METHOD, OSTOMY SYSTEM, AND MONITORING DEVICE

Abstract

This document describes a method, ostomy system, and monitoring device. It concerns a monitoring device (6) for coupling to a sensor assembly of an ostomy appliance. The monitoring device comprises a housing, a processor disposed in said housing, and an apparatus interface configured to couple the monitoring device to the sensor assembly. The apparatus interface comprises a plurality of terminals for connection to a plurality of electrodes of the sensor assembly. Additionally, the monitoring device comprises a three-axis geometric accelerometer (540) configured to generate a position signal. Furthermore, a method for determining a rotational displacement of a sensor assembly relative to an ostomy and a system comprising a monitoring device and a sensor assembly are disclosed.

Description

/ 81 METHOD, OSTOMY SYSTEM, AND MONITORING DEVICE

[001] The present disclosure relates to a monitoring device for a sensor mount comprising an accelerometer for determining spatial orientation. Additionally, the present disclosure relates to a method for determining a rotational displacement of a sensor mount relative to an ostomy. Brief Description of the Drawings

[002] The attached drawings are included to provide a further understanding of the embodiments and are incorporated into and form part of this descriptive report. The drawings illustrate embodiments and, together with the description, serve to explain the principles of the embodiments. Other embodiments and several of the anticipated advantages of the embodiments will be readily observed as they become better understood by reference to the detailed description below. The elements of the drawings are not necessarily to scale with each other. Similar reference numbers designate similar corresponding parts.

[003] Figure 1 illustrates an exemplary ostomy system, Figure 2 illustrates an example of a monitoring device for an ostomy system. Figure 3 illustrates an exploded view of a base plate of an ostomy device. Figure 4 illustrates an exploded view of an exemplary electrode assembly. Figure 5 illustrates a proximal view of parts of a baseplate and / or sensor patch. Figure 6 illustrates a distal view of an exemplary electrode configuration. Figure 7 illustrates a distal view of an exemplary masking element. Petition 870210096510, dated 10 / 19 / 2021, page 11 / 133 / 81 Figure 8 illustrates a distal view of an exemplary first adhesive layer. Figure 9 illustrates a proximal view of the first adhesive layer of Figure 8. Figure 10 illustrates a distal view of a portion of the baseplate and / or sensor patch that includes a monitor interface. Figure 11 illustrates a distal view of the electrode configuration of Figure 6. Figure 12 illustrates a distal view of an exemplary electrode configuration. Figure 13 illustrates a distal view of an exemplary masking element. Figure 14 illustrates a distal view of an exemplary first adhesive layer. Figure 15 illustrates a distal view of an exemplary electrode configuration. Figure 16 illustrates one embodiment of a schematic monitoring device comprising a 3-axis geometric accelerometer coupled to a schematic baseplate and / or sensor patch. Figure 17 illustrates one embodiment of a rotating baseplate and / or sensor patch coupled to a monitoring device. Figure 18A illustrates one embodiment of a person wearing a baseplate and / or sensor patch coupled to a monitoring device. Figure 18B illustrates an embodiment of an accessory device comprising a visual representation, Figure 19A illustrates one embodiment of a person using a baseplate and / or sensor patch coupled to a monitoring device. Figure 19B illustrates an embodiment of an accessory device comprising a visual representation, Petition 870210096510, dated 10 / 19 / 2021, page 12 / 133 / 81 Figure 20 illustrates eight exemplary orientations of a schematic monitor device comprising a 3-axis geometric accelerometer. Figure 21 illustrates a plot of an experimental dataset originating from an accelerometer and Figure 22 illustrates an embodiment of a monitor device comprising a 3-axis geometric accelerometer. Detailed Description

[004] Various exemplary embodiments and details are described hereafter, with reference to the Figures where relevant. It should be noted that the Figures may or may not be drawn to scale and that elements of similar structures or functions are represented by similar reference numerals throughout the Figures. It should also be noted that the Figures are intended only to facilitate the description of the embodiments. They are not intended to be an exhaustive description of the invention or a limitation of the scope of the invention. Furthermore, an illustrated embodiment need not have all the aspects or advantages shown. An aspect or advantage described in combination with a particular embodiment is not necessarily limited to that embodiment and may be practiced in any other embodiments even if not so illustrated, or if not so explicitly described.

[005] Throughout this disclosure, the words stoma and ostomy are used to denote a surgically created opening that bypasses a person's intestines or urinary tract system. The words are used interchangeably and no differentiated meaning is intended. The same applies to any word or expression derived from them, for example, stoma, ostomies, etc. In addition, the solid and liquid waste emanating from the stoma may be referred to as efflux, residue (or residues), "liquids," and fluids. Petition 870210096510, dated 10 / 19 / 2021, page 13 / 133 / 81. The terms "ostomy" and "stoma" are used interchangeably. An individual who has undergone ostomy surgery may be referred to as an ostomy patient or an ostomy patient, as well as a patient or user. However, in some cases, "user" may also relate to or refer to a healthcare professional (HCP), such as a surgeon or an ostomy care nurse or others. In these cases, it will be explicitly stated or implied from the context that the user is not properly the patient.

[006] Next, whenever referring to the proximal side or surface of a layer, element, device, or part of a device, the reference is to the side or surface facing the skin when a user wears the ostomy appliance. Similarly, whenever referring to the distal side or surface of a layer, element, device, or part of a device, the reference is to the side or surface facing away from the skin when a user wears the ostomy appliance. In other words, the proximal side or surface is the side or surface closest to the user when the appliance is fitted to a user, and the distal side is the opposite side or surface—the side or surface away from the user during use.

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

[008] A radial direction is defined as perpendicular to the axial direction. In some sentences, the words internal and external may be used. These qualifiers should generally be understood with reference to the radial direction, so that a reference to an external element means that the element is further from a central portion of the ostomy appliance than an element termed internal. Furthermore, more internal should be interpreted as the portion of a component that forms a center of the component and / or being adjacent to the center of the Petition 870210096510, dated 10 / 19 / 2021, page 14 / 133 / 81 component. Analogously, the outermost term should be interpreted as a portion of a component that forms an outer edge or outer contour of a component and / or that is adjacent to that outer edge or outer contour.

[009] The use of the term substantially as a qualifier for certain features or effects in this disclosure is intended simply to signify that any divergences are within tolerances that would normally be expected of an individual versed in the relevant field.

[0010] The use of the word “generally” as a qualifier for certain features or effects in this disclosure is intended simply to mean – for a structural feature: that a greater part or the majority of the portion of such feature exhibits the feature in question and – for a functional feature or effect: that a greater part of the results involving the feature provide the effect, but that, exceptionally, the results do not provide the effect.

[0011] The present disclosure provides a monitor device for coupling to a sensor assembly of an ostomy appliance, a method for determining a rotational displacement of a sensor assembly relative to an ostomy, and an ostomy system comprising a sensor assembly and a monitor device.

[0012] In a first aspect of the invention, a monitoring device for coupling to a sensor assembly of an ostomy appliance is disclosed. The monitoring device comprises a housing, a processor disposed in the housing, and an apparatus interface configured to couple the monitoring device to the sensor assembly. The apparatus interface comprises a plurality of terminals for connection to a plurality of electrodes of the sensor assembly. Additionally, the monitoring device comprises a three-axis geometric accelerometer configured to generate a position signal. The accelerometer of Petition 870210096510, dated 10 / 19 / 2021, page 15 / 133 / 81 states that the accelerometer has the capacity to evaluate / measure acceleration in a three-dimensional space encompassed by a geometric axis x, a geometric axis y, and a geometric axis z that are mutually orthogonal. It then states that the accelerometer comprises a geometric axis x, a geometric axis y, and a geometric axis z. Thus, the geometric axes of the accelerometer encompass a Cartesian coordinate system. In the embodiments, the accelerometer is a two-geometric-axis accelerometer.

[0013] The present disclosure relates to an ostomy system and devices thereof, such as an ostomy appliance, a baseplate for an ostomy appliance, a sensor patch for application to a baseplate, a monitoring device, and optionally, one or more accessory devices. Additionally, methods relating to the ostomy system and devices thereof are disclosed. An accessory device (also referred to as an external device) may be a mobile phone or other portable device. In the embodiments, an accessory device is a personal electronic device, for example, a wearable device such as a watch or other electronic device to be worn on the wrist. An accessory device may be a docking station. In the embodiments, the docking station is configured to electrically and / or mechanically couple the monitoring device to the docking station.In the embodiments, the docking station is configured to charge a monitor device battery and / or configured to transfer data between the monitor device and the docking station. The ostomy system may comprise a server device. In the embodiments, the server device is operated and / or controlled by the ostomy appliance manufacturer and / or a service center.

[0014] The present disclosure provides an ostomy system and devices thereof, such as an ostomy appliance, a baseplate for an ostomy appliance, a sensor patch for application to a baseplate, a monitor device and, optionally, one or more. Petition 870210096510, dated 10 / 19 / 2021, page 16 / 133 / 81 accessory devices that, alone or together, facilitate the reliable determination of the nature, severity, and speed of wetting spread in the adhesive material provided for attaching the baseplate and / or sensor patch to the skin surface of a user. Depending on the nature of the wetting spread pattern in the adhesive, the ostomy system and its devices enable the user to receive information about the type of failure and, in turn, provide an indication to the user of the severity and thus the remaining time to replace the ostomy appliance without experiencing serious leakage and / or skin damage.

[0015] In the embodiments, the ostomy appliance comprises a baseplate and an ostomy bag (also called an ostomy pouch). The ostomy appliance can be a colostomy appliance, an ileostomy appliance, or a urostomy appliance. In the embodiments, the ostomy appliance is a two-part ostomy appliance, that is, the baseplate and the ostomy bag can be removablely attached, for example, with a mechanical and / or adhesive coupling, for example, to allow a plurality of ostomy bags to be used (changed) with one baseplate. Additionally, a two-part ostomy appliance can facilitate the correct application of the baseplate to the skin, for example, for better user visibility of the stoma region. In the embodiments, the ostomy appliance is a one-part ostomy appliance, that is, the baseplate and the ostomy bag can be fixedly attached to each other.The baseplate is configured to attach to the stoma and / or the skin surrounding the stoma of a user, such as the peristomal skin area.

[0016] In the embodiments, the ostomy appliance includes a baseplate, such as a one-piece monolithic baseplate, for example, integrated with a sensor mounting part, or a separate sensor mounting part, such as a sensor mounting part to be subsequently applied to a baseplate. In the embodiments, the part of Petition 870210096510, dated 10 / 19 / 2021, page 17 / 133 / 81. A sensor mount is a sensor patch for application to a baseplate, such as the proximal surface of the baseplate. Thus, an arbitrary baseplate, such as a conventional baseplate, can achieve the capabilities as described herein. The capabilities described with respect to the baseplate's detection / monitoring capabilities in this document can be provided by a sensor mount of a sensor patch to be applied to a baseplate, for example, by the user, and vice versa. In these embodiments, the sensor patch is adapted to adhere to a baseplate.

[0017] In embodiments, a method for affixing a baseplate that has detection capabilities, for example, by providing a sensor patch, to a user's stoma and / or the skin surrounding the stoma, such as the peristomal skin area, comprises affixing the sensor patch to a baseplate and affixing the baseplate, i.e., together with the affixed sensor patch, to a user's stoma and / or the skin surrounding the stoma, such as the peristomal skin area. Alternatively, the method for affixing the baseplate to a user's stoma and / or the skin surrounding the stoma comprises affixing the sensor patch to a user's stoma and / or the skin surrounding the stoma and affixing the baseplate to a user's stoma and / or the skin surrounding the stoma above the affixed sensor patch, i.e., on a distal surface of the sensor patch.

[0018] In the embodiments, the baseplate and / or sensor patch comprises a first adhesive layer with a proximal side configured for affixing the baseplate and / or sensor patch to the skin surface of a user. In the embodiments, the first adhesive layer has a stomatic opening, such as a first adhesive stomatic opening, with a central point.

[0019] In the embodiments, the baseplate and / or sensor patch comprises a plurality of electrodes including a first electrode Petition 870210096510, dated 10 / 19 / 2021, p. 18 / 133 / 81 of leakage, a second leakage electrode and a third leakage electrode provided in an electrode assembly of a sensor assembly. In the embodiments, the plurality of electrodes is configured to detect the presence of liquid, such as leakage, on the proximal side of the first adhesive layer and / or wetting content in the first adhesive layer. In the embodiments, the electrode assembly of the sensor assembly is configured to detect the presence of liquid, such as leakage, on the proximal side of the first adhesive layer and / or wetting content in the first adhesive layer in a primary detection zone and a secondary detection zone, separate from the primary detection zone.In these embodiments, the primary detection zone is arranged in a primary angle space from the center point of the first adhesive layer, and / or the secondary detection zone is arranged in a secondary angle space, separate from the primary angle space, from the center point of the first adhesive layer. Alternatively or additionally, the primary detection zone may be arranged in a primary radial space from the center point of the first adhesive layer and the secondary detection zone may be arranged in a secondary radial space from the center point of the first adhesive layer. In these embodiments, the electrode assembly of the sensor assembly is configured to detect the presence of liquid, such as outflow, on the proximal side of the first adhesive layer and / or wetting content in the first adhesive layer in three or more detection zones.

[0020] In embodiments, the monitoring device comprises a housing, a processor, a memory, a first interface (also referred to as an appliance interface) connected to the processor and memory, and a second interface connected to the processor. The first interface is configured to obtain ostomy data from the baseplate and / or the sensor patch attached to the first interface. The ostomy data comprises primary ostomy data from an electrode array. Petition 870210096510, dated 10 / 19 / 2021, p. 19 / 133 / 81 primary from the baseplate and / or sensor patch, and secondary ostomy data from a secondary electrode set of the baseplate and / or sensor patch. In the embodiments, the processor is configured to: obtain primary parameter data based on primary ostomy data; obtain secondary parameter data based on secondary ostomy data; and detect the presence of fluid on the proximal side of the first adhesive layer and / or wetting in the first adhesive layer in a primary detection zone based on primary parameter data. In the embodiments, the primary detection zone is arranged in a primary angle space from the center point of the first adhesive layer and / or arranged in a primary radial space from the center point of the first adhesive layer.Additionally, in the embodiments, the processor is configured to detect the presence of liquid on the proximal side of the first adhesive layer and / or wetting in the first adhesive layer in a secondary detection zone based on secondary parameter data. In the embodiments, the secondary detection zone is arranged in a secondary angle space from the center point of the first adhesive layer and / or arranged in a secondary radial space from the center point of the first adhesive layer.In these modes, according to a detection of the presence of liquid and / or humidification in the primary detection zone, the processor is configured to transmit a primary monitor signal comprising monitor data indicative of the presence of liquid and / or humidification in the primary detection zone via the second interface; and according to a detection of the presence of liquid and / or humidification in the secondary detection zone, to transmit a secondary monitor signal comprising monitor data indicative of the presence of liquid and / or humidification in the secondary detection zone via the second interface.

[0021] The baseplate and / or sensor patch comprise a first adhesive layer. During use, the first adhesive layer adheres to the Petition 870210096510, dated 10 / 19 / 2021, page 20 / 133 / 81 user's skin (peristomal area) and / or additional seals, such as sealing paste, sealing tape and / or sealing ring. Thus, in the embodiments, the first adhesive layer is configured for affixing the baseplate and / or sensor patch to the surface of a user's skin. In the embodiments, the first adhesive layer has a stoma opening, such as a first adhesive stoma opening, with a central point or is at least prepared to form a stoma opening with a central point. A baseplate and / or a sensor patch, according to the present disclosure, enables the detection of the presence of liquid or outflow on the proximal side of the first adhesive layer (between a surface of the user's skin, such as the peristomal skin area, and the proximal surface of the first adhesive layer).

[0022] In the embodiments, the first adhesive layer is produced from a first composition. In the embodiments, the first composition comprises one or more polyisobutenes and / or styrene-isoprene-styrene. In the embodiments, the first composition comprises one or more hydrocolloids. In the embodiments, the first composition comprises one or more water-soluble or water-expandable hydrocolloids. In the embodiments, the first composition is a pressure-sensitive adhesive composition suitable for medical purposes comprising a rubberized elastomeric base and one or more water-soluble or water-expandable hydrocolloids. In the embodiments, 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 polybutenes and the absorbent properties of hydrocolloids 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 copolymer... Petition 870210096510, dated 10 / 19 / 2021, page 21 / 133 / 81. The styrene block may comprise 5% to 20% of the total adhesive composition. The butene component is suitably a conjugated butadiene polymer selected from polybutadiene or polyisoprene. Polybutenes are preferably present in an amount of 35-50% of the total adhesive composition. Preferably, the polybutene is polyisobutylene (PIB). Suitable hydrocolloids for incorporation into the first composition are selected from naturally occurring hydrocolloids, semi-synthetic hydrocolloids, and synthetic hydrocolloids. The first composition may comprise 20-60% hydrocolloids. A preferred hydrocolloid is carboxymethylcellulose (CMC). Optionally, the first composition may contain other components, such as fillers, tack enhancers, plasticizers and / or other additives.

[0023] The first adhesive layer may have a substantially uniform thickness. The first adhesive layer may have a thickness in the range of 0.1 mm to 1.5 mm, for example, in the range of 0.2 mm to 1.2 mm, such as 0.8 mm or 1.0 mm. The first adhesive layer may have a primary thickness in a primary part of the first adhesive layer, for example, in a primary region within a primary radial distance or in a range of primary radial distance from the central point of the stomatal opening. The primary thickness may be in the range of 0.2 mm to 1.5 mm, such as about 1.0 mm. The primary radial distance may be in the range of 20 mm to 50 mm, such as in the range of 25 mm to 35 mm, for example, 30 mm. The first adhesive layer may have a secondary thickness in a secondary part of the first adhesive layer, for example, in a secondary region outside a secondary radial distance or in a range of secondary radial distance from the central point of the stomatal opening.The secondary thickness can be in the range of 0.2 mm to 1.0 mm, such as approximately 0.5 mm. The secondary radial distance can be in the range of 20 mm to 50 mm, as well as in the range of 25 mm to 35 mm, for example, 30 mm. Petition 870210096510, dated 10 / 19 / 2021, p. 22 / 133 / 81

[0024] In the embodiments, the baseplate and / or sensor patch comprise a second layer. In the embodiments, the second layer is an adhesive layer. In the embodiments, the second layer has a second radial extension that is larger than a first radial extension of the first adhesive layer at least in a first angular band of the baseplate and / or sensor patch. Consequently, a portion of a proximal surface of the second layer may be configured for affixation to the skin surface of a user. The portion of a proximal surface of the second layer configured for affixation to the skin surface of a user is also denoted the skin affixation surface of the second adhesive layer. The second layer may have a stomal opening, such as a second layer stomal opening and / or a second adhesive stomal opening, with a central point.

[0025] In the embodiments, the second adhesive layer is produced from a second composition. In the embodiments, the second composition comprises one or more polyisobutenes and / or styrene-isoprene-styrene. In the embodiments, the second composition comprises one or more hydrocolloids. In the embodiments, the second composition comprises one or more water-soluble or water-expandable hydrocolloids. In the embodiments, the second composition is a pressure-sensitive adhesive composition suitable for medical purposes comprising a rubberized elastomeric base and one or more water-soluble or water-expandable hydrocolloids. In the embodiments, 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 adhesive properties of polybutenes and the absorbent properties of hydrocolloids 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. Petition 870210096510, dated 10 / 19 / 2021, page 23 / 133 / 81 Preferably, one or more styrene-isoprene (SIS) block copolymers are employed. The amount of styrene block copolymer can be from 5% to 20% of the total adhesive composition. The butene component is suitably a conjugated butadiene polymer selected from polybutadiene, polyisoprene. Polybutenes are preferably present in an amount of 35-50% of the total adhesive composition. Preferably, the polybutene is polyisobutylene (PIB). Suitable hydrocolloids for incorporation into the second composition are selected from naturally occurring hydrocolloids, semi-synthetic hydrocolloids, and synthetic hydrocolloids. The second composition may comprise 20-60% hydrocolloids. A preferred hydrocolloid is carboxymethylcellulose (CMC). Optionally, the second composition may contain other components, such as fillers, tack enhancers, plasticizers, and / or other additives.

[0026] Different ratios of contents may alter 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 polyisobutenes, styrene-isoprene-styrene and / or hydrocolloids. For example, the second adhesive layer may 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 may be thinner than the first adhesive layer. Alternatively or additionally, the second adhesive layer may be less absorbent of water and / or sweat than the first adhesive layer. Alternatively or additionally, the second adhesive layer may be less moldable than the first adhesive layer.In these applications, the second adhesive layer provides a second barrier against leakage. Petition 870210096510, dated 10 / 19 / 2021, page 24 / 133 / 81

[0027] The second layer may have a substantially uniform thickness. The second layer may have a thickness in the range of 0.1 mm to 1.5 mm, 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.

[0028] Providing a baseplate with detection capabilities, for example via an incorporated sensor mount or via a sensor patch comprising a sensor mount, provides optimal or improved use of an ostomy appliance. In particular, it facilitates that a baseplate is not changed too late (resulting in adhesive failure, leakage and / or skin damage), or at least that a user is informed that a leak is going to occur, is occurring or has occurred. Consequently, the user or a healthcare professional is able to monitor and plan the use of the ostomy appliance.

[0029] In the embodiments, the base plate and / or the sensor patch comprises one or more electrodes, such as a plurality of electrodes, such as two, three, four, five, six, seven or more electrodes. The sensor patch may be applied to the base plate, such as to provide the base plate with one or more electrodes. In the embodiments, the electrodes are provided in an electrode assembly. In the embodiments, the electrode assembly is provided in a sensor assembly.

[0030] In the embodiments, the electrodes, for example, some or all of the electrodes, are arranged between the first adhesive layer and the second adhesive layer. In the embodiments, the electrodes are arranged in an electrode assembly, for example, an electrode layer of a sensor assembly. In the embodiments, an electrode comprises a connection part for connecting the electrodes to other components and / or interface terminals / terminal elements, such as for connecting the electrodes to a monitoring device. In the embodiments, an electrode comprises one or more conductor parts and / or one or more sensing parts. A part of Petition 870210096510, dated 10 / 19 / 2021, p. 25 / 133 / 81. A conductor can be considered part of an electrode that connects two or more detection parts, and / or connects a detection part with a connection part of the respective electrode. A detection part can be considered a part of the electrode that is suitable for detecting, for example, liquid, such as liquid content, and / or output, such as output resulting from a leak, or an imminent leak. The detection part may be suitable for detecting, for example, through its shape, said shape being potentially circular, oval, or rectangular. Thus, the conductor part can conduct a signal arising from the detection part. In the embodiments, an electrode comprises alternative conductor parts and detection parts. In the embodiments, the electrode assembly is disposed between the first adhesive layer and the second adhesive layer.The base plate and / or sensor patch, for example, the electrode assembly, may comprise a first electrode, a second electrode, and optionally a third electrode. The base plate and / or sensor patch, for example, the electrode assembly, may comprise a fourth electrode and / or a fifth electrode. The base plate and / or sensor patch, for example, the electrode assembly, optionally comprises a sixth electrode. In the embodiments, the base plate and / or sensor patch, for example, the electrode assembly, comprises a grounding electrode. The grounding electrode may comprise a first electrode part. In the embodiments, the first electrode part of the grounding electrode forms a ground or reference for the first electrode. In the embodiments, the first electrode part forms a closed circuit. The grounding electrode may comprise a second electrode part.In these embodiments, the second electrode part of the grounding electrode forms a ground or reference for the second electrode. The grounding electrode may comprise a third electrode part. In these embodiments, the third electrode part of the grounding electrode forms a ground or reference for the third electrode. The electrode of... Petition 870210096510, dated 10 / 19 / 2021, page 26 / 133 / 81 grounding may comprise a quarter electrode. In embodiments, the quarter electrode of the grounding electrode forms a ground or reference for the fourth electrode and / or the fifth electrode. In embodiments, the grounding electrode is configured as or forms a (common) reference electrode for some or all of the other electrodes in the electrode assembly.

[0031] The electrodes are electrically conductive and may comprise one or more of the following materials: metallic (e.g., silver, copper, gold, titanium, aluminum, stainless steel), ceramic (e.g., ITO), polymeric (e.g., PEDOT, PANI, PPy), and carbonaceous (e.g., carbon black, carbon nanotube, carbon fiber, graphene, graphite).

[0032] In the embodiments, the electrode assembly comprises a backing layer, also referred to as a backing film. In the embodiments, the sensor assembly comprises the electrode assembly and the backing layer. One or more electrodes may be formed, for example, printed, on the proximal side of the backing layer. One or more electrodes may be formed, for example, printed, on the distal side of the backing layer. Thus, one or more electrodes may be arranged between the backing layer and the first adhesive layer. The electrode assembly, like the backing layer of the electrode assembly, may have a stomatal opening, such as an electrode assembly stomatal opening and / or a backing layer stomatal opening, with a central point. In the embodiments, the backing layer comprises polymeric materials (e.g., polyurethane, PTFE, PVDF) and / or ceramic materials (e.g., alumina, silica).In one or more exemplary baseplates and / or sensor patches, the backing layer is produced from thermoplastic polyurethane (TPU). The backing layer material may be produced from or comprise one or more of the following: polyester, a thermoplastic elastomer (TPE), polyamide, polyimide, ethylene vinyl acetate (EVA), polyurea, and silicones. Thermoplastic elastomers. Petition 870210096510, dated 10 / 19 / 2021, page 27 / 133 / 81, examples of the support layer are styrenic block copolymers (TPS, TPE-s), thermoplastic polyolefin elastomers (TPO, TPE-o), thermoplastic vulcanizates (TPV, TPE-v), thermoplastic polyurethanes (TPU), thermoplastic copolyester (TPC, TPE-E) and thermoplastic polyamides (TPA, TPE-A).

[0033] Determining humidification pattern types or angular leakage patterns is useful to help reduce the risk of a user experiencing leakage from an ostomy appliance. Additionally, determining humidification pattern types and classifying operating states and / or leakage patterns of the ostomy appliance is further useful to help reduce the risk of skin damage in a user.

[0034] In the embodiments, the primary detection zone of the baseplate and / or sensor patch is arranged in a primary angle space from the center point of the first adhesive layer. In the embodiments, the primary angle space encompasses a primary angle in the range of 45° to 315°, as well as in the range of 45° to 135°. In the embodiments, the primary angle depends on the number of angle detection zones in the baseplate and / or sensor patch. For example, the primary angle may be approximately 180° ± 15°, for example, for a baseplate and / or sensor patch with two or more detection zones. The primary angle may be approximately 120° ± 15°, for example, for a baseplate and / or sensor patch with two, three or more detection zones. The primary angle can be approximately 90° ± 15°, for example, for a baseplate and / or a sensor patch with two, three, four or more detection zones. The detection zones are separate and do not overlap.

[0035] Alternatively or additionally, the primary detection zone may be arranged in a primary radial space from the central point of the first adhesive layer. In the embodiments, the primary radial space encompasses Petition 870210096510, dated 10 / 19 / 2021, p. 28 / 133 / 81 a primary radius in the range of 10-50 mm, as well as in the range of 10-25 mm, as well as in the range of 19-20 mm. In the embodiments, the primary radius depends on the number of radial detection zones on the base plate and / or sensor patch.

[0036] In the embodiments, the secondary detection zone is arranged in a secondary angle space from the center point of the first adhesive layer. In the embodiments, the secondary angle space encompasses a secondary angle in the range of 45° to 315°, as well as in the range of 45° to 135°. In the embodiments, the secondary angle depends on the number of angular detection zones on the baseplate and / or sensor patch. For example, the secondary angle may be approximately 180° ± 15°, for example, for a baseplate and / or sensor patch with two or more detection zones. The secondary angle may be approximately 120° ± 15°, for example, for a baseplate and / or sensor patch with two, three or more detection zones. The secondary angle may be approximately 90° ± 15°, for example, for a baseplate and / or sensor patch with two, three, four or more detection zones.

[0037] Alternatively or additionally, the secondary detection zone may be arranged in a secondary radial space from the central point of the first adhesive layer. In the embodiments, the secondary radial space encompasses a secondary radius in the range of 15-50 mm, as in the range of 20-30 mm, as in the range of 25-26 mm. In the embodiments, the secondary radius depends on the number of radial detection zones on the base plate and / or sensor patch. In the embodiments, the secondary radius is larger than the primary radius.

[0038] In the modalities, the plurality of electrodes is configured to detect the presence of liquid on the proximal side in a tertiary detection zone. In the modalities, the tertiary detection zone is arranged in a tertiary angle space from the central point of the first adhesive layer. In the modalities, the tertiary angle space encompasses a Petition 870210096510, dated 10 / 19 / 2021, p. 29 / 133 / 81 tertiary angle in the range of 45° to 315°, as well as in the range of 45° to 180°, for example, in the range of 45° to 135°. In the embodiments, the tertiary angle depends on the number of angular detection zones on the base plate and / or sensor patch. For example, the tertiary angle may be approximately 180° ± 15°, for example, for a base plate and / or sensor patch with three or more detection zones. The tertiary angle may be approximately 120° ± 15°, for example, for a base plate and / or sensor patch with three or more detection zones. The tertiary angle can be approximately 90° ± 15°, for example, for a baseplate and / or a sensor patch with three, four, or more detection zones.

[0039] Alternatively or additionally, the tertiary detection zone may be arranged in a tertiary radial space from the central point of the first adhesive layer. In the embodiments, the tertiary radial space encompasses a tertiary radius in the range of 15-50 mm, as in the range of 25-50 mm, as in the range of 29-30 mm. In the embodiments, the tertiary radius depends on the number of radial detection zones on the baseplate and / or sensor patch. In the embodiments, the tertiary radius may be larger than the secondary radius and / or the primary radius.

[0040] In the modalities, the primary detection zone and the secondary detection zone are separate detection zones, i.e., non-overlapping. The primary detection zone and the tertiary detection zone may be separate detection zones, i.e., non-overlapping. The secondary detection zone and the tertiary detection zone may be separate detection zones, i.e., non-overlapping.

[0041] In these embodiments, the primary detection zone, the secondary detection zone and / or the tertiary detection zone cover electrodes embedded in, or in contact with, the first adhesive layer, as well as leakage electrodes that are exposed to the surroundings. Thus, the propagation or absorption of moisture in the first adhesive layer can be Petition 870210096510, dated 10 / 19 / 2021, page 30 / 133 / 81 detected in one or more of the detection zones, thus providing a determination of the direction of wetting propagation in the first adhesive layer. Similarly, the outflow propagation between the user's skin and the first adhesive layer can be determined by the exposed leakage electrodes. Leakage electrodes can be exposed by means of sensor point openings. A sensor point opening in the first adhesive layer is configured to overlap a (detection) portion of a leakage electrode, for example, to form a sensor point. In the embodiments, a sensor point opening in the first adhesive layer has a suitable shape and size that facilitates access to a leakage electrode from the proximal side of the first adhesive layer.

[0042] In the embodiments, two electrodes of the electrode assembly form a sensor. In the embodiments, the first leak electrode and the second leak electrode form a primary leak sensor or pair of primary leak electrodes to detect the presence of liquid on the proximal side of the first adhesive layer in the primary detection zone. In the embodiments, the second leak electrode and the third leak electrode form a secondary leak sensor or pair of secondary leak electrodes to detect the presence of liquid on the proximal side of the first adhesive layer in the secondary detection zone. In the embodiments, the first leak electrode and the third leak electrode form a tertiary leak sensor or pair of tertiary leak electrodes to detect the presence of liquid on the proximal side of the first adhesive layer in the tertiary detection zone.

[0043] In the embodiments, the baseplate and / or sensor patch comprises a monitor interface (also referred to as a mounting interface). In the embodiments, the monitor interface is configured to electrically and / or mechanically connect the ostomy appliance (baseplate and / or sensor patch) to the monitor device. In the embodiments, the interface of Petition 870210096510, dated 10 / 19 / 2021, page 31 / 133 / 81 monitor is configured to wirelessly connect the ostomy appliance (baseplate and / or sensor patch) to the monitor device. Thus, the monitor interface of the baseplate and / or sensor patch can be configured to electrically and / or mechanically couple the ostomy appliance and the monitor device.

[0044] In the embodiments, the monitor interface of the baseboard and / or sensor patch comprises, for example, as part of a first connector of the monitor interface, a coupling part to form a mechanical connection, such as a releasable coupling between the monitor device and the baseboard and / or sensor patch. In the embodiments, the coupling part is configured to engage with a coupling part of the monitor device to releasably couple the monitor device to the baseboard and / or sensor patch.

[0045] The present disclosure provides a monitoring device comprising a three-axis geometric accelerometer configured to generate a position signal. The three-axis geometric accelerometer is configured to evaluate / measure acceleration (relative), the direction of gravity, and the force of gravity along a geometric x-axis, a geometric y-axis, and a geometric z-axis that are mutually orthogonal, i.e., spanning a Cartesian (three-dimensional) coordinate system. In embodiments, the accelerometer is configured to detect movement of the monitoring device. A three-axis geometric accelerometer may be referred to as a triaxial accelerometer. In embodiments, the evaluated / measured acceleration, the direction of gravity, and / or the force of gravity are contained within a position signal.Thus, the monitoring device has the capability to measure relative acceleration (motion) and gravitational force in a three-dimensional space, that is, space as encompassed by a Cartesian coordinate system. In particular, the monitoring device has the capability to measure relative acceleration and gravitational force along... Petition 870210096510, of 10 / 19 / 2021, page 32 / 133 / 81 of each of the geometric x-axis, geometric y-axis, geometric z-axis of such three-dimensional space. In the embodiments, the position signal is communicated to the processor and / or a memory of the monitor device. In the embodiments, the position signal forms the basis for a determination of a spatial orientation, such as an inclination, of the monitor device.

[0046] In the embodiments, the accelerometer is configured to generate one or more position signals proportional to an acceleration of the monitor device relative to one or more geometric axes of the three-dimensional coordinate system, wherein these position signals may represent the movement of the monitor device (through the use of the monitor device) or user input (through touching the monitor device).In the modalities, touch, or touch sequences, is a procedure in which the user uses their finger or equivalent to generate certain position signals, such as position signals that belong to a specific touch pattern (task profile). Thus, typically, touch refers to short, yet significant movements of the monitor device. In other words, touch causes the monitor device to move at a relatively high acceleration due to the short period of time the monitor device is moved during each touch.

[0047] Hereafter, whenever referring to a particular geometric axis, such as an x-axis, a y-axis, or a z-axis, of the accelerometer, the reference is to the geometric axis along which an acceleration can be measured / detected by such a 3-axis accelerometer. In embodiments, the accelerometer measures along all three geometric axes simultaneously. Thus, the reference is to the concept of detecting, measuring, or generating position signals proportional to an acceleration along the given geometric axis rather than a physical shape of the accelerometer. It should be understood that a reference to a particular geometric axis, such as the x-axis, can also be Petition 870210096510, dated 10 / 19 / 2021, p. 33 / 133 / 81 replaced by a reference to any other geometric axis, such as the geometric axis y and the geometric axis z, applying a rotation of the reference frame / coordinate system. Rotation of the reference frame / coordinate system can be done through the apparatus of a rotation matrix according to linear algebra. Thus, in the modalities, the reference to a specific geometric axis is merely for illustrative purposes. The same reasoning applies to any reference to a geometric plane covered by the geometric axes.

[0048] In the embodiments, the accelerometer comprises certain processing capabilities, so that the accelerometer can be switched on independently of the power status of the monitor device's processor. For example, the accelerometer's processing capabilities include analyzing position signals and sending relevant instructions to the processor. In the embodiments, the accelerometer has the ability to switch the monitor device's processor on / off as part of a power management system.

[0049] In the embodiments, the accelerometer is a capacitive MEMS accelerometer. In the embodiments, the accelerometer is a piezoelectric accelerometer. In the embodiments, the accelerometer is a piezoresistive accelerometer. In the embodiments, the accelerometer has analog outputs. In the embodiments, the accelerometer has digital outputs. In the embodiments, the accelerometer has the capability to measure at least + / - 2 g. In the embodiments, the accelerometer can measure acceleration between -50 g and 50 g, such as between -20 g and 20 g, or such as between -10 g and 10 g. In the embodiments, the accelerometer has a bandwidth of at least 10 Hz, such as 50 Hz.

[0050] The present disclosure provides the use of a baseplate and / or sensor patch comprising multiple sensing zones, such as angularly distributed sensing zones, as described Petition 870210096510, dated 10 / 19 / 2021, page 34 / 133 / 81 previously. In the embodiments, the present disclosure provides communication to the user in which zone a leak occurs. In the embodiments, the user is free to apply the baseplate and / or sensor patch at any angle of rotation around their ostomy. For example, the presence of scars and / or wrinkles on the skin may cause the user to rotate the baseplate and / or sensor at a particular angle, for example, based on experience and / or personal comfort. In the embodiments, the baseplate and / or sensor patch appears to be rotationally symmetrical to the user, despite the detection zones being provided in a particular arrangement on a sensor assembly of the baseplate and / or sensor patch. In one embodiment, the detection zone data is collected by the monitoring device through a physical connection to the electrodes of the sensor / electrode assembly.In the embodiments, such physical connection is provided by a neck portion affixed to / integrated into the baseplate and / or sensor patch, wherein the electrodes of the electrode assembly may extend into the neck portion and connect to a monitor device coupled to a mounting interface. Thus, in the embodiments, the baseplate and / or sensor patch comprises a neck portion that extends radially in the opposite direction to a user's stoma, the neck portion comprising a mounting interface that allows a monitor device to be coupled to the baseplate and / or sensor patch and, through this, to the sensor / electrode assembly. In the embodiments, the monitor device is configured to be coupled to the baseplate and / or sensor patch and thus to be used in close proximity to the user's skin.Thus, the monitoring device is configured to be attached to the base plate and / or sensor patch in a designated portion thereof and remains in such a fixed position relative to the base plate and / or sensor patch during use, i.e., during monitoring, such as monitoring for leakage from the base plate and / or sensor patch. When attached to the base plate and / or sensor patch in a fixed position, a. Petition 870210096510, dated 10 / 19 / 2021, page 35 / 133 / 81: The spatial orientation of the monitoring device, such as a tilt relative to a natural orientation, is indicative of an equivalent tilt / rotation of the baseplate and / or sensor patch. In other words, the (coupled) monitoring device is fixed relative to the detection zones provided in a sensor mount of the baseplate and / or sensor patch. Additionally, in other words, the spatial orientation of a monitoring device coupled to a baseplate and / or sensor patch applies in the same way to the baseplate and / or sensor patch through its fixed relative position.

[0051] By providing the monitoring device with an accelerometer, it is possible to determine the spatial orientation of such monitoring device. Thus, since the monitoring device is configured to be attached to the baseplate and / or sensor patch in a fixed position, it is possible to determine the spatial orientation, such as a rotational displacement, of the baseplate and / or sensor patch relative to the ostomy and, therefore, of the detection zones provided on the baseplate and / or sensor patch. In this way, it is possible to communicate to the user where (in which detection zone) a possible leak occurs and / or where the moisture content absorbed in the adhesive is high / increasing.

[0052] In one embodiment, the position signal comprises a value for a force of gravity along a geometric x-axis, along a geometric y-axis and along a geometric z-axis, wherein the geometric axes are mutually orthogonal, and / or a value for a primary angular displacement of the geometric x-axis relative to a predefined orientation, a secondary angular displacement of the geometric y-axis relative to a predefined orientation and a tertiary angular displacement of the geometric z-axis relative to a predefined orientation.

[0053] In the modalities, the geometric x-axis, the geometric y-axis, and the geometric z-axis are mutually orthogonal, according to the system of Petition 870210096510, dated 10 / 19 / 2021, page 36 / 133 / 81 Cartesian coordinates, as covered by the 3-axis geometric accelerometer, as described previously.

[0054] In the modalities, the position signal is mathematically represented as a vector or matrix. In the modalities, the position signal additionally includes a time mark. By applying trigonometric functions, the total gravitational force can be calculated. Next, the gravitational force g is measured in Newtons ([N]), and for a freely falling object, 1 g = 9.8 N = 9.8 m / s2.

[0055] In the modalities, the position signal comprises information pertaining to the force of gravity along the geometric x-axis, the force of gravity along the geometric y-axis, and the force of gravity along the geometric z-axis.

[0056] In the embodiments, additionally or alternatively, the position signal comprises information pertaining to a primary angular displacement of the geometric x-axis relative to a predefined orientation, a secondary angular displacement of the geometric y-axis relative to a predefined orientation, and a tertiary angular displacement of the geometric z-axis relative to a predefined orientation.

[0057] In the modalities, an angular displacement means the angular deviation between a predefined orientation and a given axial component, such as the geometric x-axis, the geometric y-axis, or the geometric z-axis. In the modalities, a predefined orientation is an orientation in which one of the geometric axes (such as the geometric x-axis, or the geometric y-axis, or the geometric z-axis) is aligned with the direction of gravity, while the remaining set of geometric axes (such as the geometric y-axis, the geometric z-axis, or the geometric y-axis, or the geometric ze-axis) spans a geometric (horizontal) plane that is normal / perpendicular to the direction of gravity. For example, an angular displacement of a geometric axis can be measured with Petition 870210096510, dated 10 / 19 / 2021, p. 37 / 133 / 81 in relation to the direction of gravity or in relation to the horizontal plane.

[0058] In the modes, the position signal comprises a value for the relative acceleration of the monitor device along the geometric x-axis, the geometric y-axis, and the geometric z-axis. Thus, information pertaining to the movement of the monitor device can be read directly from the position signal, or from two or more position signals. In the modes, the relative acceleration is indicative of the movement of the monitor device. In the modes, the relative acceleration can be calculated from information pertaining to the force of gravity along the geometric x-axis, along the geometric y-axis, and along the geometric z-axis.

[0059] In the embodiments, the predefined orientation is a predefined natural orientation of the accelerometer. In the embodiments, an angular displacement indicates deviations from the natural orientation. Thus, in the embodiments, an angular displacement indicates a tilt of the accelerometer and, therefore, of the monitoring device comprising said accelerometer. In embodiments where the monitoring device is coupled to a baseplate and / or sensor patch comprising a sensor assembly, in particular, a sensor assembly comprising two or more sensing zones, the indication of a tilt of the monitoring device is, likewise, an indication of a rotational tilt / displacement of the baseplate and / or sensor patch. In the embodiments, the processor generates a displacement parameter based on one or more position signals.In these modes, the displacement parameter is used to compensate for any tilt of the monitor / baseplate / sensor patch when communicating the presence and position of a potential ostomy-related leak.

[0060] In one embodiment, the position signal is sampled at a rate of at least 0.1 Hz. In other words, in the embodiments, the sampling rate of the position signal is at least 0.1 Hz. Additionally, in Petition 870210096510, dated 10 / 19 / 2021, page 38 / 133 / 81 In other words, a position signal is obtained at least every ten seconds. Sampling the position signal means that a position signal is obtained by the accelerometer at least every ten seconds. Thus, every ten seconds, the spatial orientation of the accelerometer, and therefore of the monitoring device, is evaluated. In the modalities, the position signal is sampled at a rate of at least 1 Hz, that is, once every second. In the modalities, 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 precise evaluation of the spatial orientation of the monitoring device is obtained. In the modalities, such a more precise evaluation is useful for recording touch sequences, as described previously.Furthermore, this more precise assessment provides the possibility of using the monitoring device to track activity and / or physiological changes, such as steps taken by the user, time spent in bed, respiratory rate, or heart rate.

[0061] In the modalities, the monitoring device has the capability to track the activity of the user wearing the monitoring device, that is, to monitor movements and possibly the intensity of such movements. In other words, in the modalities, the monitoring device tracks the user's activity by generating position signals that pertain to the movement of the monitoring device and therefore to the user. In the modalities, during activity tracking, the sampling rate is at least 100 Hz, or at least 200 Hz, or at least 2000 Hz. In the modalities, the monitoring device has the capability to differentiate between different activities, including walking, running, cycling, tennis, etc. In the modalities, such different activities yield different movements and therefore different (distinguishable) position signals, which can be attributed to the different activities.In these modalities, data pertaining to activity tracking can be communicated to a system. Petition 870210096510, dated 10 / 19 / 2021, page 39 / 133 / 81, which has the capacity to determine or predict a future operating state of the ostomy appliance. In other words, in the embodiments, a system has the capacity to determine or predict the possibility of a leak or deterioration of the adhesive properties of the ostomy appliance. In the embodiments, such a system has the capacity to warn the user (for example, through an accessory device) of the possibility of a leak, for example, due to a certain activity, as tracked and determined by the monitoring device. In the embodiments, data pertaining to activity tracking, for example, the specific type of activity, are used to predict an amount of sweat generated. In the embodiments, a predicted amount of sweat is used to determine a future operating state of the ostomy appliance.

[0062] In some modes, the sampling rate is adjustable, for example, according to a power management system of the monitor device. In some modes, the sampling rate depends on a power management mode of the monitor device. In some modes, the sampling rate is low, such as less than 1 Hz, such as 0.1 Hz, when the monitor device determines that the user is at rest, for example, during the night or when sitting or lying down. In some modes, the sampling rate is high, such as greater than 1 Hz, or greater than 100 Hz, such as 2000 Hz, when the monitor device determines that the user is active, such as during the day or when walking / exercising.

[0063] In the embodiments, the monitor device comprises a power management mode in which the monitor device, or at least the processor, remains in a power-saving mode (e.g., when the processor is switched off or remains in a standby mode when certain functions are switched off) unless significant accelerations are measured / detected by the accelerometer. In the embodiments, Petition 870210096510, dated 10 / 19 / 2021, page 40 / 133 / 81 Significant accelerations are accelerations that pertain to intentional touch on the monitoring device. Significant accelerations mean accelerations of more than + / - 0.2 g, such as more than + / - 0.5 g, or more than + / - 1 g, such as + / - 2 g. Thus, a significant acceleration can be defined as a threshold value, for example, a threshold value that incorporates one of the exemplary accelerations. In this way, the battery is saved while the monitoring device is only exposed to minor accelerations, that is, accelerations that are less than a threshold value that defines a significant acceleration, as explained above. Thus, in power management mode modes, the accelerometer does not respond to minor accelerations, but is configured to respond to significant accelerations, as defined above.Thus, in certain modes, once exposed to significant accelerations, the accelerometer instructs the processor to exit power saving mode.

[0064] In one embodiment, the position signal is indicative of a spatial orientation of the monitoring device. In the embodiments, the position signal is indicative of a spatial orientation of the monitoring device relative to the predefined natural orientation. Since the position signal comprises information pertaining to relative acceleration, the force of gravity, and / or angular displacement / tilt, and since the accelerometer is fixed within the monitoring device, the spatial orientation of the monitoring device can be determined. In the embodiments, a motion of the monitoring device is determined by calculating a difference between two time-separated position signals. In this way, (relative) motions of the monitoring device can be tracked.In embodiments where the monitoring device is coupled to a base plate and / or sensor patch comprising a sensor mount, in particular, a sensor mount comprising two or more detection zones, the indication of a tilt of the monitoring device is, therefore... Petition 870210096510, dated 10 / 19 / 2021, page 41 / 133 / 81 in the same way, an indication of a rotational tilt / displacement of the base plate and / or sensor patch. Thus, the position signal can be used to generate a displacement parameter used to compensate for such tilt when communicating the presence and position of a possible leak in relation to the ostomy to the user, for example, through a graphical user interface (GUI), such as a UGI included in an accessory device, such as a smartphone.

[0065] In one embodiment, the accelerometer comprises a predefined natural orientation, wherein the primary angular displacement of the geometric x-axis relative to the direction of gravity is zero, or the secondary angular displacement of the geometric y-axis relative to the direction of gravity is zero, or the tertiary angular displacement of the geometric z-axis relative to the direction of gravity is zero.

[0066] By introducing / defining a natural orientation, such natural orientation forms a reference for any tilt / rotation displacement. In the modalities, the natural orientation is an orientation of the accelerometer and therefore of the monitoring device, in which one of the geometric axes (x, y, z) of a Cartesian coordinate system is aligned with the direction of gravity, and in which the remaining set of geometric axes encompasses a geometric plane (horizontal) that is perpendicular / normal to the direction of gravity. In the modalities, the natural orientation is defined as the situation in which the geometric axis y is aligned with the direction of gravity, and the geometric axis x and geometric axis z encompass a geometric plane that is thus horizontal. In the modalities, the natural orientation is defined as the situation in which the geometric axis x is aligned with the direction of gravity, and the geometric axis y and geometric axis z encompass a geometric plane that is thus horizontal.In these modalities, natural orientation is defined as the situation in which the geometric z-axis is aligned with the direction of gravity, and the axis. Petition 870210096510, dated 10 / 19 / 2021, page 42 / 133 / 81 geometric xeo geometric axis y encompass a geometric plane that is, therefore, horizontal. In the embodiments, being aligned means that the respective geometric axis is parallel to the direction of gravity, however, the direction of the geometric axis can be positive or negative in the direction of gravity. In the embodiments, the natural orientation is predefined by the manufacturer, thus allowing the manufacturer or a service provider to know how to communicate the leakage state (where a leak occurs). In the embodiments, the natural orientation is resettable or redefinable, such as by the user.

[0067] In other words, a natural orientation can be indicated as a neutral orientation or a predefined orientation.

[0068] In one embodiment, the accelerometer comprises a predefined natural orientation, wherein the force of gravity along the geometric x-axis of the accelerometer is 0 g and wherein the force of gravity along the geometric y-axis of the accelerometer is -1 g.

[0069] In this way, a specific embodiment of a natural orientation is provided in which the geometric y-axis of the accelerometer is parallel to the direction of gravity, and in which the positive direction of the geometric y-axis is opposite to the direction of gravity, that is, the force of gravity along the geometric y-axis is -1 g. Similarly, since the geometric x-axis is orthogonal to the geometric y-axis, according to a Cartesian coordinate system, the force of gravity along such geometric x-axis is 0 g. Consequently, the force of gravity along the geometric z-axis is likewise 0 g. In the embodiments, the force of gravity along the geometric y-axis is +1 g. Thus, according to the embodiment, the geometric x-axis and the geometric z-axis encompass a geometric plane that is horizontal, that is, perpendicular to the direction of gravity and to the geometric y-axis. Thus, the direction of gravity is normal to the geometric plane covered by the geometric x-axis and the geometric z-axis. Petition 870210096510, dated 10 / 19 / 2021, page 43 / 133 / 81

[0070] In the modes, the accelerometer comprises a predefined natural orientation in which the force of gravity along the geometric y-axis is + / - 1 g. In the modes, the accelerometer comprises a predefined natural orientation in which the force of gravity along the geometric x-axis is + / - 1 g. In the modes, the accelerometer comprises the predefined natural orientation in which the force of gravity along the geometric z-axis is + / - 1 g.

[0071] In one embodiment, the accelerometer is configured to determine its spatial orientation relative to a user's ostomy based on a user-generated movement pattern. In the embodiments, the movement pattern is generated by a user wearing the monitoring device. When the user has affixed the baseplate and / or sensor patch to the peristomal skin area, i.e., the sensor mount at least partially surrounds an ostomy, it is challenging to know how the possible detection zones of the sensor mount are arranged in relation to the ostomy. For most users, it will be natural to consider upwards as the direction pointing towards the head and downwards as the direction pointing towards the lower body / feet. However, such terminology may be considered vague in a general sense when the user exercises, lies down, sits, is upside down, etc.Thus, a monitoring device capable of determining its spatial orientation, and thereby the orientation of the sensor mount relative to an ostomy, is desired. As previously revealed in the embodiments, by knowing the spatial orientation of the monitoring device, any rotation of the sensor mount (which potentially comprises detection zones) can be inferred.

[0072] In these embodiments, the accelerometer is configured to generate position signals at a given sampling rate, such as 0.1 Hz or 1 Hz, or greater than 1 Hz, such as when the monitoring device is coupled to the baseplate and / or sensor patch, and the baseplate and / or patch Petition 870210096510, dated 10 / 19 / 2021, page 44 / 133 / 81 The sensor is affixed to the peristomal skin area, that is, the sensor mount of the baseplate and / or sensor patch surrounds the ostomy. Each position signal comprises information pertaining to the spatial orientation of the monitoring device at the moment a specific position signal was generated. Thus, in the modalities, by sampling over a given time interval, a trend in the position signals is formed. For example, if the user, after affixing the baseplate and / or sensor patch and the monitoring device, walks / stands, the trend may reveal an average angular displacement of the monitoring device relative to a predefined natural orientation. In the modalities, the average angular displacement is indicative of the rotational displacement of the sensor mount of the baseplate and / or sensor patch relative to the natural orientation.In these modalities, the movement pattern / position signals generated by a standing / walking user are different from those of a bedridden user and a seated user. Therefore, in these modalities, the monitoring device is configured to differentiate between the different body positions.

[0073] In the embodiments, the average angular displacement is communicated to an accessory device, such as a smartphone. In the embodiments, the accessory device comprises a GUI configured to display a visual representation of at least two detection zones of the sensor mount. In the embodiments, the visual representation comprises information pertaining to a state of the region covered by the respective detection zone, where the state may be an indication of the presence of liquid, for example, a leak. In the embodiments, the average angular displacement is applied to the visual representation, for example, in a mathematical model that generates the visual representation, in a manner that reflects the physical orientation of the sensor mount in the visual representation relative to the user's ostomy. For example, if the user prefers to wear their baseplate and / or sensor patch slightly rotated due to the presence of Petition 870210096510, dated 10 / 19 / 2021, page 45 / 133 / 81 scars or wrinkles, such rotation is reflected in the visual representation on the IGU. In particular, the presence of a neck portion that is integrated into the baseplate and / or sensor patch may cause the user to rotate their baseplate and / or sensor patch to avoid affixing an adhesive surface of such neck portion to the scars and / or wrinkles.

[0074] In one mode, the movement pattern comprises a plurality of position signals sampled over a predefined time period. In the modes, the predefined time period depends on the sampling rate of the plurality of position signals. In the modes, the predefined time period 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 the modes, the movement pattern is generated continuously from the user's movement. In the modes, the movement pattern comprises a plurality of position signals sampled over a fluctuating time period, such as the previous 10 minutes, or any previous time period selected between 1 minute and 60 minutes, such as the previous 30 minutes.

[0075] In the embodiments, the mean angular displacement occurs based on a calculated average / median value of at least 10 position signals, or at least 100 position signals, or at least 500 position signals. In the embodiments, the mean angular displacement is indicative of the rotational displacement of the base plate and / or sensor patch relative to a predefined natural orientation.

[0076] In one embodiment, the spatial orientation of the accelerometer is indicative of a rotational displacement of the sensor mount when the monitoring device is coupled to said sensor mount. In the embodiments, the monitoring device is coupled to a sensor mount of a base plate or a sensor patch. Thus, the spatial orientation, such as an inclination, of the accelerometer and, thus, of the Petition 870210096510, dated 10 / 19 / 2021, page 46 / 133 / 81 monitor device, is indicative of / corresponds to a rotational displacement of the sensor assembly. In the embodiments, the rotational displacement is relative to a natural orientation, such as a natural orientation, as previously disclosed. In the embodiments, the spatial orientation of the accelerometer is indicative of the position of one or more, such as two or more, detection zones relative to an ostomy. In the embodiments, the spatial orientation of the accelerometer is an average angular displacement of the accelerometer and, therefore, an average value obtained from a plurality of position signals, as described above.

[0077] In one embodiment, the processor is configured to generate a displacement parameter based on an angular displacement of the accelerometer from its natural orientation. In another embodiment, the processor is configured to communicate the position signal and / or the displacement parameter to an accessory device.

[0078] In the embodiments, the accelerometer is configured to generate a displacement parameter based on an angular displacement of the accelerometer from its natural orientation. In the embodiments, the monitoring device is coupled to a sensor mount of a baseplate or a sensor patch. Thus, in the embodiments, the displacement parameter is a parameter indicative of a rotational displacement of the sensor mount relative to a natural orientation. In the embodiments, the angular displacement can be considered to belong to a two-dimensional plane, such as a geometric plane encompassed by two of the geometric axes of the accelerometer, the geometric plane being selected, such as to be substantially parallel to a plane in which the baseplate and / or sensor patch resides.

[0079] In the modes, the displacement parameter is communicated to an accessory device. In the modes, the monitoring device comprises a transceiver for wireless communication with a Petition 870210096510, dated 10 / 19 / 2021, page 47 / 133 / 81 accessory device. In the embodiments, the monitor device is configured to transmit a signal indicating the displacement parameter to an accessory device. In the embodiments, communicating, for example, to communicate a parameter from the monitor device to an accessory device, means transmitting a signal indicating the parameter, such as according to a wireless protocol, such as via a Bluetooth connection. In the embodiments, the accessory device comprises a graphical user interface. In the embodiments, the displacement parameter is used to generate a visual representation of the sensor mount, such that the visual representation incorporates the rotational displacement of the physical sensor mount as applied to the peristomal skin area by means of the baseplate or sensor patch.

[0080] In one embodiment, the housing comprises a skin-facing surface, and the x-axis and y-axis of the accelerometer encompass a geometric plane that is substantially parallel to said skin-facing surface of the housing, and the z-axis of the accelerometer extends in a direction that is normal to said geometric plane. In the embodiments, the housing defines the spatial extent of the monitoring device, that is, the external shape of the monitoring device. In the embodiments, the monitoring device, and thus its housing, is configured to be worn by a user under their clothing, near an ostomy, so that the monitoring device can obtain data related to a sensor mount disposed in the peristomal skin area. Thus, in the embodiments, the housing is small and / or discreet.In the embodiments, the housing comprises a skin-facing surface that is substantially flat to level with the skin or a neck portion of the baseplate and / or sensor patch. In the embodiments, the substantially flat skin-facing surface is parallel to the geometric plane encompassed by the x-axis and the y-axis of the accelerometer. Petition 870210096510, dated 10 / 19 / 2021, page 48 / 133 / 81, in which the geometric z-axis of the accelerometer is normal to the geometric plane. In the embodiments, the substantially flat skin-facing surface of the housing is adapted to be arranged parallel to a geometric plane encompassed by the baseplate and / or sensor patch. Thus, consequently, the geometric plane encompassed by the geometric x-axis and geometric y-axis of the accelerometer is adapted to be arranged parallel to the geometric plane encompassed by the baseplate and / or sensor patch.

[0081] Thus, the accelerometer and the housing share a certain geometry useful for giving the user a sense of orientation of the monitor device. Furthermore, an inclination of the accelerometer in the geometric plane encompassed by its xey geometric axis corresponds to an inclination of the baseplate and / or sensor patch, since the geometric plane encompassed by the baseplate and / or sensor patch is parallel to the geometric plane encompassed by the xey geometric axis of the accelerometer, and since the accelerometer (as fixed in the monitor device housing) is fixed relative to the baseplate and / or sensor patch.

[0082] In embodiments, the geometric x-axis and the geometric z-axis of the accelerometer encompass a geometric plane that is substantially parallel to the skin-facing surface of the housing, and the geometric y-axis of the accelerometer extends in a direction that is normal to said geometric plane.

[0083] In embodiments, the geometric axis y and the geometric axis z of the accelerometer encompass a geometric plane that is substantially parallel to the skin-facing surface of the housing, and the geometric axis x of the accelerometer extends in a direction that is normal to said geometric plane.

[0084] In the modalities, two geometric axes selected from the geometric axis x, the geometric axis y and the geometric axis z of Petition 870210096510, dated 10 / 19 / 2021, page 49 / 133 / 81 accelerometers encompass a geometric plane that is substantially parallel to the skin-facing surface of the housing, and the geometric axis of the unselected accelerometer extends in a direction that is normal to said geometric plane.

[0085] In one embodiment, the device interface is configured to couple to a plurality of electrodes that form at least two sensors arranged in at least two separate detection zones configured to monitor a peristomal skin surface. In the embodiments, monitoring means that the sensors are configured to detect the presence of fluids, such as outflow, in the peristomal skin, or (an increase in) moisture content in the adhesive layer of the baseplate and / or sensor patch. In the embodiments, the device interface comprises the number of terminals required to connect to a corresponding number of electrodes. In the embodiments, two electrodes form one sensor. In the embodiments, two sensors require the presence of four electrodes. In the embodiments, the first and second electrodes share a common ground, and thus three electrodes are sufficient to form two sensors.Thus, in modalities where one of the electrodes is a common ground, the device interface comprises at least three terminals configured to couple to three electrodes. The at least two sensors are arranged in at least two detection zones. The detection zones may be a primary detection zone and a secondary detection zone arranged in a primary angle space and a secondary angle space around an ostomy.

[0086] In one embodiment, the processor is configured to determine a spatial distribution of at least two detection zones based on one or more position signals. In other embodiments, the processor is configured to determine a spatial distribution of at least two sensors based on one or more position signals, such as with respect to Petition 870210096510, dated 10 / 19 / 2021, page 50 / 133 / 81 an ostomy when the monitoring device is affixed to a baseplate or a sensor patch adhered to the peristomal skin surface. As previously disclosed, by knowing an angular displacement of the monitoring device relative to a natural orientation and, thus, of the sensor mount when the monitoring device is coupled to the sensor mount, it is possible to determine how the at least two sensing zones are distributed around an ostomy. In particular, by knowing how the sensor mount, as a whole, is rotated around an ostomy relative to a natural orientation, and by knowing how the sensor zones are arranged in the sensor mount, it is possible to determine the actual spatial distribution as applied to the peristomal skin. In the embodiments, the arrangement of the sensing zones in the sensor mount is predefined.In these configurations, the arrangement of the detection zones in the sensor assembly is predefined by a manufacturer.

[0087] In one embodiment, one or more task profiles are stored in a monitor device memory, and the monitor device is configured to detect one or more touch sequences contained in one or more position signals. In the embodiments, the memory is a non-transient memory. The one or more task profiles may correspond to one or more touch sequences generated by a user and contained in one or more position signals. A touch sequence that is contained in one or more position signals means that the position signals comprise information pertaining to any movements of the monitor device (accelerometer), such as touches, as applied by a user. Thus, movements of the monitor device (accelerometer) due to such a touch are contained in one or more position signals.In these modes, the sampling rate of position signals is at least 1 Hz, or at least 10 Hz, or at least 2,000 Hz in order to determine a ringing sequence. Petition 870210096510, dated 10 / 19 / 2021, p. 51 / 133 / 81

[0088] For example, a touch sequence can be two short, substantially identical taps on the monitor device with one finger. Such a touch sequence can be compared to a specific task profile stored in the monitor device's memory; that is, a specific task profile can correspond to two short, substantially identical taps on the monitor device with one finger. By comparing a detected touch sequence (i.e., comparing one or more position signals) with one or more task profiles stored in the monitor device's memory, it is possible to assign an output / action to each of the touch sequences. In this way, in the modes, the user can control certain aspects of the monitor device simply by touching the monitor device.

[0089] In one embodiment, the processor is configured to compare a given touch sequence from one or more touch sequences with one or more task profiles and to generate an output associated with that given touch sequence. In the embodiments, the output is configured to affect a function of the monitor device. An output means an action that affects the function of the monitor device. In the embodiments, when touching the monitor device, the resulting movements are detected by the accelerometer and contained in one or more of the position signals. In the embodiments, the position signals, i.e., the touch sequence, are compared with one or more task profiles. In the embodiments, the comparison is made by the processor. In the embodiments, the comparison is made by the accelerometer. In the embodiments, a specific output is generated based on a finding of conformity between a stored task profile and the detected touch sequence.In these modes, the output, and thus the subsequently triggered function of the monitor device, depends on the specific touch sequence.

[0090] In one mode, the output is selected from waking the monitor device from standby mode, activating pairing mode Petition 870210096510, dated 10 / 19 / 2021, page 52 / 133 / 81 or enter standby mode. In the modes, the output depends on the given touch sequence. In the modes, the output affects the function of the monitor device, for example, by sending appropriate instructions to the processor, accelerometer, or other components included in the monitor device. In the modes, monitor device functions include standby exit / entry and pairing mode activation. In the modes, a task profile, when implemented through the generation of an output that triggers the monitor device to wake up from standby mode, is stored in the monitor device's memory. Thus, in the modes, touching the monitor device in a first given pattern / in a given first touch sequence awakens the monitor device from standby mode.In these modes, by tapping the monitor device in a specific second pattern / in a specific second tap sequence, the monitor device enters / activates pairing mode. In these modes, pairing mode is a mode of the monitor device in which a transceiver included in the monitor device is active for wireless pairing with an accessory device that includes another transceiver. Thus, by tapping in a specific second pattern, the user can connect the monitor device to an accessory device via a wireless connection. In these modes, by tapping the monitor device in a specific third pattern / in a specific third tap sequence, the monitor device enters standby mode. In these modes, standby mode is a state in which the monitor device saves battery / power by disabling certain pre-selected functions.

[0091] In the modes, in response to a specific touch sequence, the monitor device can enter airplane mode, in which wireless connections are turned off. Thus, by touching the monitor device according to a specific task profile, wireless connections can Petition 870210096510, dated 10 / 19 / 2021, page 53 / 133 / 81 to be switched off, for example, to comply with rules pertaining to such wireless connections. In the modes, the monitor device can exit airplane mode by tapping the monitor device according to a second task profile. In the modes, the monitor device functions include entering / exiting airplane mode.

[0092] In the modes, obtaining ostomy data, as described above, is a predefined function of the monitor device automatically activated by coupling the monitor device to a sensor mount. In the modes, obtaining ostomy data is a function of the monitor device controllable via a touch sequence.

[0093] In this way, the user can control different functions of the monitor device simply by touching anywhere on the monitor device, where the touch results in a movement of the monitor device and, in this way, in a position signal generated by the accelerometer that comprises information that pertains to / indicates the movement.

[0094] In one embodiment, the monitoring device is configured to switch off or enter a standby mode if no movement is detected for a predetermined period of time. In the embodiments, if a plurality of consecutive position signals are identical, the monitoring device is configured to switch off or enter a standby mode. In the embodiments, if, within a given period of time, such as 10 minutes, the position signals obtained are identical, the monitoring device is configured to switch off or enter a standby mode. In practice, it is generally impossible for a human being to use a monitoring device comprising an accelerometer for an extended period (e.g., 10 minutes) without causing detectable movement, i.e., without the movement being detected / sensed by the accelerometer and the information that Petition 870210096510, dated 10 / 19 / 2021, page 54 / 133 / 81, belonging to the movement, are contained in a position signal. Thus, in the modalities, if a plurality of position signals is identical (or; if the plurality of consecutive position signals that are sampled in the predetermined time period is identical), this is indicative of an unused monitoring device. In the modalities, the number of consecutive position signals to be identical before the monitoring device is switched off or enters standby mode (i.e., the predetermined time period) can be specified by the user or the manufacturer. In the modalities, the number of consecutive position signals to be identical before the monitoring device is switched off or enters standby mode depends on the sampling rate, so the monitoring device can be switched off after 1 minute, regardless of the sampling rate.In other words, for a sampling rate of 0.1 Hz, six position signals are generated within one minute, while for a sampling rate of 1 Hz, 60 position signals are generated within one minute. Thus, in the modes, the monitoring device is switched off depending on an elapsed time comprising identical position signals. In the modes, the monitoring device is switched off or enters standby mode if no movement has been detected (i.e., identical position signals) for at least 1 minute, such as for 1 minute, or such as for 5 minutes, or such as for 10 minutes.

[0095] In the modes, the monitoring device remains switched off or in standby until, for example, the user manually switches the monitoring device back on. In the modes, when the monitoring device is switched off or in standby, the accelerometer can periodically wake up and check for movement. Thus, in the modes, when the accelerometer senses movement, for example, by generating two non-identical position signals, the monitoring device can be switched back on automatically.

[0096] According to a second aspect of the invention, a method Petition 870210096510, dated 10 / 19 / 2021, page 55 / 133 / 81, to determine a rotational displacement of a sensor assembly of an ostomy device relative to an ostomy is disclosed. The sensor assembly is attachable to a monitoring device, such that the position of the monitoring device relative to the sensor assembly is fixed. The monitoring device comprises a housing, a processor disposed in the housing, and a device interface configured to couple the monitoring device to the sensor assembly, wherein the device interface comprises a plurality of terminals for connection to a plurality of electrodes of the sensor assembly. Additionally, the monitoring device comprises an accelerometer (3 geometric axes) configured to generate a position signal.The sensor assembly comprises a plurality of electrodes forming two or more sensors, such as two or more sensors configured to determine the presence of fluid in a peristomal skin area. The two or more sensors are arranged in at least two separate sensing zones, such as for monitoring the peristomal skin area. Additionally, the sensor assembly comprises a mounting interface configured to couple to the appliance interface of the monitoring device. The method comprises the steps of obtaining one or more position signals from the accelerometer (e.g., when the ostomy appliance comprising the sensor assembly is placed in a peristomal skin area and the monitoring device is coupled to the sensor assembly) and determining a rotational displacement of the sensor assembly based on the one or more position signals. The rotational displacement may be relative to a natural orientation of the accelerometer.One or more position signals are indicative of (that is, they comprise information pertaining to) a spatial orientation of the accelerometer and, thus, of the monitoring device as such.

[0097] In the modalities, the ostomy device is a base plate and / or sensor patch, as described previously. Thus, the device of Petition 870210096510, dated 10 / 19 / 2021, page 56 / 133 / 81 ostomy is equipped with an adhesive, such as a first adhesive layer, to provide fixation to the peristomal skin area.

[0098] Thus, a method is provided for determining the rotational displacement of a sensor assembly relative to an ostomy, in particular, when the rotational displacement is determined relative to a predefined natural orientation. The method utilizes a monitoring device, as previously disclosed, in relation to the first aspect of the invention. In this way, the above-disclosed embodiments of the monitoring device apply similarly to a monitoring device for use in a method for determining a rotational displacement of a sensor assembly relative to an ostomy, as disclosed in this document.

[0099] In one embodiment, the method comprises an initial step of defining a natural orientation of the monitor / accelerometer device. In the embodiments, the natural orientation is defined according to the embodiments disclosed above that pertain to the monitor device. In the embodiments, 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 the embodiments, the natural orientation of the monitor device is predefined by the manufacturer.

[00100] In one embodiment, the monitor interface is in communication with an accessory device comprising a graphical user interface, and the method further comprises the steps of communicating the rotational displacement to the accessory device and generating (e.g., by means of a processor in the accessory device) a visual representation in the graphical user interface. The visual representation incorporates the rotational displacement and illustrates the position of at least two sensing zones relative to an ostomy. In the embodiments, the accessory device (also referred to as an external device) is a mobile phone, Petition 870210096510, dated 10 / 19 / 2021, page 57 / 133 / 81 such as a smartphone, or other portable device. In the embodiments, the accessory device is a personal electronic device, for example, a wearable device, such as a watch or other electronic device to be worn on the wrist. In the embodiments, the accessory device is a docking station. In the embodiments, the docking station is configured to electrically and / or mechanically couple the monitor device to the docking station.

[00101] In the embodiments, the graphical user interface (GUI) is a screen configured to display the visual representation of at least two detection zones relative to an ostomy. In the embodiments, the visual representation is included in an application (app) of the accessory device. In the embodiments, the visual representation visualizes the position of at least two detection zones relative to an ostomy around which a sensor assembly included in a baseplate and / or sensor patch is arranged. In this way, the visual representation provides an easily accessible way to communicate to the user the status of their baseplate and / or sensor patch, for example, in a way that communicates the possible presence of a leak, i.e., the presence of a liquid, such as discharge, in the peristomal skin area.A visual representation incorporating rotational displacement means that rotational displacement is implemented in the visual representation, so that the visual representation visualizes the sensor assembly including any possible rotational displacement. In this way, the user is provided with an easy-to-understand visualization of their baseplate and / or sensor patch comprising a sensor patch, and can better see and understand where (in which detection zone) a possible leak occurs, or where (in which detection zones) the adhesive weakens due to increased / large moisture absorption in an adhesive layer.

[00102] In the modalities, a plurality of detection zones is provided, with each detection zone covering an angle space. Petition 870210096510, dated 10 / 19 / 2021, p. 58 / 133 / 81 (separate). In the modalities, rotational displacement is used as a correction factor, so that the visualization of the sensor assembly / detection zones is corrected by rotational displacement. In the modalities, the positions of each of the detection zones are floating, which means that the positions of each of the detection zones are defined by a mathematical model using rotational displacement as an input parameter.For example, the visual representation is static (it always appears the same on the screen, as opposed to the example described above where the visual representation reflects the physically attached baseplate and / or sensor patch), however, the data used to illustrate a possible leak is corrected by rotational displacement, so that the visual representation illustrates the leak occurring in a relative position, for example, to the neck portion and / or the monitoring device of the baseplate and / or sensor patch, rather than the relative position, for example, to the user's body features (up, down). In this mode, a large plurality of detection zones (e.g., three or more, such as four or five) enhances visualization, as more detection zones provide better sensitivity.

[00103] In a third aspect of the invention, an ostomy system comprising a sensor assembly and a monitoring device is provided. The monitoring device comprises a housing, a processor disposed in the housing, a device interface comprising a plurality of terminals for connection to a plurality of electrodes of the sensor assembly, and an accelerometer (e.g., three-axis geometric) configured to generate a position signal. The sensor assembly comprises a plurality of electrodes forming two or more sensors, such as those configured to determine the presence of fluid / moistening in a peristomal skin area. The two or more sensors are arranged in at least two detection zones. Petition 870210096510, dated 10 / 19 / 2021, pp. 59 / 133 / 81 separate. Additionally, the sensor mount comprises a mounting interface configured to couple to the device interface of the monitor. The monitor is configured to couple with the sensor mount. The monitor can thus be fixed relative to the sensor mount, such that a spatial orientation of the monitor translates into a corresponding orientation of the sensor mount. Thus, an ostomy system is provided that utilizes a monitor as disclosed above, wherein the ostomy system has the capability to determine a rotational displacement of the sensor mount by providing an accelerometer (three geometric axes) in the monitor.

[00104] In one embodiment, the device interface is configured to couple with the mounting interface. In the embodiments, the coupling is a mechanical coupling. In the embodiments, the coupling is a wireless coupling. In the embodiments of a wireless coupling, the monitor device is configured to be affixed to the user or to an ostomy appliance of the sensor mount in a predefined and fixed position relative to the sensor mount.

[00105] In one embodiment, the sensor mount is provided on an ostomy appliance. In the embodiments, the ostomy appliance is a baseplate or a sensor patch, as previously disclosed. Thus, a means is provided for attaching, for example, adhering, the sensor mount to the user's peristomal skin area.

[00106] In one embodiment, the monitor device's accelerometer comprises a predefined natural orientation, and the monitor device is configured to determine a rotational displacement of the sensor mount relative to the predefined natural orientation.

[00107] In this way, an ostomy system is provided that has the capacity to determine a rotational displacement of the assembly. Petition 870210096510, dated 10 / 19 / 2021, page 60 / 133 / 81 sensor and therefore to locate two or more detection zones provided in the sensor assembly. Detailed Description of the Drawings

[00108] Figure 1 illustrates an exemplary ostomy system. The ostomy system 1 comprises an ostomy appliance 2 which includes a baseplate 4. The baseplate 4 is adapted to support an ostomy bag (not shown). Additionally, the ostomy system 1 comprises a monitor device 6 and an accessory device 8 (mobile phone / smartphone). The monitor device 6 is connectable to the baseplate 4 via the respective first connectors of the monitor device 6 and baseplate 4. The monitor device 6 is configured for wireless communication with the accessory device 8. Optionally, the accessory device 8 is configured to communicate with a server device 10 of the ostomy system 1, for example, via a network 12. The server device 10 can be operated and / or controlled by the ostomy appliance manufacturer and / or a service center.Ostomy data or parameter data based on ostomy data are obtained from electrodes / sensors of the device 2 with the monitoring device 6. The monitoring device 6 processes the ostomy data and / or parameter data based on ostomy data. Based on the processed ostomy data, the monitoring device 6 can determine which monitoring data is transmitted to the accessory device 8. In the illustrated ostomy system, the accessory device 8 is a mobile phone; however, the accessory device 8 can be incorporated as another portable device, such as a tablet-type device, or a wearable device, such as a watch or other wearable electronic device on the wrist. Consequently, the monitoring device 6 is configured to determine and transmit monitoring data to the accessory device 8. The base plate 4 comprises a coupling member 14 in the form of a coupling ring 16. Petition 870210096510, dated 10 / 19 / 2021, page 61 / 133 / 81 attach an ostomy bag (not shown) to the baseplate (two-part ostomy appliance). The baseplate 4 has a stoma opening 18 with a central point 19. The size and / or shape of the stoma opening 18 is typically adjusted by the user or nurse before applying the ostomy appliance to accommodate the user's stoma.

[00109] The ostomy system 1 optionally comprises a docking station 20 which forms an alternative / additional accessory device to the ostomy system 1. The docking station 20 comprises a docking monitor interface which includes a first connector 22 configured to electrically and / or mechanically connect the monitor device 6 to the docking station 20. The docking monitor interface may be configured to wirelessly connect the monitor device to the docking station. The docking station 20 comprises a user interface 24 for receiving user input and / or providing feedback to the user on the operational state of the docking station 20. The user interface 24 may comprise a touch screen. The user interface 24 may comprise one or more physical buttons and / or one or more visual indicators, such as light-emitting diodes.

[00110] Figure 2 is a schematic block diagram of an exemplary monitoring device. The monitoring device 6 comprises a monitoring device housing 100, a processor 101, and one or more interfaces, wherein the one or more interfaces include a first interface 102 (device interface) and a second interface 104 (accessory interface). The monitoring device 6 comprises a memory 106 for storing ostomy data and / or parameter data based on ostomy data. The memory 106 is connected to the processor 101 and / or the first interface 102.

[00111] The first interface 102 is configured as a device interface for electrically and / or mechanically connecting the monitor device. Petition 870210096510, dated 10 / 19 / 2021, page 62 / 133 / 81 to the ostomy appliance, for example, ostomy appliance 2. The first interface 102 comprises a plurality of terminals for forming electrical connections with the respective terminals of the ostomy appliance 2 (baseplate 4). The first interface 102 comprises a ground terminal 108, a first terminal 110, a second terminal 112 and a third terminal 114. The first interface 102 optionally comprises a fourth terminal 116 and a fifth terminal 118. The first interface 102 of the monitor device 6 comprises a coupling part 120 for forming a mechanical connection, such as a releasable coupling between the monitor device and the baseplate. The coupling part 120 and terminals 108, 110, 112, 114, 116, and 118 of the first interface 102 form (at least part of) a first connector of the monitor device 6.

[00112] The monitor device 6 comprises a power unit 121 for powering the monitor device and its active components, that is, the power unit 121 is connected to the processor 101, the first interface 102, the second interface 104, and the memory 106. The power unit comprises a battery and a charging circuit assembly. The charging circuit assembly is connected to the battery and to the terminals of the first interface 102 for charging the battery via terminals of the first interface, for example, terminals of the first connector.

[00113] 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 accessory device 8. The second interface 104 comprises an antenna 122 and a wireless transceiver 124 configured for wireless communication with the accessory device (or accessory devices). Optionally, the second interface 104 comprises a loudspeaker 126 and / or a tactile feedback element 128 for providing the respective audio signal and / or tactile feedback to the user. Petition 870210096510, dated 10 / 19 / 2021, page 63 / 133 / 81

[00114] The monitor device 6 comprises a 3-axis geometric accelerometer 540 connected to the processor 101.

[00115] Processor 101 is configured to apply a processing scheme, and the first interface 102 (device interface) is configured to collect ostomy data from the baseplate and / or sensor patch attached to the first interface, wherein the ostomy data comprises leakage ostomy data from the leakage electrodes of the ostomy device. The ostomy data optionally comprises first ostomy data from a first pair of electrodes on the baseplate and / or sensor patch, second ostomy data from a second pair of electrodes on the baseplate and / or sensor patch, and / or third ostomy data from a third pair of electrodes on the baseplate and / or sensor patch. The ostomy data can be stored in memory 106 and / or processed in processor 101 to obtain parameter data. The parameter data can be stored in memory 106.Processor 101 is configured to apply a processing scheme, wherein applying a processing scheme comprises obtaining primary leakage parameter data based on primary leakage ostomy data; obtaining secondary leakage parameter data based on secondary leakage ostomy data; and obtaining tertiary leakage parameter data based on tertiary leakage ostomy data. Optionally, the processing scheme comprises obtaining first parameter data based on first ostomy data; obtaining second parameter data based on second ostomy data; and obtaining third parameter data based on third ostomy data. In other words, Processor 101 can be configured to obtain first, second, and third parameter data based on the respective first, second, and third ostomy data. Applying a processing scheme is understood to mean... Petition 870210096510, dated 10 / 19 / 2021, page 64 / 133 / 81 to determine an operating state of the baseplate and / or sensor patch of the ostomy appliance based on one or more, for example, all primary leak parameter data, secondary leak parameter data and tertiary leak parameter data, where the operating state is indicative of an acute leak risk in a detection zone for the ostomy appliance.The monitoring device 6 is configured to, according to a determination that the operating state is a primary leakage operating state, transmit a primary leakage monitor signal comprising monitor data indicative of the primary leakage operating state of the base plate and / or sensor patch via the second interface; and according to a determination that the operating state is a secondary leakage operating state, transmit a secondary leakage monitor signal comprising monitor data indicative of the secondary leakage operating state of the base plate and / or sensor patch via the second interface.The monitoring device 6 can be configured to, according to a determination that the operating state is a tertiary leakage operating state, transmit a tertiary leakage monitor signal comprising monitor data indicative of the tertiary leakage operating state of the base plate and / or sensor patch via the second interface.

[00116] Figure 3 illustrates an exploded view of an exemplary baseplate of an ostomy appliance. The baseplate 4 comprises a first adhesive layer 200 with a stoma opening 18A. During use, a proximal surface of the first adhesive layer 200 adheres to the user's skin in the peristomal area and / or to additional seals, such as sealing paste, sealing tape and / or sealing ring. The baseplate 4 optionally comprises a second adhesive layer 202, also referred to as a rim adhesive layer, with a stoma opening 18B. The baseplate 4 Petition 870210096510, dated 10 / 19 / 2021, page 65 / 133 / 81, comprises a plurality of electrodes arranged 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 comprises a backing layer with a stoma opening 18C and electrodes formed on a proximal surface of the backing layer. The baseplate 4 comprises a release liner 206 that is peeled off by the user before applying the baseplate 4 to the skin. The baseplate 4 comprises a top layer 208 with a stoma opening 18D and a coupling ring 209 for attaching an ostomy bag to the baseplate 4. The top layer 208 is a protective layer that protects the second adhesive layer 202 from external tension and stress during use.

[00117] Baseplate 4 comprises a monitor interface. The monitor interface is configured to electrically and / or mechanically connect the ostomy appliance (baseplate 4) to the monitor device. The baseplate monitor interface comprises a coupling part 210 to form a mechanical connection, such as a releasable coupling, between the monitor device and the baseplate. The coupling part 210 is configured to engage with a coupling part of the monitor device to releasably couple the monitor device to baseplate 4. Additionally, the baseplate monitor interface 4 comprises a plurality of terminal elements that respectively form a plurality of terminals 212 to form electrical connections with the respective terminals of the monitor device. The coupling part 210 and the terminals 212 form a first connector 211 of baseplate 4.Base plate 4 comprises a first intermediate element 213 on the proximal side of the electrode assembly. The first intermediate element 213 is disposed between the terminal elements that form the terminals 212 and the first adhesive layer (not shown). The first intermediate element 213 covers the terminal elements that form the terminals 212 of the plate. Petition 870210096510, dated 10 / 19 / 2021, page 66 / 133 / 81 base 4 when viewed in the axial direction and protects the first adhesive layer from mechanical stress on the terminal elements of the base plate.

[00118] As described previously, some parts of the illustrated baseplate 4 may be supplied as a separate patch to be applied to an existing baseplate, for example, comprising one or more of the components as described, such as to supply a baseplate like baseplate 4 as described. For example, a sensor patch 700 may be supplied, for example, comprising electrode assembly 204, first connector 211, first intermediate element 213, first adhesive layer 200 and release liner 206. Additionally, the sensor patch 700 may also comprise the second adhesive layer 202 and / or the top layer 208. It may be provided that the user may supply a hole in the layers of the baseplate where the sensor patch 700 is to be applied, to allow the first connector 211 of the sensor patch 700 to project through the layers of the baseplate where the sensor patch 700 is applied.Alternatively, the 700 sensor patch can be applied to the base plate so that the first connector 211 is positioned outside the periphery of the base plate.

[00119] Figure 4 illustrates an exploded view of an exemplary electrode assembly 204 of a baseplate and / or sensor patch. The electrode assembly 204 has a distal side 204A and a proximal side 204B. The electrode assembly 204 comprises a support layer 214 with a proximal surface 214B and electrodes 216 arranged on the proximal side of the support layer 214, including a grounding electrode, a first electrode, a second electrode, a third electrode, a fourth electrode, and a fifth electrode, wherein each electrode has a respective connection part 217 for connecting the electrodes 216 to the respective terminal elements of the monitor interface. The electrodes 216 are positioned and / or formed on a proximal side 214B of the support layer 214. Additionally, the Petition 870210096510, dated 10 / 19 / 2021, page 67 / 133 / 81 electrode assembly 204 comprises a masking element 218 with proximal surface 218B and configured to isolate electrode parts 216 from the first adhesive layer of the baseplate and / or the sensor patch. The masking element 218 covers or overlaps the electrode parts 216 when viewed in the axial direction.

[00120] Figure 5 is a proximal view of the proximal surfaces of the baseplate portions of the baseplate and / or sensor patch without the first adhesive layer and release liner. The baseplate 4 and / or sensor patch 700 comprises a first intermediate element 213 on the proximal side of the electrode assembly, i.e., between the electrode assembly 204 and the first adhesive layer (not shown). The first intermediate element 213 covers the terminal elements of the baseplate 4 when viewed in the axial direction and protects the first adhesive layer from mechanical stress of the terminal elements of the baseplate and / or sensor patch.

[00121] Figure 6 is a distal view of an exemplary electrode configuration 220 of electrodes 216 of electrode assembly 204. Electrode assembly 204, such as electrode configuration 220 of electrode assembly 204, comprises a grounding electrode 222, a first electrode 224, a second electrode 226, a third electrode 228, a fourth electrode 230, and a fifth electrode 232. The grounding electrode 222 comprises a ground connection part 222A, and the first electrode 224 comprises a first connection part 224A. The second electrode 226 comprises a second connection part 226A, and the third electrode 228 comprises a third connection part 228A. The fourth electrode 230 comprises a fourth connection part 230A, and the fifth electrode 232 comprises a fifth connection part 232A.

[00122] The fourth electrode (second leakage electrode) 230 comprises the fourth detection parts 230B. The fifth electrode (third leakage electrode) 232 comprises the fifth detection parts 232B. Petition 870210096510, dated 10 / 19 / 2021, p. 68 / 133 / 81

[00123] Grounding electrode 222 comprises a first electrode part 234 to form a ground or reference for the first electrode 224. Grounding electrode 222 comprises a second electrode part 236 to form a ground or reference for the second electrode 226. Grounding electrode 222 comprises a third electrode part 238 to form a ground or reference for the third electrode 228. Masking element 218 is disposed proximal to electrodes 222, 224, 226, 228, covering and isolating parts of the electrodes from the first adhesive and forming the respective conductor parts of electrodes 222, 224, 226, 228. Parts of electrodes 222, 224, 226, 228 not covered by masking element 219 come into contact with the first adhesive layer and form detection parts. 224B, 226B, 228B of electrodes 224, 226, 228, respectively.Additionally, electrode parts 234, 236, and 238 form detection parts for grounding electrode 222.

[00124] The first sensing part 224B extends circularly at least 330 degrees around the stomach opening at a first radial distance R1 from the central point 19, see also Figure 11. The first radial distance R1 is 14 mm. The first electrode part 234 is disposed inside the first sensing part (i.e., closer to the central point) and extends circularly at least 330 degrees around the stomach opening at a first ground distance RG1 from the first sensing part (radially from the central point). The first ground distance RG1 is about 1 mm.

[00125] The second sensing part 226B extends circularly at least 330 degrees around the stomach opening at a second radial distance R2 from the central point 19, see also Figure 11. The second radial distance R2 is 18 mm. The second electrode part 236 is located inside the second sensing part 226B (i.e., closer to the central point) and extends circularly at least 330 degrees around the opening. Petition 870210096510, dated 10 / 19 / 2021, p. 69 / 133 / 81 stomal at a second RG2 ground distance from the second part of detection 226B (radially from the center point). The second RG2 ground distance is approximately 1 mm.

[00126] The third sensing part 228B extends circularly at least 330 degrees around the stomach opening at a third radial distance R3 from the center point 19, see also Figure 11. The third radial distance R3 is about 26 mm. The third electrode part 238 is disposed inside the third sensing part 228B (i.e., closer to the center point) and extends circularly at least 330 degrees around the stomach opening at a third ground distance RG3 from the third sensing part 228B (radially from the center point). The third ground distance RG3 is about 1 mm.

[00127] Grounding electrode 222 comprises a quarter part of electrode 240 to form a ground or reference for the fourth electrode 230 and the fifth electrode 232. The quarter part of electrode 240 of the grounding electrode forms the first leakage electrode. The quarter part of electrode 240 of grounding electrode 222 extends at least 300 degrees around the stomach opening and comprises ground detection parts 222B. The quarter detection parts 230B, fifth detection parts 232B and ground detection parts of the quarter part of electrode 240 are circularly distributed around the central point 19 in a leakage radius from the central point. The 230B detection quarters, 232B detection fifths, and the fourth electrode's ground detection quarters may have a radial extension 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 230B detection quarters, 232B detection fifths, and 240 electrode fourth detection ground parts may have a circumferential extension (perpendicular to the radial extension) greater than 1.0 mm, such as in the range of 2.5 mm to 5.0 mm, for example, about 3.5 mm. On one or more base plates and / or patches. Petition 870210096510, dated 10 / 19 / 2021, p. 70 / 133 / 81 exemplary sensors, electrodes 224, 226, 228 and electrode parts 234, 236, 238 may be omitted from the electrode configuration / electrode assembly.

[00128] Figure 7 is a distal view of an exemplary masking element. The masking element 218 optionally has a plurality of terminal openings which includes six terminal openings. The plurality of terminal openings comprises 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 be aligned with the respective connection parts 222A, 224A, 226A, 228A, 230A, 232A of the electrodes of the electrode assembly.

[00129] The masking element 218 has a plurality of sensor point openings. The sensor point openings comprise primary sensor point openings shown within the dashed line 254, each primary sensor point opening being configured to overlap a portion of the grounding electrode (first leakage electrode) 222 and / or a portion of the fourth electrode (second leakage electrode) 230. The primary sensor point openings 254 comprise, in the exemplary masking element illustrated, five primary sensor point openings 254A each configured to overlap a respective sensing portion of the grounding electrode (first leakage electrode) 222.The primary sensor point openings 254 comprise, in the illustrated exemplary masking element, four primary sensor point openings 254B each configured to overlap a respective detection part of the fourth electrode (second leakage electrode) 230. The point openings of... Petition 870210096510, dated 10 / 19 / 2021, page. 71 / 133 / 81 sensors comprise secondary sensor point openings shown within the dashed line 256, wherein each second sensor point opening is configured to overlap a portion of the fourth electrode (second leakage electrode) 230 and / or a portion of the fifth electrode (third leakage electrode) 232. The secondary sensor point openings 256 comprise, in the illustrated exemplary masking element, five secondary sensor point openings 256A each configured to overlap a respective detection portion of the fifth electrode (third leakage electrode) 232. The secondary sensor point openings 256 comprise, in the illustrated exemplary masking element, four secondary sensor point openings 256B each configured to overlap a respective detection portion of the fourth electrode (second leakage electrode) 230.The sensor point openings comprise tertiary sensor point openings shown within the dashed line 258, each tertiary sensor opening configured to overlap a portion of the fifth electrode (third leakage electrode) 232 and / or a portion of the grounding electrode (first leakage electrode) 222. The tertiary sensor point openings 258 comprise, in the illustrated exemplary masking element, five tertiary sensor point openings 258A each configured to overlap a respective detection portion of the fifth electrode (third leakage electrode) 232. The tertiary sensor point openings 258 comprise, in the illustrated exemplary masking element, four tertiary sensor point openings 258B each configured to overlap a respective detection portion of the grounding electrode (first leakage electrode) 222.The sensor point openings 254A, 254B, 256A, 256B, 258A, 258B are circularly arranged within a leakage radius of approximately 30 mm from the central point 19.

[00130] Figure 8 is a distal view of a first adhesive layer. Petition 870210096510, dated 10 / 19 / 2021, pp. 72 / 133 / 81, is an example. The first adhesive layer 200 has a plurality of sensor point openings. The sensor point openings of the first adhesive layer comprise primary sensor point openings shown within the dashed line 260, each primary sensor point opening being configured to overlap a portion of the grounding electrode 222 and / or a portion of the fourth electrode 230 of the electrode assembly. The primary sensor point openings comprise, in the first exemplary adhesive layer illustrated, five primary sensor point openings 260A, each configured to overlap a respective sensing portion of the grounding electrode 222.The primary sensor point openings comprise, in the first exemplary adhesive layer illustrated, four primary sensor point openings 260B, each configured to overlap a respective sensing part of the fourth electrode 230. The sensor point openings of the first adhesive layer comprise secondary sensor point openings shown within the dashed line 262, each second sensor point opening being configured to overlap a part of the fourth electrode 230 and / or a part of the fifth electrode 232 of the electrode assembly. The secondary sensor point openings comprise, in the first exemplary adhesive layer illustrated, five secondary sensor point openings 262A, each configured to overlap a respective sensing part of the fifth electrode 232.The secondary sensor point openings comprise, in the first exemplary adhesive layer illustrated, four secondary sensor point openings 262B, each configured to overlap a respective sensing part of the fourth electrode 230. The sensor point openings of the first adhesive layer comprise tertiary sensor point openings shown within the dashed line 264, each tertiary sensor opening being configured to overlap a part of the fifth electrode 232 and / or a part of the grounding electrode. Petition 870210096510, dated 10 / 19 / 2021, pp. 73 / 133 / 81 222 of the electrode assembly. The tertiary sensor point openings comprise, in the first exemplary adhesive layer illustrated, five tertiary sensor point openings 264A, each configured to overlap a respective sensing part of the fifth electrode 232. The tertiary sensor point openings comprise, in the first exemplary adhesive layer illustrated, four tertiary sensor point openings 264B, each configured to overlap a respective sensing part of the grounding electrode 222.

[00131] Figure 9 is a proximal view of the first adhesive layer of Figure 8. The sensor point openings 260A, 260B, 262A, 262B, 264A, 264B are circularly arranged at a leakage radius of approximately 30 mm from the center point.

[00132] Figure 10 is a more detailed distal view of a part of the base plate 4 and / or the sensor patch 700. The base plate 4 and / or sensor patch 700 comprises a monitor interface. The monitor interface comprises the first connector 211. The first connector 211 comprises the coupling part 210 configured to loosely couple the monitor device to the base plate and / or the sensor patch and thus form a loose coupling. The first connector 211 of the monitor interface comprises a plurality of terminals formed by the respective terminal elements to form the respective electrical connections with the respective terminals of the monitor device.

[00133] The plurality of terminals of the first connector 211 of the monitor interface comprises a terrestrial terminal element 282 forming a terrestrial 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 comprises a fourth terminal element 290 forming Petition 870210096510, dated 10 / 19 / 2021, page 74 / 133 / 81 a fourth terminal 290A and / or a fifth terminal element 292 that forms a fifth terminal 292A. The terminal elements 282, 284, 286, 288, 290, 292 come into contact with the respective connection parts 222A, 224A, 226A, 228A, 230A, 232A of electrodes 222, 224, 226, 228, 230, 232.

[00134] The position of the first connector on the base plate and / or sensor patch, the number of terminals, and the position of the terminals on the coupling part can be adapted to the electrode configuration used in the electrode assembly of the base plate and / or sensor patch. For example, a first connector for a base plate and / or sensor patch with electrode configuration 220A shown in Figure 11 comprises four terminals respectively connected to connection parts 222A, 224A, 226A, 228A of the electrodes, and a first connector for a base plate and / or sensor patch with electrode configuration 220B shown in Figure 12 comprises three terminals respectively connected to connection parts 222A, 224A, 226A of the electrodes.

[00135] The first connector may be located in a neck portion of the baseplate and / or sensor patch. The neck portion may be an integral part of the first and / or second adhesive layer and may extend radially in the opposite direction to the stomach opening. Thus, the neck portion is adapted for adhesion to the user's skin.

[00136] Figure 11 is a distal view of the exemplary electrode configuration 220 of Figure 6 for a sensor baseplate and / or plaster. The electrode configuration 220 comprises a first leakage electrode 222, a second leakage electrode 230, and a third leakage electrode 232. The leakage electrodes 222, 230, and 232 are configured to detect the presence of fluid on the proximal side of the first adhesive layer in three detection zones (three angular detection zones in the illustrated example): primary detection zone 400, secondary detection zone 402, and tertiary detection zone 404. The primary detection zone Petition 870210096510, dated 10 / 19 / 2021, pp. 75 / 133 / 81 400 is located in a primary angle space between a first direction 406 and a second direction 408 from the central point 19, where the primary angle space encompasses a primary angle V1 of 120°. The secondary detection zone 402 is located in a secondary angle space between the second direction 408 and a third direction 410 from the central point 19, where the secondary angle space encompasses a secondary angle V2 of 120°. The tertiary detection zone 404 is located in a tertiary angle space between the third direction 410 and the first direction 406 from the central point 19, where the tertiary angle space encompasses a tertiary angle V3 of 120°.

[00137] The first leak electrode 222 comprises five primary detection parts 222D arranged in the primary detection zone 400 and four tertiary detection parts 222E arranged in the tertiary detection zone 404. Each primary detection part 222D is aligned with a respective primary sensor point opening 254A of the masking element 218 (see Figure 7). Additionally, each primary detection part 222D is aligned with a respective primary sensor point opening 260A of the first adhesive layer 200 (see Figure 8). Each tertiary detection part 222E of the first leak electrode 222 is aligned with a respective tertiary sensor point opening 258B of the masking element 218 (see Figure 7). Additionally, each first tertiary detection part 222E is aligned with a corresponding tertiary sensor point aperture 264B of the first adhesive layer 200 (see Figure 8).

[00138] The second leakage electrode 230 comprises four primary detection parts 230D arranged in the primary detection zone 400 and four secondary detection parts 230E arranged in the secondary detection zone 402. Each primary detection part 230D is aligned with a respective primary sensor point aperture 254B of the element. Petition 870210096510, dated 10 / 19 / 2021, p. 76 / 133 / 81 of masking 218 (see Figure 7). Additionally, each primary sensing part 230D is aligned with a respective primary sensing point aperture 260B of the first adhesive layer 200 (see Figure 8). Each secondary sensing part 230E is aligned with a respective secondary sensing point aperture 256B of the masking element 218 (see Figure 7). Additionally, each secondary sensing part 230E is aligned with a respective secondary sensing point aperture 262B of the first adhesive layer 200 (see Figure 8).

[00139] The third leakage electrode 232 comprises five secondary detection parts 232D arranged in the secondary detection zone 402 and five tertiary detection parts 232E arranged in the tertiary detection zone 404. Each secondary detection part 232D is aligned with a respective secondary sensor point opening 256A of the masking element 218 (see Figure 7). Additionally, each secondary detection part 232D is aligned with a respective secondary sensor point opening 262A of the first adhesive layer 200 (see Figure 8). Each tertiary detection part 232E is aligned with a respective tertiary sensor point opening 258A of the masking element 218 (see Figure 7). Additionally, each tertiary sensing part 232E is aligned with a corresponding tertiary sensing point aperture 264A of the first adhesive layer 200 (see Figure 8).

[00140] Detection parts 222D, 222E, 230D, 230E, 232D, 232E are circularly arranged in a leakage radius RL of approximately 30 mm from the center point.

[00141] Figure 12 is a distal view of an exemplary electrode configuration 220A for a baseplate and / or a sensor patch. The electrode configuration 220 comprises a first leakage electrode 222, a second leakage electrode 230 and a third electrode Petition 870210096510, dated 10 / 19 / 2021, p. 77 / 133 / 81 leak 232. Leak electrodes 222, 230, 232 are configured to detect the presence of fluid on the proximal side of the first adhesive layer in two angle detection zones, the primary detection zone 400 and the secondary detection zone 402. The primary detection zone 400 is arranged in a primary angle space between a first direction 406 and a second direction 408 from the central point 19, where the primary angle space encompasses a primary angle V1 of approximately 185°. The secondary detection zone 402 is arranged in a secondary angle space between the second direction 408 and the first direction 406 from the central point 19, where the secondary angle space encompasses a secondary angle V2 of approximately 175°.

[00142] The first leakage electrode 222 comprises primary detection parts 222D arranged in the primary detection zone 400 and secondary detection parts 222F arranged in the secondary detection zone 402. The second leakage electrode 230 comprises primary detection parts 230D arranged in the primary detection zone 400. The third leakage electrode 232 comprises secondary detection parts 232D arranged in the secondary detection zone 402. Each primary detection part 222D, 230D is aligned with a respective primary sensor point opening of the masking element 219 (see Figure 13) and with a respective primary sensor point opening of the first adhesive layer 201 (see Figure 14). The detection parts 222D, 222F, 230D and 232D are circularly arranged within a leakage radius RL of approximately 30 mm from the center point.

[00143] Figure 13 is a distal view of masking layer 219 for electrode configuration 220A in Figure 12. Masking layer 219 comprises primary sensor point openings 254 and secondary sensor point openings 256. Figure 14 is a distal view of the first adhesive layer 201 for electrode configuration 220A in Petition 870210096510, dated 10 / 19 / 2021, pp. 78 / 133 / 81 Figure 12 shows a baseplate and / or a sensor patch with two detection zones arranged at separate angle spaces. The masking layer 201 comprises primary sensor point apertures 260 and secondary sensor point apertures 262.

[00144] Figure 15 is a distal view of an exemplary electrode configuration 220B for a sensor baseplate and / or patch. The electrode configuration 220B comprises first leakage electrode 222, second leakage electrode 230, third leakage electrode 232, fourth leakage electrode 412, and fifth leakage electrode 414. 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 angled detection zones 400, 402, 404, 416. The primary detection zone 400 is arranged in a primary angle space encompassing a primary angle V1 of approximately 85°. The secondary detection zone 402 is arranged in a secondary angle space encompassing a secondary angle V2 of approximately 95°. Tertiary detection zone 404 is arranged in a tertiary angle space encompassing a tertiary angle V3 of approximately 95°.The quaternary detection zone 416 is arranged in a quaternary angle space encompassing a quaternary angle V4 of approximately 85°.

[00145] Although exemplary baseplate and / or sensor patch parts with two, three and four detection zones have been described in more detail, the baseplate and / or sensor patch may comprise one or a greater number of detection zones, such as five, six, seven, eight or more detection zones.

[00146] Figure 16 illustrates a schematic monitoring device 6 comprising a 3-axis geometric accelerometer 540 coupled to a schematic baseplate 4 and / or sensor patch 700 comprising a neck portion 510 extending radially in the opposite direction to the stoma opening 18 configured to enclose an ostomy. The accelerometer of Petition 870210096510, dated 10 / 19 / 2021, page 79 / 133 / 81 geometric axes 540 encompasses a three-dimensional space (Cartesian coordinate system) as illustrated by the geometric x-axis, geometric y-axis, and geometric z-axis, which are mutually orthogonal. The geometric z-axis is normal to the geometric plane encompassed by the geometric x-axis and geometric y-axis. In other words, the accelerometer has the capability to measure motion, such as acceleration, in a three-dimensional space, as encompassed by the geometric x-axis, geometric y-axis, and geometric z-axis. In particular, the accelerometer is configured to generate a position signal. The position signal comprises information pertaining to the spatial orientation of the accelerometer 540 and, thus, of the monitoring device 6. The direction of gravity g is illustrated pointing downwards.In these embodiments, the geometric x-axis, geometric y-axis, and geometric z-axis form / encompass a local coordinate system relative to the baseplate 4 and / or sensor patch 700. In these cases, the geometric x-axis, geometric y-axis, and geometric z-axis are fixed relative to the baseplate 4 and / or sensor patch 700, and the rotation of the baseplate 4 and / or sensor patch 700 corresponds to a rotation of the geometric x-axis, geometric y-axis, and geometric z-axis. Consequently, the direction of gravity g changes relative to the geometric x-axis, geometric y-axis, and geometric z-axis in response to a change in the orientation of the baseplate 4 and / or sensor patch 700 (for example, as shown in Figure 17). In certain configurations, the baseplate 4 and / or sensor patch 700 generally encompasses a geometric plane that is parallel to the geometric plane encompassed by the geometric x-axis and the geometric y-axis of the accelerometer.Alternatively, the base plate 4 and / or sensor patch 700 generally covers a geometric plane that is parallel to a geometric plane covered by two of the accelerometer's geometric axes.

[00147] The monitoring device 6 is coupled to a base plate 4 and / or sensor patch 700 comprising three detection zones 500, 502, 504. Petition 870210096510, dated 10 / 19 / 2021, pages 80 / 133 / 81 The detection zones are provided by the appropriate arrangement of electrodes, as revealed above and illustrated, for example, in Figures 11, 12 and 15. Because the user is free to apply the baseplate 4 and / or sensor patch 700, for example, taking into account any personal preferences and / or the presence of skin folds / scars, the neck portion 510 can assume any position (i.e., along the 360° circle) around the ostomy around the baseplate 4 and / or sensor patch 700 that is configured to be positioned. In the present illustration, the neck portion 510 extends from the baseplate 4 and / or sensor patch 700 in a direction that is opposite and parallel to the direction of gravity g.

[00148] According to embodiments of the invention, the monitoring device 6 provides communication about which zone of a sensor assembly comprising two or more detection zones (e.g., detection zones 500, 502, 504) a possible leak occurs. According to embodiments of the invention, the monitoring device 6 comprises a 3-axis geometric accelerometer 540 configured to generate a position signal. By providing the monitor device 6 with an accelerometer 540, it is possible to determine a spatial orientation of the monitor device 6 and, therefore, of the base plate 4 and / or sensor patch 700, since the base plate 4 and / or sensor patch 700 are coupled to the monitor device 6. In other words, because the base plate 4 and / or sensor patch 700 are coupled 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 sensor patch 700.

[00149] By defining a natural orientation N of the 540 accelerometer, it is possible to determine any angular deviations / displacements from that natural orientation. In the modalities, the natural orientation N can be defined relative to a global coordinate system that includes a global x' geometric axis, a global y' geometric axis, and a global z' geometric axis. In these cases, the axis Petition 870210096510, dated 10 / 19 / 2021, page 81 / 133 / 81 geometric axis x', geometric axis y' and geometric axis z' are fixed in relation to a rotation of the base plate 4 and / or sensor patch 700. Furthermore, for example, the natural orientation N may be an orientation in which the force of gravity along the geometric axis y' is -1 g, and in which the force of gravity along the geometric axis x' and geometric axis z' is 0 g. According to such a definition, the accelerometer 540 is in a natural orientation when the geometric axis y (of the local coordinate system of the accelerometer) is parallel to the geometric axis y' and to the direction of gravity g, and the geometric axis x, consequently, is parallel to the geometric axis x' and is arranged perpendicular to the direction of gravity g, and thus, is horizontal.The force of gravity being -1 g for the geometric axis y' is a result of the direction of the geometric axis y' and can, therefore, be positive (+1 g) if the direction of the geometric axis y' is reversed, for example, by definition. Alternatively, the natural orientation N can be defined as an orientation in which an angular displacement of the geometric axis x' relative to the direction of gravity g is zero, or in which an angular displacement of the geometric axis y' relative to the direction of gravity g is zero, or in which an angular displacement of the geometric axis z' relative to the direction of gravity g is zero. In Figure 16, the natural orientation N is illustrated by a set of intersecting dashed lines, where one is parallel to the geometric axis y' and the direction of gravity g, and the other is parallel to the geometric axis x' and perpendicular to the direction of gravity g.

[00150] In Figure 16, the orientation of the accelerometer 540 and therefore of the local coordinate system (i.e., the geometric x-axis, geometric y-axis, geometric z-axis) and of the monitor device and the base plate 4 and / or coupled sensor patch 700, is seen as aligned with the predefined natural orientation N (for example, the geometric y-axis is parallel to the direction of gravity g and to the geometric y' axis of the global coordinate system and therefore the force of gravity along the geometric y-axis is -1 g). Thus, Petition 870210096510, dated 10 / 19 / 2021, pp. 82 / 133 / 81, it can be said that an angular displacement, or rotational displacement of the base plate 4 and / or sensor patch 700 is zero. In the embodiments, such rotational displacement can be communicated (for example, by transmitting a signal indicating the rotational displacement according to a wireless protocol) to an accessory device, such as a smartphone, in order to visually illustrate / reflect the physical base plate and / or sensor patch in a graphical user interface, such as in a smartphone app. In particular, the visual representation of the physical base plate and / or sensor patch facilitates communication about where (in which detection zone) a possible leak occurs.

[00151] Figure 17 illustrates a rotated baseplate 4 and / or sensor patch 700 (relative to a natural orientation N) coupled to a monitor device 6, as discussed above in relation to Figure 16. The geometric axes of the accelerometer 540 are shown to deviate from the natural orientation N and the global coordinate system. To highlight this, the geometric x and y axes of the accelerometer 540 have been translated into the representation of the natural orientation N. Here, it is easily seen how the geometric y axis of the now rotated accelerometer 540 is rotated by an angle (angular displacement) of W1 from the direction parallel to the direction of gravity g (i.e., the geometric axis y'), and how the geometric x axis of the now rotated accelerometer 540 is rotated by the same angle (angular displacement) of W1 from a direction that is perpendicular to the direction of gravity g (i.e., the geometric axis x').

[00152] In the modes, the monitor device 6 calculates W1 based on the measurements of the accelerometer 540 since the total sum of the accelerations measured on the geometric x-axis, geometric y-axis and geometric z-axis is equal to 1 g, in order to determine that the base plate 4 and / or sensor patch 700 has stopped moving. Otherwise, in certain cases, the acceleration due to the movement of the base plate 4 and / or patch Petition 870210096510, dated 10 / 19 / 2021, page 83 / 133 / 81 sensor 700 and the corresponding measurements detected by accelerometer 540 may result in an incorrect calculation for W1. Additionally or alternatively, the measurements from accelerometer 540 are transmitted by the monitoring device 6 to an accessory device 8, and the accessory device 8 calculates W1.

[00153] In certain modalities, W1 is the angle of rotation in the xy plane and, even if the geometric z-axis is non-zero with respect to the geometric z' axis of the natural orientation, the angle of the geometric z-axis with respect to the geometric z' axis is ignored by subtracting the acceleration measured on the geometric z-axis from 1 g, in order to calculate W1 in the xy plane.

[00154] In other words, Figure 17 illustrates an orientation of the accelerometer 540 and therefore of the monitor device 6 and the base plate 4 and / or coupled sensor patch 700, which are tilted / displaced at an angle W1 relative to the predefined natural orientation N / to the global coordinate system. Thus, it can be said that the angular displacement, or rotational displacement of the base plate 4 and / or sensor patch 700 is W1. In embodiments, such rotational displacement can be communicated to an accessory device, such as a smartphone, in order to visually illustrate / reflect the physical base plate and / or sensor patch in a GUI, such as in a smartphone app. In particular, the visual representation of the physical base plate and / or sensor patch facilitates communication to the user where (in which detection zone) a possible leak occurs.

[00155] When, or if, the base plate 4 and / or sensor patch 700 is detected rotated at an angle W1 relative to a predefined natural orientation N, that angle W1 is incorporated into the visual representation. Since the base plate 4 and / or sensor patch 700 is provided with a neck portion 510, the user can easily translate the visual representation onto their body and vice versa. In other words, the neck portion 510 breaks the Petition 870210096510, dated 10 / 19 / 2021, page 84 / 133 / 81 symmetry of the base plate 4 and / or sensor patch possibly substantially circular 700. By breaking the symmetry, the neck portion 510 can constitute a reference point for the user when they need to locate where (in which detection zone) a possible leak occurs. When the visual representation in the GUI of the accessory device incorporates the rotational displacement of, here, W1, the user obtains a better spatial understanding of their base plate and / or sensor patch and where the possible leak occurs.

[00156] Figure 18A illustrates a person 499 using a baseplate 4 and / or sensor patch 700 coupled to a monitoring device 6 as described above. The baseplate 4 and / or sensor patch 700 comprises three angularly spaced detection zones 500, 502, and 504. Note that the separation of the detection zones is illustrated by dashed lines, but in reality, the detection zones are separated due to a specific electrode arrangement, for example, as illustrated in Figures 11, 12, and 15. The neck portion 510 of the baseplate and / or sensor patch is seen extended radially in the opposite direction to the stomach opening 18 in a direction that is parallel to the direction of gravity g. The monitor device 6 comprises an accelerometer 540. A natural orientation N of the accelerometer 540 was defined according to a previously disclosed definition.According to this definition of natural orientation N, the monitor device 6 and therefore the base plate 4 and / or sensor patch 700, as illustrated, does not comprise a rotational displacement, since the geometric axis y of the accelerometer is parallel to the direction of gravity g (in other words, the force of gravity along the geometric axis y is -1 g) and the geometric axis x is perpendicular to the direction of gravity g (in other words, the force of gravity along the geometric axis x is 0 g).

[00157] Consequently, according to the embodiments, the visual representation of the base plate 4 and / or sensor patch 700 does not Petition 870210096510, dated 10 / 19 / 2021, page 85 / 133 / 81, includes no rotational displacement, as illustrated in Figure 18B.

[00158] Figure 18B illustrates an accessory device 8 (smartphone) comprising a GUI 8a, such as a screen. The GUI 8a is configured to show a visual representation 8b of the baseplate 4 and / or sensor patch 700 as applied to the user's body (see Figure 18A). In particular, the visual representation illustrates the detection zones (reference numbers 500, 502 and 504 in Figure 18A) of the baseplate 4 and / or sensor patch 700. The detection zones can be illustrated by means of annular segments 500a, 502a, 504a. As illustrated, the detection zones 500, 502, 504 of the baseplate 4 and / or sensor patch 700 translate directly into the visual representation 8b. In particular, visual representation 8b is oriented so that up and down are in accordance with the natural orientation of the accessory device 8, or a common understanding of the orientation of the accessory device used 8.In other words, the orientation of visual representation 8b conforms to a normal understanding of accessory device 8. Additionally, in other words, the orientation of visual representation 8b conforms to the orientation of accessory device 8. For example, when accessory device 8 is a smartphone, in a portrait orientation, the direction of gravity can be considered parallel to a longitudinal direction, for example, a long edge, of the smartphone. Similarly, in a landscape orientation of the smartphone, the direction of gravity can be considered parallel to a short edge of the smartphone. Such an orientation conforms to a normal understanding of the function of a smartphone.Although a particular visual representation has been described, it will be understood that other visual representations may be employed, including other visual representations, such as equivalents, that have the capacity to provide a similar representation. Petition 870210096510, dated 10 / 19 / 2021, page 86 / 133 / 81 representation of a state of leakage.

[00159] Figure 19A illustrates a person 499 using a baseplate 4 and / or sensor patch 700 coupled to a monitoring device 6 as described above. The baseplate 4 and / or sensor patch 700 comprises three angularly spaced detection zones 500, 502, and 504. The neck portion 510 of the baseplate and / or sensor patch is shown extended radially in the opposite direction to the stomach opening 18 in a direction inclined / deviated from the direction of gravity g. The monitoring device 6 comprises an accelerometer 540. A natural orientation N of the accelerometer 540 has been defined according to a previously disclosed definition. According to this definition of the natural orientation N, the monitor device 6, and therefore the base plate 4 and / or sensor patch 700, comprises an angular / rotational displacement of W2, as highlighted by the translation of the geometric axis xey of the accelerometer 540 in the natural orientation N.

[00160] Figure 19B illustrates an accessory device 8 (smartphone) comprising a GUI 8a, such as a screen. The GUI 8a is configured to show a visual representation 8b of the baseplate 4 and / or sensor patch 700 as applied to the user's body (see Figure 19A). As illustrated, the detection zones 500, 502, 504 of the baseplate 4 and / or sensor patch 700 translate directly into the visual representation 8b, such that the annular segments 500b, 502b, 504b illustrating the detection zones 500, 502, 504, respectively, are rotated according to the rotational displacement W2 of Figure 19A. The dashed lines / angle drawn in visual representation 8b are for illustrative purposes only and illustrate how the annular segments 500b, 502b, 504b are rotated by the rotational displacement of W2.

[00161] Figure 20 illustrates eight exemplary orientations of a monitor device 6 comprising a 3-axis geometric accelerometer 540. In particular, Figure 20 illustrates eight rotations Petition 870210096510, dated 10 / 19 / 2021, page 87 / 133 / 81, provides examples of how a user can choose to orient their baseplate and / or sensor patch comprising a plurality of detection zones. In a clockwise direction, the first position is a position where the geometric y-axis of the accelerometer is aligned / parallel to the direction of gravity, where the force of gravity along the geometric y-axis is -1 g, so that the angular displacement of the geometric y-axis relative to the natural orientation N is zero degrees. The second position is a position where the geometric y-axis of the accelerometer is rotated by an angle of 45° from the y-component Ny of the natural orientation N, that is, the component that is aligned / parallel to the direction of gravity. Continuing in a clockwise direction, the orientations of the monitor device are positions where the geometric y-axis of the accelerometer is rotated in increments of 45°.At each position, the angular displacement can be defined as the angle between the geometric y-axis of the accelerometer and the y-component Ny of the natural orientation N.

[00162] Figure 21 illustrates a plot of an experimental dataset (position signals) originating from an accelerometer. The accelerometer was housed in a monitor device and used by a human. The plot illustrates a plurality of position signals obtained from the accelerometer over time, each position signal comprising information pertaining to a spatial orientation / angular displacement of the accelerometer relative to a natural orientation. The concentric circles illustrate the force of gravity, as measured in m / s², such that 9.8 m / s² = 1 g. The (angular) distribution of the data points / position signals indicates that the user moved, for example, walked. Over time, due to the continuous vertical position of a walking human, the data points form a trend. In this case, the data points converge around an average angular displacement Δ of 106°. In other words, 106° represents Petition 870210096510, dated 10 / 19 / 2021, p. 88 / 133 / 81 the direction of gravity (average). Thus, data suggest that the monitor device was used in such a way that the geometric axis yex of the accelerometer was inclined 106° with respect to the natural orientation of the respective geometric axis yex.

[00163] Since the monitoring device must be used by a human being, a way to determine the actual rotational displacement of the baseplate and / or sensor patch (attached) is necessary. A single assessment of the accelerometer's spatial orientation relative to a natural orientation can vary considerably, as the user may move, shift their weight from leg to leg, jump, bend, etc. Thus, if one were to determine the accelerometer's spatial orientation, and therefore the rotational displacement of the baseplate and / or sensor patch, based on a single accelerometer reading / a single position signal, the user would have to stand in a perfect, predefined, e.g., vertical position, which is virtually impossible. In other words, a single assessment of spatial orientation is merely indicative of a particular user movement at a particular point in time.However, by averaging the position signals obtained over a given period of time, a trend can be formed. The trend will reveal how the accelerometer, and therefore the baseplate and / or sensor patch, is positioned relative to the user and thus to the ostomy. In the example dataset illustrated by the plot in Figure 21, the average angular displacement A is 106°. Therefore, despite the user walking, the monitoring device, through the use of the accelerometer, was able to determine how the monitoring device, and therefore the baseplate and / or sensor patch, is positioned with a sufficient degree of accuracy. The angular displacement of 106° is relative to a predefined natural orientation. Thus, the monitoring device, and therefore the baseplate and / or sensor patch, was rotated 106° from the predefined natural orientation. According to modalities, the angular displacement is... Petition 870210096510, dated 10 / 19 / 2021, page 89 / 133 / 81 incorporated into a visual representation of the baseplate and / or sensor patch in a graphical user interface of an accessory device, as described above, for example, in relation to Figures 18A-19B. Different movements or positions (e.g., standing, sitting, or lying down) of the user may result in different distributions of position signals. In this way, it is possible to distinguish such different movements or positions. Thus, the monitoring device can double as an activity tracker.

[00164] Figure 22 illustrates an exemplary monitor device 6 comprising a housing 100 and a device interface 102. The monitor device 6 comprises a processor 101 and a 3-axis geometric accelerometer 540. The accelerometer 540 is capable of measuring motion in a three-dimensional space as encompassed by a Cartesian coordinate system and is configured to generate a position signal indicative of a spatial orientation of the monitor device 6. Thus, the accelerometer 540 is capable of measuring acceleration along a geometric x-axis, a geometric y-axis, and a geometric z-axis that are mutually orthogonal. In certain embodiments, the geometric axes of the accelerometer extend in the directions as indicated. The housing 100 comprises a skin-facing surface 100a.The skin-facing surface 100a can be considered substantially flat, so that the surface can be level with the skin or a distal surface of the baseplate and / or sensor patch. Leveling means that the geometric plane defined by the skin-facing surface is configured to be substantially parallel to the skin surface on which it is to be used. In certain embodiments, a geometric plane of the accelerometer, for example, encompassed by its geometric axis x and y, is configured to be parallel to such a geometric plane defined by the skin-facing surface. In this way, the accelerometer is provided with an orientation that conforms to the... Petition 870210096510, dated 10 / 19 / 2021, pp. 90 / 133 / 81 modalities described in this document.

[00165] Although certain geometric axes and geometric planes of the accelerometer have been assigned specific directions and / or properties throughout the present disclosure, it will be understood that other geometric axes, or even intermediate directions that are capable of being described by the set of geometric axes (for example, described in the form (x,y,z)), can be assigned the same specific directions and properties by a simple matter of defining the coordinate system. For example, when the geometric axis y is described as aligned / parallel to the direction of gravity, it will be understood that the geometric axis x, the geometric axis z, or an intermediate direction (for example, described in the form (x,y,z)) can be equally well defined as the geometric axis aligned / parallel to the direction of gravity. In other words, the coordinate system encompassed by the accelerometer can be rotated at any angle (three-dimensional) without affecting the scope of the invention.

[00166] Although particular features have been shown and described, it will be understood that these are not intended to limit the claimed invention, and it will become obvious to those skilled in the art that various alterations and modifications can be made without departing from the spirit and scope of the claimed invention. The descriptive report and drawings should, consequently, be considered in an illustrative rather than restrictive sense. The claimed invention is intended to cover all alternatives, modifications and equivalents. Petition 870210096510, dated 10 / 19 / 2021, pp. 91 / 133

Claims

1 / 6 CLAIMS 1. Method for determining a rotational displacement of a sensor assembly of an ostomy device (2) relative to an ostomy, wherein the sensor assembly is attachable to a monitor device (6), wherein the monitor device (6) comprises: - a housing (100), - a processor (101) disposed in said housing, - a device interface (102) configured to couple the monitor device to the sensor assembly, wherein the device interface comprises a plurality of terminals for connection to a plurality of electrodes (216) of the sensor assembly, and - an accelerometer (540) configured to generate a position signal;wherein the sensor assembly comprises: - a plurality of electrodes (216) forming two or more sensors arranged in at least two separate detection zones (500, 502), and - a mounting interface configured to couple with the device interface (102) of the monitor device, and characterized in that the method comprises the steps of: - disposing of the ostomy device comprising the sensor assembly in a peristomal skin area and coupling the monitor device to the sensor assembly, - obtaining one or more position signals from the accelerometer, wherein the one or more position signals are indicative of a spatial orientation of the accelerometer, - determining a rotational displacement of the sensor assembly based on the one or more position signals. Petition 870250094601, dated 10 / 16 / 2025, page 13 / 25 2 / 6; 2. Method according to claim 1, wherein the method is characterized in that it comprises an initial step of defining a natural orientation of the monitor device.

3. A method according to any one of claims 1 to 2, characterized in that the monitoring device is in communication with an accessory device (8a) comprising a graphical user interface (8a), and wherein the method further comprises the steps of communicating the rotational displacement with the accessory device and generating a visual representation in said graphical user interface, wherein the visual representation incorporates said rotational displacement and illustrates the position of at least two detection zones relative to an ostomy.

4. Ostomy system (1), characterized in that it comprises an ostomy appliance (2), a sensor assembly provided in the ostomy appliance and a monitoring device (6), wherein the monitoring device comprises: - a housing (100), - a processor (101) disposed in said housing, - an appliance interface (102) comprising a plurality of terminals for connection with a plurality of electrodes (216) of the sensor assembly, and - an accelerometer (540) configured to generate a position signal; wherein the sensor assembly comprises: - a plurality of electrodes (216) forming two or more sensors arranged in at least two separate detection zones (500, 502), wherein the plurality of electrodes is configured for detection of the presence of liquid on a proximal side of a first adhesive layer (200) and / or moisture content in the first adhesive layer (200) of the device Petition 870250094601, of 10 / 16 / 2025, page.14 / 25 3 / 6 ostomy, and - a mounting interface configured to mate with the device interface of the monitor, and wherein the monitor is configured to mate in a releasable manner with the sensor mount.

5. Ostomy system according to claim 4, characterized in that the accelerometer of the monitoring device comprises a predefined natural orientation, and wherein the monitoring device is configured to determine a rotational displacement of the sensor assembly relative to the predefined natural orientation.

6. Monitoring device (6) for releasable coupling to a sensor assembly of a baseplate (4) or a sensor patch (700) for application to a baseplate (4) of an ostomy device (2), wherein the monitoring device (6) comprises: - a housing (100), - a processor (101) disposed in said housing, and characterized in that the monitoring device further comprises a device interface (102) configured for releasable coupling of the monitoring device to the sensor assembly in a fixed position relative to said sensor assembly, wherein the device interface comprises a plurality of terminals for connection to a plurality of electrodes (216) of the sensor assembly, and wherein the monitoring device further comprises a three-axis geometric accelerometer (540), and wherein the accelerometer is configured to generate a position signal.

7. A monitoring device according to claim 6, characterized in that the position signal comprises a value for a force of gravity along a geometric x-axis, along a geometric y-axis and along a geometric z-axis, wherein the geometric axes are mutually orthogonal, and / or a value for a primary angular displacement of the geometric x-axis relative to a predefined orientation, a secondary angular displacement of the geometric y-axis relative to a predefined orientation and a tertiary angular displacement of the geometric z-axis relative to a predefined orientation.

8. A monitoring device according to any one of claims 6 to 7, characterized in that the position signal is sampled at a rate of at least 0.1 Hz.

9. A monitoring device according to any one of claims 6 to 8, characterized in that the position signal is indicative of a spatial orientation of the monitoring device.

10. Monitoring device according to any one of claims 6 to 9, characterized in that the accelerometer is configured to determine its spatial orientation relative to a user's ostomy based on a user-generated movement pattern.

11. Monitoring device according to claim 10, characterized in that the motion pattern comprises a plurality of position signals sampled during a predefined period of time.

12. A monitoring device according to any one of claims 10 to 11, characterized in that the spatial orientation of the accelerometer is indicative of a rotational displacement of the sensor assembly when the monitoring device is coupled to said sensor assembly.

13. Monitoring device according to any one of claims 6 to 12 characterized in that the accelerometer comprises a predefined natural orientation, wherein the primary angular displacement of the geometric x-axis relative to the direction of gravity is zero degrees, or the secondary angular displacement of the geometric y-axis relative to the direction of gravity is zero degrees, or the tertiary angular displacement of the geometric z-axis relative to the direction of gravity is zero degrees.

14. Monitoring device according to any one of claims 6 to 13, characterized in that the accelerometer comprises a predefined natural orientation, in which the force of gravity along the geometric x-axis of the accelerometer is 0 g and the force of gravity along the geometric y-axis of the accelerometer is -1 g.

15. A monitoring device according to any one of claims 13 to 14, characterized in that the processor is configured to generate a displacement parameter based on an angular displacement of the accelerometer from the predefined natural orientation.

16. Monitoring device according to any one of claims 6 to 15, characterized in that the processor is configured to communicate the position signal and / or the displacement parameter with an accessory device (8).

17. Monitoring device according to any one of claims 6 to 16, characterized in that the housing comprises a skin-facing surface (100a), and in which the geometric axis x and the geometric axis y of the accelerometer encompass a geometric plane that is substantially parallel to said skin-facing surface of the housing, and in which the geometric axis z of the accelerometer extends in a direction that is normal to said geometric plane.

18. Monitoring device according to any one of claims 6 to 17, characterized in that the device interface is configured to couple to a plurality of electrodes (216) of a sensor assembly, the plurality of electrodes forming at least two sensors arranged in at least two separate detection zones (500, 502) configured to monitor a peristomal skin surface. Petition 870250094601, 10 / 16 / 2025, p. 17 / 25 6 / 6 19. Monitoring device according to claim 18, characterized in that the processor is configured to determine a spatial distribution of at least two detection zones based on one or more position signals.

20. Monitor device according to any one of claims 6 to 19, wherein the monitor device is characterized in that it comprises a memory (106) and in that one or more task profiles are stored in the memory, and in that the monitor device is configured to detect one or more touch sequences contained in one or more position signals.

21. A monitor device according to claim 20, characterized in that the processor is configured to compare a given touch sequence from one or more touch sequences with one or more task profiles and to generate an output associated with the given touch sequence.

22. A monitoring device according to claim 21, characterized in that the output is selected from waking the monitoring device from a standby mode, activating pairing mode, or entering standby mode.

23. Monitoring device according to any one of claims 6 to 22, wherein the monitoring device is characterized in that it is configured to switch off or enter a standby mode if no movement is detected for a predetermined period of time. Petition 870250094601, dated 10 / 16 / 2025, p. 18 / 25

Images