Method of determining future operating state of ostomy system and related auxiliary device, and ostomy system

Abstract

To provide a method for monitoring an ostomy system executed by an auxiliary device.SOLUTION: An auxiliary device includes an interface configured to communicate with one or more devices of an ostomy system, and the interface includes a display. The auxiliary device is configured to communicate with the ostomy system. The ostomy system includes a monitor device and / or an ostomy prosthesis configured to be placed on a user's skin surface. The ostomy prosthesis includes a base plate. A method includes: acquiring monitor data from one or more devices; acquiring context data; determining one or more future operating states of the ostomy prosthesis on the basis of the monitor data and the context data, one future operating state indicating a future adhesive state of the ostomy prosthesis; and communicating with the one or more future operating states.SELECTED DRAWING: Figure 13C

Description

[Technical field]

[0001] The present disclosure relates to an ostomy system, a device thereof, and a method for monitoring an ostomy appliance. The ostomy appliance system includes an ostomy appliance and an ostomy monitor device. In particular, the present disclosure relates to communicating the future operational state of a base plate of an ostomy appliance. Summary of the Invention [Means for solving the problem]

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

[0003] [Figure 1] FIG. 1 illustrates an exemplary ostomy system. [Diagram 2] FIG. 2 illustrates an exemplary monitoring device for an ostomy system. [Diagram 3] FIG. 3 is an exploded view of the base plate of the ostomy appliance. [Figure 4] FIG. 4 is an exploded view of an exemplary electrode assembly. [Diagram 5] FIG. 5 is a proximal view of the base plate. [Figure 6] FIG. 6 is a distal view of an exemplary electrode configuration. [Figure 7] FIG. 7 is a distal view of an exemplary masking element. [Figure 8] FIG. 8 is a distal view of an exemplary first adhesive layer. [Figure 9]FIG. 9 is a proximal view of the first adhesive layer of FIG. [Figure 10] FIG. 10 is a distal view of the base plate including the monitor interface. [Figure 11A] FIG. 11A illustrates an example method for communicating a future operating state according to the present disclosure. [Figure 11B] FIG. 11B illustrates an example method for communicating a future operating state according to the present disclosure. [Figure 12] FIG. 12 illustrates an exemplary accessory device according to the present disclosure. [Figure 13A] FIG. 13A is an example user interface displayed on an example accessory device for communication of one or more future operational states for a base plate of an ostomy appliance according to the present disclosure. [Figure 13B] FIG. 13B is an example user interface displayed on an example accessory device for communication of one or more future operational states for a base plate of an ostomy appliance according to the present disclosure. [Figure 13C] FIG. 13C is an example user interface displayed on an example accessory device for communication of one or more future operational states for a base plate of an ostomy appliance according to the present disclosure. [Figure 13D] FIG. 13D is an example user interface displayed on an example accessory device for communication of one or more future operational states for a base plate of an ostomy appliance according to the present disclosure. [Figure 14] FIG. 14 is an exemplary graph depicting parameter data as a function of time. [Figure 15] FIG. 15 is an exemplary graph depicting parameter data as a function of time. [Figure 16] FIG. 16 is an exemplary graph depicting parameter data as a function of time. [Figure 17] FIG. 17 is an exemplary graph depicting parameter data as a function of time and whitened zone diameter as a function of time. [Figure 18A]FIG. 18A is an exemplary graph depicting peel force as a function of peel distance traveled by a peeling action exerting a peel force on a first adhesive layer of a base plate. [Figure 18B] FIG. 18B is an exemplary graph depicting peel force as a function of peel distance traveled by a peeling action exerting a peel force on a first adhesive layer of a base plate. [Figure 19A] FIG. 19A is an exemplary graph depicting white zone diameter. [Figure 19B] FIG. 19B is an exemplary graph depicting white zone diameter. [Figure 20A] FIG. 20A is an exemplary graph of first parameter data as a function of time for various semi-solid materials. [Figure 20B] FIG. 20B is an exemplary graph of the first parameter data as a function of the percentage of semi-solid material in the mixture applied to the stoma opening. [Figure 21A] FIG. 21A is an exemplary graph of parameter data as a function of time for different predetermined temperatures. [Figure 21B] FIG. 21B is an exemplary graph of parameter data as a function of time for different predetermined temperatures. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

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

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

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

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

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

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

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

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

[0012] The ostomy system includes an ostomy appliance and a monitoring device, where the ostomy appliance includes a base plate, and the monitoring device is a monitoring device as described herein.

[0013] An ostomy system is disclosed that includes a monitoring device and an ostomy appliance including a base plate, the base plate having a first adhesive layer having a proximal side configured to attach the base plate to a skin surface of a user, the first adhesive layer having a stoma opening having a central point, the monitoring device including a processor and a sensor unit including a first sensor having a first sensor surface housed within a monitoring device housing, the monitoring device housing having a sensor opening on a proximal surface of the monitoring device, the sensor opening forming at least a portion of a sensor path from the periphery of the proximal surface to the first sensor surface.

[0014] Also disclosed is a monitor device for an ostomy appliance of an ostomy system, the monitor device including a processor and a sensor unit including a first sensor having a first sensor surface housed within a monitor device housing, the monitor device housing having a sensor opening in a proximal face of the monitor device, the proximal face configured to face a user's skin during use, and the sensor opening forming at least a portion of a sensor path from a periphery of the proximal face to the first sensor surface.

[0015] The present disclosure provides ostomy systems and devices thereof, such as an ostomy appliance, a base plate for the ostomy appliance, a monitor device, and optionally one or more accessory devices that, singly or collectively, may facilitate reliable monitoring of the ostomy appliance.

[0016] The ostomy appliance includes a base plate and an ostomy pouch (also called an ostomy bag). The ostomy appliance may be an artificial anus appliance, an ileostomy appliance, or an artificial bladder appliance. The ostomy appliance may be a two-piece ostomy appliance, i.e., the base plate and the ostomy pouch may be releasably coupled, for example, using mechanical and / or adhesive coupling, thereby allowing, for example, multiple ostomy pouches to be utilized (interchangeable) with one base plate. Furthermore, the two-piece ostomy appliance may facilitate accurate application of the base plate to the skin, for example, by facilitating improved user vision of the stoma area. The ostomy appliance may be a single-piece ostomy appliance, i.e., the base plate and the ostomy pouch may be fixedly attached to each other. The base plate is configured to couple to the peristomal skin, such as the stoma and / or surrounding skin area of ​​the user.

[0017] A base plate for an ostomy appliance is disclosed, the base plate including a first adhesive layer having a proximal side configured to attach the base plate to a skin surface of a user, the first adhesive layer having a stoma opening having a central point, and a plurality of electrodes including a ground electrode, a first electrode, and optionally a second electrode, the ground electrode including a ground connection portion, the first electrode including a first connection portion, and the second electrode including a second connection portion, the ground electrode forming a ground for the first electrode and / or the second electrode.

[0018] The base plate includes a first adhesive layer. In use, the first adhesive layer adheres to the user's skin (peristomal area) and / or additional seals such as sealing paste, sealing tape, and / or sealing ring. The first adhesive layer may therefore be configured to attach the base plate to the user's skin surface. The first adhesive layer has a stoma opening with a center point, or is at least fabricated to form a stoma opening with a center point. The base plate, having three electrodes whose sensing unit contacts the first adhesive layer, can identify the erosion / expansion characteristics or properties of the first adhesive layer and / or identify the degree of erosion and / or expansion of the first adhesive layer.

[0019] It is an advantage of the present disclosure that optimal or improved use of the ostomy appliance is provided. In particular, the present disclosure facilitates avoiding replacing the base plate too early (leading to increased cell detachment from the skin and increased risk of skin damage, resulting in increased wasted costs and / or materials) or too late (leading to adhesion failure, leakage, and / or skin damage from excess discharge). Thus, the user or medical practitioner can monitor and plan the use of the ostomy appliance.

[0020] The present disclosure provides a simple, efficient, and easy-to-use ostomy appliance system that provides a high level of comfort for the user.

[0021] The first adhesive layer may be made of a first composition. The first composition may include one or more polyisobutenes and / or styrene-isoprene-styrene. The first composition may include one or more hydrocolloids.

[0022] The first composition may be a pressure sensitive adhesive composition suitable for medical purposes, comprising a resilient elastomeric base and one or more water-soluble or water-swellable hydrocolloids. The first composition may comprise one or more polybutenes, one or more styrene copolymers, one or more hydrocolloids, or any combination thereof. The adhesive properties of the polybutene combined with the absorbency of the hydrocolloids makes the first composition suitable for use with ostomy appliances. The styrene copolymer may be, for example, a styrene-butadiene-styrene block copolymer or a styrene-isoprene-styrene block copolymer. Preferably, one or more styrene-isoprene-styrene (SIS) block type copolymers are utilized. The amount of styrene block copolymer may be 5% to 20% of the total adhesive composition. The butene component is suitably a conjugated butadiene polymer selected from polybutadiene, polyisoprene. The polybutene is preferably present in an amount of 35% to 50% of the total adhesive composition. Preferably, the polybutene is polyisobutylene (PIB). Suitable hydrocolloids for incorporation into the first composition are selected from hydrocolloids of natural origin, semi-synthetic hydrocolloids and synthetic hydrocolloids. The first composition may contain 20% to 60% hydrocolloid. A preferred hydrocolloid is carboxymethylcellulose (CMC). The first composition may optionally contain other ingredients such as fillers, tackifiers, plasticizers and other additives.

[0023] The first adhesive layer may have a plurality of sensor point openings configured to overlap (sensing) portions of the electrodes, for example to form sensor points.

[0024] The sensor point openings of the first adhesive layer may include a primary sensor point opening. The primary sensor point openings may include one or more first primary sensor point openings and one or more second primary sensor point openings, where the first primary sensor point openings are configured to overlap a (sensing) portion of an electrode and the second primary sensor point openings are configured to overlap a (sensing) portion of another electrode different from the electrode that the first primary sensor point openings at least partially overlap.

[0025] The sensor point openings of the first adhesive layer may include secondary sensor point openings. The secondary sensor point openings may include one or more first secondary sensor point openings and one or more second secondary sensor point openings, where the first secondary sensor point openings are configured to overlap a (sensing) portion of an electrode and the second secondary sensor point openings are configured to overlap a (sensing) portion of another electrode different from the electrode that the first secondary sensor point openings at least partially overlap.

[0026] The sensor point openings of the first adhesive layer may include tertiary sensor point openings. The tertiary sensor point openings may include one or more first tertiary sensor point openings and one or more second tertiary sensor point openings, where the first tertiary sensor point openings are configured to overlap a (sensing) portion of an electrode and the second tertiary sensor point openings are configured to overlap a (sensing) portion of another electrode different from the electrode that the first tertiary sensor point openings at least partially overlap.

[0027] 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, for example 0.8 mm or 1.0 mm.

[0028] The first adhesive layer may have a primary thickness in a primary portion of the first adhesive layer, for example a primary region within a primary radial distance or range of radial distances from a center point of the stoma opening. The primary thickness may be in the range of 0.2 mm to 1.5 mm, such as about 1.0 mm. The primary radial distance may be in the range of 20 mm to 50 mm, such as in the range of 25 mm to 35 mm, for example 30 mm.

[0029] The first adhesive layer may have a secondary thickness in a secondary portion of the first adhesive layer, e.g., a secondary region a secondary radial distance or range of radial distances away from the center point of the stoma opening. The secondary thickness may be in the range of 0.2 mm to 1.0 mm, such as about 0.5 mm. The secondary radial distance may be in the range of 20 mm to 50 mm, such as in the range of 25 mm to 35 mm, e.g., 30 mm.

[0030] The base plate may include a second layer. The second layer may be an adhesive layer. The second layer may have a second radial extent greater than the first radial extent of the first adhesive layer, at least in a first angular range of the base plate. Thus, a portion of the proximal surface of the second layer may be configured to be attached to a skin surface of a user. The portion of the proximal surface of the second layer configured to be attached to a skin surface of a user is also indicated as a skin attachment surface of the second adhesive layer. The second layer may have a stoma opening having a center point.

[0031] The second adhesive layer may be made of a second composition. The second composition may include one or more polyisobutenes and / or styrene-isoprene-styrene. The second composition may include one or more hydrocolloids.

[0032] The second composition may be a pressure sensitive adhesive composition suitable for medical purposes, comprising a resilient elastomeric base and one or more water-soluble or water-swellable hydrocolloids. The second composition may comprise one or more polybutenes, one or more styrene copolymers, one or more hydrocolloids, or any combination thereof. The adhesive properties of the polybutene combined with the absorbency of the hydrocolloids makes the second composition suitable for use with ostomy appliances. The styrene copolymer may be, for example, a styrene butadiene styrene block copolymer or a styrene-isoprene-styrene block copolymer. Preferably, one or more styrene-isoprene-styrene (SIS) block type copolymers are utilized. The amount of styrene block copolymer may be 5% to 20% of the total adhesive composition. The butene component is suitably a conjugated butadiene polymer selected from polybutadiene, polyisoprene. The polybutene is preferably present in an amount of 35% to 50% of the total adhesive composition. Preferably, the polybutene is polyisobutylene (PIB). Suitable hydrocolloids for incorporation into the second composition are selected from hydrocolloids of natural origin, semi-synthetic hydrocolloids and synthetic hydrocolloids. The second composition may contain 20% to 60% hydrocolloid. A preferred hydrocolloid is carboxymethylcellulose (CMC). The second composition may optionally contain other ingredients such as fillers, tackifiers, plasticizers and other additives.

[0033] The different ratios of content may change the properties of the first and / or second adhesive layer. The second adhesive layer and the first adhesive layer may have different properties. The second adhesive layer (second composition) and the first adhesive layer (first composition) may have different ratios of polyisobutene, styrene-isoprene-styrene and / or hydrocolloid. For example, the second adhesive layer may provide stronger adhesion to the skin compared to the attachment to the skin provided by the first adhesive layer. Alternatively or additionally, the second adhesive layer may be thinner than the first adhesive layer. Alternatively or additionally, the second adhesive layer may absorb less water and / or sweat than the first adhesive layer. Alternatively or additionally, the second adhesive layer may be less moldable than the first adhesive layer. The second adhesive layer may provide a second leak-resistant barrier.

[0034] The second layer may have a substantially uniform thickness. The second layer may have a thickness in the range of 0.1 mm to 1.5 mm, such as 0.5 mm, 0.6 mm, or 0.7 mm, for example in the range of 0.2 mm to 1.0 mm.

[0035] The base plate includes one or more electrodes, such as a plurality of electrodes, such as 2, 3, 4, 5, 6, or more than 6 electrodes. The electrodes, e.g., some or all of the electrodes, may be disposed between a first adhesive layer and a second adhesive layer. The electrodes may be disposed in an electrode assembly, e.g., an electrode layer. The electrodes include connections connecting the electrodes to other components and / or interface terminals / terminal elements. The electrodes may include one or more conductor portions and / or one or more sensing portions. The electrode assembly may be disposed between a first adhesive layer and a second adhesive layer. The base plate, e.g., the electrode assembly, may include a first electrode, a second electrode, and optionally a third electrode. The base plate, e.g., the electrode assembly, may include a fourth electrode and / or a fifth electrode. The base plate, e.g., the electrode assembly, optionally includes a sixth electrode. The base plate, e.g., the electrode assembly, may include a ground electrode. The ground electrode may include the first electrode portion. The first electrode portion of the ground electrode may form a ground or reference for the first electrode. The ground electrode may include a second electrode portion. The second electrode portion of the ground electrode may form a ground or reference for the second electrode. The ground electrode may include a third electrode portion. The third electrode portion of the ground electrode may form a ground or reference for the third electrode. The ground electrode may include a fourth electrode portion. The fourth electrode portion of the ground electrode may form a ground or reference for the fourth electrode and / or the fifth electrode.

[0036] The ground electrode or an electrode portion of the ground electrode may be configured as or form a (common) reference electrode for some or all of the other electrodes of the electrode assembly. The ground electrode may also be referred to as the reference electrode.

[0037] The electrodes are electrically conductive and may include one or more of metallic materials (e.g., silver, copper, gold, titanium, aluminum, stainless steel), ceramic materials (e.g., ITO), polymeric materials (e.g., PEDOT, PANI, PPy), and carbonaceous materials (e.g., carbon black, carbon nanotubes, carbon fibers, graphene, graphite).

[0038] The ground electrode may include a first electrode portion and a second electrode portion, the first electrode portion forming a ground for the first electrode and the second electrode portion forming a ground for the second electrode. The first electrode portion may form a closed loop.

[0039] The electrodes are electrically conductive and may include one or more of metallic materials (e.g., silver, copper, gold, titanium, aluminum, stainless steel), ceramic materials (e.g., ITO), polymeric materials (e.g., PEDOT, PANI, PPy), and carbonaceous materials (e.g., carbon black, carbon nanotubes, carbon fibers, graphene, graphite).

[0040] Two electrodes of the electrode assembly may form a sensor. The first electrode and the ground electrode (e.g., the first electrode portion of the ground electrode) may form a first sensor or a first electrode pair. The second electrode and the ground electrode (e.g., the second electrode portion of the ground electrode) may form a second sensor or a second electrode pair. The third electrode and the ground electrode (e.g., the third electrode portion of the ground electrode) may form a third sensor or a third electrode pair. The fourth electrode and the ground electrode (e.g., the fourth electrode portion of the ground electrode) may form a fourth sensor or a fourth electrode pair. The fifth electrode and the ground electrode (e.g., the fifth electrode portion of the ground electrode) may form a fifth sensor or a fifth electrode pair. The fourth electrode and the fifth electrode may form a sixth sensor or a sixth electrode pair.

[0041] The electrode may include one sensing portion or multiple sensing portions, i.e., the portion of the electrode used for sensing. The first electrode may include a first sensing portion. The first sensing portion may be in contact with the first adhesive layer and is optionally arranged around the stoma opening in an at least partially annular manner. The first electrode may include a first conductor portion, which is insulated from the first adhesive layer by a masking element arranged between the first conductor portion and the first adhesive layer. The first sensing portion may extend over at least 270 degrees around the stoma opening, for example at least 300 degrees around the stoma opening. The first sensing portion of the first electrode may be arranged at a first ground distance from the first electrode portion of the ground electrode. The first ground distance may be less than 5 mm, for example less than 3 mm, for example about 1.0 mm.

[0042] The second electrode may include a second sensing portion. The second sensing portion may be in contact with the first adhesive layer. The second sensing portion may be disposed at least partially annularly around the stoma opening. The second sensing portion may extend over at least 270 degrees around the stoma opening, for example at least 300 degrees around the stoma opening. The second sensing portion of the second electrode may be disposed a second ground distance from the second electrode portion of the ground electrode. The second ground distance may be less than 5 mm, for example less than 3 mm, for example about 1.0 mm.

[0043] The first sensing portion may be disposed at a first radial distance from the center point, and the second sensing portion may be disposed at a second radial distance from the center point. The second radial distance may be greater than the first radial distance. The second electrode may include a second conductive portion that is insulated from the first adhesive layer, for example by a masking element disposed between the second conductive portion and the first adhesive layer. The first radial distance may vary depending on an angular position relative to a zero direction from the center point. The second radial distance may vary depending on an angular position relative to a zero direction from the center point. The zero direction may be defined as a vertically upward direction when the base plate is in an intended mounting position for an upright user.

[0044] The first radial distance R1 may be in the range of 5 mm to 40 mm, such as in the range of 10 mm to 25 mm, e.g., about 14 mm. In one or more embodiments, the first radial distance R1 may be about 13 mm, e.g., 12.5 mm. The second radial distance R2 may be in the range of 10 mm to 50 mm, such as in the range of 10 mm to 25 mm, e.g., about 18 mm. In one or more embodiments, the second radial distance R2 may be 17 mm.

[0045] The base plate may include a third electrode including a third connection portion. The ground electrode may form a ground for the third electrode. The ground electrode may include a third electrode portion, the third electrode portion forming a ground for the third electrode. The third electrode may include a third conductor portion, which is insulated from the first adhesive layer, for example by a masking element disposed between the third conductor portion and the first adhesive layer. The third electrode may include a third sensing portion, the third sensing portion contacting the first adhesive layer. The third sensing portion may be disposed at least partially annularly around the stoma opening. The third sensing portion may be disposed at a third radial distance from the center point. The third radial distance may be greater than the first radial distance and / or greater than the second radial distance. The third radial distance may be in the range of 15 mm to 50 mm, for example in the range of 20 mm to 30 mm, for example about 26 mm. In one or more embodiments, the third radial distance R3 is 21 mm. The third sensing portion may extend at least 270 degrees around the stoma opening, such as at least 300 degrees around the stoma opening. The third sensing portion of the third electrode is disposed at a third ground distance from the third electrode portion of the ground electrode. The third ground distance may be less than 5 mm, such as less than 3 mm, such as about 1.0 mm. The base plate having the ground electrode, the first electrode, the second electrode, and the third electrode may provide a fail-safe base plate when the first electrode is cut or otherwise destroyed, such as during fabrication of the base plate.

[0046] The base plate may include a fourth electrode including a fourth connection portion. The ground electrode may form the ground of the fourth electrode. The ground electrode may include a fourth electrode portion, the fourth electrode portion forming the ground of the fourth electrode. The fourth electrode may include one or more fourth sensing portions, for example at least five fourth sensing portions. The fourth sensing portions may be distributed around the stoma opening or a central point thereof. The fourth sensing portions may be disposed at a fourth radial distance each from the central point. The fourth radial distance may be greater than the third radial distance. The fourth radial distance may be in the range of 25 mm to 50 mm, for example about 30 mm.

[0047] The base plate may include a fifth electrode including a fifth connection portion. The ground electrode may form the ground of the fifth electrode. The ground electrode may include a fifth electrode portion, the fifth electrode portion forming the ground of the fifth electrode. The fifth electrode may include one or more fifth sensing portions, for example at least five fifth sensing portions. The fifth sensing portions may be distributed around the stoma opening or its central point. The fifth sensing portions may be disposed at a fifth radial distance each from the central point. The fifth radial distance may be greater than the third radial distance. The fifth radial distance may be equal to or greater than the fourth radial distance. The fifth radial distance may be in the range of 25 mm to 50 mm, for example about 30 mm.

[0048] The first electrode may form an open loop. The second electrode may form an open loop, and / or the third electrode may form an open loop. The fourth electrode may form an open loop. The fifth electrode may form an open loop. Open loop electrodes allow for electrode placement into few or one electrode layers.

[0049] The base plate may include a second adhesive layer, with the plurality of electrodes disposed between the first and second adhesive layers.

[0050] The electrode assembly may include a support layer, also referred to as a support membrane. One or more electrodes may be formed, e.g., printed, on a proximal side of the support layer. One or more electrodes may be formed, e.g., printed, on a distal side of the support layer. Thus, one or more electrodes may be disposed between the support layer and the first adhesive layer. The electrode assembly may have a stoma opening having a central point.

[0051] The support layer may include a polymeric material (e.g., polyurethane, PTFE, PVDF) and / or a ceramic material (e.g., alumina, silica). In one or more exemplary base plates, the support layer is made of thermoplastic polyurethane (TPU). The support layer material may be made of or include one or more of polyester, thermoplastic elastomer (TPE), polyamide, polyimide, ethylene vinyl acetate (EVA), polyurea, and silicone.

[0052] Exemplary thermoplastic elastomers for the support layer are styrene block copolymers (TPS, TPE-s), thermoplastic polyolefin elastomers (TPO, TPE-o), thermoplastic vulcanizates (TPV, TPE-v), thermoplastic polyurethanes (TPU), thermoplastic copolyesters (TPC, TPE-E) and thermoplastic polyamides (TPA, TPE-A).

[0053] The electrode assembly / base plate may include a masking element configured to insulate at least a portion of the electrode from the first adhesive layer of the base plate. The masking element may include two or more sensor point openings, such as one or more. The sensor point openings may include a primary sensor point opening and / or a secondary sensor point opening. The sensor point openings may include a tertiary sensor point opening. The sensor point openings may include a quaternary sensor point opening. The sensor point openings of the masking element overlap at least one of the electrodes of the electrode assembly when viewed in the axial direction, thereby forming, for example, a sensor point. For example, the primary sensor point opening may overlap a (sensing) portion of the ground electrode and / or a (sensing) portion of the fourth electrode. The secondary sensor point opening may overlap a (sensing) portion of the fourth electrode and / or a (sensing) portion of the fifth electrode. The tertiary sensor point opening may overlap a (sensing) portion of the fifth electrode and / or a (sensing) portion of the ground electrode.

[0054] The masking element may include two or more, such as one or more, terminal openings. The terminal openings may overlap one or more connections of the electrodes. In one or more exemplary base plates, each terminal opening overlaps one connection of the electrodes.

[0055] The masking element may include a polymeric material (e.g., polyurethane, PTFE, PVDF) and / or a ceramic material (e.g., alumina, silica). In one or more exemplary base plates, the masking element is made of or includes a thermoplastic polyurethane (TPU). In one or more exemplary base plates, the masking element is made of or includes a polyester. The masking element material may be made of or include one or more of polyester, thermoplastic elastomer (TPE), polyamide, polyimide, ethylene vinyl acetate (EVA), polyurea, and silicone.

[0056] Exemplary thermoplastic elastomers for the masking element are styrene block copolymers (TPS, TPE-s), thermoplastic polyolefin elastomers (TPO, TPE-o), thermoplastic vulcanizates (TPV, TPE-v), thermoplastic polyurethanes (TPU), thermoplastic copolyesters (TPC, TPE-E) and thermoplastic polyamides (TPA, TPE-A).

[0057] The base plate may include a first intermediate element. The first intermediate element may be disposed between the electrode / electrode layer and the first adhesive layer and / or between the second layer and the first adhesive layer. The first intermediate layer may be made of an insulating material.

[0058] The base plate may include a release liner, which is a protective layer that protects the adhesive layer during shipping and storage and is peeled off by the user before applying the base plate to the skin. The release liner may have a stoma opening with a center point.

[0059] The base plate may include a top layer. The top layer is a protective layer that protects the adhesive layer from external strain and stress when a user wears the ostomy appliance. The electrodes, e.g., some or all of the electrodes, may be disposed between the first adhesive layer and the top layer. The top layer may have a stoma opening with a center point. The top layer may have a thickness in the range of 0.01 mm to 1.0 mm, such as 0.04 mm, e.g., in the range of 0.02 mm to 0.2 mm. The top layer may have a stoma opening with a center point.

[0060] The base plate includes a monitor interface. The monitor interface may be configured to electrically and / or mechanically connect the ostomy appliance (base plate) to a monitoring device. The monitor interface may be configured to wirelessly connect the ostomy appliance (base plate) to the monitoring device. Thus, the monitor interface of the base plate is configured to electrically and / or mechanically couple the ostomy appliance and the monitoring device.

[0061] The monitor interface of the base plate may include a coupling portion that forms a mechanical connection, such as a releasable coupling, between the monitor device and the base plate, e.g., as part of the first connector of the monitor interface. The coupling portion may be configured to engage with a monitor device coupling portion that releasably couples the monitor device to the base plate.

[0062] The monitor interface of the base plate may include a plurality of terminals, e.g., 2, 3, 4, 5, 6, or more than 6 terminals, forming an electrical connection with each terminal of the monitor device as part of the first connector of the monitor interface. The monitor interface may include a ground terminal element forming a ground terminal. The monitor interface may include a first terminal element forming a first terminal, a second terminal element forming a second terminal, and optionally a third terminal element forming a third terminal. The monitor interface may include a fourth terminal element forming a fourth terminal and / or a fifth terminal element forming a fifth terminal. The monitor interface may optionally include a sixth terminal element forming a sixth terminal. The terminal elements of the monitor interface may contact each electrode (connection portion) of the base plate / electrode assembly. The first intermediate element may be disposed between the terminal element and the first adhesive layer. The first intermediate element may cover or overlap the terminal element of the base plate when viewed in the axial direction. Thus, the first adhesive layer may be protected from or experience more evenly distributed mechanical stress from the terminal elements of the base plate, thereby reducing the risk of the terminal elements penetrating or otherwise damaging the first adhesive layer. The first intermediate element may protect or mechanically and / or electrically shield the first adhesive layer from the terminal elements of the base plate.

[0063] The terminal elements, such as the ground terminal element, the first terminal element, the second terminal element, the third terminal element, the fourth terminal element, the fifth terminal element, and / or the sixth terminal element, may include a distal end and a proximal end. The terminal elements, such as the ground terminal element, the first terminal element, the second terminal element, the third terminal element, the fourth terminal element, the fifth terminal element, and / or the sixth terminal element, may include a distal portion, a central portion, and / or a proximal portion. The distal portion may be between the distal end and the central portion. The proximal portion may be between the proximal end and the central portion. The proximal end / proximal portion of the terminal element may contact the connection portion of the electrode. The terminal elements, such as the ground terminal element, the first terminal element, the second terminal element, the third terminal element, the fourth terminal element, the fifth terminal element, and / or the sixth terminal element, may be gold plated copper.

[0064] The base plate may include a connection ring or other connecting member that connects the ostomy pouch to the base plate (two-piece ostomy appliance). The center point may be defined as the center of the connection ring.

[0065] The base plate has a stoma opening with a center point. The size and / or shape of the stoma opening is typically adjusted by the user or a nurse to fit the user's stoma prior to application of the ostomy appliance. In one or more exemplary base plates, the user forms the stoma opening while preparing the base plate for application.

[0066] The monitoring device includes a processor that controls the operation of the monitoring device, including collecting and processing ostomy data from the base plate of the ostomy appliance, processing, e.g., storing, sensor data from the sensor unit, and generating / transmitting monitor data to an attached device.

[0067] The monitoring device includes a memory for storing the ostomy data and / or parameter data based on the ostomy data. The processor may be configured to process and store the sensor data in the memory.

[0068] The monitor device includes a monitor device housing, optionally made of a plastic material. The monitor device housing may be an elongated housing having a first end and a second end. The monitor device housing may have a length, i.e., a maximum extent along a longitudinal axis, in the range of 1 cm to 10 cm. The monitor device housing may have a width, i.e., a maximum extent perpendicular to the longitudinal axis, in the range of 0.5 cm to 5 cm, e.g., 0.8 cm to 3 cm. The monitor device housing may be curved.

[0069] The monitoring device housing may have multiple sensor openings, e.g., multiple sensor openings for the sensors and / or a sensor opening for each of multiple sensors. The monitoring device may include one or more sensor openings on a distal face of the monitoring device. The monitoring device may include one or more sensor openings on a side face of the monitoring device. The monitoring device may include one or more sensor openings on an end face of the monitoring device.

[0070] The sensor opening of the proximal surface is disposed at a sensor opening distance from the first end. The sensor opening distance, also denoted as D_S, can be in the range of 0.25L to 0.75L, for example, 0.35L to 0.65L, where L is the length of the monitoring device housing. The sensor opening distance can be in the range of 10mm to 70mm.

[0071] The monitoring device housing includes or forms a sensor pathway from the periphery of the proximal surface to the first sensor surface. The sensor pathway communicates temperature and / or humidity of the proximal surface of the monitoring device / monitoring device housing to the first sensor surface. The sensor opening forms part of the sensor pathway and is optionally within 0.2 mm. 2 ~10mm 2 The sensor opening may be a circular sensor opening with a diameter in the range of 0.3 mm to 1.4 mm, for example 0.6 mm to 1.0 mm.

[0072] The monitor device includes a sensor unit having one or more sensors, including a first sensor. The sensor unit is connected to the processor to provide sensor data to the processor. The sensor unit may include a humidity sensor that provides humidity data to the processor. Thus, the sensor data may include humidity data. For example, the first sensor may be a humidity sensor that provides humidity data to the processor. Thus, the present disclosure allows humidity detection near the user's skin and / or distal to the base plate, and thus can be used for more accurate inference of the operating state of the base plate.

[0073] The sensor unit may include a temperature sensor that provides temperature data to the processor. Thus, the sensor data may include temperature data. For example, the first sensor may be a temperature sensor that provides temperature data to the processor. Thus, the present disclosure allows for temperature detection near the user's skin and / or distal to the base plate, which itself can be used for more accurate inference of the operating state of the base plate.

[0074] The first sensor may be a combined humidity and temperature sensor that provides humidity and temperature data to the processor.

[0075] The sensor unit of the monitoring device may include a second sensor, such as an accelerometer, that provides acceleration data to the processor. The sensor unit of the monitoring device may include a third sensor, such as a gyroscope, that provides gyroscope data to the processor. The sensor unit of the monitoring device may include a fourth sensor, such as a magnetometer, that provides magnetometer data to the processor.

[0076] The processor is configured to process the ostomy data obtained from the base plate and generate or identify monitor data to be transmitted to the attached device. The monitor data may include sensor data obtained from the sensor unit.

[0077] The monitor device includes a first interface that connects the monitor device to the base plate. The first interface can be disposed on a proximal surface of the monitor device housing. The first interface can be disposed a first interface distance from the first end. The first interface distance can be less than 0.50L, for example less than 0.4L, where L is a length of the monitor device housing.

[0078] The monitoring device may include a sealing element that forms a seal between the first sensor and the housing portion of the monitoring device housing. The sealing element may be, for example, an O-ring made of a rubber material. The sealing element may surround the first sensor surface to expose the first sensor surface (membrane) to the sensor path while providing a closed cavity of the monitoring device, which houses the PCB, processor, and other electrical circuitry. Glue may form the sealing element.

[0079] The ostomy system allows for reliable and accurate measurement of various parameters related to monitoring of the ostomy appliance. In the ostomy system, the distance between the proximal surface of the monitoring device and the distal surface of the base plate is in the range of 0.2 mm to 10 mm, for example in the range of 0.5 mm to 5 mm, in the coupled state. In the coupled state, the monitoring device is attached to the base plate and placed in its intended position during use of the ostomy system.

[0080] The monitor device includes a first interface connected to the processor. The first interface may be configured as an appliance interface that electrically and / or mechanically connects the monitor device to the ostomy appliance. Thus, the appliance interface is configured to electrically and / or mechanically couple the monitor device and the ostomy appliance. The first interface may be configured as an accessory device interface that electrically and / or mechanically connects the monitor device to an accessory device, such as a docking station. The first interface may be configured to be coupled to a docking station of an ostomy system, for example, for charging the monitor device and / or for data transmission between the monitor device and the docking station.

[0081] The first interface of the monitoring device may include multiple terminals, such as 2, 3, 4, 5, 6, or more than 6 terminals, that form an electrical connection with the terminals and / or electrodes of the ostomy appliance. One or more terminals of the first interface may be configured to form an electrical connection with the terminals of an accessory device, such as a docking station. The first interface may include a ground terminal. The first interface may include a first terminal, a second terminal, and optionally a third terminal. The first interface may include a fourth terminal and / or a fifth terminal. The first interface optionally includes a sixth terminal. In one or more exemplary monitoring devices, the first interface has M terminals, where M is an integer in the range of 4 to 8.

[0082] The first interface of the monitoring device may include a coupling portion that forms a mechanical connection, e.g., a releasable coupling, between the monitoring device and the base plate, the coupling portion and the terminal of the first interface forming (at least a part of) the first connector of the monitoring device.

[0083] The monitoring device includes a power unit for powering the monitoring device. The power unit may include a battery. The power unit may include a charging circuit connected to the battery and to terminals of the first interface for charging the battery via the first interface, e.g., the first connector. The first interface may include separate charging terminals for charging the battery.

[0084] The monitoring device includes a second interface connected to the processor. The second interface may be configured as an accessory interface for connecting, e.g., wirelessly, the monitoring device to one or more accessory devices. The second interface may include, for example, an antenna and a wireless transceiver configured for wireless communication at a frequency in the range of 2.4 GHz to 2.5 GHz. The wireless transceiver may be a Bluetooth transceiver, i.e., the wireless transceiver may be configured for wireless communication according to a Bluetooth protocol, e.g., Bluetooth Low Energy, Bluetooth 4.0, Bluetooth 5. The second interface optionally includes a loudspeaker and / or a haptic feedback element for providing audio signals and / or haptic feedback to the user, respectively. The processor may be configured to transmit the monitoring data as a wireless monitoring signal via the antenna and the wireless transceiver.

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

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

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

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

[0089] The present disclosure provides a method of monitoring an ostomy system performed by an accessory device (i.e., an accessory device of an ostomy system disclosed herein). The accessory device includes an interface configured to communicate with one or more devices of the ostomy system, the interface including a display. The accessory device is configured to communicate with an ostomy system disclosed herein. The ostomy system includes a monitor device and / or an ostomy appliance configured to be placed on a skin surface of a user. The ostomy appliance includes a base plate.

[0090] The method includes: acquiring monitor data from one or more devices; acquiring contextual data; determining one or more future operating states of the ostomy appliance based on the monitor data and the contextual data, where a future operating state is indicative of a future adhesion performance of the ostomy appliance; and communicating the one or more future operating states.

[0091] The method includes obtaining the monitor data from one or more devices, e.g., from a monitoring device, e.g., from an ostomy appliance (e.g., from a base plate), e.g., from a server device in a network. The method may include obtaining the monitor data from a memory of an attached device. Obtaining the monitor data from the monitoring device may include retrieving and / or receiving the monitor data from the monitoring device.

[0092] The ostomy appliance includes a base plate, such as a base plate disclosed herein. The ostomy appliance includes an ostomy pouch. The base plate includes a first adhesive layer having a proximal side. In use, the proximal surface of the first adhesive layer adheres to the user's skin in the peristomal area and / or an additional seal, such as a sealing paste, sealing tape, and / or a sealing ring. The base plate may include one or more electrodes configured to measure an electrical characteristic of the first adhesive layer. The electrical characteristic may be indicative of a conductive path of the first adhesive layer, thereby indicative of a moisture level and may be indicative of a status of the ostomy appliance.

[0093] The method may include obtaining monitor data from one or more devices, obtaining contextual data, determining one or more future operational states of the ostomy appliance (e.g., of a base plate) based on the monitor data and the contextual data, where a future operational state is indicative of a future adhesion performance of the ostomy appliance (e.g., of a base plate), and communicating the one or more future operational states.

[0094] The monitor data may indicate a status of the ostomy appliance, for example, a status of a base plate as disclosed herein. The status of the ostomy appliance or of the base plate as disclosed herein may refer to a level of a physical property of at least a portion of the ostomy appliance, for example, a moisture and / or temperature level of at least a portion of the base plate, for example, a level of a physical property of at least one layer of the base plate, for example, a moisture and / or temperature level of at least one layer of the base plate, for example, a level of a physical property of at least one adhesive layer of the base plate (e.g., a first adhesive layer proximal to the user's skin). In one or more exemplary accessory devices, the interface is configured to obtain the monitor data by obtaining monitor data indicative of a condition including a moisture level of the first adhesive layer of the base plate and / or a moisture level proximal to the first adhesive layer. The moisture level may be viewed as representing a conductive path in, for example, through, the first adhesive layer. The monitor data may include data representing a measurement of an electrical property of, for example, the first adhesive layer. In other words, the status may be viewed as a status of the first adhesive layer.

[0095] The monitor data may include ostomy data and / or parameter data. The monitor device is configured to process the ostomy data and / or parameter data based on the ostomy data to identify monitor data to be transmitted to the ancillary device. The ostomy data and / or parameter data may be indicative of resistance between electrodes of the base plate, capacitance and / or inductance between the electrodes, and / or changes in any of the above. For example, the ostomy data and / or parameter data may be indicative of changes in resistance, capacitance, inductance between the electrodes. For example, the ostomy data and / or parameter data may include timing information, such as time-stamped data or information from which timing is derived.

[0096] The method includes obtaining (e.g., receiving, retrieving, deriving) the context data from a memory of the auxiliary device, e.g., from one or more user applications installed on the auxiliary device. The auxiliary device may be configured to have one or more user applications installed thereon, the one or more user applications including a first application (e.g., an ostomy user application) and a second application (e.g., a third party application, e.g., an application other than the ostomy user application). Obtaining the context data may include obtaining the context data from a second application different from the first application. For example, the second application includes a calendar application, a weather application, an analytics application, a health application, a sports application, an activity tracker application, a social media application, a photo application, a camera, and / or a medical application. The second application may include an input application (configured to accept user input related to the context data). The second application may be integrated / connected to an application server configured to provide relevant context data to the auxiliary device, e.g., upon request from the auxiliary device.

[0097] In one or more exemplary methods, the context data includes application data, for example from the second application. The context data may refer to data indicative of a context in which the ostomy appliance may operate, such as data characterizing a context or environment that adversely affects the operation of the ostomy appliance and of the baseplate. For example, the context data may be referred to as contextual data.

[0098] The method includes determining one or more future operating states of the ostomy appliance based on the monitor data and the context data. The future operating state is indicative of a future adhesive performance of the ostomy appliance. The future operating state may include at least one of a wear time, an adhesive quality, and a moisture pattern representation. The wear time may include an average wear time, a nominal wear time, a minimum wear time, a maximum wear time, a median wear time, and / or any other statistical metric derivable from the wear time. The wear time may include a wear time and / or a current wear time and / or an elapsed wear time. The adhesive quality may include a metric indicative of erosion of a layer of the base plate (e.g., of the first adhesive layer), such as a moisture pattern representation.

[0099] The operational state of the present disclosure indicates a dynamic internal state of the base plate of the ostomy appliance (e.g., of the base plate currently being worn by the user) with respect to the adhesive performance of the base plate. The adhesive performance of the ostomy appliance may relate to the internal conditions of the ostomy appliance (e.g., of the base plate of the ostomy appliance), such as the internal conditions of the adhesive layer of the base plate. The adhesive performance, and thereby the operational state, may be affected by several factors, such as humidity, temperature, misalignment of the ostomy appliance on the stoma, and / or malfunction of the ostomy appliance. The adhesive performance, and thereby the operational state, may relate to misalignment of the base plate on the stoma. One or more factors may affect the adhesive performance of the base plate alone or together. The operational state may change over time. The operational state may indicate the degree of erosion of the base plate (e.g., radial erosion and / or transverse erosion), such as the degree of erosion of a layer of the base plate, such as the degree of erosion of the first adhesive layer. The operational state may indicate the presence of liquid on the proximal surface of the first adhesive layer.

[0100] Many of the factors can be captured by the contextual data obtained by the attached device. Therefore, utilizing the contextual data and correlating it with the monitor data is likely to lead to improvements in the determination of future operating conditions (e.g., improved accuracy and timeliness of the determined future operating conditions) and therefore improved longevity of the Ostomy device (because the Ostomy device, given a more accurate future operating condition, can plan and prevent any undesirable situations due to, for example, leakage of the ostomy appliance).

[0101] Adhesive performance may indicate wear characteristics, such as wear time and / or wear comfort.

[0102] In one or more exemplary accessory devices, the operating status is configured to indicate whether the base plate is operating properly based on its adhesive performance (e.g., wear characteristics, such as wear time and / or wear comfort).

[0103] For example, the operational state may indicate the severity and / or urgency of the leak (e.g., low, medium, urgent). The operational state may include Z operational states, where Z is an integer. The operational state may include a first operational state, a second operational state, and / or a third operational state (e.g., good, check, replace within X hours / soon).

[0104] The current operating state indicates the current adhesive performance of the ostomy appliance (e.g., of the base plate). The current operating state may be viewed as the operating state at the time of the determination. The current operating state may be viewed as the operating state at the time of the determination at a time indicated in the monitor data (e.g., a recent time indicated in the monitor data, e.g., a recent period up to the recent time).

[0105] Determining a future operational state of the ostomy appliance based on the monitor data and the context data includes determining a future operational state of a future base plate of the ostomy appliance based on the monitor data and the context data. The future operational state is indicative of a future adhesion performance of the base plate of the ostomy appliance. The future adhesion performance may be viewed as a prophetic adhesion state, i.e., a predicted adhesion performance of the base plate in the future (e.g., a predicted adhesion performance of the ostomy appliance). The future operational state may be viewed as an operational state predicted to be reached after a current operational state. In other words, the future operational state may be viewed as an operational state provided in advance.

[0106] The contextual data may be quantified in one or more context parameters, which may be associated with one or more adjustment factors. The attached device may maintain a local or remote database (or look-up table) that associates the contextual parameters with corresponding adjustment factors. Determining a future operating state of the base plate of the ostomy appliance based on the monitored data and the contextual data may include determining a future operating state of the base plate of the ostomy appliance based on the monitored data and the one or more contextual parameters (e.g., with one or more adjustment factors).

[0107] In an illustrative example where the technology of the present application is applied, initially, the operational state of the baseplate may indicate a default or normal operational state of the baseplate, the default operational state indicating very low or no degree of radial erosion of the baseplate and / or no leakage. After extended use of the ostomy appliance, the accessory device may determine the operational state of the ostomy appliance, which may indicate the degree of radial erosion of the baseplate, for example of the first adhesive layer, and / or an imminent risk of leakage of the ostomy appliance.

[0108] The method may include determining a current operating state of the ostomy appliance based on the monitor data and / or the context data, the current operating state being indicative of a current adhesive performance of the baseplate, the current operating state including at least one of a wear time, an adhesive quality, and a moisture pattern representation.

[0109] Determining one or more future operational states of the ostomy appliance based on the monitor data and the contextual data may include determining the future operational states based on the current operational state and the contextual data.

[0110] The method includes communicating the one or more future operating states, e.g., to a user, e.g., via an interface, configured to communicate (e.g., output, display, or transmit) the one or more future operating states, e.g., to the user and / or one or more devices of the ostomy system and / or to one or more accessory devices of the user coupled with the disclosed accessory device.

[0111] Communicating the future operational state may include communicating the future operational state of a first application, the first application being an ostomy user application installed on the accessory device.

[0112] The interface may be configured to communicate (e.g., output, display, or transmit) a combination of current and future operating states, for example, to a user and / or one or more devices of the ostomy system and / or to one or more accessory devices of the user coupled with the disclosed accessory devices.

[0113] It is an advantage of the present disclosure that an ostomy appliance user or a healthcare professional is provided with an improved tool for monitoring and planning the use of the ostomy appliance in daily life, a tool that utilizes the contextual data obtainable by the accessory device. The disclosed accessory device can foresee and predict leakage risk by determining one or more operating conditions based on the monitored data and the contextual data. Thus, communication of one or more future operating conditions of the ostomy appliance helps to reduce the risk of the user experiencing leakage from the ostomy appliance (e.g., leakage of fecal material from the ostomy appliance) during the planned activity. Reducing the leakage risk in turn helps to reduce the risk of skin damage to the user (to support the avoidance of leakage due to, for example, adhesion erosion, malfunction, and misplacement of the ostomy appliance on the stoma). In particular, in accordance with the present disclosure, the determination and communication of one or more future operating states is based on monitor data indicative of the status of the ostomy appliance, which may not be visible to the user (because it is beneath or within the base plate of the ostomy appliance), supplemented with contextual data obtainable by an accessory device.

[0114] Additionally, the present disclosure is found to provide a clear distinction or differentiation between the following current and future events: adhesion failure, leakage (including partial leakage) of fecal material that is harmful to the skin, and ostomate sweating.

[0115] The present disclosure improves the accuracy of monitoring and predicting the performance of an ostomy appliance with improved comfort for the user. The present disclosure allows for more accurate derivation of future operating states by taking into account contextual data that is seen to affect the operating state. In other words, the disclosed method allows for the dynamic internal state of the ostomy appliance to be predicted and presented to the user, which helps the user coordinate the use of the ostomy appliance with the planning of daily life activities.

[0116] Obtaining the context data may include displaying a user interface field in a first application user interface of the first application, the user interface field configured to accept discourse input, detecting a first user input into the user interface field, and determining the context data based on the detected first user input. The discourse input may include text input and / or voice input. The discourse input may include the context data and may indicate, for example, an activity, food intake, diet, medication, etc.

[0117] Obtaining the context data may include obtaining calendar data from a calendar application installed on the accessory device. The calendar data includes dates, times, and calendar events, including event dates, event start times, event end times, event reoccurrences, event locations, and event participants. The method may include deriving one or more regular events not derived from the calendar application, such as commuting, climbing stairs, walking a dog, and including the derived one or more regular events in the context data. For example, depending on a current operating state of the ostomy appliance, the accessory device may identify one or more future operating states based on a calendar event that is a sports activity. If the operating state of the base plate indicates a medium risk of leakage before the sports activity, the accessory device may determine the future operating state as a higher risk of leakage at any time during the sports activity, for example due to sweating and movements that affect the adhesive performance of the base plate, and may communicate the future operating state accordingly. In this manner, the user may be notified and replace the base plate before the sports activity. Obtaining the context data may include obtaining sensor data from one or more sensor modules of the attached device.

[0118] Obtaining the context data may include obtaining the context data including location data derived from connectivity data, for example derived from location sensor data. The location data may be obtained from a GPS sensor, an accelerometer, a gyroscope, a magnetometer, a cellular base station, a wireless access point, and / or a short-range connection. Obtaining the location data may include obtaining one or more future positions, for example using calendar data. The attached device may include one or more of a GPS sensor, an accelerometer, a gyroscope, a magnetometer, a cellular base station, a wireless access point, and / or a short-range connection. The attached device may include a calendar application.

[0119] Obtaining the context data may include obtaining environmental data (e.g., weather data, temperature data, humidity data, light data, and / or pressure data). The environmental data may be obtained via a barometer, a camera, a proximity sensor, and / or a temperature sensor. The attached device may include a barometer, a camera, a proximity sensor, and / or a temperature sensor.

[0120] For example, optionally considering a current operating state of the ostomy appliance, the attached device may determine one or more future operating states based on a calendar event, which is to board an airplane for three hours. The attached device may obtain environmental data regarding the status of the airplane. The attached device may correlate the calendar data, the environmental data, and optionally the location data indicating that the user is at an airport to determine the future operating state. The attached device may determine the future operating state based on the monitor data and the context data, i.e., the calendar data, the environmental data, and optionally the location data. The attached device may communicate the future operating state in a timely manner so that the replacement of the ostomy appliance is performed at a convenient location. In this way, the user may be notified and replace the base plate, for example, before boarding the airplane.

[0121] Obtaining the contextual data may include obtaining nutritional data (e.g., foods consumed by the user, e.g., indicating what the user ate, e.g., based on user input and / or based on a photo taken with a photo-enabled application). Food intake affects the nature, concentration, and flow of waste generated by the user's body, which in turn affects the operating state. For example, optionally considering the current operating state of the ostomy appliance, the attached device obtains nutritional data from a photo application that took a photo of the user's last meal. For accuracy, the attached device may correlate the nutritional data with calendar data indicating a particular type of restaurant (e.g., an Indian restaurant) and optionally location data indicating that the user is at a particular type of restaurant to determine a future operating state. The attached device may determine the future operating state based on the monitor data and the contextual data, i.e., the nutritional data optionally correlated with the calendar data and optionally the location data. The attached device may determine a more severe future operating state (e.g., more severe if medication is not taken into account) based on the nutritional data and communicate the future operating state in a timely manner so that the ostomy appliance can be replaced. In this way, the user is notified and can replace the base plate in good time to prevent any unexpected leakage due to food ingestion.

[0122] Acquiring the context data may include acquiring medication data (e.g., prescriptions, etc., indicative of medications taken by the user). The medication data may be acquired via a medical user application (e.g., a user application used to store prescriptions or to communicate with a medical team). Medication affects the nature, concentration, and flow of waste generated by the user's body, which in turn affects the operating state. For example, optionally considering the current operating state of the ostomy appliance, the attached device may acquire medication data, e.g., from a user input or a medical application. The attached device may determine a future operating state based on the monitor data and the context data, including the medication data. Based on the medication data, the attached device may determine a more severe future operating state (e.g., more severe than if medication was not taken into account) and communicate the future operating state in a timely manner so that the ostomy appliance can be replaced. In this way, the user may be notified and may replace the base plate at the right time to prevent any unexpected leakage due to medication.

[0123] Acquiring the context data may include acquiring health data. The health data may include age, sex, the user's medical condition, prescriptions, one or more illnesses, heart rate, the user's metabolic data, health status data. The health data may be acquired via a health user application, a heart rate sensor, an activity tracker, etc. The health data affects the nature, concentration, and flow of waste generated by the user's body, which in turn affects the operating condition. The attached device may determine a future operating condition based on the monitor data and the context data including the health data. The attached device may determine a more severe future operating condition based on the medication data and communicate the future operating condition in a timely manner so that the ostomy appliance can be replaced. In this way, the user may be notified and replace the base plate at the right time to prevent any unexpected leakage due to medication.

[0124] The user metabolic data may include a user metabolic parameter indicative of the user's general metabolism. The user health data may include a user health parameter indicative of the user's health, such as a current health, an average health, or a health profile over time. For example, the health parameter may include a first health and a second health. The user health I may indicate that the user is healthy, has a chronic condition, or has a temporary condition. For example, if the health parameter indicates inflammation, the processor may be configured to determine a future operating state that replacement is needed sooner than if the health parameter indicates a healthy state.

[0125] Obtaining the context data may include obtaining activity data. The activity data may include physical activity data (e.g., sports, locomotion, etc.), data from a sports application, data from an accelerometer. The activity data may indicate a user's activity level and may include user activity parameters. The user activity level may be characterized by user activity parameters indicative of the user's activity level, such as a current activity level, an average activity level, an activity level profile within a period and / or space. For example, the user activity parameters may include a first activity level, such as resting or sleeping, and a second activity level, such as running or walking. The user activity level may indicate whether the user is stationary, sitting, moving, exercising, exerting physical effort, resting, or sleeping. The user activity parameters may include an activity level identifier and / or an activity level percentage. For example, if the user activity level is high (e.g., the user is running), the processor may be configured to determine a future operating state that requires replacement sooner than if the user were less active. This is because the adhesion between the first adhesive layer and the user's skin surface deteriorates more quickly due to movement and possibly increased sweating when the user's activity level is high.

[0126] Obtaining the context data may include obtaining the context data over a period of time. The memory may be configured to store the received context data over the period of time. Determining the one or more future operating states may be based on the context data obtained over the period of time and / or the monitor data obtained over the period of time.

[0127] Communicating the one or more future operating states may include displaying, via the display, a first user interface object indicative of the one or more future operating states.

[0128] A user interface object, as used herein, refers to a graphical representation of an object that is displayed on the display of an attached device. A user interface object may be user interactive or selectable by user input. For example, images (e.g., icons), buttons, and text (e.g., hyperlinks) each optionally constitute a user interface object. A user interface object may form part of a widget. A widget can be viewed as a mini-application that can be used and created by a user. A user interface object may include a prompt and / or an application launch icon.

[0129] The first user interface object representing the future operating state may be part of a widget, for example a widget displayed within a widget user interface screen. The first user interface object representing the future operating state may be displayed at a reduced size within the widget.

[0130] A user interface screen, as used herein, refers to a graphical representation that includes a collection of user interface objects. A user interface screen contains one or more user interface objects.

[0131] Communicating one or more future operating states may include, for example, communicating a recommendation to replace the base plate within a particular time frame before reaching a predetermined future operating state indicating a leak, to check for supplies before a calendar event (e.g., a drive or activity) or when at a location, such as at home.

[0132] Communicating the future operating state may include displaying a notification indicating the one or more future operating states via a display, such as on a lock screen and / or a home screen of the accessory device.

[0133] The method may include displaying, via a display of the auxiliary device, a second user interface object that prompts a user to provide an indication as to whether the determined one or more future operating states are erroneous.

[0134] The method may include detecting a second user input selecting the first user interface object or the notification, and in response to detecting the second user input, opening the ostomy user application. If the display is a touch-sensitive display, the second user input may include touching the touch-sensitive display.

[0135] The method may include, in response to opening the ostomy user application, displaying, within the first application user interface, a third user interface object representing a current operational state of the ostomy appliance.

[0136] In response to detecting user input adding the context data, the method may include displaying a fourth user interface object representing the context data, where the fourth user interface object may include one or more context user interface objects indicating one or more of each of the calendar data, location data, environmental data, nutritional data, activity data, medication data, and / or health data.

[0137] The method may include, in response to opening the ostomy user application, displaying a calendar event user interface object within the first application user interface, eg, overlaid on the first user interface object.

[0138] The present disclosure provides an accessory device. The accessory device forms a part of an ostomy system. The accessory device includes a memory, an interface, and a processor operatively connected to the memory, and an interface configured to communicate with one or more devices of the ostomy system. The one or more devices include a monitor device coupled to the accessory device and the ostomy appliance and / or an ostomy appliance configured to be placed on a skin surface of a user, the ostomy appliance including a base plate.

[0139] The interface includes a display. The interface may include a transceiver. The interface is configured to obtain monitor data from one or more devices, for example from a monitor device.

[0140] The processor is configured to retrieve context data, eg, from the memory, eg, from one or more user applications installed on the auxiliary device.

[0141] The processor is configured to determine one or more future operational states of the ostomy appliance based on the monitor data and the context data, a future operational state being indicative of a future adhesion performance of the ostomy appliance.

[0142] The interface is configured to communicate one or more future operating states, for example to.

[0143] The interface includes a display, e.g., a touch-sensitive display. The interface of the accessory device is configured to communicate with one or more of a user, a monitor device, and / or a server device. The interface of the accessory device may be configured to communicate with the server device over a network.

[0144] The interface may include a monitor interface for connecting, e.g., wirelessly, the attached device to one or more monitor devices. The attached device interface may include an antenna and a wireless transceiver configured for wireless communication at a frequency in the range of, e.g., 2.4 GHz to 2.5 GHz. The wireless transceiver may be a Bluetooth transceiver, i.e., the wireless transceiver may be configured for wireless communication according to a Bluetooth protocol, e.g., Bluetooth Low Energy, Bluetooth 4.0, Bluetooth 5.

[0145] The auxiliary device is configured to receive monitor data from one or more monitoring devices. The auxiliary device may be configured to transmit the auxiliary data, for example to a server device. For example, a processor of the auxiliary device may be configured to transmit the auxiliary data as a wireless auxiliary signal via an antenna and a wireless transceiver.

[0146] The interface of the accessory device includes a display and is configured to acquire monitor data from a monitoring device coupled to the ostomy appliance. The monitor data may include sensor data acquired from one or more sensors in the monitoring device. The monitor data may include ostomy data acquired from electrodes of the base plate and / or parameter data based on the ostomy data acquired from the electrodes of the base plate.

[0147] The accessory device is configured to obtain the context data, for example, from one or more user applications installed on the accessory device and / or from a memory of the accessory device. The accessory device may be configured to have one or more user applications installed thereon, the one or more user applications including a first application (e.g., an ostomy user application) and a second application (e.g., a third party application, e.g., an application other than the ostomy user application). Obtaining the context data may include obtaining the context data from a second application different from the first application. For example, the second application includes a calendar application, a weather application, a health application, a sports application, an activity tracker application, a social media application, a photo application, a camera, and / or a medical application. The second application may include an input application (configured to accept user input related to the context data). The context data may include calendar data, location data, environmental data, nutrition data, health data, activity data, and / or medication data. The contextual data may be quantified in terms of one or more context parameters, which may be functions parameterized by one or more associated adjustment factors and, optionally, the adjustment factors. The attached device may maintain a local or remote database or look-up table that associates the contextual parameters with corresponding adjustment factors.

[0148] For example, the processor may be configured to determine one or more future operating states of the baseplate based on the monitor data and the context data by determining one or more current moisture pattern types based on the monitor data, and by generating one or more future operating states based on the one or more current moisture pattern types and the context data. Determining the one or more current moisture pattern types may be based on ostomy data and / or parameter data (e.g., the first parameter data and the second parameter data), e.g., measurements taken by the electrodes, e.g., resistance, capacitance, and / or inductance measurements, etc., e.g., timing information. For example, the processor may be configured to determine a future operating state of the ostomy appliance based on the monitor data and the context data by determining one or more future moisture pattern types based on the monitor data and the context data, where the monitor data includes ostomy data and / or parameter data (e.g., first parameter data and second parameter data), e.g., measurements obtained by electrodes, e.g., resistance, capacitance, and / or inductance measurements, e.g., timing information, and the context data includes calendar data, location data, environmental data, nutritional data, health data, activity data, and / or medication data. Determining the one or more future moisture pattern types based on the monitor data and the context data may include adjusting the one or more future moisture pattern types determined based on the monitor data based on one or more context parameters (e.g., one or more adjustment factors).

[0149] The moisture pattern type optionally indicates the adhesion condition (eg, poor) of the base plate and / or the risk of leakage of the ostomy appliance, and / or the risk of skin damage to a user of the ostomy system.

[0150] For example, the processor may be configured to determine a future operating condition of the base plate by determining one or more future moisture pattern types based on the parameter data (e.g., the first parameter data and the second parameter data (and optionally the third parameter data)). Determining the one or more future moisture pattern types may include selecting a moisture pattern type from a set of predefined moisture pattern types based on trends identified in the monitor data over a period of time and adjusting the selection based on the context data (e.g., based on one or more context parameters). The set of predefined moisture pattern types may include M moisture pattern types, e.g., at least three moisture pattern types, at least four moisture pattern types, at least five moisture pattern types. The number M of moisture pattern types may be in the range of 4 to 20. For example, determining the one or more future moisture pattern types may include selecting a selected function based on the context data (the function is parameterized with one or more context parameters, e.g., one or more adjustment factors) and identifying the future moisture pattern type by fitting the selected function to the parameter data. The processor may be configured to determine the future operating state based on one or more context parameters and the current operating state and, optionally, any operating state prior to determining the future operating state.

[0151] In one or more exemplary accessory devices, the first parameter data, the second parameter data, and the third parameter data may indicate resistance between the first electrode pair, the second electrode pair, and the third electrode pair, respectively. The first parameter data, the second parameter data, and the third parameter data may indicate voltage (and thus resistance) between the first electrode pair, the second electrode pair, and the third electrode pair, respectively. The first parameter data, the second parameter data, and the third parameter data may indicate current (and thus resistance) between the first electrode pair, the second electrode pair, and the third electrode pair, respectively.

[0152] The first, second, and third parameter data may indicate a rate of resistance change between the first, second, and third electrode pairs, respectively. In one or more exemplary monitoring devices, the first, second, and third parameter data may indicate a rate of voltage change between the first, second, and third electrode pairs, respectively. In one or more exemplary monitoring devices, the first, second, and third parameter data may indicate a rate of current change between the first, second, and third electrode pairs, respectively.

[0153] Determining the current and / or future operating state of the base plate may include determining the operating state (e.g., the current and / or future operating state) from a set of operating states. In other words, identifying the current and / or future operating state may include selecting an operating state from a set of predefined operating states based on the context data. The set of predefined operating states may include a plurality of operating states, e.g., at least two operating states, at least three operating states, at least four operating states, at least five operating states. The number of operating states may be in a range of 4 to 20. In one or more exemplary attached devices, the number of operating states in the set of predefined operating states is greater than 10, e.g., greater than 20, or even greater than 50.

[0154] In one or more exemplary auxiliary devices, the processor is configured to determine a future operating state of the base plate when a change criterion is met. The change criterion may be based on the context data and the monitor data (e.g., the first parameter data, the second parameter data, and / or the third parameter data). The change criterion may be met when the parameter data changes, for example, when the change in the parameter data is greater than a change threshold selected based on the context data. Thus, the determination of the current and / or future operating state may be conditional or dependent on the change in the parameter data conditioned by the context data, which in turn leads to optimal use of power or battery resources of the monitor device, since the determination of the current and / or future operating state may be made when a change in the operating state is likely as a result of the change in the parameter data.

[0155] In one or more exemplary accessory devices, determining the current and / or future operating state of the baseplate is based on a first set of criteria based on the context data and the parameter data (first parameter data and / or second parameter data), and the current and / or future operating state is determined to be the first operating state when the first set of criteria is satisfied. The first set of criteria may include one or more first criteria based on one or more of the first parameter data, the second parameter data, and the third parameter data. The first set of criteria may include a first primary criterion based on the first parameter data. The first set of criteria may include a first secondary criterion based on the second parameter data. The first set of criteria may include a first tertiary criterion based on the third parameter data.

[0156] It may be envisaged that the first criterion set may be selected based on the context data, e.g., based on one or more context parameters. It may be envisaged that the attached device may maintain a look-up table with one or more criterion sets associated with certain context data, e.g., one or more context parameters.

[0157] In one or more exemplary accessory devices, determining the current and / or future operating state of the base plate may be based on a first set of threshold values including one or more of a first threshold value. The first set of threshold values may include, for example, one or more of the threshold values to be applied to a first set of criteria. The first set of threshold values may include a first primary threshold value. The first set of threshold values may include a first secondary threshold value. The first set of threshold values may include a first tertiary threshold value.

[0158] The first set of criteria may be (P_1_1 < TH_1_1), (P_2_1 > TH_1_2), and (P_3_1 > TH_1_3) given by or at least may include, where P_1_1 is a first primary parameter based on first parameter data, TH_1_1 is a first primary threshold value, P_2_1 is a second primary parameter based on second parameter data, TH_1_2 is a first secondary threshold value, P_3_1 is a third primary parameter based on third parameter data, TH_1_3 is a first tertiary threshold value, and the first operating state indicates low radial leakage or radial expansion in the base plate. The first threshold values (TH_1_1, TH_1_2, and TH_1_3) may be the same or different, for example, depending on the electrode configuration of the base plate. The first tertiary criterion (P_3_1 < TH_1_3) may be omitted from the first set of criteria. For example, the first operating state indicating low radial erosion in the base plate may indicate, for example, radial progression of moisture to a first pair of electrodes corresponding to non-alarming and / or normal radial progression of moisture (but not to a second pair of electrodes and a third pair of electrodes).

[0159] In one or more exemplary embodiments, when the first parameter data, the second parameter data, and the third parameter data indicate resistance between the first electrode pair, the second electrode pair, and the third electrode pair, respectively, the first thresholds (TH_1_1, TH_1_2, and TH_1_3) may correspond to a first resistance threshold. In one or more exemplary embodiments, the first primary threshold TH_1_1 may correspond to an upper resistance threshold. The upper resistance threshold may be set to a value less than 30 megaohms, such as 25 megaohms, 20.5 megaohms, 20.4 megaohms, etc. In one or more exemplary embodiments, the first secondary threshold TH_1_2 may correspond to an upper resistance threshold. In one or more exemplary embodiments, the first tertiary threshold TH_1_3 may correspond to an upper resistance threshold.

[0160] The first primary parameter P_1_1 may be indicative of a resistance between a first electrode pair (first electrode portion of the first electrode and ground electrode) of the base plate. The first parameter data may include a first secondary parameter that may be derived from the first primary parameter and / or a first tertiary parameter that may be derived from the first primary parameter. The first secondary parameter P_1_2 may include or be a slope derived from the first primary parameter. In one or more embodiments, the first primary parameter P_1_1 may be indicative of a voltage between a first electrode pair (first electrode portion of the first electrode and ground electrode) of the base plate.

[0161] In one or more exemplary embodiments, when the first parameter data, the second parameter data, and the third parameter data indicate voltages between the first electrode pair, the second electrode pair, and the third electrode pair, respectively, the first thresholds (TH_1_1, TH_1_2, and TH_1_3) may correspond to a first voltage threshold. In one or more exemplary embodiments, the first primary threshold TH_1_1 may correspond to an upper voltage threshold. The upper voltage threshold may be set to a value less than 5 volts, such as 3 volts, 2.86 volts, etc. In one or more exemplary embodiments, the first secondary threshold TH_1_2 may correspond to an upper voltage threshold. In one or more exemplary embodiments, the first tertiary threshold TH_1_3 may correspond to an upper voltage threshold.

[0162] The first set of criteria may be, for example: (P_4_1>TH_1_4) where P_4_1 is a fourth primary parameter based on the fourth parameter data and indicates a resistance, voltage, or current between the fourth electrode pair, and TH_1_4 is a first quaternary threshold, and the first operating state indicates an absence of fluid proximal to the first adhesive layer of the base plate of the ostomy appliance. In one or more exemplary embodiments, the first quaternary threshold TH_1_4 may correspond to an upper resistance threshold. The upper resistance threshold may be set to a value less than 30 megaohms, such as 25 megaohms, 20.5 megaohms, 20.4 megaohms, etc.

[0163] In one or more exemplary embodiments, the following additional criteria may be determined: (P_1_1 <TH_low) where P_1_1 is a first primary parameter based on the first parameter data, and TH_low is a threshold value corresponding to the rheostat threshold. In one or more exemplary embodiments, the lower resistance threshold may be set to a value less than 1 megohm, such as 100 kOhms, 80 kOhms, 79 kOhms, etc. This indicates saturation of the first electrode pair due to the detected moisture, with no further change expected by the first primary parameter. The moisture will likely continue to progress.

[0164] In one or more exemplary embodiments, the following additional criteria may be determined: (P_2_1 <TH_low) where P_2_1 is a second primary parameter based on the second parameter data. TH_low is a threshold value corresponding to a lower resistance threshold. In one or more exemplary embodiments, the lower resistance threshold may be set to a value less than 1 megohm, such as 100 kOhms, 80 kOhms, 79 kOhms, etc. This indicates saturation of the second electrode pair due to the detected moisture, with no further change expected by the second primary parameter. The moisture will likely continue to progress.

[0165] In one or more exemplary embodiments, the following additional criteria may be determined: (P_3_1>TH_low) where P_3_1 is a third primary parameter based on the third parameter data. TH_low is a threshold value corresponding to a lower resistance threshold. In one or more exemplary embodiments, the lower resistance threshold may be set to a value less than 1 megohm, such as 100 kOhms, 80 kOhms, 79 kOhms, etc. This indicates saturation of the third electrode pair due to the detected moisture, with no further change expected by the third primary parameter. The moisture will likely continue to progress.

[0166] In one or more exemplary embodiments, one or more criteria of the criteria set, e.g., one or more first criteria of the first criteria set and / or one or more second criteria of the second criteria set, may be based on timing information and / or one or more delay parameters based on the parameter data. In one or more exemplary embodiments, one or more delay parameters or time differences associated with different parameter data, e.g., associated with the first parameter data and the second parameter data, are identified.

[0167] In one or more exemplary embodiments, the one or more first criteria of the first criteria set may be based on timing information (e.g., one or more delay parameters of the parameter data and / or one or more times at which the parameters cross a threshold).

[0168] In one or more exemplary embodiments, the timing information may include a time difference D_1_2_1 between a time T1 when P_1_1 crosses a threshold, such as TH_1_1, and a time T2 when P_2_1 crosses a threshold, such as TH_1_2. Thus, a delay parameter or time difference D_1_2_1 may be given as D_1_2_1=T2-T1.

[0169] In one or more exemplary embodiments, for example, the timing information used in the first set of criteria may include a time difference D_2_3_1 between a time T2 when P_2_1 crosses a threshold, such as TH_1_2, and a time T3 when P_3_1 crosses a threshold, such as TH_1_3. Thus, the delay parameter or time difference D_2_3_1 may be given as D_2_3_1=T3-T2.

[0170] In one or more exemplary embodiments, one or more criteria sets, such as the third criteria set and / or the second criteria set, include: D_1_2_1>Z D_2_3_1>Z where Z is a time lag constant that characterizes the moisture progression (e.g., 3 hours, e.g., 2 hours). Different time lag constants may be utilized for different criteria sets / different time delays.

[0171] In one or more exemplary embodiments, one or more criteria sets, such as the second criteria set and / or the third criteria set, include: D_1_2_1>Z where Z is a time lag constant that characterizes the moisture progression (e.g., 3 hours, e.g., 2 hours).

[0172] The second primary parameter may be indicative of a resistance between a second electrode pair (the second electrode portion of the second electrode and the ground electrode) of the base plate. The second parameter data may include a second secondary parameter and / or a second tertiary parameter derived from the second primary parameter. The second secondary parameter may be indicative of a voltage between the second electrode pair (the second electrode portion of the second electrode and the ground electrode) of the base plate.

[0173] The third primary parameter may be indicative of a resistance between a third electrode pair (the third electrode and the third electrode portion of the ground electrode) of the base plate. The third parameter data may include a third secondary parameter and / or a third tertiary parameter that may be derived from the third primary parameter. The third secondary parameter may be indicative of a voltage between a second electrode pair (the second electrode and the second electrode portion of the ground electrode) of the base plate.

[0174] In one or more exemplary accessory devices, identifying the current and / or future operating state of the base plate is based on a second set of criteria based on context data and parameter data (e.g., second parameter data and / or third parameter data), and the current and / or future operating state is determined to be a second operating state when the second set of criteria is met. The second set of criteria may be based on first parameter data.

[0175] The second set of criteria may include one or more second criteria based on context data and parameter data (e.g., one or more of the first parameter data, the second parameter data, and the third parameter data). The second set of criteria may include a second primary criterion based on the first parameter data and a portion of the context data. The second set of criteria may include a second secondary criterion based on the second parameter data and a portion of the context data. The second set of criteria may include a second tertiary criterion based on the third parameter data and a portion of the context data.

[0176] In one or more exemplary accessory devices, determining the current and / or future operating state of the base plate is based on a second set of thresholds including one or more of the second thresholds. The second set of thresholds may include, for example, one or more of the thresholds to be applied to the second set of criteria. The second set of thresholds may include a second primary threshold. The second set of thresholds may include a second secondary threshold. The second set of thresholds may include a second tertiary threshold.

[0177] The second set of criteria is (P_1_1 < TH_2_1), (P_2_1 < TH_2_2), and (P_3_1 > TH_2_3) be given by or at least include, where P_1_1 is a first primary parameter based on first parameter data, indicating the resistance between a first pair of electrodes, TH_2_1 is a second primary threshold, P_2_1 is a second primary parameter based on second parameter data, indicating the resistance between a second pair of electrodes, TH_2_2 is a second secondary threshold, P_3_1 is a third primary parameter based on third parameter data, indicating the resistance between a third pair of electrodes, TH_2_3 is a second tertiary threshold, and the second operating state indicates moderate radial leakage or radial expansion at the base plate. The second thresholds (TH_2_1, TH_2_2, and TH_2_3) can be the same or different, for example, depending on the electrode configuration of the base plate. The second primary criterion (P_1_1 < TH_2_1) and / or the second tertiary criterion (P_3_1 > TH_2_3) can be omitted from the second set of criteria. The second operating state indicating moderate radial erosion at the base plate can indicate the radial progression of moisture to the first and second pairs of electrodes (not to the third pair of electrodes). The second operating state indicating moderate radial erosion at the base plate can indicate the radial progression of moisture to the first and second pairs of electrodes.

[0178] In one or more exemplary embodiments, when the first parameter data, the second parameter data, and the third parameter data indicate resistance between the first electrode pair, the second electrode pair, and the third electrode pair, respectively, the second thresholds (TH_2_1, TH_2_2, and TH_2_3) may correspond to a second resistance threshold. In one or more exemplary embodiments, the second primary threshold TH_2_1 may correspond to an upper resistance threshold. The upper resistance threshold may be set to a value less than 30 megaohms, such as 25 megaohms, 20.5 megaohms, 20.4 megaohms, etc. In one or more exemplary embodiments, the second secondary threshold TH_2_2 may correspond to an upper resistance threshold. In one or more exemplary embodiments, the second tertiary threshold TH_2_3 may correspond to an upper resistance threshold. In one or more exemplary embodiments, the second primary threshold TH_2_1 may correspond to a medium resistance threshold. The medium resistance threshold may be set to a value less than 10 megaohms, such as 5 megaohms, 3 megaohms, 2 megaohms, 1 megaohm, etc.

[0179] In one or more exemplary embodiments, when the first parameter data, the second parameter data, and the third parameter data indicate voltages between the first electrode pair, the second electrode pair, and the third electrode pair, respectively, the second thresholds (TH_2_1, TH_2_2, and TH_2_3) may correspond to a second voltage threshold. In one or more exemplary embodiments, the second primary threshold TH_2_1 may correspond to an upper voltage threshold. The upper voltage threshold may be set to a value less than 5 volts, such as 3 volts, 2.86 volts, etc. In one or more exemplary embodiments, the second secondary threshold TH_2_2 may correspond to an upper voltage threshold. In one or more exemplary embodiments, the second tertiary threshold TH_2_3 may correspond to an upper voltage threshold. In one or more exemplary embodiments, the second primary threshold TH_2_1 may correspond to a medium resistance threshold. The medium voltage threshold may be set to a value less than 10 megaohms, such as 5 megaohms, 3 megaohms, 2 megaohms, 1 megaohm, etc.

[0180] In one or more exemplary embodiments, the second set of criteria is: D_1_2_1>Z where Z is a time lag constant (e.g., 3 hours, e.g., 2 hours) that characterizes the progression of moisture.

[0181] In one or more exemplary accessory devices, determining the current and / or future operating state of the base plate is based on a default criterion set based on the first parameter data, and if the default criterion set is satisfied, the current and / or future operating state is determined to be the default operating state, and in accordance with determining that the current and / or future operating state is the default operating state, a default monitor signal is transmitted including monitor data indicative of a default operating state of the ostomy appliance.

[0182] The default criteria set is (P_1_1>TH_D_1), (P_2_1>TH_D_2), and (P_3_1>TH_D_3) where P_1_1 is a first primary parameter based on the first parameter data and indicative of a resistance between the first electrode pair, TH_D_1 is a default primary threshold, P_2_1 is a second primary parameter based on the second parameter data and indicative of a resistance between the second electrode pair, TH_D_2 is a default secondary threshold, P_3_1 is a third primary parameter based on the third parameter data and indicative of a resistance between the third electrode pair, and TH_D_3 is a default tertiary threshold, and the default operating condition is indicative of no or very low radial leakage or radial expansion at the base plate. The default thresholds (TH_D_1, TH_D_2, and TH_D_3) may be the same or different depending on, for example, the electrode configuration of the base plate. In one or more exemplary embodiments, when the first parameter data, the second parameter data, and the third parameter data indicate resistance between the first electrode pair, the second electrode pair, and the third electrode pair, respectively, the default thresholds (TH_D_1, TH_D_2, and TH_D_3) may correspond to a default resistance threshold. In one or more exemplary embodiments, the second primary threshold TH_D_1 may correspond to an upper resistance threshold. The upper resistance threshold may be set to a value less than 30 megaohms, such as 25 megaohms, 20.5 megaohms, 20.4 megaohms, etc. In one or more exemplary embodiments, the default secondary threshold TH_D_2 may correspond to an upper resistance threshold. In one or more exemplary embodiments, the default tertiary threshold TH_D_3 may correspond to an upper resistance threshold.

[0183] In one or more exemplary embodiments, when the first parameter data, the second parameter data, and the third parameter data respectively indicate voltages between a first pair of electrodes, between a second pair of electrodes, and between a third pair of electrodes, the default thresholds (TH_D_1, TH_D_2, and TH_D_3) may correspond to default voltage thresholds. In one or more exemplary embodiments, the default primary threshold TH_D_1 may correspond to an upper voltage threshold. The upper voltage threshold may be set to a value less than 5 volts, such as 3 volts, 2.86 volts, etc. In one or more exemplary embodiments, the default secondary threshold TH_D_2 may correspond to the upper voltage threshold. In one or more exemplary embodiments, the default tertiary threshold TH_D_3 may correspond to the upper voltage threshold.

[0184] In one or more exemplary accessory devices, determining the current and / or future operating state of the base plate is based on a third set of criteria based on context data and the third parameter data. When the third set of criteria is met, the current and / or future operating state is determined to be the third operating state, and in accordance with the determination that the current and / or future operating state is the third operating state, a third monitor signal is transmitted that includes monitor data indicating the third operating state of the ostomy appliance.

[0185] In one or more exemplary accessory devices, the third operating state of the base plate corresponds to a situation where the first adhesive layer of the base plate has undergone a third degree of radial leakage or radial expansion, for example, a situation where the first adhesive layer has leaked to the third radial distance of the third pair of electrodes.

[0186] The third set of criteria is (P_1_1 < TH_3_1), (P_2_1 < TH_3_2), and (P_3_1 < TH_3_3) may be provided by or at least include, wherein P_1_1 is a first primary parameter based on first parameter data, indicating the resistance between a first pair of electrodes, TH_3_1 is a third primary threshold, P_2_1 is a second primary parameter based on second parameter data, indicating the resistance between a second pair of electrodes, TH_3_2 is a third secondary threshold, P_3_1 is a third primary parameter based on third parameter data, indicating the resistance between a third pair of electrodes, TH_3_3 is a third tertiary threshold, and the third operating state indicates a high degree of radial leakage or radial expansion at the base plate. The third thresholds (TH_3_1, TH_3_2, and TH_3_3) may be the same or different, for example, depending on the electrode configuration of the base plate. The third primary criterion (P_1_1 < TH_3_1) and / or the third secondary criterion (P_2_1 < TH_3_2) may be omitted from the third set of criteria. The third operating state indicating a high degree of radial advancement at the base plate may indicate a high probability of leakage, for example, at the proximal side of the base plate, within a time period, for example, within the next 20 minutes. The third operating state may indicate the radial progression of moisture to the first pair of electrodes, the second pair of electrodes, and the third pair of electrodes.

[0187] In one or more exemplary embodiments, when the first parameter data, the second parameter data, and the third parameter data each indicate the resistance between a first pair of electrodes, a second pair of electrodes, and a third pair of electrodes, respectively, the third thresholds (TH_3_1, TH_3_2, and TH_3_3) may correspond to third resistance thresholds. In one or more exemplary embodiments, the third primary threshold TH_3_1 may correspond to an upper resistance threshold. In one or more exemplary embodiments, the third secondary threshold TH_3_2 may correspond to an upper resistance threshold. In one or more exemplary embodiments, the third tertiary threshold TH_3_3 may correspond to an upper resistance threshold. The upper resistance threshold may be set to a value less than 30 megaohms, such as 25 megaohms, 20.5 megaohms, 20.4 megaohms, etc.

[0188] In one or more exemplary embodiments, the third primary threshold TH_3_1 may correspond to a lower resistance threshold. In one or more exemplary embodiments, the lower resistance threshold may be set to a value less than 1 Megaohm, such as 100 kiloohms, 80 kiloohms, 79 kiloohms, etc. In one or more exemplary embodiments, the third secondary threshold TH_3_2 may correspond to a medium resistance threshold. The medium resistance threshold may be set to a value less than 10, such as 5 Megaohms, 3 Megaohms, 2 Megaohms, 1 Megaohm, etc. In one or more exemplary embodiments, the third tertiary threshold TH_3_3 may correspond to an upper resistance threshold. The upper resistance threshold may be set to a value less than 30 Megaohms, such as 25 Megaohms, 20.5 Megaohms, 20.4 Megaohms, etc.

[0189] In one or more exemplary embodiments, when the first parameter data, the second parameter data, and the third parameter data indicate voltages between the first electrode pair, the second electrode pair, and the third electrode pair, respectively, the third thresholds (TH_3_1, TH_3_2, and TH_3_3) may correspond to a third voltage threshold. In one or more exemplary embodiments, the third primary threshold TH_3_1 may correspond to an upper voltage threshold. In one or more exemplary embodiments, the third secondary threshold TH_3_2 may correspond to an upper voltage threshold. In one or more exemplary embodiments, the second tertiary threshold TH_2_3 may correspond to an upper voltage threshold.

[0190] In one or more exemplary embodiments, the third primary threshold TH_3_1 may correspond to a lower voltage threshold. In one or more exemplary embodiments, the lower voltage threshold may be set to a value that is less than 1 volt, such as 0.5 volts, 0.25 volts, 0.22 volts, etc. In one or more exemplary embodiments, the third secondary threshold TH_3_2 may correspond to a mid-voltage threshold. The mid-voltage threshold may be set to a value that is less than 2 volts, such as 1.5 volts. In one or more exemplary embodiments, the second tertiary threshold TH_2_3 may correspond to an upper voltage threshold.

[0191] In one or more exemplary embodiments, the third set of criteria is: D_1_2_1 <Z D_2_3_1 <Z where Z is a time difference constant characterizing the moisture progression (e.g. 3 hours, e.g. 2 hours), the time difference D_1_2_1 is between the time T1 when P_1_1 crosses TH_1_1 and the time T2 when P_2_1 crosses TH_1_2, and the time difference D_2_3_1 is between the time T2 when P_2_1 crosses TH_1_2 and the time T3 when P_3_1 crosses TH_1_3.

[0192] In one or more example devices and methods, the ostomy data includes fourth ostomy data from a fourth electrode pair of the base plate. Applying the processing scheme may include obtaining fourth parametric data based on the fourth ostomy data and determining an operational state of the base plate of the ostomy appliance based on the fourth parametric data. The monitoring device may be configured to transmit a fourth monitor signal including monitor data indicative of the fourth operational state of the ostomy appliance pursuant to determining that the operational state is the fourth operational state.

[0193] In one or more exemplary devices and methods, a fourth operating state of the base plate corresponds to a situation in which the fourth electrode pair detects fluid, such as excreta, at a fourth radial distance between the proximal surface of the first adhesive layer and the user's skin, such that in the fourth operating state there is a high risk of leakage from the ostomy appliance.

[0194] The fourth set of criteria is: (P_4_1 <TH_4_4) where P_4_1 is a fourth primary parameter based on the fourth parameter data and indicative of a resistance between the fourth electrode pair, and TH_4_4 is a fourth quaternary threshold, and the fourth operating state is indicative of a high risk of leakage from the ostomy appliance. In one or more exemplary embodiments, the fourth quaternary threshold TH_4_4 may correspond to an upper resistance threshold.

[0195] In one or more exemplary embodiments, the fifth operating state of the base plate corresponds to a situation where the fourth electrode pair detects a fluid such as sweat at a fourth radial distance between the proximal surface of the first adhesive layer and the user's skin, and thus, there is no leakage from the ostomy appliance in the fifth operating state.

[0196] The fifth operating state may be determined according to a determination that one or more fifth criteria of a fifth set of criteria are satisfied.

[0197] The fifth set of criteria may be given by, or at least include, (P_4_1 < TH_5_1) (P_4_2 < TH_5_2) (P_4_3 < TH_5_3) (∇P_4_1 < V) (∇P_4_2 < V) and (∇P_4_3 < V) where P_4_1 is a fourth primary parameter based on fourth parameter data, indicating the resistance between the fourth electrode pair, P_4_2 is a fourth secondary threshold indicating the resistance between the fourth electrode and the fifth electrode, P_4_3 is a fourth tertiary parameter based on fourth parameter data, indicating the resistance between the fifth electrode pair, TH_5_1 is a fifth primary threshold, TH_5_2 is a fifth secondary threshold, TH_5_3 is a fifth tertiary threshold, ∇P_4_1 is the gradient of P_4_1, ∇P_4_2 is the gradient of P_4_2, ∇P_4_3 is the gradient of P_4_3, and V is a gradient limit (e.g., 80%). In one or more exemplary embodiments, the fifth primary threshold TH_5_1 may correspond to an upper resistance threshold. In one or more exemplary embodiments, TH_5_2 may correspond to an upper resistance threshold. In one or more exemplary embodiments, TH_5_3 may correspond to an upper resistance threshold. The upper resistance threshold may be set to a value less than 30 megaohms, such as 25 megaohms, 20.5 megaohms, 20.4 megaohms, etc. The fifth operating state may refer to the presence of sweat detected by fourth parameter data indicating moisture detected uniformly in all directions from the stoma opening.

[0198] In one or more exemplary embodiments, the sixth operating state of the base plate corresponds to a situation where the fourth electrode pair detects a fluid such as an exudate between the proximal surface of the first adhesive layer and the user's skin at a fourth radial distance, and thus, in the sixth operating state, there is a sudden leakage from the ostomy appliance.

[0199] The sixth operating state may be determined according to a determination that one or more sixth criteria of a sixth reference set are satisfied by the fourth parameter data.

[0200] The sixth reference set may include a sixth primary criterion, and the sixth primary criterion is (P_4_1 < TH_6_1) and (∇P_4_1 > V) may be included.

[0201] The sixth reference set may include a sixth secondary criterion, and the sixth secondary criterion is (P_4_2 < TH_6_2) and (∇P_4_2 > V) may be included.

[0202] The sixth reference set may include a sixth tertiary criterion, and the sixth tertiary criterion is (P_4_3 < TH_6_3) and (∇P_4_3 > V) where P_4_1 is a fourth primary parameter based on the fourth parameter data and indicative of a resistance between the fourth electrode pair, P_4_2 is a fourth secondary parameter indicative of a resistance between the fourth electrode and the fifth electrode, P_4_3 is a fourth tertiary parameter indicative of a resistance between the fifth electrode pair (the fifth electrode and the ground electrode), TH_6_1 is a sixth primary threshold, TH_6_2 is a sixth secondary threshold, TH_6_3 is a sixth tertiary threshold, ∇P_4_1 is a slope of P_4_1, ∇P_4_2 is a slope of P_4_2, ∇P_4_3 is a slope of P_4_3, and V is a slope limit (e.g., 80%). In one or more exemplary embodiments, the sixth primary threshold TH_6_1 may correspond to an upper resistance threshold. In one or more exemplary embodiments, TH_6_2 may correspond to an upper resistance threshold. In one or more exemplary embodiments, TH_6_3 may correspond to an upper resistance threshold. The upper resistance threshold may be set to a value less than 30 megaohms, such as 25 megaohms, 20.5 megaohms, 20.4 megaohms, etc. The sixth operating state may refer to the presence of an ejection detected by the fourth parameter data indicative of a sudden leak, e.g., an ongoing leak. In one or more exemplary embodiments, if time T is less than the placement of the base plate minus X, which is between 5 and 60 minus, and any of P_1_1, P_2_1, P_3_1 is less than a default threshold corresponding to the upper resistance threshold over T, this indicates that any of the first electrode pair, the second electrode pair, and the third electrode pair have been disconnected (e.g., disconnected by a user when preparing the base plate for placement around the stoma). In one or more exemplary embodiments, if time T is less than base plate placement minus X, which is between 5 and 60 minus, and any of P_4_1, P_4_2, P_4_3 is, on average, less than a default threshold corresponding to an upper resistance threshold over T, this indicates the presence of an immediate leak, e.g., proximal ejection.

[0203] In one or more exemplary embodiments, the first criteria set, the second criteria set, the third criteria set, the fourth criteria set, the default criteria set, the fifth criteria set, and the sixth criteria set may be used to define one or more additional criteria sets to determine one or more operating conditions.

[0204] In one or more exemplary embodiments, different sets of criteria may be used to determine the same operating condition.

[0205] The interface may be configured to communicate the one or more future operating states by displaying, via the display, a first user interface object indicative of the one or more future operating states.

[0206] The interface may be configured to communicate one or more future operating states via the display, such as by displaying a notification indicating the one or more operating states on a lock screen and / or a home screen of the auxiliary device.

[0207] The interface may be configured to display, via a display of the auxiliary device, a second user interface object that prompts the user to provide an indication as to whether the determined trends in the one or more future operating states are incorrect.

[0208] The processor and interface may be configured to detect a second user input selecting the first user interface object and, in response to detecting the second user input, open the ostomy user application. If the display is a touch-sensitive display, the second user input may include touching the touch-sensitive display.

[0209] The processor and interface may be configured to, in response to opening the ostomy user application, display the first application user interface including a third user interface object representing a current operational state of the ostomy appliance.

[0210] The interface may be configured to display a fourth user interface object representing the contextual data.

[0211] The interface may include a display, and the interface may be configured to communicate by displaying, via the display, a current operating state and / or one or more future operating states and / or features indicative of the future operating states. The features may be in the form of a graph or collection of functions providing the current operating state and / or one or more future operating states over a period of time. For example, the interface may be configured to communicate by displaying, via the display, a graph providing the current remaining wear time and / or one or more future remaining wear times versus time, the time axis including the current time, a past period up to the current time (e.g., hours or days), and a future time frame beyond the current time (e.g., hours).

[0212] The interface may be configured to communicate by notifying the user of the current and / or future operational state of the ostomy appliance via the interface, for example by displaying a notification on a display of the attached device. The notification may include user interface objects representing the current and / or future operational state. The notification may include a notification indicator that opens an application related to the ostomy appliance.

[0213] The present disclosure provides an ostomy appliance system including an ostomy appliance as disclosed herein, an accessory device as disclosed herein, and a monitor device as disclosed herein, wherein the ostomy appliance includes an ostomy base plate as disclosed herein.

[0214] The present disclosure provides a computer-readable storage medium storing one or more programs, the one or more programs including instructions that, when executed by an accessory device having an interface, a memory, and a processor, cause the accessory device to perform any of the methods disclosed herein.

[0215] FIG. 1 illustrates an exemplary ostomy system. The ostomy system 1 includes an ostomy appliance 2 including a base plate 4 and an ostomy pouch (not shown). Furthermore, the ostomy system 1 includes a monitor device 6 and an accessory device 8 (a mobile phone). The monitor device 6 is connectable to the base plate 4 via a first connector of the monitor device 6 and the base plate 4, respectively. The monitor device 6 is configured to wirelessly communicate with the accessory device 8. Optionally, the accessory device 8 is configured to communicate with a server device 10 of the ostomy system 1, for example, via a network 12. The server device 10 may be operated and / or controlled by an ostomy appliance manufacturer and / or a service center. Ostomy data or parameter data based on the ostomy data is obtained from an electrode / sensor of the ostomy appliance 2 with the monitor device 6. The monitor device 6 processes the ostomy data and / or the parameter data based on the ostomy data to identify monitor data to be transmitted to the accessory device 8. In the ostomy system shown, the accessory device 8 is a mobile phone, however, the accessory device 8 may be implemented as another handheld device, such as a tablet device or a wearable, such as a watch or other wrist-worn electronic device. The monitor device 6 is thus configured to identify and transmit monitor data to the accessory device 8. The base plate 4 includes a coupling member 14 in the form of a coupling ring 16 that couples an ostomy pouch (not shown) to the base plate (a two-piece ostomy appliance). The base plate has a stoma receiving opening 18 with a stoma center point. The size and / or shape of the stoma opening 18 is typically adjusted by the user or a nurse to fit the user's stoma prior to application of the ostomy appliance.

[0216] The ostomy system 1 optionally includes a docking station 20 forming an accessory device of the ostomy system 1. The docking station 20 includes a docking monitor interface including a first connector 22 configured to electrically and / or mechanically connect the monitor device 6 to the docking station 20. The docking monitor interface may be configured to wirelessly connect the monitor device to the docking station. The docking station 20 includes a user interface 24 to receive user input and / or provide feedback to the user about the operational status of the docking station 20. The user interface 24 may include a touch screen. The user interface 24 may include one or more physical buttons and / or one or more visual indicators, such as light emitting diodes.

[0217] 2 is a block diagram of an exemplary monitor device. The monitor device 6 includes a monitor device housing 100, a processor 101, and one or more interfaces, including a first interface 102 (appliance interface) and a second interface 104 (accessory interface). The monitor device 6 includes a memory 106 that stores ostomy data and / or parameter data based on the ostomy data. The memory 106 is connected to the processor 101 and / or the first interface 102.

[0218] The first interface 102 is configured as an appliance interface that electrically and / or mechanically connects the monitoring device 6 to an ostomy appliance, such as the ostomy appliance 2. The first interface 102 includes a plurality of terminals that form an electrical connection with respective terminals of the ostomy appliance 2 (base plate 4). The first interface 102 includes a ground terminal 108, a first terminal 110, a second terminal 112, and a third terminal 114. The first interface 102 optionally includes a fourth terminal 116 and a fifth terminal 118. The first interface 102 of the monitoring device 6 includes a coupling portion 120 that forms a mechanical connection, such as a releasable coupling, between the monitoring device and the base plate. The coupling portion 120 and the terminals 108, 110, 112, 114, 116, and 118 of the first interface 102 form (at least a part of) a first connector of the monitoring device 6.

[0219] The monitoring device 6 comprises a power unit 121 for powering the monitoring device and its active components, i.e. the power unit 121 is connected to the processor 101, the first interface 102, the second interface 104 and the memory 106. The power unit comprises a battery and a charging circuit. The charging circuit is connected to the battery and to terminals of the first interface 102 for charging the battery via the terminals of the first interface, e.g. the terminals of the first connector.

[0220] The monitoring device second interface 104 is configured as an accessory interface that connects the monitoring device 6 to one or more accessory devices, such as the accessory device 8. The second interface 104 includes an antenna 122 and a wireless transceiver 124 configured to wirelessly communicate with the accessory device. Optionally, the second interface 104 includes a loudspeaker 126 and / or a haptic feedback element 128 that provide audio signals and / or haptic feedback to the user, respectively.

[0221] The monitor device 6 includes a sensor unit 140 connected to the processor 101. The sensor unit 140 includes a temperature sensor that provides temperature data to the processor and a G-sensor or accelerometer that provides acceleration data to the processor 101.

[0222] FIG. 3 shows an exploded view of an exemplary base plate of an ostomy appliance. The base plate 4 includes a first adhesive layer 200. In use, a proximal surface of the first adhesive layer 200 adheres to the user's skin in the peristomal area and / or additional seals such as sealing paste, sealing tape, and / or sealing rings. The base plate 4 optionally includes a second adhesive layer 202, also referred to as a rim adhesive layer. The base plate 4 includes a plurality of electrodes disposed on an electrode assembly 204. The electrode assembly 204 is disposed between the first adhesive layer 200 and the second adhesive layer 202. The electrode assembly 204 includes a support layer having electrodes formed on a proximal surface of the support layer. The base plate 4 includes a release liner 206 that is peeled off by the user before applying the base plate 4 to the skin. The base plate 4 includes a top layer 208 and a bonding ring 209 that bonds the ostomy pouch to the base plate 4. The top layer 208 is a protective layer that protects the second adhesive layer 202 from external strains and stresses during use.

[0223] The base plate 4 includes a monitor interface. The monitor interface is configured to electrically and / or mechanically connect the ostomy appliance (base plate 4) to a monitor device. The monitor interface of the base plate includes a coupling portion 210 that forms a mechanical connection, such as a releasable coupling, between the monitor device and the base plate. The coupling portion 210 is configured to engage with the coupling portion of the monitor device to releasably couple the monitor device to the base plate 4. Furthermore, the monitor interface of the base plate 4 includes a plurality of terminals that respectively form a plurality of terminals 212 that form an electrical connection with a respective terminal of the monitor device. The coupling portion 210 and the terminals 212 form a first connector 211 of the base plate 4. The base plate 4 includes a first intermediate element 213 on the distal side of the electrode assembly. The first intermediate element 213 is disposed between the terminal element that forms the terminal 212 and a first adhesive layer (not shown). The first intermediate element 213 covers, when viewed in the axial direction, the terminal elements forming the terminals 212 of the base plate 4 and protects the first adhesive layer from mechanical stresses from the terminal elements of the base plate.

[0224] 4 illustrates an exploded view of an exemplary electrode assembly 204 of the base plate. The electrode assembly 204 includes a support layer 214 having a proximal surface 214B and an electrode 216 disposed proximally of the support layer 214, the electrode 216 including a ground electrode, a first electrode, a second electrode, a third electrode, a fourth electrode, and a fifth electrode, each electrode having a respective connection portion connecting the electrode to a respective terminal element of the monitor interface. Additionally, the electrode assembly 204 includes a masking element 218 having a proximal surface 218B and configured to insulate an electrode portion of the electrode 216 from the first adhesive layer of the base plate. The masking element 218 covers or overlaps a portion of the electrode 216 when viewed in the axial direction.

[0225] 5 is a proximal view of the proximal face of the base plate portion of the base plate without the first adhesive layer and release liner. The base plate 4 includes a first intermediate element 213 on the distal side of the electrode assembly, i.e., between the electrode assembly 204 and the first adhesive layer (not shown). The first intermediate element 213 covers the terminal element of the base plate 4 when viewed in the axial direction and protects the first adhesive layer from mechanical stress from the terminal element of the base plate.

[0226] 6 is a distal view of an exemplary electrode configuration 220 of the electrode 216 of the electrode assembly 204. The electrode configuration 220 / electrode assembly 204 includes a ground electrode 222, a first electrode 224, a second electrode 226, a third electrode 228, a fourth electrode 230, and a fifth electrode 232. The ground electrode 222 includes a ground connection 222A, and the first electrode 224 includes a first connection 224A. The second electrode 226 includes a second connection 226A, and the third electrode 228 includes a third connection 228A. The fourth electrode 230 includes a fourth connection 230A, and the fifth electrode 232 includes a fifth connection 232A.

[0227] The fourth electrode 230 includes a fourth detection portion 230B. The fifth electrode 232 includes a fifth detection portion 232B.

[0228] The ground electrode 222 includes a first electrode portion 224 that forms a ground for the first electrode 224. The ground electrode 222 includes a second electrode portion 236 that forms a ground for the second electrode 226. The ground electrode 222 includes a third electrode portion 238 that forms a ground for the third electrode 228. The ground electrode 222 includes a fourth electrode portion 240 that forms a ground for the fourth electrode 230 and the fifth electrode 232. The fourth electrode portion 240 of the ground electrode 222 includes a ground detection portion 222B.

[0229] The first sensing portion 224B extends at least 330 degrees circularly around the stoma opening at a first radial distance R1 from the center point 19. The first radial distance R1 may be about 14 mm. In one or more embodiments, the first radial distance R1 may be about 13 mm, such as 12.5 mm. The first electrode portion 234 is disposed inside (i.e., closer to the center) the first sensing portion and extends at least 330 degrees circularly around the stoma opening at a first ground distance RG1 from the first sensing portion (radially from the center point). The first ground distance RG1 between the sensing portion and the first electrode portion of the first electrode is about 1 mm.

[0230] The second sensing portion 226B extends at least 330 degrees circularly around the stoma opening at a second radial distance R2 from the center point 19. The second radial distance R2 may be 18 mm. In one or more embodiments, the second radial distance R2 may be 17 mm. The second electrode portion 236 is disposed inside (i.e., closer to the center) the second sensing portion 226B and extends at least 330 degrees circularly around the stoma opening at a second ground distance RG2 (radially from the center point) from the second sensing portion 226B. The second ground distance RG2 between the sensing portion of the second electrode and the second electrode portion is about 1 mm.

[0231] The third sensing portion 228B extends at least 330 degrees circularly around the stoma opening at a third radial distance R3 from the center point 19. The third radial distance R3 is about 26 mm. In one or more embodiments, the third radial distance R3 is 21 mm. The third electrode portion 238 is disposed inside (i.e., closer to the center) the third sensing portion 228B and extends at least 330 degrees circularly around the stoma opening at a third ground distance RG3 (radially from the center point) from the third sensing portion 228B. The third ground distance RG3 between the sensing portion of the third electrode and the third electrode portion of the third electrode is about 1 mm.

[0232] The ground electrode 222 includes a fourth electrode portion 240 that forms a ground or reference for the fourth electrode 230 and the fifth electrode 232. The fourth electrode portion 240 of the ground electrode 222 extends at least 300 degrees around the stoma opening and includes a ground sensing portion 222B. The fourth sensing portion 230B, the fifth sensing portion 232B, and the ground sensing portion of the fourth electrode portion 240 are circularly distributed around a center point 19 at a leakage radius from the center point (such as leakage radius R5, which may be about 32 mm from the center point). The fourth sensing portion 230B, the fifth sensing portion 232B, and the ground sensing portion of the fourth electrode portion may have a radial spread in the range of 1.5 mm to 3.0 mm, for example greater than 1.0 mm, such as about 2.0 mm. The fourth sensing portion 230B, the fifth sensing portion 232B, and the ground sensing portion of the fourth electrode portion 240 may have a circumferential extent (orthogonal to the radial extent) in the range of 2.5 mm to 5.0 mm, for example greater than 1.0 mm, such as about 3.5 mm.

[0233] 7 is a distal view of an exemplary masking element. Masking element 218 optionally has a plurality of terminal openings, including six terminal openings. The plurality of terminal openings includes a ground terminal opening 242, a first terminal opening 244, a second terminal opening 246, a third terminal opening 248, a fourth terminal opening 250, and a fifth terminal opening 252. The terminal openings 242, 244, 246, 248, 250, 252 of masking element 218 are configured to overlap and / or align with respective connections 222A, 224A, 226A, 228A, 230A, 232A of the electrodes of the electrode assembly.

[0234] The masking element 218 has a plurality of sensor point openings. The sensor point openings include primary sensor point openings shown within dashed lines 254, each configured to overlap a portion of the ground electrode 222 and / or a portion of the fourth electrode 230. The primary sensor point openings 254, in the illustrated exemplary masking element, include five first primary sensor point openings 254A, each configured to overlap a portion of the ground electrode 222. The primary sensor point openings 254, in the illustrated exemplary masking element, include four second primary sensor point openings 254B, each configured to overlap a portion of the fourth electrode 230. The sensor point openings include secondary sensor point openings shown within dashed lines 256, each configured to overlap a portion of the fourth electrode 230 and / or a portion of the fifth electrode 232. The secondary sensor point openings 256 include five first secondary sensor point openings 256A each configured to overlap a portion of the fifth electrode 232 in the illustrated exemplary masking element. The secondary sensor point openings 256 include four second secondary sensor point openings 256B each configured to overlap a portion of the fourth electrode 230 in the illustrated exemplary masking element. The sensor point openings include tertiary sensor point openings shown within dashed lines 258, each tertiary sensor opening configured to overlap a portion of the fifth electrode 232 and / or a portion of the ground electrode 222. The tertiary sensor point openings 258 include five first tertiary sensor point openings 258A each configured to overlap a portion of the fifth electrode 232. The tertiary sensor point openings 258 include four second tertiary sensor point openings 258B each configured to overlap a portion of the ground electrode 222 in the illustrated exemplary masking element.

[0235] 8 is a distal view of an exemplary first adhesive layer. The first adhesive layer 200 has a plurality of sensor point openings. The sensor point openings of the first adhesive layer include primary sensor point openings shown within dashed lines 260, each configured to overlap a portion of the ground electrode 222 and / or a portion of the fourth electrode 230 of the electrode assembly. The primary sensor point openings 260 include five first primary sensor point openings 260A, each configured to overlap a portion of the ground electrode 222, in the exemplary masking element shown. The primary sensor point openings 260 include four second primary sensor point openings 260B, each configured to overlap a portion of the fourth electrode 230, in the exemplary masking element shown. The sensor point openings of the first adhesive layer include secondary sensor point openings shown within dashed lines 262, each configured to overlap a portion of the fourth electrode 230 and / or a portion of the fifth electrode 232 of the electrode assembly. The secondary sensor point openings 262 include five first secondary sensor point openings 262A each configured to overlap a portion of the fifth electrode 232 in the illustrated exemplary masking element. The secondary sensor point openings 262 include four second secondary sensor point openings 262B each configured to overlap a portion of the fourth electrode 230 in the illustrated exemplary masking element. The first adhesive layer sensor point openings include tertiary sensor point openings shown within dashed lines 264, each tertiary sensor opening configured to overlap a portion of the fifth electrode 232 and / or a portion of the ground electrode 222 of the electrode assembly. The tertiary sensor point openings 264 include five first tertiary sensor point openings 264A each configured to overlap a portion of the fifth electrode 232 in the illustrated exemplary masking element. The tertiary sensor point openings 264 include four second tertiary sensor point openings 264B each configured to overlap a portion of the ground electrode 222 in the illustrated exemplary masking element. FIG. 9 is a proximal view of the first adhesive layer of FIG.

[0236] 10 is a more detailed distal view of the base plate 4. The monitor interface of the base plate includes a first connector 211. The first connector 211 includes a coupling portion 210 configured to releasably couple a monitor device to the base plate, thereby forming a releasable coupling. The first connector 221 / monitor interface includes a plurality of terminals formed by respective terminal elements that form respective electrical connections with respective terminals of the monitor device.

[0237] The terminals of the first connector 211 / monitor interface include a ground terminal element 282 forming a ground terminal 282A, a first terminal element 284 forming a first terminal 284, a second terminal element 286 forming a second terminal 286A, and a third terminal element 288 forming a third terminal 288A. The monitor interface optionally includes a fourth terminal element 290 forming a fourth terminal 290A and / or a fifth terminal element 292 forming a fifth terminal 290. The terminal elements 282, 284, 286, 288, 290, 292 contact respective connections 222A, 224A, 226A, 228A, 230a, 232A of the electrodes 222, 224, 226, 228, 230, 232.

[0238] The location of the first connector on the base plate, the number of terminals on the coupling portion and the locations of the terminals may be adapted to the electrode configuration used in the electrode assembly of the base plate.

[0239] 11a-11b are flow diagrams illustrating an exemplary method 300 according to the present disclosure. Method 300 is performed within an accessory device (e.g., the accessory device of FIGS. 1 and 12). Method 300 is performed to determine and communicate one or more future operational states of a baseplate of an ostomy appliance disclosed herein, e.g., to monitor the operational state of a baseplate of an ostomy appliance, e.g., to monitor the future operational state of a baseplate, e.g., of an ostomy appliance.

[0240] The accessory device 8 is configured to communicate with one or more devices of an ostomy system (e.g., the ostomy system of FIG. 1). As shown in FIG. 1, the ostomy system 1 includes a monitor device 6 and / or an ostomy appliance 2 configured to be placed on a skin surface of a user.

[0241] The ostomy appliance 2 includes a base plate 4 as disclosed herein. The ostomy appliance includes an ostomy pouch. The base plate may include a first adhesive layer having a proximal side. In use, the proximal surface of the first adhesive layer is adhered to the peristomal area of ​​the user's skin and / or an additional seal, such as a sealing paste, sealing tape, and / or a sealing ring. The base plate may include one or more electrodes configured to measure an electrical characteristic of the first adhesive layer. The electrical characteristic may be indicative of a conductive path of the first adhesive layer, thereby indicating a moisture level and thus a status of the ostomy appliance.

[0242] The method 300 includes obtaining 302 monitor data from one or more devices, such as from a monitor device coupled to the ostomy appliance and an accessory device. The monitor data may include ostomy data and / or parameter data. The monitor data may include, for example, parameter data representative of a measurement of an electrical property of the first adhesive layer.

[0243] Obtaining 302 the monitor data may include retrieving and / or receiving the monitor data from a monitoring device. Obtaining 302 the monitor data may include receiving the monitor data over a period of time. The ostomy data and / or parameter data may be indicative of resistance between the electrodes of the base plate, capacitance and / or inductance between the electrodes, and / or any changes therein. For example, the ostomy data and / or parameter data may be indicative of changes in resistance, capacitance, and / or inductance between the electrodes. For example, the ostomy data and / or parameter data may include timing information, such as time-stamped data or information from which timing can be derived.

[0244] Method 300 includes obtaining 304 (e.g., receiving, retrieving, deriving) context data, for example from one or more user applications installed on the auxiliary device, and / or from a memory of the auxiliary device, for example a portion of memory dedicated to storing application data relating to the one or more user applications. The auxiliary device may be configured to have one or more user applications installed thereon, the one or more user applications including a first application (e.g., an ostomy user application) and a second application (e.g., an application other than an ostomy user application).

[0245] Obtaining 304 the context data may include obtaining 304a the context data from a second application different from the first application. For example, the second application may include a calendar application, a weather application, a health application, a sports application, an activity tracker application, an analytics application, a photo application, a camera, and / or a medical application. The context data may be quantified with one or more context parameters, which may be associated with one or more adjustment factors. The attached device may maintain a local or remote database (or lookup table) that associates the context parameters with corresponding adjustment factors.

[0246] The method 300 includes determining 306 one or more future operating states of the ostomy appliance based on the monitor data and the context data. The future operating state is indicative of a future adhesive performance of the ostomy appliance. The future operating state may include at least one of a wear time, an adhesive quality, and a moisture pattern representation. The future operating state may include at least one of a wear time at a future time, an adhesive quality at a future time, and a moisture pattern representation at a future time. The wear time may include an average wear time, a nominal wear time, a minimum wear time, a maximum wear time, a median wear time, and / or any other statistical metric derivable from the wear time. The wear time may include a remaining wear time and / or a current wear time and / or an elapsed wear time. The adhesive quality may include a metric indicative of erosion of a layer of the base plate, e.g., a first adhesive layer, and a moisture pattern representation.

[0247] Determining 306 one or more future operating states of the base plate of the ostomy appliance based on the monitor data and the context data may include determining one or more future operating states of the base plate of the ostomy appliance based on the monitor data and one or more context parameters (e.g., using one or more adjustment factors).

[0248] The method may include determining 310 a current operating status of the ostomy appliance based on the monitor data and / or the context data. The current operating status is indicative of a current adhesive performance of the ostomy appliance. The current operating status includes at least one of wear time, adhesive quality, and moisture pattern representation.

[0249] The method 300 includes communicating 308 the one or more future operating states, e.g., to a user, e.g., via an interface, to one or more devices of an ostomy system. Communicating 308 the one or more future operating states may include communicating 308a the future operating states in a first application, the first application being an ostomy user application installed on an accessory device. Communicating may include outputting, displaying, and / or transmitting, e.g., to the user and / or one or more devices of the ostomy system, and / or to one or more accessory devices of the user coupled to the disclosed accessory device.

[0250] It is an advantage of the present disclosure that an ostomy appliance user or a medical professional is given an improved tool for monitoring and planning the use of the ostomy appliance in daily life by utilizing contextual data obtainable by an accessory device. The present disclosure provides improved accuracy in monitoring and predicting the performance of the ostomy appliance with improved comfort for the user. The present disclosure allows future operating states to be derived in a more accurate manner, depending on the contextual data that is seen to affect the operating state. In other words, the disclosed method allows the dynamic internal state of the ostomy appliance to be predicted and presented to the user, which helps the user coordinate the use of the ostomy appliance with the planning of daily life activities.

[0251] Obtaining 304 the context data may include displaying 304b a user interface field in a first application user interface of the first application, the user interface field configured to accept discourse input, detecting 304c a first user input on the user interface field, and determining 304d the context data based on the detected first user input. The discourse input may include text input and / or voice input. The discourse input may indicate the context data, for example, an activity, an eating, a diet, a medication, etc.

[0252] Obtaining 304 the context data may include obtaining calendar data from a calendar application installed on the accessory device. The calendar data may include dates, times, and calendar events, including event dates, event start times, event end times, event reoccurrences, event locations, event participants, and the like. The method 300 may include deriving one or more regular events not derived from the calendar application, such as commuting, climbing stairs, walking a dog, and the like, and including the derived one or more regular events in the context data. For example, if the calendar data indicates a sports activity (e.g., running), the accessory device may determine a future operating state that requires earlier replacement than if the user is less active. This is because the adhesion between the first adhesive layer and the user's skin surface may deteriorate at a faster pace due to movement and possibly increased sweating when the user's activity level is high.

[0253] Obtaining 304 the context data may include obtaining location data derived from connectivity data, for example derived from location sensor data. The location data may be obtained from a GPS sensor, an accelerometer, a gyroscope, a magnetometer, a cellular base station, a wireless access point, and / or a short-range connection. For example, if the location data indicates an athletic activity (e.g., running), the accessory device may determine a future operating state that requires an earlier replacement than if the user is less active. This is because the adhesion between the first adhesive layer and the user's skin surface may deteriorate at a faster pace due to movement and possibly increased sweating when the user's activity level is high. For example, the processor of the accessory device may be configured to determine the future operating state based on location data that characterizes a region or country of residence. It should be noted that, as described in connection with FIG. 17, different regions and countries have different routines and recommendations that support optimal use of the ostomy appliance. For example, in the European region, an ostomy appliance having a base plate disclosed herein may be indicated to a user as being in an optimal state (corresponding to a first operating state) when the radial thickness of the whitening ring is between 0 mm and 15 mm (for users not in compliance with preferred use), such as between 0 mm and 7 mm (for users in compliance with preferred use), such as between 0 mm and 5 mm (recommended by a nurse).

[0254] For example, in Europe, a radial thickness of the whitening ring between 5mm and 10mm (recommended by nurses), between 7mm and 10mm (for users who comply with preferred use), and / or between 15mm and 30mm (for users who do not comply with preferred use), etc., may indicate to the user that an ostomy appliance having a base plate disclosed herein is in a less than optimal state (corresponding to a second operating state), thereby indicating consideration of replacing the base plate.

[0255] For example, in Europe, if the radial thickness of the whitening ring is greater than 10 mm (as recommended by a nurse), such as greater than 15 mm (for users who comply with preferred use), greater than 30 mm (for users who do not comply with preferred use), it may be indicated to the user that the ostomy appliance having a base plate disclosed herein is in a faulty state (corresponding to the third operating state) indicating a need to replace the base plate.

[0256] For example, in other regions (e.g., the United States), a radial thickness of the whitening ring between 0 mm and 10 mm (for users who comply with preferred use), between 0 mm and 20 mm (for users who do not comply with preferred use), etc., between 0 mm and 10 mm (recommended by a nurse), may indicate to a user that an ostomy appliance having a base plate as disclosed herein is in an optimal state (corresponding to a first operating state).

[0257] For example, in other regions (e.g., the United States), a radial thickness of the whitening ring between 10 mm and 20 mm (recommended by nurses), between 10 mm and 20 mm (for users who comply with preferred use), and / or between 20 mm and 40 mm (for users who do not comply with preferred use), etc., may indicate to the user that an ostomy appliance having a base plate disclosed herein is in a less than optimal state (corresponding to a second operating state), thereby indicating consideration of replacing the base plate.

[0258] For example, in other regions (e.g., the United States), if the radial thickness of the whitening ring is greater than 20 mm (as recommended by a nurse), such as greater than 20 mm (for users who comply with preferred use), greater than 40 mm (for users who do not comply with preferred use), it may be indicated to the user that the ostomy appliance having a base plate disclosed herein is in a faulty state (corresponding to a third operating state) indicating a need to replace the base plate.

[0259] The disclosed methods and accessory devices allow for accommodating local preferences of users in the use of the ostomy appliance, such as by adjusting operational state thresholds to local preferences or use and predicting future operational states accordingly.

[0260] Acquiring 304 the context data may include acquiring environmental data (e.g., weather data, temperature data, humidity data, light data, and / or pressure data). The environmental data may be acquired via a barometer, a camera, a proximity sensor, or a temperature sensor. For example, if the environmental data indicates high temperature and / or humidity, the accessory device may determine a future operating state that requires a quicker replacement than if the user is in a cooler and / or less humid location. This is because the adhesion between the first adhesive layer and the user's skin surface may deteriorate at a faster pace due to increased sweating caused by moisture and high temperature. For example, the processor of the accessory device may be configured to determine the future operating state based on temperature data that characterizes the temperature of the environment in which the base plate operates. It should be noted that, as described with respect to FIGS. 21A-21B, various illustrated scaling factors may be applied to the current operating state to derive the future operating state. A scaling factor may be applied to the operating condition (e.g., mounting time) of the base plate such that the scaling factor negatively affects the operating condition of the base plate with increasing temperature (e.g., decreasing mounting time) and / or the scaling factor positively affects the operating condition of the base plate with decreasing temperature (e.g., increasing mounting time).

[0261] In some embodiments, the scale-up rate can be predetermined. In these embodiments, the predetermined scale-up rate can be constant. Alternatively, the predetermined scale-up rate can be interactively adjusted based on which of the first electrode pair, the second electrode pair, and / or the third electrode pair are triggered. In at least some of these embodiments, the predetermined scale-up rate can be interactively adjusted.

[0262] Obtaining 304 the contextual data may include obtaining nutritional data (e.g., indicative of a user's eating, e.g., what the user ate, e.g., based on user input and / or based on a photo taken in a photo-enabled application). For example, if the nutritional data indicates consumption of spicy food, the auxiliary device may determine a future operating state that calls for an earlier change than if the user had not eaten spicy food, because waste concentration and flow may be greater after consumption of spicy food than if the user had not eaten spicy food.

[0263] Obtaining 304 the context data may include obtaining medication data (e.g., prescriptions, etc., indicating medication taken by the user). The medication data may be obtained via a medical user application (e.g., a user application used to store prescriptions or communicate with a medical team).

[0264] Acquiring 304 the context data may include acquiring health data. The health data may include age, gender, the user's medical condition, prescriptions, one or more illnesses, heart rate, the user's metabolic data, health status data. The health data may be acquired via a health user application, a heart rate sensor, an activity tracker, etc. The user's health status may affect the viscosity of the waste, which affects the first parameter data and thus the current and future operating states. The viscosity of the waste is affected by one or more factors, namely nutritional data (type of food eaten by the user, water intake, etc.), medication data (e.g., vitamins / supplements, prescriptions, etc.), and health data (e.g., the user's medical condition, illnesses, ostomy, ileostomy, etc.). The exemplary results in FIG. 20A-B show how the viscosity of the waste affects the first parameter data and thus the current and future operating states. For example, by obtaining whether the user is an ileal or colonic ostomist, the future operating state can be determined by applying the corresponding velocity data, for example, of FIG. 20B.

[0265] The health data may include an ostomy health condition, such as an ileostomy and / or a colonostomy. An ileostomy output may be more liquid than a colonostomy output. A user's health condition may be associated with a dilution percentage of the output based on whether the user is an ileostomy or a colonostomy. FIGS. 20A-B show dilution-related data between the first parameter data and a dilution grade of the output mixture. The accessory device may be configured to retrieve dilution-related data associated with the user's health condition. A memory of the accessory device may have the dilution-related data stored therein or may be configured to store the dilution-related data, such that a processor of the accessory device may determine a current operating condition and / or a future operating condition based on the monitor data using the dilution-related data.

[0266] Obtaining 304 the context data may include obtaining activity data. The activity data may include physical activity data (e.g., sports, locomotion, etc.), data from a sports application, and data from an accelerometer. For example, when the user's activity level is high (e.g., when the user is running), the processor may be configured to determine a future operating state that requires an earlier replacement than when the user is less active. The reason is that the adhesion between the first adhesive layer and the user's skin surface may deteriorate at a faster pace due to movement and possibly increased sweating when the user's activity level is high. Experimental results have demonstrated that activity (e.g., sports, bending, locomotion) may negatively affect the wear time by a reduction factor of 2-10 compared to when the user is not or hardly active (e.g., a sedentary user). For example, the wearing time may be reduced by a factor of 2-10 due to intense exercise. For example, by identifying the user's activity level, the future operating state may be determined by dividing the current operating state by, for example, a factor of 2-10.

[0267] The accessory device may include a sensor unit including an accelerometer for sensing acceleration and providing acceleration data to the processor.

[0268] Acquiring 304 the context data may include acquiring the context data over a period of time. The memory may be configured to store the received context data over a period of time. The second application may be configured to store the received context data over a period of time locally in the memory or remotely on the application (and / or associated storage server). Determining the one or more future operating states may be based on the acquired context data over a period of time and / or the acquired monitor data over a period of time. Statistical analysis of previous operating states and / or monitor history data may be illustrated in FIGS. 18A-B.

[0269] The method includes communicating 308 the one or more future operating states.

[0270] Communicating 308 the one or more future operating conditions may include displaying 308b via the display a first user interface object indicating the one or more future operating conditions. Communicating 308 the one or more future operating conditions may include communicating a recommendation to check supplies before an event (e.g., driving or activity) or when at home, to replace within a certain time frame before an event (e.g., a leak).

[0271] Communicating 308 the future operating state includes displaying 308c a notification indicating the one or more future operating states via a display, such as on a lock screen and / or a home screen of the accessory device.

[0272] The method may include displaying 312 a second user interface object via a display of the auxiliary device that prompts the user to provide an indication as to whether the determined trends in the one or more future operating states are incorrect.

[0273] The method may include detecting a second user input selecting the first user interface object or the notification 314, and in response to detecting the second user input, opening an ostomy user application 316. If the display is a touch-sensitive display, the second user input may include touching the touch-sensitive display.

[0274] The method may include displaying 318, in response to opening the ostomy user application, within the first application user interface, a third user interface object representing a current operational state of the ostomy appliance.

[0275] In response to detecting user input adding the context data, method 300 may include displaying a fourth user interface object representing the context data, where the fourth user interface object may include one or more context user interface objects each indicating one or more of calendar data, location data, environmental data, nutritional data, activity data, medication data, and / or health data.

[0276] Communicating 308 may include displaying the current operating state and one or more future operating states together or separately. Communicating 308 may include displaying, via a display, a graph providing the current operating state (e.g., current remaining wear time) and / or one or more future operating states (e.g., one or more future remaining wear times) as a function of time, with the time axis including the current time, past times up to the current time (e.g., hours or days), and future time frames beyond the current time (e.g., hours).

[0277] 12 is a block diagram illustrating an exemplary accessory device 8 according to the present disclosure. The accessory device 8 forms part of an ostomy system (e.g., ostomy system 1 of FIG. 1) and is capable of determining the operational state of an ostomy appliance (e.g., ostomy appliance 2 of FIG. 1) to be placed on a user's skin, and in particular determining the future operational state of a base plate of the ostomy appliance based on the context data. The accessory device 8 includes a memory 401, a processor 402 coupled to the memory 401, and an interface 403 coupled to the processor 402.

[0278] The interface 403 is configured to communicate with one or more devices of the ostomy system 1. With reference to Figures 1 and 3, the one or more devices include a monitor device 6 disclosed herein and / or an ostomy appliance 2 configured to be placed on a user's skin surface or any additional seal. The ostomy appliance 2 includes a base plate 4. The base plate 4 may include a first adhesive layer 200 having a proximal surface 200B. In use, the proximal surface 200B of the first adhesive layer 200 adheres to the peristomal area of ​​the user's skin and / or to an additional seal, such as a sealing paste, a sealing tape, and / or a sealing ring. The base plate 4 may include one or more electrodes configured to measure an electrical characteristic of the first adhesive layer 200. The electrical characteristic may be indicative of a conductive path in the first adhesive layer and therefore indicative of a moisture level and may be indicative of the status of the base plate.

[0279] The interface 403 includes a display 403a. The interface includes a transceiver 403b. The interface 403 is configured to obtain monitor data from one or more devices, for example, from a monitor device. The transceiver 403b may be configured to obtain monitor data from one or more devices, for example, from a monitor device 6.

[0280] The accessory device 8 may include one or more sensors. The processor 402 is configured to obtain the contextual data, for example, from the one or more sensors.

[0281] The interface 403 is configured to obtain monitor data from one or more devices, such as receiving or retrieving monitor data from the monitoring device 6. The monitor data may be indicative of a condition of the ostomy appliance, such as the condition of a layer of the ostomy appliance (e.g., a first adhesive layer of a base plate) proximal to the skin surface.

[0282] The processor 402 is configured to retrieve context data, e.g., from the memory 401, from one or more user applications 405 installed, e.g., on the attached device 8, and / or from the interface 403. The context data may be quantified in one or more context parameters, which may be associated with one or more scaling factors (e.g., the scaling factors shown in Figures 19A-19B, 20A-20B, 21A-21B). The attached device may maintain a local or remote database (or look-up table) that associates context parameters with corresponding scaling factors.

[0283] The processor 402 is configured to determine one or more future operational states of the ostomy appliance (e.g., one or more future operational states of a base plate of an ostomy appliance disclosed herein) based on the monitor data and the context data. The future operational state indicates a future adhesive performance of the ostomy appliance (e.g., a future adhesive performance of the base plate 4 of the ostomy appliance 2).

[0284] The processor 402 may be configured to determine one or more future operating states of the ostomy appliance (e.g., one or more future operating states of a base plate of an ostomy appliance disclosed herein) based on the monitor data and one or more context parameters.

[0285] The interface 403 is configured to communicate one or more future operating states, eg, to a user and / or to other devices, via the display 403a or the transceiver 403b.

[0286] The processor 402 may be configured to determine one or more future operating states of the baseplate based on the monitor data and the context data by determining one or more current moisture pattern types based on the monitor data, and by generating one or more future operating states based on the one or more current moisture pattern types and the context data. Determining the one or more current moisture pattern types may be based on ostomy data and / or parameter data (e.g., first parameter data and second parameter data), e.g., measurements taken by the electrodes, e.g., resistance, capacitance, and / or inductance measurements, e.g., timing information. For example, the processor 402 may be configured to determine a future operating status of the ostomy appliance based on the monitored data and the contextual data by determining one or more future moisture pattern types based on the monitored data and the contextual data, where the monitored data includes ostomy data and / or parameter data (e.g., first parameter data and second parameter data), e.g., measurements obtained by electrodes, e.g., resistance, capacitance, and / or inductance measurements, e.g., timing information, and the contextual data includes calendar data, location data, environmental data, nutritional data, health data, activity data, and / or medication data.

[0287] For example, the processor 402 may be configured to determine a future operating state of the ostomy appliance by determining one or more future moisture pattern types based on the parameter data (e.g., the first parameter data and the second parameter data (and optionally the third parameter data)). For example, determining the one or more future moisture pattern types may include selecting a moisture pattern type from a set of predefined moisture pattern types based on trends identified in the monitor data over a period of time and adjusting the selection based on the context data. The set of predefined moisture pattern types may include M moisture pattern types, e.g., at least three moisture pattern types, at least four moisture pattern types, at least five moisture pattern types. The number M of moisture pattern types may be in the range of 4 to 20. For example, determining the one or more future moisture pattern types may include selecting a selected function based on the context data and identifying the future moisture pattern type by applying the selected function to the parameter data.

[0288] The processor 402 may be configured to determine a future operating state based on a current operating state and, optionally, any operating state prior to determining the future operating state.

[0289] In one or more exemplary auxiliary devices, the first parameter data, the second parameter data, and the third parameter data may be indicative of resistance between the first electrode pair, the second electrode pair, and the third electrode pair, respectively.

[0290] The first parameter data, the second parameter data, and the third parameter data may indicate a rate of change of resistance between the first electrode pair, the second electrode pair, and the third electrode pair, respectively.

[0291] Determining the current and / or future operating state of the base plate of the ostomy appliance may include determining the operating state (e.g., the current and / or future operating state) from a set of operating states. In other words, identifying the current and / or future operating state may include selecting an operating state from a set of predefined operating states based on the monitor data and the context data. The set of predefined operating states may include a plurality of operating states, e.g., at least two operating states, at least three operating states, at least four operating states, at least five operating states. The number of operating states may be in a range of 4 to 20. In one or more exemplary accessory devices, the number of operating states in the set of predefined operating states is greater than 10, e.g., greater than 20, or even greater than 50.

[0292] In one or more exemplary auxiliary devices, the processor 402 is configured to determine the operating state of the baseplate when a change criterion is met. The change criterion may be based on the context data and the monitor data (e.g., the first parameter data, the second parameter data, and / or the third parameter data). The change criterion may be met when the parameter data changes, e.g., when the change in the parameter data is greater than a change threshold selected based on the context data. Thus, the determination of the current and / or future operating state may be conditioned or dependent on the change in the parameter data that is conditioned by the context data.

[0293] In one or more exemplary accessory devices, determining the current and / or future operating state of the baseplate is based on a first set of criteria based on the context data and the parameter data (first parameter data and / or second parameter data), and the current and / or future operating state is determined to be the first operating state when the first set of criteria is satisfied. The first set of criteria may include one or more first criteria based on one or more of the first parameter data, the second parameter data, and the third parameter data. The first set of criteria may include a first primary criterion based on the first parameter data. The first set of criteria may include a first secondary criterion based on the second parameter data. The first set of criteria may include a first tertiary criterion based on the third parameter data.

[0294] In one or more exemplary accessory devices, determining the current and / or future operating state of the base plate may be based on a first threshold set including one or more first thresholds. The first threshold set may include one or more thresholds to be applied, for example, in a first criteria set. The first threshold set may include a first primary threshold. The first threshold set may include a first secondary threshold. The first threshold set may include a first tertiary threshold.

[0295] The first set of criteria is: (P_1_1 <TH_1_1)、 (P_2_1>TH_1_2), and (P_3_1>TH_1_3) may be given by, or may include at least In the formula, P_1_1 is the first primary parameter based on the first parameter data, TH_1_1 is the first primary threshold, P_2_1 is the second primary parameter based on the second parameter data, TH_1_2 is the first secondary threshold, P_3_1 is the third primary parameter based on the third parameter data, TH_1_3 is the first tertiary threshold, and the first operating state indicates that the radial erosion or radial expansion of the base plate is at a low level. The first thresholds (TH_1_1, TH_1_2, and TH_1_3) can be the same or different, for example, according to the electrode configuration of the base plate. The first tertiary criterion (P_3_1 < TH_1_3) can be omitted from the first set of criteria.

[0296] The first primary parameter P_1_1 can indicate the resistance between the first pair of electrodes (the first electrode and the first electrode portion of the ground electrode) of the base plate.

[0297] The second primary parameter can indicate the resistance between the second pair of electrodes (the second electrode and the second electrode portion of the ground electrode) of the base plate.

[0298] The third primary parameter can indicate the resistance between the third pair of electrodes (the third electrode and the third electrode portion of the ground electrode) of the base plate.

[0299] In one or more exemplary attached devices, determining the current and / or future operating state of the base plate is based on a second set of criteria based on context data and parameter data (e.g., the second parameter data and / or the third parameter data), and the current and / or future operating state is determined to be the second operating state when the second set of criteria is met. The second set of criteria can be based on the first parameter data.

[0300] The second reference set may include one or more second references based on context data and parameter data (e.g., one or more of first parameter data, second parameter data, and third parameter data). The second reference set may include a second primary reference based on the first parameter data and a part of the context data. The second reference set may include a second secondary reference based on the second parameter data and a part of the context data. The second reference set may include a second tertiary reference based on the third parameter data and a part of the context data.

[0301] In one or more exemplary accessory devices, determining the current and / or future operating state of the base plate may be based on a second set of thresholds including one or more second thresholds. The second set of thresholds may include one or more thresholds that, for example, will be applied in the second reference set. The second set of thresholds may include a second primary threshold. The second set of thresholds may include a second secondary threshold. The second set of thresholds may include a second tertiary threshold.

[0302] The second reference set may be given by, or may at least include, (P_1_1 < TH_2_1), (P_2_1 < TH_2_2), and (P_3_1 > TH_2_3) and may include at least this. Wherein, P_1_1 is a first primary parameter based on the first parameter data, indicating the resistance between the first pair of electrodes, TH_2_1 is a second primary threshold value, P_2_1 is a second primary parameter based on the second parameter data, indicating the resistance between the second pair of electrodes, TH_2_2 is a second secondary threshold value, P_3_1 is a third primary parameter based on the third parameter data, indicating the resistance between the third pair of electrodes, TH_2_3 is a second tertiary threshold value, and the second operating state indicates that the radial erosion or radial expansion of the base plate is moderate. The second threshold values (TH_2_1, TH_2_2, and TH_2_3) can be the same or different, for example, according to the electrode configuration of the base plate. The second primary criterion (P_1_1 < TH_2_1) and / or the second tertiary criterion (P_3_1 > TH_2_3) can be omitted from the second set of criteria.

[0303] In one or more exemplary accessory devices, determining the current and / or future operating state of the base plate is based on a default set of criteria based on the first parameter data, and the current and / or future operating state is determined to be the default operating state when the default criteria are met, and in accordance with the determination that the current and / or future operating state is the default operating state, a default monitor signal including monitor data indicating the default operating state of the ostomy appliance is transmitted.

[0304] The default set of criteria can be (P_1_1 > TH_D_1), (P_2_1 > TH_D_2), and (P_3_1 > TH_D_3) given by, or can at least include, In the formula, P_1_1 is the first primary parameter based on the first parameter data, indicating the resistance between the first pair of electrodes; TH_D_1 is the default primary threshold; P_2_1 is the second primary parameter based on the second parameter data, indicating the resistance between the second pair of electrodes; TH_D_2 is the default secondary threshold; P_3_1 is the third primary parameter based on the third parameter data, indicating the resistance between the third pair of electrodes; TH_D_3 is the default tertiary threshold; and the default operating state indicates that the radial erosion or radial expansion of the base plate is very low or absent. The default thresholds (TH_D_1, TH_D_2, and TH_D_3) can be the same or different, for example, according to the electrode configuration of the base plate.

[0305] In one or more exemplary accessory devices, determining the current and / or future operating state of the base plate may be based on a third set of criteria based on context data and third parameter data, and the current and / or future operating state is determined to be in a third operating state when the third set of criteria is met, and in accordance with the determination that the current and / or future operating state is in the third state, a third monitor signal including monitor data indicating the third operating state of the ostomy appliance is transmitted.

[0306] In one or more exemplary accessory devices, the third operating state of the base plate corresponds to a situation where a third degree of radial erosion or radial expansion occurs in the first adhesive layer of the base plate, for example, the first adhesive layer is eroded to the third radial distance of the third pair of electrodes.

[0307] The third set of criteria may be given by, or may at least include, (P_1_1 < TH_3_1), (P_2_1 < TH_3_2), and (P_3_1 < TH_3_3) and may be given by, or may at least include, this. Wherein, P_1_1 is the first primary parameter based on the first parameter data, indicating the resistance between the first pair of electrodes, TH_3_1 is the third primary threshold, P_2_1 is the second primary parameter based on the second parameter data, indicating the resistance between the second pair of electrodes, TH_3_2 is the third secondary threshold, P_3_1 is the third primary parameter based on the third parameter data, indicating the resistance between the third pair of electrodes, TH_3_3 is the third tertiary threshold, and the third operating state indicates that the radial erosion or radial expansion of the base plate is at a high level. The third thresholds (TH_3_1, TH_3_2, and TH_3_3) can be the same or different, for example, depending on the electrode configuration of the base plate. The third primary criterion (P_1_1 < TH_3_1) and / or the third secondary criterion (P_2_1 > TH_3_2) can be omitted from the third set of criteria.

[0308] Interface 403 may be configured to communicate by displaying, via display 403a, the current operating state and / or one or more future operating states and / or features indicative of future operating states. The features may be in the form of a graph or set of functions that provide the current operating state and / or one or more future operating states over a period of time. For example, interface 403 may be configured to communicate by displaying, via display 403s, a graph that provides the current remaining wear time and / or one or more future remaining wear times over time, where the time axis includes the current time, a past period up to the current time (e.g., several hours or days), and a future time frame after the current time (e.g., several hours).

[0309] Interface 403 may be configured to communicate by notifying the user, via interface 403, of the current and / or future operating states of the ostomy appliance, for example, by displaying the notification on display 403a of the accessory device 8. The notification may include user interface objects representing the current and / or future operating states. The notification may include a notification indicator that opens an application related to the ostomy appliance.

[0310] The interface 403 may be configured to communicate the one or more future operating states by displaying, via the display 403a, a first user interface object indicative of the one or more future operating states.

[0311] The interface 403 may be configured to communicate the one or more future operating states via the display 403a, such as by displaying a notification indicating the one or more future operating states on a lock screen and / or a home screen of the accessory device.

[0312] The interface 403 may be configured to display, via the display 403a of the auxiliary device 8, a second user interface object that prompts the user to provide an indication as to whether the determined trends in one or more future operating states are incorrect.

[0313] The processor 402 and the interface 403 may be configured to detect a second user input selecting the first user interface object or the notification, and in response to detecting the second user input, open the ostomy user application. If the display is a touch-sensitive display, the second user input may include touching the touch-sensitive display.

[0314] The processor 402 and the interface 403 may be configured to display, in response to opening the ostomy user application, a third user interface object within the first application user interface, the third user interface object representing a current operational state of the ostomy appliance.

[0315] In response to detecting user input that adds the contextual data, the interface 403 may be configured to display a fourth user interface object representing the contextual data.

[0316] 13a-13d show exemplary user interfaces 500, 520, 560, and 580.

[0317] The first user interface 500 of FIG. 13a includes a first user interface object 502 that indicates one or more future operational states or that represents a first notification that indicates one or more future operational states.

[0318] The first user interface 500 may include multiple user interface objects, such as a first user interface object 502 that indicates one or more future operational states or that represents a first notification that indicates one or more future operational states.

[0319] The first user interface 500 may include an additional user interface object 504 that represents an earlier notification.

[0320] The first user interface 500 may include a lock screen of the accessory device and / or a home screen of the accessory device.

[0321] A second input selecting one of the user interface objects 502, 504 may be detected by the attached device, and in response to detecting the second input, the attached device launches or opens an ostomy user application (e.g., an ostomy user application installed on the attached device). For example, detection of a second input (e.g., a touch, tap, press, press-and-hold gesture, deep press) corresponding to selecting one of the user interface objects 502, 504 triggers the launching or opening of an ostomy user application installed on the attached device.

[0322] FIG. 13b illustrates an exemplary user interface, such as the first application user interface 520.

[0323] The first application user interface 520 includes a third user interface object 521 that represents a current operating state.

[0324] The first application user interface 520 includes a user interface object 526 representing a graph or collection of functions providing a user interface object 528 representing a previous operational state, a third user interface object 521 representing a current operational state, and a user interface object 524 representing one or more future operational states over a period of time T, e.g., over a time frame including at least a portion of the elapsed time up to the current time, the current time, and a future period after the current time. The graph includes a value indicating the operational state on the y-axis. The operational state may include a wear time, such as a remaining wear time. The first application user interface 520 may include a user interface object 530 representing a summary of the status of the baseplate, including a wear time user interface object 532 (e.g., remaining wear time and / or elapsed wear time) and a recommendation user interface object 534. The wear time user interface object 532 may be an indicator of elapsed or remaining wear time for the currently worn ostomy appliance, e.g., the currently worn baseplate. The wear time user interface object 532 may include a day indicator and a time indicator (e.g., 2 days and 15 hours). The recommendation user interface object 534 may be a text prompt such as "Your base plate is worn out. We recommend replacing it," or "All is well. No problems."

[0325] The first application user interface 520 may be viewed as one of the user interface screens displayed by the ostomy user application.

[0326] The first application user interface 520 may include a user interface object 536 for accessing a settings interface of the ostomy user application.

[0327] The first application user interface 520 may include a fifth user interface object 538 that indicates a connection between the monitor device and the baseplate. The fifth user interface object 538 may indicate a connection status (e.g., connected, not connected, searching, connection failed) for the connection between the monitor device and the baseplate.

[0328] The first application user interface 520 may include a sixth user interface object 540 that indicates a battery status of the monitoring device. The sixth user interface object 540 may indicate a remaining battery time and / or a remaining battery percentage (e.g., a charge state).

[0329] The first application user interface 560 of FIG. 13c includes a user interface field 522 configured to accept discourse input.

[0330] The first application user interface 560 of Figure 13c includes an add context data user interface object 523 for inputting (e.g., adding) context data, e.g., activity data, health data, nutrition data, to directly edit the data that is taken into account for determining one or more future operating states. A user interface field 522 may be populated with context data obtained from a second application.

[0331] By allowing direct editing of the data considered to determine one or more future operating states, the determined one or more future operating states may be adjusted based on the input context data compared to one or more future operating states determined prior to the input of the context data.

[0332] The first application user interface 580 of FIG. 13d includes a fourth user interface object, namely, a calendar event user interface object 550, which represents contextual data (e.g., a calendar event that will occur in the future), which is taken into account in determining the future operational state.

[0333] The fourth user interface object representing the context data may be displayed, for example, in response to detecting an input on user interface object 523 to add calendar data as context data. The fourth user interface object may include one or more context user interface objects each representing one or more of calendar data, location data, environmental data, nutritional data, activity data, medication data, and / or health data.

[0334] The calendar event user interface object 550 is displayed on top of the user interface object 526, for example overlaid on the first application user interface object 520, at a time corresponding to the time of the calendar event.

[0335] FIG. 14 shows an exemplary graph depicting parameter data as a function of time. In this example, the parameter data on the y-axis is in volts and time is the x-axis. Curve 1100 shows first parameter data indicative of voltage measured by a first electrode pair on the base plate as a function of time. Curve 1102 shows second parameter data indicative of voltage measured by a second electrode pair on the base plate as a function of time. Curve 1104 shows third parameter data indicative of voltage measured by a third electrode pair on the base plate as a function of time. Curves 1108, 1116, 1118 show a fourth primary parameter indicative of voltage measured by a fourth electrode pair on the base plate, a fourth secondary parameter indicative of voltage measured by the fourth and fifth electrodes on the base plate, and a fourth tertiary parameter indicative of voltage measured by a fifth electrode pair on the base plate as a function of time, respectively. Curves 1110, 1112, 1114 respectively show the slope of a fourth primary parameter indicative of the voltage gradient measured by the fourth electrode pair on the base plate, the slope of a fourth secondary parameter indicative of the voltage gradient measured by the fourth and fifth electrodes on the base plate, and the slope of a fourth tertiary parameter indicative of the voltage gradient measured by the fifth electrode pair on the base plate as a function of time. Figure 14 shows an upper voltage threshold represented as curve 1000, a middle voltage threshold represented as curve 1002, a lower voltage threshold represented as curve 1004, and curve 1006 is the gradient limit.

[0336] Curves 1108, 1116, 1118 and curves 1110, 1112, 1114 show that no moisture is detected on the proximal side of the first adhesive layer by the fourth electrode pair.

[0337] At a time less than 5 hours, curve 1100 shows that moisture is detected by the first electrode pair because the first parameter data has crossed the upper voltage threshold, while curve 1102 shows that moisture is not detected by the second electrode pair because the second parameter data has not crossed the upper voltage threshold. At this stage, the ostomy appliance is determined to be in a first operating state.

[0338] At time 5h-10h, curve 1102 shows that moisture is detected by the second electrode pair as the second parameter data crosses the upper voltage threshold, and at this stage the ostomy appliance is determined to be in a second operating state.

[0339] At approximately 45 hours, curve 1104 shows that moisture is detected by the third electrode pair as the third parameter data crosses the upper voltage threshold, at which point the ostomy appliance is determined to be in a third operating state.

[0340] FIG. 15 shows an exemplary graph depicting parameter data as a function of time. In this example, the parameter data on the y-axis is in volts and time is the x-axis. Curve 1202 shows first parameter data indicative of voltage measured by a first electrode pair on the base plate as a function of time. Curve 1204 shows second parameter data indicative of voltage measured by a second electrode pair on the base plate as a function of time. Curve 1200 shows third parameter data indicative of voltage measured by a third electrode pair on the base plate as a function of time. Curves 1206, 1208, 1210 show a fourth primary parameter indicative of voltage measured by a fourth electrode pair on the base plate, a fourth secondary parameter indicative of voltage measured by the fourth and fifth electrodes on the base plate, and a fourth tertiary parameter indicative of voltage measured by the fifth electrode pair on the base plate as a function of time, respectively. Curves 1212, 1214, 1216 respectively show the slope of a fourth primary parameter indicative of the voltage gradient measured by the fourth electrode pair on the base plate, the slope of a fourth secondary parameter indicative of the voltage gradient measured by the fourth and fifth electrodes on the base plate, and the slope of a fourth tertiary parameter indicative of the voltage gradient measured by the fifth electrode pair on the base plate as a function of time. Figure 15 shows an upper voltage threshold represented as curve 1000, a middle voltage threshold represented as curve 1002, a lower voltage threshold represented as curve 1004, and curve 1006 is the gradient limit.

[0341] Curves 1206, 1208, 1210, and curves 1212, 1214, 1216 show that moisture is detected on the proximal side of the first adhesive layer by the fourth electrode pair, the fourth and fifth electrodes, and the fifth electrode pair from time starting at 69 h to 90 h. The three electrode pairs are triggered as shown by the drop shown by 1206, 1208, 1210, and curves 1212, 1214, 1216 show a slope of less than 80%, which indicates the presence of sweat on the proximal side of the first adhesive layer.

[0342] At the 30 minute time point, curve 1202 shows that moisture is detected by the first electrode pair because the first parameter data exceeds the upper voltage threshold, while curve 1204 shows that moisture is not detected by the second electrode pair because the second parameter data does not cross the upper voltage threshold. At this stage, the ostomy appliance is determined to be in a first operating state.

[0343] At approximately 40h, curve 1204 shows that moisture is detected by the second electrode pair as the second parameter data crosses the upper voltage threshold, at which point the ostomy appliance is determined to be in a second operating state.

[0344] FIG. 16 shows an exemplary graph depicting parameter data as a function of time. In this example, the parameter data on the y-axis is in volts and time is the x-axis. Curve 1300 shows first parameter data indicative of voltage measured by a first electrode pair on the base plate as a function of time. Curve 1302 shows second parameter data indicative of voltage measured by a second electrode pair on the base plate as a function of time. Curve 1304 shows third parameter data indicative of voltage measured by a third electrode pair on the base plate as a function of time. Curves 1306, 1308, 1310 show a fourth primary parameter indicative of voltage measured by a fourth electrode pair on the base plate, a fourth secondary parameter indicative of voltage measured by the fourth and fifth electrodes on the base plate, and a fourth tertiary parameter indicative of voltage measured by a fifth electrode pair on the base plate as a function of time, respectively. Curves 1312, 1314, 1316 respectively show the slope of a fourth primary parameter indicative of the voltage gradient measured by the fourth electrode pair on the base plate, the slope of a fourth secondary parameter indicative of the voltage gradient measured by the fourth and fifth electrodes on the base plate, and the slope of a fourth tertiary parameter indicative of the voltage gradient measured by the fifth electrode pair on the base plate as a function of time. Figure 16 shows an upper voltage threshold represented as curve 1000, a middle voltage threshold represented as curve 1002, a lower voltage threshold represented as curve 1004, and curve 1006 is the gradient limit.

[0345] Curves 1306, 1308, 1310 and curves 1312, 1314, 1316 show that moisture is detected by the fourth electrode pair proximal to the first adhesive layer at a time beginning at approximately 25 h. The leak electrodes (i.e., the fourth electrode pair, the fourth and fifth electrodes, and the fifth electrode pair) are triggered as shown by the decrease shown by 1306, 1308, 1310, and curves 1312, 1314, 1316 show a slope of less than 80%, indicating the presence of discharge proximal to the first adhesive layer. This indicates a severe leak. The ostomy appliance may be determined to be in a sixth operating state.

[0346] At time 5h, curve 1300 shows that moisture is detected by the first electrode pair because the first parameter data exceeds the upper voltage threshold, while curve 1302 shows that moisture is not detected by the second electrode pair because the second parameter data does not cross the upper voltage threshold. At this stage, the ostomy appliance is determined to be in a first operating state.

[0347] At approximately 15h, curve 1302 shows that moisture is detected by the second electrode pair as the second parameter data crosses the upper voltage threshold, at which point the ostomy appliance is determined to be in a second operating state.

[0348] At a time around 30h, curve 1304 indicates that moisture was detected by the third electrode pair as the third parameter data crossed the upper voltage threshold. In instances where curves 1306, 1308, 1310 did not drop below their corresponding thresholds, curve 1304 indicates that moisture reached the third electrode pair, and the present disclosure allows the ostomy appliance to be determined to be in a third operating state.

[0349] FIG. 17 shows an exemplary graph representing parameter data as a function of time and whitening zone diameter (e.g., related to the radial thickness of the whitening ring surrounding the stoma opening) as a function of time. FIG. 17 shows moisture propagation in the first adhesive layer as a function of time and shows a correlation between parameter data detected by the first and second electrode pairs of the base plate and actual moisture at the proximal surface of the first adhesive layer of the base plate. The actual moisture propagation in the first adhesive layer may appear as a whitening zone in the first adhesive layer (e.g., a white ring around the stoma opening). Moisture affects the first adhesive layer in that it reacts with the composition of the first adhesive layer to form a white ring around the stoma opening, thereby reducing the adhesive performance of the base plate. FIG. 17 is obtained by an experiment in which water is applied from the stoma opening of the base plate using the electrodes of the base plate and the radial propagation of moisture is followed, which leads to radial erosion of the first adhesive layer of the base plate.

[0350] Curve 1502 shows first parameter data indicative of a voltage measured by a first electrode pair on the base plate as a function of time. Curve 1504 shows second parameter data indicative of a voltage measured by a second electrode pair on the base plate as a function of time. Curve 1506 shows the diameter of the white ring as a function of time. The first parameter data, for example, shows a drop in voltage measured by the first electrode pair over time. It can also be seen that the voltage of the second electrode pair, for example, drops at a later time than when the first parameter data shows a drop, e.g., a voltage drop. This correlates with the diameter of the white ring going from about 25 mm-26 mm, when the first electrode pair is triggered (e.g., the first parameter data shows a drop), to 38 mm, when the second electrode pair is triggered (the second parameter data shows a drop). This substantially corresponds to the location of the first electrode pair at twice the first radial distance R1 and the location of the second electrode pair at twice the second radial distance R2.

[0351] It should be noted that different regions and countries have different routines and recommendations to support optimal use of the ostomy appliance. For example, in European regions, an ostomy appliance having a base plate as disclosed herein may be indicated to a user as being optimal when the radial thickness of the whitening ring is 0mm-15mm (for users not complying with the preferred use), such as 0mm-7mm (for users complying with the preferred use), 0mm-5mm (recommended by nurses), etc.

[0352] For example, in Europe, a radial thickness of the whitening ring between 5mm and 10mm (recommended by nurses), between 7mm and 10mm (for users who comply with preferred use), and / or between 15mm and 30mm (for users who do not comply with preferred use), etc., may indicate to the user that an ostomy appliance having a base plate disclosed herein is in a less than optimal state (corresponding to a second operating state), thereby indicating consideration of replacing the base plate.

[0353] For example, in Europe, if the radial thickness of the whitening ring is greater than 10 mm (as recommended by a nurse), such as greater than 15 mm (for users who comply with preferred use), greater than 30 mm (for users who do not comply with preferred use), it may be indicated to the user that the ostomy appliance having a base plate disclosed herein is in a faulty state (corresponding to the third operating state) indicating a need to replace the base plate.

[0354] For example, in other regions (e.g., the United States), a radial thickness of the whitening ring between 0 mm and 10 mm (for users who comply with preferred use), between 0 mm and 20 mm (for users who do not comply with preferred use), etc., between 0 mm and 10 mm (recommended by a nurse), may indicate to a user that an ostomy appliance having a base plate as disclosed herein is in an optimal state (corresponding to a first operating state).

[0355] For example, in other regions (e.g., the United States), a radial thickness of the whitening ring between 10 mm and 20 mm (recommended by nurses), between 10 mm and 20 mm (for users who comply with preferred use), and / or between 20 mm and 40 mm (for users who do not comply with preferred use), etc., may indicate to the user that an ostomy appliance having a base plate disclosed herein is in a less than optimal state (corresponding to a second operating state), thereby indicating consideration of replacing the base plate.

[0356] For example, in other regions (e.g., the United States), if the radial thickness of the whitening ring is greater than 20 mm (as recommended by a nurse), such as greater than 20 mm (for users who comply with preferred use), greater than 40 mm (for users who do not comply with preferred use), it may be indicated to the user that the ostomy appliance having a base plate disclosed herein is in a faulty state (corresponding to a third operating state) indicating a need to replace the base plate.

[0357] The methods, ostomy appliances, monitoring devices, and accessory devices of the present disclosure allow for accommodating local preferences of users in the use of the ostomy appliance, such as adjusting operational thresholds to local preferences or use.

[0358] 18A and 18B show exemplary graphs representing peel force as a function of peel distance traveled by a peeling action exerting a peel force (e.g., perpendicular to the proximal (or distal) surface of the first adhesive layer) on a first adhesive layer of a base plate disclosed herein. The peel force relates to the force required to peel the first adhesive layer from the skin surface. The peel distance relates to an end of the first adhesive layer where the peel force begins to act. The peel distance can relate to the size or length of the first adhesive layer, and thus to the size or length of the portion of the first adhesive layer that is affected by moisture and the portion of the first adhesive layer that is not affected by moisture. The peel force shown in FIG. 18A and FIG. 18B represents the adhesive performance of the first adhesive layer of the base plate to the skin surface.

[0359] The composition of the first adhesive layer of the base plate disclosed herein in one or more embodiments is formulated to provide adhesion of the base plate to the user's skin surface when the base plate is worn, and to keep the skin surface dry and healthy. Avoiding maceration of the skin when the skin is sealed with adhesive is achieved, for example, by transferring sweat from the skin to the first adhesive layer by a hydrocolloid type and adhesive (e.g., a hydrocolloid adhesive) that forms part of the absorbent element of the first adhesive layer.

[0360] For example, when the absorbent element comes into contact with moisture (e.g., water, sweat, urine, or feces), the absorbent element absorbs the moisture, which reduces the adhesion of the first adhesive layer to the skin.

[0361] For example, the first adhesive layer goes from a dry adhesive state with acceptable adhesive performance (eg, acceptable adhesion and tack) to a wet adhesive state (eg, a gel with low or no adhesion and low tack).

[0362] Curve 1602 in Figures 18A and 18B shows the peel force imparted to the first adhesive layer as a function of the peel distance traveled by a peeling action exerting a peel force on the first adhesive layer in a dry adhesive state (e.g., unaffected by moisture). The peel force is expressed in Newtons, while the peel distance is expressed in mm. The length of the first adhesive layer in a dry adhesive state is designated X5 and corresponds to the length of the first adhesive layer 1608 in a dry adhesive state.

[0363] Curve 1602 shows that the peel force imparted to the first adhesive layer in a dry adhesive state is equal to Y1 when the peel distance is less than X1. At X1, the peel force decreases as the peel distance increases toward X5 and the end of the first adhesive layer.

[0364] Curve 1604 in FIG. 18A shows the peel force imparted to the first adhesive layer as a function of peel distance traveled by a peel operation exerting a peel force on the first adhesive layer in a wet adhesive state (e.g., affected by moisture to the point where the first adhesive layer reaches a fully wet adhesive state where it becomes a gel).

[0365] Curve 1604 shows that when the peel distance is less than X2, the peel force applied to the first adhesive layer in a wet adhesion state is equal to Y2, which has a value much lower than Y1. This indicates that the adhesive performance of the first adhesive layer is reduced when the first adhesive layer is in a wet adhesion state. At X2, the peel force decreases as the peel distance increases to the end of the first adhesive layer. Note that X2 is greater than X1 because the first adhesive layer in a wet adhesion state expands in volume and therefore in length due to gelation of the components of the first adhesive layer.

[0366] Peel experiments shown in FIG. 18A show the loss of adhesive performance when the first adhesive is in a wet adhesive state.

[0367] Curve 1606 in FIG. 18B shows the peel force imparted to the first adhesive layer as a function of the peel distance traveled by a peel action exerting a peel force on the first adhesive layer, shown as 1610, and includes a first portion 1610A in a dry adhesive state and a second portion 1610B in a wet adhesive state (e.g., affected by moisture to the point where the first adhesive layer reaches a fully wet adhesive state where it becomes a gel).

[0368] Curve 1606 shows that when the peel distance is less than X3, the peel force applied to the first adhesive layer in a wet adhesive state is equal to Y3, which is a value much lower than Y1. This shows that the adhesive performance of the first adhesive layer is reduced when the first adhesive layer includes a portion in a wet adhesive state. At X3, the peel force decreases as the peel distance increases to the end of the first adhesive layer. Note that X3 corresponds to the length of portion 1610A in a dry adhesive state.

[0369] Peel experiments shown in FIG. 18B show the loss of adhesive performance when the first bond is in a partially wet bond state.

[0370] Thus, Figures 18A and 18B demonstrate that the operating conditions determined based on the monitored data are indicative of the adhesive performance of the base plate.

[0371] 19A-19B show exemplary graphs depicting whitening zone diameter (e.g., related to the radial thickness of the whitening ring surrounding the stoma opening) as a function of time. FIG. 19A-19B show moisture propagation in the first adhesive layer as a function of time, as well as the diametrical velocity of moisture propagation on the proximal surface of the first adhesive layer of the base plate. Actual moisture propagation in the first adhesive layer may appear as a whitening zone in the first adhesive layer (e.g., a white ring around the stoma opening). FIG. 19A-19B show measurements of the diameter of the whitening zone as a function of time while moisture propagates. Moisture affects the first adhesive layer in that it reacts with the composition of the first adhesive layer to form a white ring around the stoma opening, thereby reducing the adhesive performance of the base plate.

[0372] FIG. 19A is obtained by an experiment in which water is poured through the stoma opening of a first type of base plate to measure the rate of radial propagation of water leading to radial erosion of the first adhesive layer of the first type of base plate.

[0373] 19B is obtained by an experiment in which water is poured through the stoma opening of a second type of base plate and the rate of radial propagation of water is measured, which leads to radial erosion of the first adhesive layer of the second type of base plate, which differs from the first type in that the composition of the first adhesive layer may be different for the second type compared to the first type.

[0374] Curve 2104 shows the diameter of the whitening ring of a first type of base plate measured from the cut for the stoma opening to the first electrode pair as a function of time.

[0375] Curve 2102 is a linear approximation of curve 2104, thereby characterizing the velocity from the cut to the first electrode pair. The linear approximation is Y=v01 * It can be formulated as a linear equation of the type X+A, where Y is the diameter of the whitening ring in millimeters (mm), X is time (h), v01 is the diametric velocity of moisture propagation in the first type of base plate from the cut to the first electrode pair, and A is related to the diameter of the cut. In the experiment shown in FIG. 19A, v01=0.6 mm / h and A is 22 (i.e., the diameter of the cut for the stoma opening is 22 mm). Other experiments show that v01 can be in the range of 0.5 mm / h to 0.8 mm / h, and the average diametric velocity v01 at which moisture propagates from the cut to the first electrode pair is 0.65 mm / h. From the results of FIG. 19A, to obtain the radial velocity V01 at which moisture propagates from the cut to the first electrode pair, the diametric velocity v01 is divided by 2: in the illustrated experiment, V01=0.3 mm / h.

[0376] Curve 2106 shows the diameter of the whitening ring for a first type of base plate, measured from the first electrode pair to the second electrode pair, as a function of time.

[0377] Curve 2108 is a linear approximation of curve 2106, thereby characterizing the velocity from the first electrode pair to the second electrode pair. The linear approximation is Y=v * It can be formulated as a linear equation of the type X+B, where Y is the diameter of the whitening ring in millimeters (mm), X is time (h), v12 is the diametrical velocity of moisture propagation in the first type base plate from the first electrode pair to the second electrode pair, and B is related to the rough location of the first electrode pair from the center of the stoma opening. In the experiment shown in FIG. 19A, v12=0.2 mm / h and B is 27.3 mm (i.e., the first electrode pair is placed at about 27.3 mm). Other experiments have shown that v12 can be in the range of 0.15 mm / h to 0.22 mm / h, and the average diametrical velocity at which moisture propagates from the first electrode pair to the second electrode pair is 0.18 mm / h. From the results in FIG. 19A, to obtain the radial velocity V12 at which moisture propagates from the first electrode pair to the second electrode pair, the diametral velocity v12 is divided by 2: in the experiment shown, V12=0.1 mm / h.

[0378] Curve 2112 shows the diameter of the whitening ring of the second type of base plate measured from the cut for the stoma opening to the first electrode pair as a function of time.

[0379] Curve 2110 is a linear approximation of curve 2112, thereby characterizing the velocity from the cut to the first electrode pair. The linear approximation is Y=v01 *It can be formulated as a linear equation of the type X+A, where Y is the diameter of the whitening ring in millimeters (mm), X is time (h), v01 is the diametric velocity of moisture propagation in the second type base plate from the cut to the first electrode pair, and A is related to the diameter of the cut. In the experiment shown in FIG. 19B, v01=0.3 mm / h and A is 21.9 (i.e., the diameter of the cut for the stoma opening is 21.9 mm). Other experiments show that v01 can be in the range of 0.2 mm / h to 0.32 mm / h, and the average diametric velocity v01 at which moisture propagates from the cut to the first electrode pair is 0.275 mm / h. From the results of FIG. 19B, to obtain the radial velocity V01 at which moisture propagates from the cut to the first electrode pair, the diametric velocity v01 is divided by 2: in the experiment shown, V01=0.15 mm / h.

[0380] Curve 2114 shows the diameter of the whitening ring for the second type of base plate, measured from the first electrode pair to the second electrode pair, as a function of time.

[0381] Curve 2116 is a linear approximation of curve 2114, thereby characterizing the velocity from the first electrode pair to the second electrode pair. The linear approximation is Y=v * It can be formulated as a linear equation of the type X+B, where Y is the diameter of the whitening ring in millimeters (mm), X is time (h), v12 is the diametric velocity of moisture propagation in the second type base plate from the first electrode pair to the second electrode pair, and B is related to the rough location of the first electrode pair from the center of the stoma opening. In the experiment shown in FIG. 19B, v12=0.2 mm / h and B is 25.9 mm (i.e., the first electrode pair is placed at about 25.9 mm). Other experiments have shown that v12 can be in the range of 0.15 mm / h to 0.22 mm / h, and the average diametric velocity at which moisture propagates from the first electrode pair to the second electrode pair is 0.1 mm / h. From the results in FIG. 19B, to obtain the radial velocity V12 at which moisture propagates from the first electrode pair to the second electrode pair, the diametral velocity v12 is divided by 2: in the experiment shown, V12=0.5 mm / h.

[0382] The experiment shown in Figures 19A-19B corresponds substantially to the positioning of a first electrode pair at twice the first radial distance R1 and a second electrode pair at twice the second radial distance R2.

[0383] The present disclosure utilizes derivable rates to determine future operating conditions based on monitor data and / or current and / or previous operating conditions.

[0384] 20A shows an example graph of a first parameter data as a function of time, in this example, the parameter data on the y-axis is in units of millivolts and time is on the x-axis.

[0385] 20A is obtained by an experiment in which various dilutions of semi-solid substances are poured through the stoma opening of the base plate and the first electrode pair of the base plate is used to track the radial propagation of moisture leading to the radial erosion of the first adhesive layer of the base plate. The dilutions are performed with tap water and the semi-solid substances.

[0386] The example results in Fig. 20A show and mimic how the water content of the waste affects the first parameter data and thus the operating condition. This is done by mixing a semi-solid substance with water at various dilution factors. The water content in real life changes the viscosity of the waste and is influenced by one or more of the following factors: nutrition (type of food eaten by the user, water intake, etc.), medication (e.g. vitamins / supplements, prescriptions, etc.), and health data (e.g. user's medical condition, illness, ostomy, ileostomy, etc.).

[0387] Curve 2202 shows first parameter data showing the voltage measured by a first electrode pair on the base plate as a function of time when a mixture of 0% semi-solid material and 100% tap water is applied to the stoma opening of the base plate.

[0388] Curve 2204 shows first parameter data illustrating the voltage measured by the first electrode pair on the base plate as a function of time when a mixture of 30% semi-solid material and 70% tap water is applied. Curve 2204A shows first parameter data illustrating the voltage measured by the first electrode pair on the base plate as a function of time when a mixture of 30% semi-solid material and 70% tap water is applied.

[0389] Curve 2206 illustrates first parameter data showing the voltage measured by the first electrode pair on the base plate upon application of a mixture of 30% semi-solid material and 70% tap water as a function of time.

[0390] Curve 2208 illustrates first parameter data showing the voltage measured by the first electrode pair on the base plate when exposed to a mixture of 50% semi-solid material and 50% tap water as a function of time.

[0391] Curve 2210 shows first parameter data illustrating the voltage measured by a first electrode pair on a base plate when exposed to a mixture of 100% semi-solid material and 0% tap water as a function of time.

[0392] Curve 2212 shows first parameter data illustrating the voltage measured by the first electrode pair on the base plate when exposed to a mixture of 100% semi-solid material and 0% tap water as a function of time.

[0393] Note that the more dilute the effluent, the sooner the first electrode pair will be triggered.

[0394] FIG. 20B illustrates an exemplary graph of the first parameter data as a function of the percentage of emissions in the applied mixture.

[0395] Curve 2214 shows a linear approximation relating the trigger time of the first electrode pair to the percentage of semi-solid material, thereby characterizing how the viscosity of the semi-solid material affects the propagation of moisture within the first adhesive layer. Curve 2214 represents a linear equation with a coefficient of 10.6 with an approximation accuracy of 87% for the exemplary results. This supports the determination of future operating conditions based on one or more of nutritional data (type of food eaten by the user, water intake, etc.), medication data (e.g., vitamins / supplements, prescriptions, etc.), and health data (e.g., medical condition of the user, illness, ostomy, ileostomy, etc.).

[0396] A lean exhaust may be detected based on an early trigger time of the first electrode pair, and it may be anticipated that future operating conditions may be determined accordingly.

[0397] Depending on the activity (e.g., sports, bending, locomotion), experimental results show that the performance state can be negatively affected by a factor ranging from 2 to 10 compared to when the user is not or is only slightly active (e.g., a sedentary user). For example, the wearing time can be reduced by a factor of 2 to 10 due to vigorous activity.

[0398] FIG 21A shows an example graph 2302 of parameter data as a function of time for a first type of base plate at a first predetermined temperature. The first predetermined temperature in the example shown in FIG 21A is 32 degrees Celsius. FIG 21B shows an example graph 2304 of parameter data as a function of time for a first type of base plate at a second predetermined temperature. The second predetermined temperature in the example shown in FIG 21B is 37 degrees Celsius. The temperatures were selected to closely approximate human skin temperature.

[0399] 21A and 21B were obtained by applying fluid to the stoma opening of the base plate, which had a diameter of 22 mm. The residual humidity of the environment for both experiments was 50%. As the fluid was absorbed by the base plate over time, parameter data (e.g., voltage (mV) was measured between the first electrode pair, the second electrode pair, and / or the third electrode pair, respectively, as the fluid propagated radially outward from the stoma opening.

[0400] Specifically, in Figure 21A, curve 2306 shows the voltage drop as a function of time for the first electrode pair at about 8.3 hours, curve 2308 shows a constant voltage as a function of time for the second electrode pair, and curve 2310 shows a constant voltage as a function of time for the third electrode pair.

[0401] 21B, curve 2312 shows the voltage drop at about 7.6 hours for the first electrode pair, curve 2314 shows the constant voltage as a function of time for the second electrode pair, and curve 2316 shows the constant voltage as a function of time for the third electrode pair.

[0402] In other words, in this example, moisture propagated approximately 11% faster when the temperature was 37 degrees Celsius compared to when the temperature was 32 degrees Celsius. This comparison indicates that higher temperatures accelerate moisture propagation and adhesion degradation, thus shortening the base plate mounting time.

[0403] Another experiment was performed to measure the propagation speed of a fluid applied to the stoma opening of the second type of base plate. As in the experiment shown in Figures 21A and 21B, the diameter of the stoma opening was 22 mm and the residual humidity of the environment was 50%. The second type of base plate differs from the first type of base plate in that the composition of the first adhesive layer of the first type of base plate differs from the composition of the first adhesive layer of the second type of base plate.

[0404] In this experiment, when the temperature was 32 degrees Celsius, the fluid propagated between the center of the hole and the first electrode pair at about 0.15 mm / hour, whereas when the temperature was 37 degrees Celsius, the fluid propagated at about 0.2 mm / hour. Therefore, this experiment also revealed that for the other types of base plates, when the temperature was lower, the attachment time of the second type of base plate was shorter due to the accelerated moisture propagation and adhesion degradation.

[0405] In view of the above results, the scaling factor may be applied to the operating state of the base plate (e.g., mounting time), where the scaling factor has a negative effect on the operating state between the base plate when the temperature increases (e.g., mounting time decreases), and / or the scaling factor has a positive effect on the operating state between the base plate when the temperature decreases (e.g., mounting time increases).

[0406] In some embodiments, the scale-up rate may be predetermined. In these embodiments, the predetermined scale-up rate may be constant. Alternatively, the predetermined scale-up rate may be repeatedly adjusted based on when the first electrode pair, the second electrode pair, and / or the third electrode pair are triggered. In at least some of these embodiments, the predetermined scale-up rate may be repeatedly adjusted.

[0407] The use of terms such as "first", "second", "third" and "fourth", "primary", "secondary", "tertiary", etc. does not imply any particular order, but is included to identify individual elements. Furthermore, the use of terms such as "first", "second", "third" and "fourth", "primary", "secondary", "tertiary", etc. does not imply any order or importance, but rather terms such as "first", "second", "third" and "fourth", "primary", "secondary", "tertiary", etc. are used to distinguish one element from another. It is noted that terms such as "first", "second", "third" and "fourth", "primary", "secondary", "tertiary", etc. are used herein and elsewhere for labeling purposes only, and are not intended to indicate any particular spatial or temporal order. Furthermore, the label of a first element does not imply the presence of a second element, and vice versa.

[0408] While certain features have been illustrated and described, it will be understood that no limitation of the claimed invention is intended, and it will be apparent to one skilled in the art that various changes and modifications may be made without departing from the spirit and scope of the claimed invention. The specification and drawings are to be regarded in an illustrative rather than a restrictive sense. The invention as claimed is intended to embrace all alternatives, modifications and equivalents. [Explanation of symbols]

[0409] 1 Ostomy system 2 Ostomy appliance 4 Base plate 6 Monitor Devices 8 Attached Devices 10 Sensor Devices 12 Network 14 Connecting members 16 Coupling Ring 18, 18A, 18B, 18C, 18D Stoma receiving opening 20 Docking Station 22 First Connector 24 User Interface 100 monitor device case 101 Processor 102 First Interface 104 Second Interface 106 Memory 108 Ground terminal of the monitoring device 110 First terminal of the monitor device 112 Second terminal of monitor device 114 The third terminal of the monitor device 116 4th terminal of monitor device 118 5th terminal of monitor device 120 Joint 121 Power Unit 122 Antenna 124 Radio Transceiver 126 Loudspeaker 128 Haptic Feedback Elements 140 Sensor unit 200 First adhesive layer 200A Distal surface of first adhesive layer 200B proximal surface of first adhesive layer 202 Second adhesive layer 202A Distal surface of second adhesive layer 202B proximal surface of second adhesive layer 204 Electrode assembly 206 Release Liner 206A Distal surface of release liner 206B Proximal surface of release liner 208 Upper layer 208A Distal surface of upper layer 208B Proximal surface of upper layer 209 Coupling Ring 210 First connector coupling portion 211 First Connector 212 Terminal of the first connector 213 First intermediate element 213A Distal surface of first intermediate element 213B proximal surface of first intermediate element 214 Support layer for electrode assembly 214A Distal surface of support layer 214B Proximal surface of support layer 216 Electrode of electrode assembly 218 Masking Elements 218A Distal surface of masking element 218B Proximal surface of masking element 220 Electrode configuration 222 Ground electrode 222A Ground Connection 222B Ground detection unit 224 First electrode 224A 1st Connection 226 Second Electrode 226A Second Connection 228 Third Electrode 228A 3rd Connection 230 Fourth Electrode 230A 4th Connection 230B Fourth detector 232 Fifth Electrode 232A 5th Connection 232B 5th detector 234 First electrode portion of ground electrode 236 Second electrode portion of ground electrode 238 Third electrode part of ground electrode 240 Fourth electrode part of the ground electrode 242 Ground terminal opening 244 First terminal opening 246 Second terminal opening 248 Third terminal opening 250 4th terminal opening 252 5th terminal opening 254 Primary Sensor Point Aperture of Masking Element 254A 1st Primary Sensor Point Aperture 254B Second Primary Sensor Point Aperture 256 Secondary Sensor Point Aperture of Masking Element 256A First Secondary Sensor Point Aperture 256B Secondary Sensor Point Aperture 258 Masking element tertiary sensor point opening 258A First Tertiary Sensor Point Aperture 258B Second Tertiary Sensor Point Aperture 260 Primary sensor point opening of first adhesive layer 260A First Primary Sensor Point Aperture 260B Second Primary Sensor Point Aperture 262 Secondary sensor point opening of first adhesive layer 262A First Secondary Sensor Point Aperture 262B Secondary Sensor Point Aperture 264 Tertiary sensor point opening of first adhesive layer 264A First Tertiary Sensor Point Aperture 264B Second Tertiary Sensor Point Aperture 282 Ground Terminal Element 282A ground terminal 284 First Terminal Element 284A 1st Terminal 286 Second Terminal Element 286A 2nd Terminal 288 Third Terminal Element 288A 3rd Terminal 290 Fourth Terminal Element 290A 4th Terminal 292 Fifth Terminal Element 292A 5th Terminal 300 How to communicate future operating states 302 Get monitor data 304 Get Context Data 304a Obtaining context data from a second application different from the first application 304b displays a user interface field in a first application user interface of a first application. 304c Detect a first user input on a user interface field. 304d Determine context data based on the detected first user input. 306 Determining one or more future operating states of the base plate based on the monitor data and the context data 308 Communicating one or more future operating states 308a Communicating future operating state within first application 308b displays, via the display, a first user interface object indicating one or more future operating states. 308c Displaying notifications indicating one or more operating conditions via the display 310 Determine the current operating state of the ostomy appliance based on monitor data and / or context data A Continued from Figure 11a to Figure 11b 312 displays, via a display of the accessory device, a second user interface object that prompts the user to provide an indication as to whether the determined trends in one or more future operating states are incorrect. 314 Detecting a second user input selecting a first user interface object or a notification. 316 In response to detecting a second user input, open an ostomy user application. 318. Displaying a third user interface object within the first application user interface, the third user interface object representing a current operational state of the ostomy appliance. 401 Attached Device Memory 402 Attached device processor 403 Attached Device Interface 403a Display of attached device 403b Attached device transceiver 500 Exemplary First User Interface Screen 502 a first primary user interface object that indicates one or more future operational states or represents a first notification that indicates one or more future operational states 504 Additional User Interface Objects 520 Exemplary First Application User Interface 521 A third user interface object that represents the current operating state 522 User Interface Fields 523 Add Context Data User Interface Objects 524 A user interface object that represents one or more future action states 526 User interface objects that represent graphs 528 A user interface object that represents one or more previous action states 530 User interface object that represents an overview of the base plate status 532 Wear Time User Interface Object 534 Recommended User Interface Objects 536 User interface object for accessing user settings for the Ostomy application 538 Fifth User Interface Object 540 6th User Interface Object 550 Calendar Event User Interface Objects 560 Exemplary First Application User Interface 580 Exemplary First Application User Interface 1000 Curve representing upper voltage threshold 1002 Curve showing intermediate voltage threshold 1004 Curve showing lower voltage threshold 1006 Curve showing gradient limit 1100 A curve showing first parameter data illustrating voltage measured by a first electrode pair on a base plate as a function of time. 1102 a curve showing a second parameter data showing a voltage measured by a second electrode pair on the base plate as a function of time; 1104 a curve showing a third parameter data showing a voltage measured by a third electrode pair on the base plate as a function of time. 1108 a curve showing a fourth primary parameter indicative of a voltage measured by a fourth electrode pair on the base plate as a function of time; 1110 A curve showing the slope of a fourth linear parameter, which is a voltage gradient, as a function of time. 1112 A curve showing the slope of a fourth quadratic parameter, which represents the voltage gradient, as a function of time. 1114 A curve showing the slope of a fourth cubic parameter that indicates the voltage gradient as a function of time. 1116 A curve showing a fourth quadratic parameter that indicates the measured voltage as a function of time. 1118 A curve showing a fourth cubic parameter showing the measured voltage as a function of time. 1200 A curve showing a third parameter data showing the voltage measured by the third electrode pair on the base plate as a function of time. 1202 a curve showing first parameter data showing a voltage measured by a first electrode pair on a base plate as a function of time; 1204 a curve showing a second parameter data showing a voltage measured by a second electrode pair on the base plate as a function of time. 1206 a curve showing a fourth primary parameter indicative of a voltage measured by a fourth electrode pair on the base plate as a function of time. 1208 A curve showing a fourth quadratic parameter indicating the measured voltage as a function of time. 1210 A curve showing a fourth cubic parameter showing the measured voltage as a function of time. 1212 a curve showing the slope of a fourth linear parameter representing the voltage gradient measured by a fourth electrode pair on the base plate as a function of time; 1214. A curve showing the slope of a fourth secondary parameter data showing the measured voltage slope as a function of time. 1216 A curve showing the slope of a fourth cubic parameter showing the measured voltage slope as a function of time. 1300 A curve showing first parameter data illustrating voltage measured by a first electrode pair on a base plate as a function of time. 1302 a curve showing a second parameter data showing a voltage measured by a second electrode pair on the base plate as a function of time; 1304 a curve showing a third parameter data showing a voltage measured by a third electrode pair on the base plate as a function of time. 1306 a curve showing a fourth primary parameter data showing a voltage measured by a fourth electrode pair on the base plate as a function of time. 1308 A curve showing a fourth quadratic parameter showing the measured voltage as a function of time. 1310 A curve showing a fourth cubic parameter showing the measured voltage as a function of time. 1312 a curve showing the slope of a fourth linear parameter representing the voltage gradient measured by a fourth electrode pair on the base plate as a function of time; 1314. A curve showing the slope of a fourth quadratic parameter, which shows the measured voltage slope as a function of time. 1316 A curve showing the slope of a fourth cubic parameter showing the measured voltage slope as a function of time. 1502 a curve showing first parameter data showing a voltage measured by a first electrode pair on a base plate as a function of time; 1504 a curve showing a second parameter data showing a voltage measured by a second electrode pair on the base plate as a function of time. 1506 Curve showing the diameter of the white ring as a function of time 1602 Curve showing the peel force applied to the first adhesive layer in a dry adhesive state as a function of the peel distance 1604 Peel force applied to the first adhesive layer as a function of the peel distance traveled by a peeling action exerting a peel force on the first adhesive layer in a wet-adhesive state. 1606 Peel force imparted to the first adhesive layer as a function of peel distance traveled by a peeling action exerting a peel force on the partially wetted first adhesive layer. 1608 Length of the first adhesive layer 1608 in a dry adhesive state 1610 A first adhesive layer including a first portion in a dry adhesive state and a second portion in a wet adhesive state. 1610A First part in dry adhesive state 1610B Second part in wet adhesion state 2104 A curve showing the diameter of the whitening ring of a first type of base plate measured from the cut for the stoma opening to the first electrode pair as a function of time. 2102 Linear approximation of curve 2104 2106 A curve showing the diameter of the whitening ring of a first type of base plate measured from a first electrode pair to a second electrode pair as a function of time. 2108 Linear approximation of curve 2106 2110 Linear approximation of curve 2112 2112. A curve showing the diameter of the whitening ring of a second type of base plate measured from the cut for the stoma opening to the first electrode pair as a function of time. 2114. A curve showing the diameter of the whitening ring of a second type of base plate measured from a first electrode pair to a second electrode pair as a function of time. 2116 Linear approximation of curve 2114 2202 A curve showing first parameter data as a function of time. 2204 A curve showing first parameter data as a function of time. 2204A is a curve showing first parameter data illustrating the voltage measured by a first electrode pair on a base plate when subjected to a mixture of 30% waste and 70% tap water as a function of time. 2206 is a curve showing first parameter data illustrating voltage measured by a first electrode pair on a base plate when subjected to a mixture of 30% waste and 70% tap water as a function of time. 2208 A curve showing first parameter data illustrating the voltage measured by a first electrode pair on a base plate when subjected to a mixture of 50% waste and 50% tap water as a function of time. 2210 A curve showing first parameter data illustrating the voltage measured by the first electrode pair of the base plate when subjected to a mixture of 100% waste and 0% tap water as a function of time. 2212 is a curve showing first parameter data illustrating the voltage measured by a first electrode pair on a base plate when subjected to a mixture of 100% waste and 0% tap water as a function of time. 2214 A curve showing a linear approximation relating the trigger time of the first electrode pair to the percentage of ejection. 2302 A graph of parameter data as a function of time at a first predetermined temperature. 2304 A graph of parameter data as a function of time at a second predetermined temperature. 2306 A curve showing the voltage drop for a first electrode pair at a first predetermined temperature as a function of time. 2308 A curve showing the constant voltage for the second electrode pair at a first given temperature as a function of time. 2310 a curve showing the constant voltage for the third electrode pair at a first given temperature as a function of time 2312 a curve showing the voltage drop for a first electrode pair at a second given temperature as a function of time. 2314 A curve showing the constant voltage for a second electrode pair at a second given temperature as a function of time. 2316 A curve showing the constant voltage for the third electrode pair at a second given temperature as a function of time.

Claims

1. A method performed in an accessory device of an ostomy system, The aforementioned accessory device includes an interface configured to communicate with the ostomy system's monitoring device and the user, the interface including a display, The ostomy system includes the monitoring device and an ostomy appliance configured to be placed on the user's skin surface, the ostomy appliance includes a base plate, The base plate includes a first adhesive layer having a proximal surface, the proximal surface being configured to adhere to the skin in the user's stoma area. The aforementioned method, - Obtaining monitor data from the aforementioned monitor device, where the monitor data indicates the physical state of the base plate. - Obtain context data indicating the context in which the ostomy appliance is operating. - Determining one or more future operating states of the ostomy appliance based on the monitoring data and the context data, where a certain future operating state indicates the future adhesive performance of the base plate of the ostomy appliance, and - Communicating one or more of the aforementioned future operating states, A method that includes this.

2. The method according to claim 1, wherein the future operating state includes at least one of the wearing time and moisture pattern representation.

3. The method according to any one of claims 1 to 2, wherein the method includes determining the current operating state based on the monitor data and / or the context data.

4. The method according to claim 3, wherein the current operating state includes at least one of the wearing time and a moisture pattern representation.

5. The method according to any one of claims 1 to 4, wherein communicating the future operating state includes communicating the future operating state in a first application, the first application being an ostomy user application installed on the accessory device.

6. The method according to claim 5, wherein obtaining the context data includes obtaining the context data from a second application different from the first application.

7. Obtaining the aforementioned context data means - Displaying a user interface field in the first application user interface of the first application, wherein the user interface field is configured to accept text input and / or voice input. - Detecting the text input and / or voice input received in the user interface field as the first user input, - Determining the context data based on the detected first user input, The method according to any one of claims 5 to 6, including

8. The method according to any one of claims 1 to 7, wherein obtaining the context data includes obtaining calendar data from a calendar application installed on the accessory device.

9. The method according to any one of claims 1 to 8, wherein obtaining the context data includes obtaining location data.

10. The method according to any one of claims 1 to 9, wherein obtaining the context data includes obtaining environmental data.

11. The method according to any one of claims 1 to 10, wherein obtaining the context data includes obtaining nutritional data.

12. The method according to any one of claims 1 to 11, wherein obtaining the context data includes obtaining medication data.

13. The method according to any one of claims 1 to 12, wherein obtaining the context data includes obtaining health data.

14. The method according to any one of claims 1 to 13, wherein obtaining the context data includes obtaining activity data.

15. The method according to any one of claims 1 to 14, wherein acquiring the context data includes acquiring the context data over a period of time, and the processor of the accessory device is configured to store the context data received over a period of time in the memory of the accessory device or remotely in a storage server.

16. The method according to any one of claims 5 to 15, wherein communicating one or more future operating states includes displaying a first user interface object indicating one or more future operating states via the display.

17. The method according to any one of claims 5 to 16, wherein communicating the future operating state includes displaying a notification indicating one or more future operating states via the display.

18. The method according to any one of claims 1 to 17, further comprising displaying a second user interface object via the display that prompts the user to provide an indicator of whether the trend in one or more future operating states determined to be incorrect.

19. The aforementioned method, - Detecting a second user input that selects the first user interface object or the notification, - In response to detecting the second user input, open the ostomy user application. The method according to claim 17, which is dependent on claim 16, including the method described in claim 17.

20. The aforementioned method, - In response to opening the ostomy user application, a third user interface object representing the current operating state of the ostomy appliance is displayed within the first application user interface. The method according to claim 19, including the method described in claim 19.

21. In an ostomy system including an accessory device and a plurality of devices, the plurality of devices include a monitoring device and an ostomy appliance configured to be placed on the user's skin surface, and the ostomy appliance includes a base plate. The base plate includes a first adhesive layer having a proximal surface, the proximal surface being configured to adhere to the skin in the user's ostomy area. The aforementioned auxiliary device is Memory and A processor operationally connected to the interface and the memory, The interface configured to communicate with the monitoring device and the user of the ostomy system, Includes, The aforementioned interface includes a display, The interface is configured to acquire monitoring data from the monitoring device, and the monitoring data indicates the physical state of the base plate. The aforementioned processor, - Obtain context data indicating the context in which the ostomy appliance is operating, - Based on the monitor data and context data, determine one or more future operating states of the ostomy appliance, where a certain future operating state indicates the future adhesive performance of the base plate of the ostomy appliance. It is configured in such a way, The interface is configured to communicate one or more future operating states. Ostomy system.

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