indicates a certain movement of the wearer at a certain point in time. However, by averaging the position signals obtained over a certain amount of time, a trend can be formed. This trend will reveal how the accelerometer and hence the base plate and / or the sensing patch are oriented relative to the wearer and the stoma fixation. In Figure 21 the exemplary data set shown in the figure of, the average angular offset A is 106°. Thus, despite the wearer moving around, by using the accelerometer, the monitor device has been able to determine with sufficient accuracy how the monitor device and hence the base plate and / or the sensing patch are arranged. The angular offset of 106° is relative to the predefined natural orientation. Thus, the monitor device and hence the base plate and / or the sensing patch have been rotated 106° from the predefined natural orientation. According to an embodiment, as previously described with respect to, for example, with respect to Figures 18A to 19B stated, the angular offset is incorporated into the visual representation of the base plate and / or the sensing patch in the graphical user interface of the accessory device. Different movements or positions of the wearer (e.g., standing, sitting, or lying down) may cause different distributions of the position signals. From this, such different movements or positions can be distinguished. Thus, the monitor device can also serve as an activity tracker.

[0188] Figure 22An exemplary monitor device 6 including a housing 100 and an appliance interface 102 is shown. The monitor device 6 includes a processor 101 and a 3-axis accelerometer 540. The accelerometer 540 is capable of measuring motion in a three-dimensional space spanned by a Cartesian coordinate system and is configured to generate a position signal indicative of the spatial orientation of the monitor device 6. Thus, the accelerometer 540 is capable of measuring accelerations along mutually orthogonal x, y, and z axes. In certain embodiments, the axes of the accelerometer extend in the indicated directions. The housing 100 includes a skin-facing surface 100a. The skin-facing surface 100a can be considered to be substantially planar such that the surface can be flush with the skin or the distal surface of a base plate and / or a sensing patch. Flush means that the geometric plane defined by the skin-facing surface is configured to be substantially parallel to the skin surface on which it should be worn. In certain embodiments, the geometric plane of the accelerometer (e.g., spanned by its x and y axes) is configured to be parallel to such geometric plane defined by the skin-facing surface. Thereby, the accelerometer is provided with an orientation in accordance with the embodiments described herein.

[0189] Although throughout this disclosure, certain axes and geometric planes of the accelerometer have been assigned certain directions and / or properties, it should be understood that other axes, or even intermediate directions that can be described by the set of axes (e.g., described in the form (x, y, z)), can be assigned the same certain directions and properties by a simple definition of the coordinate system. For example, in the case where the y axis is described as being aligned / parallel with the direction of gravity, it will be understood that the x axis, the z axis, or an intermediate direction (e.g., described in the form (x, y, z)) can equally be defined as an axis aligned / parallel with the direction of gravity. In other words, without affecting the scope of the present invention, the coordinate system spanned by the accelerometer can be rotated by any (three-dimensional) angle.

[0190] Although specific features have been shown and described, it should be understood that they are not intended to limit the claimed invention, and various changes and modifications will be apparent to those skilled in the art without departing from the spirit and scope of the claimed invention. Accordingly, the specification and drawings are to be regarded as illustrative rather than restrictive. The claimed invention is intended to cover all alternatives, modifications, and equivalents.

Claims

1. A method for determining a rotational offset of a sensor assembly of a stoma appliance relative to a stoma, the sensor assembly being connectable to a monitor device, wherein, The monitor device comprises: - A housing, - A processor disposed in the housing, - An appliance interface configured to couple the monitor device to the sensor assembly, the appliance interface including a plurality of terminals for connection to a plurality of electrodes of the sensor assembly, and - An accelerometer configured to generate a position signal; Wherein, the sensor assembly comprises: - A plurality of electrodes forming two or more sensors, the sensors being disposed in at least two separate sensing zones, and - A component interface configured to couple to the appliance interface of the monitor device, and Wherein, the method comprises the steps of: - Disposing a stoma appliance including the sensor assembly in a peristomal skin area and coupling the monitor device to the sensor assembly such that the position of the monitoring device relative to the sensor assembly is fixed, - Obtaining one or more position signals from the accelerometer, the one or more position signals indicating the spatial orientation of the accelerometer, - Determining a rotational offset of the sensor assembly based on the one or more position signals.

2. The method according to claim 1, wherein The method includes an initial step of defining a natural orientation of the monitor device.

3. The method according to any one of claims 1 to 2, wherein, The monitor device communicates with an accessory device including a graphical user interface, and wherein the method further comprises the steps of transmitting the rotational offset to the accessory device and generating a visual representation in the graphical user interface, the visual representation incorporating the rotational offset and showing the position of the at least two separate sensing zones relative to the stoma.

4. A stoma system, comprising a stoma appliance, a sensor assembly disposed in the stoma appliance, and a monitor device, wherein, The monitor device comprises: - A housing, - A processor disposed in the housing, - An appliance interface including a plurality of terminals for connection to a plurality of electrodes of the sensor assembly, and - An accelerometer configured to generate a position signal; Wherein, the sensor assembly comprises: - A plurality of electrodes forming two or more sensors, the sensors being disposed in at least two separate sensing zones, the plurality of electrodes being configured to detect the presence of liquid on the proximal side of a first adhesive layer of the stoma appliance and / or the moisture content in the first adhesive layer of the stoma appliance, and - A component interface configured to couple to the appliance interface of the monitor device, and Wherein, the position of the monitoring device relative to the sensor assembly is fixed, the monitor device being configured to releasably couple to the sensor assembly, wherein the position signal indicates the spatial orientation of the monitor device in order to determine a rotational offset of the sensor assembly of the stoma appliance relative to the stoma.

5. The stoma system according to claim 4, wherein, The appliance interface is configured to couple to the component interface.

6. The stoma system according to any one of claims 4 to 5, wherein, The accelerometer of the monitor device includes a predefined natural orientation, and wherein the monitor device is configured to determine a rotational offset of the sensor assembly relative to the predefined natural orientation.

7. A monitor device for releasably coupling to a sensor assembly attachable to a base plate or a sensing patch for application to the base plate of a stoma appliance, the monitor device comprising: - A housing, - A processor disposed in the housing, and - An appliance interface configured to releasably couple the monitor device to the sensor assembly at a position fixed relative to the sensor assembly, the appliance interface including a plurality of terminals for connection to a plurality of electrodes of the sensor assembly. Wherein, the monitor device further includes a triaxial accelerometer, and wherein, the accelerometer is configured to generate a position signal, wherein, the position signal indicates the spatial orientation of the monitor device to determine the rotational offset of the sensor assembly of the ostomy appliance relative to the stoma.

8. The monitor device according to claim 7, wherein, The position signal includes: gravitational values along the x-axis, along the y-axis, and along the z-axis, the axes being orthogonal to each other; and / or values of a first angular offset of the x-axis relative to a predefined orientation; values of a second angular offset of the y-axis relative to a predefined orientation; and values of a third angular offset of the z-axis relative to a predefined orientation.

9. The monitor device according to any one of claims 7 to 8, wherein, The position signal is sampled at a rate of at least 0.1 Hz.

10. The monitor device according to claim 7 or 8, wherein, The accelerometer includes a predefined natural orientation, wherein, the first angular offset of the x-axis relative to the direction of gravity is zero, or the second angular offset of the y-axis relative to the direction of gravity is zero, or the third angular offset of the z-axis relative to the direction of gravity is zero.

11. The monitor device according to claim 7 or 8, wherein The accelerometer includes a predefined natural orientation, wherein, the gravity along the x-axis of the accelerometer is 0 g, and wherein, the gravity along the y-axis of the accelerometer is -1 g.

12. The monitor device according to claim 7 or 8, wherein, The accelerometer is configured to determine its spatial orientation relative to the user's ostomy based on a motion pattern generated by the user.

13. The monitor device according to claim 12, wherein, The motion pattern includes a plurality of position signals sampled during a predefined amount of time.

14. The monitor device according to claim 12, wherein, The spatial orientation of the accelerometer indicates the rotational offset of the sensor assembly when the monitor device is coupled to the sensor assembly.

15. The monitor device according to claim 10, wherein, The processor is configured to generate an offset parameter based on the angular offset of the accelerometer relative to its predefined natural orientation.

16. The monitor device according to claim 15, wherein, The processor is configured to transmit the position signal and / or the offset parameter to an accessory device.

17. The monitor device according to claim 7 or 8, wherein The housing includes a skin-facing surface, and wherein, the x-axis and the y-axis of the accelerometer span a geometric plane substantially parallel to the skin-facing surface of the housing, and wherein, the z-axis of the accelerometer extends in a direction normal to the geometric plane.

18. The monitor device according to claim 7 or 8, wherein, The appliance interface is configured to couple to a plurality of electrodes of the sensor assembly, the plurality of electrodes forming at least two sensors, the at least two sensors being arranged in at least two separate sensing zones configured to monitor the skin surface around the stoma.

19. The monitor device according to claim 18, wherein, The processor is configured to determine the spatial distribution of the at least two separate sensing zones based on one or more position signals.

20. The monitor device according to claim 7 or 8, wherein, The monitor device includes a memory, and wherein, one or more task profiles are stored on the memory, and wherein, the monitor device is configured to detect one or more tap sequences included in one or more position signals.

21. The monitor device according to claim 20, wherein, The processor is configured to compare a given tap sequence among the one or more tap sequences with the one or more task profiles and generate an output associated with the given tap sequence.

22. The monitor device according to claim 21, wherein, The output is selected from waking up the monitor device from the sleep mode, initiating the pairing mode, or entering the sleep mode.

23. The monitor device according to claim 7 or 8, wherein, The monitor device is configured to turn off or enter the sleep mode if no movement is detected within a predefined amount of time.

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