Accessory device for an ostomy system, and related method for monitoring an ostomy system

Abstract

This disclosure provides an accessory device and related method for an ostomy system, including a method for monitoring the ostomy system performed in the accessory device. The ostomy system includes a monitoring device and an ostomy appliance, the ostomy appliance including a base plate configured to be placed on the surface of a user's skin. The accessory device includes an interface configured to communicate with at least the monitoring device of the ostomy system. The method includes: obtaining monitor data from the monitoring device, the monitor data indicating the status of the ostomy system; determining, based on the monitor data, the operational status of the ostomy system during a first time period following a first event; transmitting a first-level instruction via the interface, based on the operational status during the first time period as a first-level operational status; determining, based on the monitor data, the operational status of the ostomy system during a second time period following the first time period; and transmitting a second instruction, different from the first-level instruction, via the interface, based on the operational status during the second time period as a first-level operational status.

Description

[0001] This disclosure relates to an accessory device for an ostomy system and a related method for monitoring the ostomy system. The ostomy system includes ostomy appliances, an accessory device, and a monitoring device. In particular, this disclosure relates to a method for monitoring the ostomy system and its components. Attached Figure Description

[0002] The accompanying drawings are included to provide a further understanding of the embodiments and are incorporated in and are 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 anticipated advantages of the embodiments will be readily appreciated as they will become better understood with reference to the following detailed description. Elements of the drawings are not necessarily to scale. The same reference numerals indicate corresponding similar parts.

[0003] Figure 1 An exemplary ostomy system is shown.

[0004] Figure 2 An exemplary monitoring device for a stoma system is shown.

[0005] Figure 3 This is an exploded view of the base plate of the ostomy instrument.

[0006] Figure 4 This is an exploded view of an exemplary electrode assembly.

[0007] Figure 5 This is a near-side view of a portion of the base plate.

[0008] Figure 6 This is a distal view of an exemplary electrode configuration.

[0009] Figure 7 This is a far-side view of an exemplary masking element.

[0010] Figure 8 This is a distal view of an exemplary first adhesive layer.

[0011] Figure 9 yes Figure 8 A near-side view of the first adhesive layer.

[0012] Figure 10 This is a rear view of a portion of the baseplate, including the monitor interface.

[0013] Figure 11 Exemplary auxiliary devices according to this disclosure are shown.

[0014] Figure 12A and Figure 12B An exemplary method for monitoring ostomy systems is shown.

[0015] Figure 13 The first user interface was shown, and

[0016] Figure 14 The second user interface was shown. Detailed Implementation

[0017] In the following description, various exemplary embodiments and details are illustrated with reference to the accompanying drawings, where applicable. It should be noted that the drawings may or may not be drawn to scale, and the same reference numerals are used throughout all drawings to denote elements having similar structures or functions. It should also be noted that the drawings are intended only to facilitate the description of embodiments. They are not intended as an exhaustive description of the invention or a limitation on its scope. Furthermore, the illustrated embodiments are not necessarily to have all the aspects or advantages shown. Aspects or advantages described in connection with a particular embodiment are not necessarily limited to that embodiment and may be practiced in any other embodiment even if not so shown or so explicitly described.

[0018] Throughout this disclosure, the terms “ostomy” and “ostomy procedure” are used to refer to an opening created surgically around a person’s intestinal or urinary tract system. These terms are used interchangeably and do not have distinguishing meanings. This also applies to any words or phrases derived from these terms, such as “ostomy,” “ostomy procedure,” etc. Furthermore, solid and liquid waste from the ostomy can be used interchangeably as ostomy “excretions,” “waste,” and “fluid.” A subject undergoing an ostomy procedure may be referred to as an “ostomy patient” or “ostomy person,” and also as a “patient” or “user.” However, in some cases, “user” may also refer to or refer to a healthcare professional (HCP), such as a surgeon or ostomy care nurse or other personnel. In these cases, it will be explicitly stated or implied from the context that the “user” is not the “patient” himself or her.

[0019] In the following text, whenever a layer, element, device, or part of a device is referred to as the proximal side or surface, it refers to the side or surface facing the skin when the user wears the ostomy appliance. Similarly, whenever a layer, element, device, or part of a device is referred to as the distal side or surface, it refers to the side or surface facing away from the skin when the user wears the ostomy appliance. In other words, the proximal side or surface is the side or surface closest to the user when the appliance is fitted to the user, and the distal side is the opposite side or surface, that is, the side or surface furthest from the user during use.

[0020] When a user wears the device, the axial direction is defined as the direction of the stoma. Therefore, the axial direction is approximately perpendicular to the user's skin or abdominal surface.

[0021] The radial direction is defined as perpendicular to the axial direction. In some statements, the terms "inner" and "outer" may be used. These qualifiers should generally be understood with reference to the radial direction, such that referring to an "outer" element means that the element is further away from the center of the stomatal instrument than an element referred to as "inner." Furthermore, "innermost" should be interpreted as the part forming the center of the component and / or the portion adjacent to the center of the component. Similarly, "outermost" should be interpreted as the outer edge or outer contour of the component forming the component and / or the portion adjacent to that outer edge or outer contour.

[0022] The use of the word “substantially” in this disclosure as a modifier for certain characteristics or effects is intended to simply indicate that any deviations are within tolerances typically expected by those skilled in the art.

[0023] In this disclosure, the use of the word "approximately" as a modifier for certain features or effects is intended only to indicate that, for structural features, most or the majority of the feature exhibits the property in question, and for functional features or effects, it is intended to indicate that, for most results involving the feature, the effect is provided, but anomalous results do not provide the effect.

[0024] This disclosure relates to an ostomy system and its apparatus (such as an ostomy appliance, a base plate for the ostomy appliance, a monitoring device, and optionally one or more auxiliary devices) and related methods. Additionally, methods and auxiliary devices related to the ostomy system are disclosed. The auxiliary device (also referred to as an external device) may be a mobile phone or other handheld device. The auxiliary device may be a personal electronic device, such as a wearable device, like a watch or other wrist-worn electronic device. The ostomy system may include a docking station. The auxiliary device may be a docking station. The auxiliary device can be used as a docking station. The docking station may be configured to electrically and / or mechanically connect the monitoring device to the docking station. The docking station may be configured to charge the monitoring device and / or to transfer data between the monitoring device and the docking station, and / or between the auxiliary device and the docking station, and / or via the docking station between the monitoring device and the auxiliary device. The ostomy system may include a server device. The server device may be operated and / or controlled by the ostomy appliance manufacturer and / or service center.

[0025] This disclosure provides an ostomy system and apparatus, such as an ostomy appliance, a baseplate for the ostomy appliance, a monitoring device, and optionally one or more auxiliary devices, which, individually or together, facilitate reliable determination of the nature, severity, and speed of moisture spread or presence in and / or at the adhesive material provided for attaching the baseplate to the user's skin surface. Depending on the nature of the pattern of moisture spread and / or presence in and / or at the adhesive material, the ostomy system and apparatus can provide the user with information about the type of failure, and further, can provide the user with an indication of the internal condition or severity of the ostomy system and thus the remaining timeframe for replacing the ostomy appliance / baseplate without serious leakage and / or skin damage.

[0026] The stoma device includes a base plate and a stoma bag (also referred to as a stoma pouch). The stoma device can be a colostomy device, an ileostomy device, or a urethrostomy device. The stoma device can be a two-piece stoma device, i.e., the base plate and the stoma bag can be releasably connected, for example by mechanical and / or adhesive coupling, to allow one base plate to be used (interchangeable) with multiple stoma bags. Furthermore, a two-piece stoma device can facilitate proper application of the base plate to the skin, for example, to obtain the user's observation of improvement in the stoma area. The stoma device can also be a one-piece stoma device, i.e., the base plate and the stoma bag can be securely attached to each other. The base plate is configured for attachment to the user's stoma and / or the skin around the stoma, such as the peristaltic skin area. The stoma device may include an electrode assembly, or the stoma system may optionally include an electrode assembly that can be mounted proximally to the base plate of the stoma device. The electrode assembly (also referred to as the sensor assembly) includes multiple electrodes optionally disposed on the distal side of the first adhesive layer of the stoma device or on the distal side of the first adhesive layer of the electrode assembly, the multiple electrodes forming multiple sensors (electrode pairs). The stoma device / electrode assembly may include a monitor interface for connecting the electrodes of the electrode assembly to terminals of a first interface of a monitoring device.

[0027] The baseplate and / or electrode assembly includes a first adhesive layer, also referred to as a central adhesive layer. During use, the first adhesive layer adheres to the user's skin (peristostomy area) and / or to additional sealants, such as sealant, sealing tape, and / or sealing rings. Therefore, the first adhesive layer can be configured to attach the baseplate to the user's skin surface. The first adhesive layer may have an stoma opening with a central point. A baseplate having at least three electrodes whose sensing portions contact the first adhesive layer allows for the determination of the corrosion / swelling characteristics or features of the first adhesive layer, and / or the determination of the degree of corrosion and / or swelling of the first adhesive layer.

[0028] It should be understood that the sensing / monitoring functionality of the baseplate as described herein can also be provided by a separate sensor patch configured to attach to the proximal surface of a conventional baseplate. For example, the sensor patch may include an adhesive layer (e.g., a first adhesive layer), an electrode assembly, and a layer for connecting to a monitor interface of a monitoring device. Therefore, the sensor patch can be adhered, for example, by the user preparing the baseplate to the proximal (adhesive) surface of the conventional baseplate, enabling the baseplate to perform the functionality described herein.

[0029] The advantage of this disclosure is that it provides an optimal or improved use of an ostomy device. Specifically, this disclosure facilitates the replacement of the baseplate neither too early (leading to increased cell-to-skin detachment and a greater risk of skin damage, and further increasing costs and / or material waste) nor too late (leading to adhesive failure, leakage, and / or skin damage due to erosive discharge). Accordingly, users or healthcare professionals can monitor and plan the use of the ostomy device. Furthermore, this disclosure allows for improved monitoring of the ostomy system by enabling more precise information to the user regarding the internal condition of the ostomy system / ostomy device / baseplate, such as the reasons behind the presence and / or spread of moisture.

[0030] Furthermore, determining and classifying the operational status of ostomy instruments at different times can help reduce the risk of ostomy instrument leakage for users and typically provides users with feedback on improvements in the manipulation and operation of the ostomy system. Additionally, determining and classifying the operational status of ostomy instruments can also help reduce the risk of skin damage to users. In particular, the operational status determination according to this disclosure can help provide clear distinctions or differentiations between ostomy instruments, such as those exhibiting incorrect manipulation, adhesive failure, leakage of excrement (harmful to the skin), and sweating ostomy patients.

[0031] Specifically, the embodiments disclosed herein convey different indications based on the same operational state, but the different indications are conveyed at different time periods. Thus, the same operational state can be interpreted / conveyed, for example, by an auxiliary device, depending on the time period in which it occurs. For example, an operational state indicating the presence of liquid at the interface between the skin surface and the proximal surface of the baseplate can be generated by different mechanisms depending on the time at which the operational state is determined: if this operational state (presence of liquid) is determined immediately after the baseplate is applied to the skin surface (e.g., within a first time period), the liquid is more likely to be water (e.g., due to insufficient skin cleaning / preparation) rather than discharge from the stoma; while if this operational state (presence of liquid) is determined later (e.g., within a second time period), the liquid is more likely to be discharge spreading at the interface rather than water.

[0032] This disclosure provides a simple, effective, and easy-to-use ostomy system that offers high user comfort by incorporating user feedback regarding the internal condition of the basement plate.

[0033] A method for monitoring an ostomy system, executed in an accessory device, is disclosed. The ostomy system includes a monitoring device and an ostomy appliance, the ostomy appliance including a baseplate configured to be placed on the surface of a user's skin. The accessory device includes an interface configured to communicate with at least the monitoring device of the ostomy system. The method includes: obtaining monitor data from the monitoring device, the monitor data indicating the status of the ostomy system; determining, based on the monitor data, an operational state of the ostomy system, such as the operational state of the baseplate, within a first time period following a first event; transmitting a first-level indication via the interface, based on the operational state of the first time period as a first-level operational state; determining, based on the monitor data, an operational state of the ostomy system, such as within a second time period following the first time period and / or following a second event; and transmitting a second-level indication, different from the first-level indication, via the interface, based on the operational state of the second time period as the first-level operational state.

[0034] The method may optionally include: determining whether the operation status of the first time period is the first-level operation status.

[0035] The method may optionally include: determining whether the operation status of the second time period is the first-level operation status.

[0036] The operational status of the stoma system may include the operational status of the baseplate, which may optionally indicate the adhesive properties of the baseplate and / or the presence of fluid (e.g., one or more of discharge, water, sweat, and mucus) on the proximal side or proximal surface of the first adhesive layer.

[0037] The operational status of the ostomy system may include the operational status of the ostomy instruments and / or the operational status of the connection between the ostomy instruments and the monitoring device.

[0038] The first event can be a connection event where the monitoring device connects to the ostomy instrument. This connection event can be detected by the monitoring device, and a connection indicator (such as a connection timestamp) can be included in the monitoring data. The first event can also be an application event where the ostomy instrument is applied to the user's skin. The first event can be a connection event where the monitoring device connects to an accessory device. This connection event can be detected by the accessory device. The first event can also be a user input event indicating the first event, such as when user input is detected on a user interface object on a touch-sensitive display, for example, when user input is detected by the monitoring device.

[0039] In one or more exemplary methods, the end of the first time period can trigger or become the start of the second time period. In other words, the first and second time periods can be separate and non-overlapping.

[0040] In one or more exemplary methods, the second event may trigger or become the start of a second time period. The second event may be a user input event indicative of the second event, i.e., when user input is detected on a user interface object, such as on a touch-sensitive display, by an auxiliary device. The second event may be a time following the user input event indicative of the second event, for example, 30 seconds after informing the user that the ostomy system is ready for use (i.e., the application / installation routine is complete).

[0041] The monitor data can indicate the physical condition of the baseplate, such as its dynamic internal state. The monitor data can also indicate the moisture content at the baseplate / first adhesive layer and / or the first adhesive layer, such as the moisture content between the first adhesive layer and the user's skin.

[0042] In one or more exemplary methods for monitoring a stoma system, the method includes receiving user input indicating a first event via the interface (e.g., via a touch-sensitive display), such as by a user tapping a user interface object of a user interface.

[0043] In one or more exemplary methods for monitoring an ostomy system, the ostomy appliance includes a base plate having a first adhesive layer having a proximal side, and one or more electrodes configured to measure electrical properties at or in the first adhesive layer, wherein obtaining monitor data includes obtaining ostomy data representing the electrical properties.

[0044] In one or more exemplary methods for monitoring a stoma system, a first time period has a length of less than 15 minutes. The length of the first time period can be less than 10 minutes, for example, in the range of 1 second to 5 minutes, such as 2 minutes, 3 minutes, or 4 minutes. In one or more exemplary methods, the first time period has a length of less than 1 minute, for example, in the range of 15 seconds to 45 seconds. A relatively short first time period (e.g., less than 1 minute) may be sufficient to detect potential erroneous manipulation without causing delay to the user during the application of the routine.

[0045] In one or more exemplary methods for monitoring a stoma system, a first-level operational status indicates the presence of liquid or fluid, such as water, discharge, sweat, and / or mucus, on the proximal side of the base plate.

[0046] A first-level operating condition can represent or indicate the presence of fluid on the proximal / electrode assembly of the first adhesive layer of the base plate.

[0047] In one or more exemplary methods for monitoring an ostomy system, conveying a first-level indication includes displaying a first-level user interface object on a display of an accessory device. The first-level user interface object may indicate erroneous manipulation of the ostomy appliance, such as during baseplate application, for example, indicating wet installation of the ostomy appliance. Wet installation should be understood as the presence of liquid, such as water, sweat, mucus, and / or discharge, between the first adhesive layer / electrode assembly of the baseplate and the user's skin during and / or shortly thereafter during baseplate application.

[0048] This method may include, for example, determining a first-level indication based on the first time or the start of a first time period following the first event. The first-level user object may indicate one or more of the following: a first time, a first-level operational state, the reason for the first-level operational state, and a recommended action. The first-level user object may include first-level text. Examples of first-level text may be: "Liquid has been detected between the baseplate and your skin, possibly due to misuse of your baseplate," "Your skin is wet; please replace your baseplate and ensure your skin is properly dry or clean," or "Liquid was detected 10 seconds after application due to wet installation of your baseplate; please replace it."

[0049] The first-level user object can be divided into multiple first-level user interface objects.

[0050] Determining the first-level instruction may include selecting the first-level user interface object from a set of user interface objects.

[0051] In one or more exemplary methods for monitoring a stoma system, conveying a second-level indication includes displaying a second-level user interface object on a display of an accessory device. The second-level user interface object may indicate possible discharge leakage.

[0052] This method may include, for example, determining a second-level indication based on a second time or the start of a second time period following the second event. The second-level user object may indicate one or more of the following: a second time, a first-level operational status, the reason for the first-level operational status, and a recommended action. The second-level user object may include second-level text. Examples of second-level text might be "Liquid has been detected between the baseplate and your skin, posing a high risk of leakage" and "Check your baseplate; a leak may occur immediately."

[0053] The second-level user interface object can be divided into multiple second-level user interface objects.

[0054] Determining a second-level instruction may include selecting a second-level user interface object from a set of user interface objects.

[0055] In one or more exemplary methods for monitoring an ostomy system, the method includes: conveying a first secondary indication via an interface based on an operational state during a first time period that is a first secondary operational state. The first secondary operational state may indicate erroneous operation of the monitoring device during connection of an ostomy appliance / electrode assembly, and / or indicate an incorrect connection between the ostomy appliance and the monitoring device. Conveying the first secondary indication via the interface may include displaying a first secondary user interface object and / or outputting a first secondary audio output.

[0056] The method may optionally include: determining whether the operation status of the first time period is a first or second level operation status.

[0057] In one or more exemplary methods for monitoring an ostomy system, conveying a first-level instruction includes displaying a first-level user interface object on a display of an accessory device. The first-level user interface object may indicate, for example, an incorrect connection between the monitoring device and the ostomy appliance due to the presence of liquid in the connection between the monitoring device and the ostomy appliance, by including first-level text such as “The connection between the monitoring device and the ostomy appliance is wet; please keep the connection dry.”

[0058] The method may optionally include: determining whether the operation status of the second time period is a first or second level operation status.

[0059] In one or more exemplary methods for monitoring an ostomy system, the method includes: conveying a second-level instruction via an interface based on an operational state during a second time period that is a first-level operational state. The second-level instruction may differ from the first-level instruction. Conveying the second-level instruction via the interface may include displaying a second-level user interface object that differs from the first-level user interface object. The second-level user interface object may indicate water ingress into the connection between the monitoring device and the ostomy apparatus during the second time period. The second-level user interface object may include second-level text, such as “Water ingress occurred in the connection after application; please clean and dry the connection.”

[0060] Furthermore, an accessory device for an ostomy system is disclosed, the ostomy system including an ostomy appliance, a monitoring device, and the accessory device, the accessory device including: a processor; a memory connected to the processor; and an interface configured to connect the accessory device to the monitoring device, the interface including a transceiver module connected to the processor, wherein the accessory device is configured to: obtain, for example, monitor data from a monitoring device connected to or connectable to the accessory device, the monitor data indicating the status of the ostomy system (e.g., one or more of the ostomy appliance, the monitoring device, and the connection between the ostomy appliance and the monitoring device); determine, based on the monitor data, the operational status of the ostomy system, for example, within a first time period after a first event; based on the operational status of the first time period as a first level operational status, communicate a first level instruction via the interface; determine, based on the monitor data, the operational status of the ostomy system, for example, within a second time period after the first time period or after a second event; based on the operational status of the second time period as a first level operational status, communicate a second instruction different from the first level instruction via the interface.

[0061] The accessory device's display can be configured to detect touch (e.g., the display is a touch-sensitive display), and input includes contact on the touch-sensitive display. The touch-sensitive display provides an input and output interface between the accessory device and the user. The accessory device's processor can be configured to receive electrical signals from and / or send electrical signals to the touch-sensitive display. The touch-sensitive display is configured to display visual output to the user. Visual output (such as user interface objects displayed on the display) may optionally include graphics, text, icons, video, and any combination thereof (collectively, "graphics"). For example, some or all of the visual output may be considered to correspond to a user interface object.

[0062] The processor of the auxiliary device can be configured to display one or more user interfaces, such as a user interface screen, on a display, including a first user interface and / or a second user interface. The user interface may include one or more user interface objects. For example, the first user interface may include a first-level user interface object and / or a first-level user interface object. The second user interface may include one or more second user interface objects, such as a second-level user interface object and / or a second-level user interface object. The user interface objects (such as the first-level user interface object and / or the second user interface object) may represent the operating status of the baseboard during a certain period of time.

[0063] In one or more exemplary auxiliary devices, the auxiliary device is configured to receive user input indicating a first event via an interface.

[0064] In one or more exemplary accessory devices, the stoma device includes a stoma bag and a base plate, the base plate including a first adhesive layer having a proximal side, and one or more electrodes configured to measure electrical properties at or in the first adhesive layer, wherein obtaining monitor data includes obtaining stoma data representing the electrical properties.

[0065] In one or more exemplary auxiliary devices, the first time period has a first time period length of less than 15 minutes.

[0066] In one or more exemplary accessories, a first-level operating state indicates the presence of liquid on the proximal side of the base plate.

[0067] In one or more exemplary accessories, the interface includes a display, and wherein conveying a first-level instruction includes displaying a first-level user interface object on the display. The first-level user interface object may indicate that an ostomy appliance is wet-installed.

[0068] The term "user interface" here refers to a graphical representation of a collection of user interface objects. A user interface comprises one or more user interface objects. A user interface may be referred to as a user interface screen or a graphical user interface.

[0069] User interface objects (UI objects) refer here to graphical representations of objects displayed on the display of an accessory device. UI objects can be user-interactive or selectable via user input. For example, images (e.g., icons), buttons, and text (e.g., hyperlinks) may each optionally constitute a UI object. UI objects can form part of a widget. A widget can be considered a miniature application that can be used by and created by a user. UI objects may include prompts, application launch icons, and / or action menus. Input, such as a first input and / or a second input, may include touch (e.g., tap, pressure touch, long press) and / or contact movement (e.g., swipe gestures, such as for toggling). Contact movement can be detected, for example, on a touch-sensitive surface on the display of the accessory device. Therefore, the display may be a touch-sensitive display. Input, such as a first input and / or a second input, may include lifting off. Input, such as a first input and / or a second input, may include touching and moving, and then lifting off.

[0070] In one or more exemplary auxiliary devices, conveying a second-level indication includes displaying a second user interface object on the display of the auxiliary device that indicates a possible discharge leak.

[0071] In one or more exemplary auxiliary devices, the auxiliary device is configured to convey a first secondary indication via an interface based on whether the operation state during a first time period is a first secondary operation state.

[0072] The first and second-level operating states can indicate incorrect connections between the ostomy apparatus and the monitoring device, such as when water enters and / or discharge or other fluids remain in the connection during connection. In other words, the auxiliary device can be configured to determine incorrect connections between the monitoring device and the ostomy apparatus / sensor assembly, and, based on the determination of such connection errors, to convey first and second-level indications via an interface. The first and second-level indications can represent the first and second-level operating states.

[0073] In one or more exemplary auxiliary devices, conveying a first or second level indication includes displaying a first or second level user interface object on a display indicating an erroneous connection between the monitoring device and the ostomy appliance.

[0074] It should be noted that the description of the auxiliary device being configured to perform an action also applies to the corresponding action in the operation method of the auxiliary device, and vice versa.

[0075] Additionally, a computer-readable storage medium storing one or more programs is disclosed, the programs including instructions that, when executed by an accessory device having an interface, a memory, and a processor, cause the accessory device to operate in accordance with the method for monitoring an ostomy system as described herein.

[0076] An ostomy system comprising an ostomy appliance, a monitoring device, and an accessory device is disclosed, wherein the accessory device is as described herein.

[0077] An ostomy appliance includes a first adhesive layer. The first adhesive layer may be made of a first composition. The first composition may include one or more polyisobutylenes and / or styrene-isoprene-styrene. The first composition may include one or more hydrocolloids.

[0078] The first composition may be a pressure-sensitive adhesive composition suitable for medical purposes, comprising a rubbery elastomer substrate and one or more water-soluble or water-swellable hydrocolloids. The first composition may include one or more polybutenes, one or more styrene copolymers, one or more hydrocolloids, or any combination thereof. The combination of the adhesive properties of polybutene and the absorption properties of the hydrocolloids makes the first composition suitable for use in ostomy devices. The styrene copolymer may be, for example, a styrene-butadiene-styrene block copolymer or a styrene-isoprene-styrene block copolymer. Preferably, one or more styrene-isoprene-styrene (SIS) block copolymers are used. The amount of the 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 and polyisoprene. Polybutene is preferably present in an amount of 35% to 50% of the total adhesive composition. Preferably, the polybutene is polyisobutylene (PIB). The hydrocolloid suitable for incorporation into the first composition is selected from natural hydrocolloids, semi-synthetic hydrocolloids, and synthetic hydrocolloids. The first composition may contain 20-60% hydrocolloid. A preferred hydrocolloid is carboxymethyl cellulose (CMC). The first composition may optionally contain other components, such as fillers, thickeners, plasticizers, and other additives.

[0079] The first adhesive layer may have multiple sensor point openings. The sensor point openings of the first adhesive layer may optionally be configured to overlap with a portion of the electrode, for example, to form sensor points.

[0080] The sensor point openings in the first adhesive layer may include primary sensor point openings. These primary sensor point openings may include one or more primary first sensor point openings and one or more primary second sensor point openings, wherein the primary first sensor point openings are configured to overlap with a portion of an electrode, and the primary second sensor point openings are configured to overlap with a portion of another electrode that is different from the electrode that at least partially overlaps with the primary first sensor point opening.

[0081] The sensor point openings in the first adhesive layer may include secondary sensor point openings. These secondary sensor point openings may include one or more secondary first sensor point openings and one or more secondary second sensor point openings, wherein the secondary first sensor point openings are configured to overlap with a portion of an electrode, and the secondary second sensor point openings are configured to overlap with a portion of another electrode that is different from the electrode that at least partially overlaps with the secondary first sensor point opening.

[0082] The sensor point openings in the first adhesive layer may include tertiary sensor point openings. The tertiary sensor point openings may include one or more tertiary first sensor point openings and one or more tertiary second sensor point openings, the tertiary first sensor point openings being configured to overlap a portion of an electrode, and the tertiary second sensor point openings being configured to overlap a portion of another electrode, different from the electrode that at least partially overlaps with the tertiary first sensor point opening.

[0083] The first adhesive layer can have a substantially uniform thickness. The thickness of the first adhesive layer can be in the range of 0.1 mm to 1.5 mm, for example, in the range of 0.2 mm to 1.2 mm.

[0084] The first adhesive layer may have a primary thickness in the main portion of the first adhesive layer, for example, in the main region within or within the main radial distance from the center point of the stoma opening. The primary thickness may be in the range of 0.2 mm to 1.5 mm, for example, about 1.0 mm. The primary radial distance may be in the range of 20 mm to 50 mm, for example, in the range of 25 mm to 35 mm, for example, 30 mm.

[0085] The first adhesive layer may have a secondary thickness in a secondary region, such as in a secondary region outside or within a secondary radial distance from the center point of the stoma opening. The secondary thickness may be in the range of 0.2 mm to 1.0 mm, for example, about 0.5 mm. The secondary radial distance may be in the range of 20 mm to 50 mm, for example, in the range of 25 mm to 35 mm, for example, 30 mm.

[0086] The baseplate may include a second layer. This second layer may be an adhesive layer, also referred to as a rim adhesive layer. The second layer may have a second radial extension greater than the first radial extension of the first adhesive layer, at least within a first corner of the baseplate. Accordingly, a portion of the proximal surface of the second layer may be configured to attach to the user's skin surface. This portion of the proximal surface of the second layer configured to attach to the user's skin surface is also referred to as the skin-attachment surface of the second adhesive layer. The second layer may have an ostomy opening with a center point.

[0087] The second adhesive layer may be made from the second composition. The second composition may include one or more polyisobutylenes and / or styrene-isoprene-styrene. The second composition may include one or more hydrocolloids.

[0088] The second composition may be a pressure-sensitive adhesive composition suitable for medical purposes, comprising a rubbery elastomer substrate and one or more water-soluble or water-swellable hydrocolloids. The second composition may include one or more polybutenes, one or more styrene copolymers, one or more hydrocolloids, or any combination thereof. The combination of the viscous properties of polybutene and the absorbent properties of the hydrocolloid makes the second composition suitable for use in ostomy devices. The styrene copolymer may be, for example, a styrene-butadiene-styrene block copolymer or a styrene-isoprene-styrene block copolymer. Preferably, one or more styrene-isoprene-styrene (SIS) block copolymers are used. The amount of the 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 and polyisoprene. Polybutene is preferably present in an amount of 35% to 50% of the total adhesive composition. Preferably, the polybutene is polyisobutylene (PIB). The hydrocolloid suitable for incorporation into the second composition is selected from natural hydrocolloids, semi-synthetic hydrocolloids, and synthetic hydrocolloids. The second composition may contain 20-60% hydrocolloid. A preferred hydrocolloid is carboxymethyl cellulose (CMC). The second composition may optionally contain other components, such as fillers, thickeners, plasticizers, and other additives.

[0089] Different proportions of inclusions can alter the properties of the first and / or second adhesive layers. The second adhesive layer and the first adhesive layer can have different properties. The second adhesive layer (second composition) and the first adhesive layer (first composition) can have different proportions of polyisobutylene, styrene-isoprene-styrene, and / or hydrocolloids. For example, the second adhesive layer may provide stronger adhesion to the skin compared to the adhesion 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 have lower water absorption and / or sweat absorption than the first adhesive layer. Alternatively or additionally, the second adhesive layer may have lower moldability than the first adhesive layer. The second adhesive layer can provide a second leak-proof barrier.

[0090] The second layer can have a substantially uniform thickness. The thickness of the second layer can be in the range of 0.1 mm to 1.5 mm, for example, in the range of 0.2 mm to 1.0 mm, such as 0.5 mm, 0.6 mm, or 0.7 mm.

[0091] A base plate (e.g., an electrode assembly of the base plate) or an electrode assembly configured to be mounted on a proximal surface of the base plate includes one or more electrodes, such as multiple electrodes, such as two, three, four, five, six, seven, or more electrodes. These electrodes, such as some or all of the electrodes and / or a portion thereof, may be disposed between a first adhesive layer and a second adhesive layer. These electrodes may be disposed within the electrode assembly, such as the electrode layer. The electrodes include connections for connecting the electrodes to other components and / or interface terminals. The electrodes may include one or more conductor portions and / or one or more sensing portions. The electrode assembly may be disposed between the first adhesive layer and the second adhesive layer. The electrode assembly may be implemented as an addendum to the base plate and configured to be mounted on a proximal surface of the base plate. Thus, it can be said that the electrode assembly includes a first adhesive layer. The base plate, such as the electrode assembly, may include a first electrode, a second electrode, and optionally a third electrode. The base plate, such as the electrode assembly, may include a fourth electrode and / or a fifth electrode. The base plate, such as the electrode assembly, may optionally include a sixth electrode and / or a seventh electrode. The base plate, such as the electrode assembly, may include a ground electrode. The ground electrode may include a first electrode portion. The first electrode portion of the grounding electrode can form a ground for the first electrode. The grounding electrode may include a second electrode portion. The second electrode portion of the grounding electrode can form a ground for the second electrode. The grounding electrode may include a third electrode portion. The third electrode portion of the grounding electrode can form a ground for the third electrode. The grounding electrode may include a fourth electrode portion. The fourth electrode portion of the grounding electrode can form a ground for the fourth electrode and / or the fifth electrode.

[0092] A ground electrode, or an electrode portion thereof, may be configured as or form a (common) reference electrode for some or all of the other electrodes in an electrode assembly. A ground electrode may also be referred to as a reference electrode.

[0093] These electrodes are conductive and may include one or more of the following: metallic materials (e.g., silver, copper, gold, titanium, aluminum, stainless steel), ceramic materials (e.g., ITO), polymeric materials (e.g., PEDOT, PANI, PPy), and carbonaceous materials (e.g., carbon black, carbon nanotubes, carbon fibers, graphene, graphite).

[0094] Two electrodes in an electrode assembly can form a sensor. A first electrode and a ground electrode (e.g., a first electrode portion of the ground electrode) can form a first sensor or a first electrode pair. A second electrode and a ground electrode (e.g., a second electrode portion of the ground electrode) can form a second sensor or a second electrode pair. A third electrode and a ground electrode (e.g., a third electrode portion of the ground electrode) can form a third sensor or a third electrode pair. A fourth electrode and a ground electrode (e.g., a fourth electrode portion of the ground electrode) can form a fourth sensor or a fourth electrode pair. A fifth electrode and a ground electrode (e.g., a fifth electrode portion of the ground electrode) can form a fifth sensor or a fifth electrode pair. The fourth and fifth electrodes can also form a sixth sensor or a sixth electrode pair.

[0095] The first electrode can be formed in an open loop. The second electrode can be formed in an open loop, and / or the third electrode can be formed in an open loop. The fourth electrode can be formed in an open loop. The fifth electrode can be formed in an open loop. Multiple open-loop electrodes enable the arrangement of electrodes in a few or a single electrode layer.

[0096] The electrode assembly may include a support layer, also known as a support membrane. One or more electrodes may be formed, for example, printed on the proximal side of the support layer. One or more electrodes may be formed, for example, printed on the distal side of the support layer. The electrode assembly may have an ostomy opening with a central point.

[0097] The support layer may include polymeric materials (e.g., polyurethane, PTFE, PVDF) and / or ceramic materials (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 include one or more of the following: polyester, thermoplastic elastomer (TPE), polyamide, polyimide, ethylene-vinyl acetate (EVA), polyurea, and silicone, or materials thereof.

[0098] 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).

[0099] The electrode assembly / base plate may include a masking element configured to insulate at least a portion of the electrode from a first adhesive layer of the base plate. The masking element may include one or more, such as multiple, sensor point openings. The sensor point openings may include primary sensor point openings and / or secondary sensor point openings. The sensor point openings may include (multiple) tertiary sensor point openings. The sensor point openings may include (multiple) quaternary sensor point openings. Viewed in the axial direction, the sensor point openings of the masking element overlap with at least one electrode of the electrode assembly, for example, to form sensor points. For example, a primary sensor point opening may overlap with a portion of a ground electrode and / or a portion of a fourth electrode. A secondary sensor point opening may overlap with a portion of a fourth electrode and / or a portion of a fifth electrode. A tertiary sensor point opening may overlap with a portion of a fifth electrode and / or a portion of a ground electrode.

[0100] The masking element may include one or more terminal openings, such as multiple terminal openings. The masking element may include polymeric materials (e.g., polyurethane, PTFE, PVDF) and / or ceramic materials (e.g., alumina, silica). In one or more exemplary base plates, the masking element includes or is made of thermoplastic polyurethane (TPU). In one or more exemplary base plates, the masking element includes or is made of polyester. The masking element material may include one or more of the following: polyester, thermoplastic elastomer (TPE), polyamide, polyimide, ethylene-vinyl acetate (EVA), polyurea, and silicone, or be made of these materials.

[0101] Exemplary thermoplastic elastomers for masking elements 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).

[0102] 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.

[0103] The baseplate may include a release liner. The release liner is a protective layer that protects the adhesive layers(s) during transport and storage and is peeled off by the user before the baseplate is applied to the skin. The release liner may have an ostomy opening with a center point.

[0104] The base plate may include a top layer. The top layer is a protective layer that protects the adhesive layers(s) from external strain and stress when the user wears the stoma apparatus. Electrodes, such as some or all of them, may be positioned between the first adhesive layer and the top layer. The top layer may have a stoma opening with a center point. The thickness of the top layer may range from 0.01 mm to 1.0 mm, for example, from 0.02 mm to 0.2 mm, such as 0.04 mm.

[0105] The baseplate includes a monitor interface. The monitor interface can be configured to connect (e.g., electrical and / or mechanical) an ostomy appliance (baseplate) to a monitoring device. In other words, the ostomy appliance can be connected, is connectable to, or is configured to connect to the monitoring device. The monitor interface can be configured to wirelessly connect the ostomy appliance (baseplate) to the monitoring device. Therefore, the monitor interface of the baseplate is configured for electrical and / or mechanical connection of the ostomy appliance and the monitoring device.

[0106] The monitor interface of the base plate may include, for example, a coupling portion that serves as part of a first connector of the monitor interface, for forming a mechanical connection, such as a releasable connection, between the monitoring device and the base plate. The coupling portion may be configured to engage with the coupling portion of the monitoring device to releasably couple the monitoring device to the base plate.

[0107] The monitor interface of the base plate may include, for example, multiple terminals, such as two, three, four, five, six, seven, eight, or more terminals, for forming an electrical connection with corresponding terminals of the monitoring device, as part of a first connector of the monitor interface. The monitor interface may include a grounding 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 corresponding electrodes of the base plate / electrode assembly. A first intermediate element may be disposed between the terminal elements and a first adhesive layer. When viewed in the axial direction, the first intermediate element may cover or overlap the terminal elements(s) of the base plate. Therefore, the first adhesive layer may be protected or subjected to more uniformly distributed mechanical stress from the terminal elements of the base plate, thereby reducing the risk of the terminal elements puncturing or otherwise damaging the first adhesive layer. The first intermediate element can protect the first adhesive layer from the influence of the terminal elements on the base plate, or mechanically and / or electrically isolate the first adhesive layer from the terminal elements.

[0108] The base plate may include a connecting ring or other connecting member for attaching the stoma bag to the base plate (two-piece stoma device). The center point may be defined as the center of the connecting ring.

[0109] The baseplate has an stoma opening with a center point. The size and / or shape of the stoma opening is typically adjusted by the user or nurse to fit the user's stoma before the stoma instrument is applied. In one or more exemplary baseplates, the user forms the stoma opening during preparation of the baseplate for application.

[0110] The monitoring device includes a processor and one or more interfaces, such as a first interface and / or a second interface. The first interface is configured to connect the monitoring device to an ostomy appliance / baseplate. The second interface is configured to wirelessly connect the monitoring device to an accessory device. The monitoring device may include a memory for storing ostomy data or appliance data.

[0111] Monitoring device / processor The device is configured to acquire device data, such as stoma data, or parameter data based on stoma data, via terminals of a first interface, based on device measurements. The processor is configured to determine monitor data based on the device data. The monitoring device / processor is configured to transmit the monitor data to an auxiliary device.

[0112] The monitor data may include device data that optionally indicates the physical condition of the stoma device, such as data indicating the resistance, voltage, and current between one or more electrode pairs of the stoma device / electrode assembly. The device data may include stoma data indicating the physical condition of the stoma device, and / or parametric data based on the stoma data. In other words, the monitoring device may include stoma data and / or parametric data based on the stoma data.

[0113] The monitoring device includes a housing optionally made of plastic material. The housing may be an elongated housing having a first end and a second end. The housing has a length or maximum extension range in the range of 1 cm to 15 cm along its longitudinal axis. The housing may have a width or maximum extension range in the range of 0.5 cm to 3 cm perpendicular to its longitudinal axis. The housing may be curved.

[0114] The monitoring device includes a first interface. The first interface can be configured to electrically and / or mechanically connect the monitoring device to an appliance interface of an ostomy appliance. Therefore, the appliance interface is configured to electrically and / or mechanically connect the monitoring device to the ostomy appliance. The monitoring device can be connected, is connectable to, or is configured to connect to an ostomy appliance / electrode assembly. The first interface can be configured to electrically and / or mechanically connect the monitoring device to an accessory interface, such as a docking station. The first interface can be configured to connect to a docking station of the ostomy system, for example, to charge the monitoring device and / or to enable data transfer between the monitoring device and the docking station.

[0115] The first interface of the monitoring device may include multiple terminals, such as two, three, four, five, six, seven, eight, or more terminals, to form an electrical connection with corresponding terminals and / or electrodes of an ostomy appliance, and / or to detect erroneous connections between the monitoring device and the ostomy appliance / baseplate / electrode assembly. One or more terminals of the first interface may be configured to form an electrical connection with corresponding 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 may optionally include a sixth terminal and / or a seventh terminal. In one or more exemplary monitoring devices, the first interface has M terminals, where M is an integer ranging from 4 to 8.

[0116] The first interface of the monitoring device may include a coupling portion for forming a mechanical connection, such as a releasable coupling or connection, between the monitoring device and the base plate. The coupling portion and terminals of the first interface form at least a portion of the first connector of the monitoring device.

[0117] The monitoring device includes a power supply unit for supplying power to the monitoring device. The power supply unit may include a battery. The power supply unit may include a charging circuit system connected to the battery and terminals of a first interface for charging the battery via the first interface, such as a first connector. The first interface may include multiple individual charging terminals for charging the battery.

[0118] The monitoring device may include a sensor unit having one or more sensors. The sensor unit is connected to a processor to feed sensor data to the processor. The sensor unit may include an accelerometer for sensing acceleration and providing acceleration data to the processor. The sensor unit may include a temperature sensor for providing temperature data to the processor. Sensor data from one or more sensors of the monitoring device may be included in the monitoring device. Therefore, monitor data may include sensor data from one or more sensors in the monitoring device.

[0119] The monitoring device includes a second interface connected to the processor. This second interface can be configured as an accessory interface for connecting (e.g., wirelessly) the monitoring device to an accessory device. The monitoring device can be connected, is connectable to, or is configured to connect to multiple accessory devices. The second interface may include, for example, an antenna and a wireless transceiver configured for wireless communication at frequencies ranging from 2.4 to 2.5 GHz. The wireless transceiver may be a Bluetooth transceiver; that is, the wireless transceiver may be configured for wireless communication according to Bluetooth protocols (e.g., Bluetooth Low Energy, Bluetooth 4.0, Bluetooth 5). The second interface may optionally include a speaker and / or haptic feedback elements for providing audio signals and / or haptic feedback to the user, respectively.

[0120] In one or more exemplary ostomy systems, a monitoring device forms an integral part of the ostomy appliance; for example, the monitoring device may form an integral part of the base plate of the ostomy appliance.

[0121] An ostomy system may include a docking station that forms part of the ostomy system's accessories and / or, in addition to the accessories, a docking station. The docking station may be configured to electrically and / or mechanically connect monitoring devices to it.

[0122] The expansion dock may include a monitor expansion interface. The monitor expansion interface can be configured to electrically and / or mechanically connect a monitoring device to the expansion dock. The monitor expansion interface can be configured to wirelessly connect a monitoring device to the expansion dock. The monitor expansion interface of the expansion dock can be configured for electrically and / or mechanically connecting the expansion dock and the monitoring device.

[0123] The monitor expansion interface of the docking station may include, for example, a coupling portion as part of a first connector of the monitor expansion interface, for forming a mechanical connection, such as a releasable connection, between the monitoring device and the docking station. The coupling portion may be configured to engage with the coupling portion of the monitoring device to releasably connect the monitoring device to the docking station.

[0124] The monitor expansion interface of the docking station may include, for example, multiple terminals, such as two, three, four, five, six, seven, or more terminals, for forming an electrical connection with corresponding terminals of the monitoring device, as part of a first connector of the monitor expansion interface. The monitor expansion interface may include a ground terminal. The monitor expansion interface may include a first terminal and / or a second terminal. The docking station may include a third terminal. The monitor expansion interface may include a fourth terminal and / or a fifth terminal. The monitor expansion interface may optionally include a sixth terminal.

[0125] This disclosure provides a method for monitoring an ostomy system and its components (such as one or more of the following: an ostomy appliance, a monitoring device, and the connection between the ostomy appliance and the monitoring device, and the auxiliary device) performed in an auxiliary device. The auxiliary device includes an interface configured to communicate at least with the monitoring device and, optionally, with an ostomy appliance / electrode assembly positioned on a user's skin surface or any additional seal. The method includes, for example, obtaining (e.g., receiving and / or retrieving) monitor data from the monitoring device. This monitor data indicates the presence of fluid at the proximal side of the first adhesive layer of the ostomy appliance facing the skin surface / electrode assembly. In one or more exemplary methods, the method includes: determining, based on the monitor data, an operational state, i.e., a leakage state, at the proximal side of the first adhesive layer of the ostomy appliance, and conveying an indication of the leakage state of the ostomy appliance via the interface. In other words, the monitor data can be considered as an indication of the moisture status at the proximal side (or proximal surface) / electrode assembly of the first adhesive layer of the ostomy appliance. The presence of fluid at the proximal side (or proximal surface) of the first adhesive layer of the ostomy device can be deduced based on monitor data at the accessory device.

[0126] In one or more exemplary methods, the method may include: determining, based on monitor data, that an operational state is a first-level operational state. The first-level operational state may indicate the presence of liquid, such as discharge, mucus, sweat, and / or water, on the proximal side or proximal surface of a first adhesive layer of the stoma device / electrode assembly. The first-level operational state in this disclosure may indicate a dynamic internal state of the stoma device related to the presence of fluids and / or liquids (such as discharge, mucus, sweat, and / or water), such as the severity, urgency, and timing of leakage at the proximal side (or proximal surface) of the stoma device. By rapidly identifying the presence of fluids / liquids and determining the operational state as disclosed herein, the likelihood of an outcome where discharge extends beyond the proximal side (or proximal surface), for example, into the user's clothing, is significantly reduced. Such an outcome would be extremely unacceptable to users of stoma devices due to hygiene and social acceptance concerns.

[0127] The presence of fluids, such as discharges, mucus, sweat, and / or water, on the proximal side (or proximal surface) of the first adhesive layer may affect (e.g., reduce) the adhesive properties of the ostomy device. The presence of discharges on the proximal side of the first adhesive layer affects the wearability characteristics of the ostomy device, such as wear time and / or wearing comfort.

[0128] In this disclosure, the first level of operational status can be a leakage state, and it indicates whether the stoma device needs immediate replacement based on the presence of fluid on the proximal side (or proximal surface) of the first adhesive layer of the stoma device and / or the possible causes of the fluid presence. For example, the first level of operational status can indicate a high risk of fluid exceeding the proximal side (or proximal surface) based on the corresponding moisture pattern type.

[0129] The method includes conveying a first-level indication via an interface (e.g., outputting, transmitting, displaying). The first-level indication may be associated with a first-level operational state within a first time period.

[0130] The advantage of this disclosure is that users of ostomy devices or healthcare professionals can be informed about the status of the ostomy device and plan for its replacement. Furthermore, the disclosed method allows for more personalized feedback on the dynamic internal status of the ostomy system, such as the ostomy device, monitoring device, and / or the connection between the ostomy device and the monitoring device. Communicating instructions associated with the operational status of the ostomy device can help reduce the risk of leakage from the ostomy device (e.g., leakage of excrement from the ostomy device), which can remain on the skin for extended periods and increase the risk of skin damage (due to, for example, ostomy device malfunction or misalignment in the stoma). Additionally, communicating instructions associated with the operational status of the ostomy device can assist the user in manipulating, for example, applying, the ostomy device. Specifically, the determination of operational status and the communication of instructions according to this disclosure are performed based on monitor data indicating the presence of fluid on the proximal side (or proximal surface) of the stoma device, which is invisible to the user when the device is worn (because it is located below the base plate of the device). This achieves a significant improvement in the comfort provided by the stoma device, as the possible cause of the fluid presence is immediately communicated to the user via an accessory, thereby allowing for changes as quickly as possible and / or allowing the user to modify the stoma device application routine.

[0131] A key advantage is that the ostomy system can suggest improvements to the optimal installation / application routine, including the application of ostomy appliances and the connection of monitoring devices to the ostomy appliances.

[0132] This disclosure provides a highly comfortable, effective, and easy-to-use method for communicating the internal status of an ostomy appliance system. This disclosure allows for the derivation and instantaneous (e.g., substantially real-time) communication of instructions based on monitor data that is inaccessible or invisible to the user or healthcare professional. In other words, the disclosed method allows the user to be informed of the dynamic internal status of the ostomy appliance and / or the causes of the detected operational status. This allows the user to adjust routines to prevent leaks from reaching the user's clothing and attracting the attention of others nearby, ultimately improving the ostomy patient's life.

[0133] In one or more exemplary methods, the stoma device includes a stoma bag and a base plate. In one or more exemplary methods, the base plate includes a first adhesive layer having a proximal (or proximal surface). During use, the proximal surface of the first adhesive layer adheres to the periphery of the stoma under the user's skin and / or to additional sealants, such as sealant, sealing tape, and / or sealing rings. In one or more exemplary methods, obtaining monitor data includes obtaining monitor data indicating the presence of fluid at the proximal side of the first adhesive layer on the base plate. The presence of fluid at the proximal side of the first adhesive layer, such as on the proximal surface of the first adhesive layer, creates a conduction path, thereby reducing the resistance between electrodes of one or more electrode pairs disposed at or in the first adhesive layer.

[0134] In one or more exemplary methods, the monitor data includes ostomy data and / or parameter data. For example, parameter data is derived from ostomy data. Ostomy data or parameter data based on ostomy data is obtained from electrodes / sensors of an ostomy apparatus having a monitoring device. The monitoring device can be configured to process ostomy data and / or parameter data based on ostomy data to determine monitor data to be sent to and received by an auxiliary device.

[0135] In one or more exemplary methods, a plurality of electrodes of the baseplate / electrode assembly are configured to detect the presence of fluid proximally, in a primary sensing area (and / or a first zone), and a secondary sensing area (and / or a second zone), by measuring the electrical characteristics between pairs of electrodes. These electrical characteristics may indicate a conduction path in or at a first adhesive layer, thereby indicating the presence of fluid proximally to the first adhesive layer of the stoma device. In one or more exemplary methods, obtaining monitor data includes obtaining data representing measurements of electrical characteristics proximally to and / or in the first adhesive layer. In one or more exemplary methods, stoma data and / or parameter data indicate the resistance between any two of the plurality of electrodes, the capacitance and / or inductance between any two of the plurality of electrodes, and / or any changes thereto. In one or more exemplary methods, stoma data and / or parameter data indicate changes in resistance, capacitance, and / or inductance between the electrodes. In one or more exemplary methods, stoma data and / or parameter data include timing information, such as timestamp data or information from which timing can be derived.

[0136] In one or more exemplary methods, the monitor data includes local monitor data relating to a location and / or area proximal to the first adhesive layer of the baseplate. Determining the operational status may include determining leak location and / or leak time information. The location and / or area proximal to the first adhesive layer of the baseplate may be associated with a location proximal to the first adhesive layer where electrical properties have been measured by the one or more electrodes. In one or more exemplary methods, obtaining the monitor data includes obtaining (e.g., receiving from and / or retrieving from one or more devices in the stoma system) local monitor data relating to a location and / or area proximal to the first adhesive layer of the baseplate. In one or more exemplary methods, the local monitor data may relate to a first location, a second location, a third location. In one or more exemplary methods, the local monitor data may relate to a first area, a second area, and / or a third area proximal to the first adhesive layer of the baseplate. The operational status of the stoma apparatus may be based on a moisture pattern type determined using parameter data obtained, for example, from one or more devices, such as a monitoring device connected to a baseplate / electrode assembly having, for example, electrodes placed in a corresponding area of ​​the baseplate (e.g., ...). Figure 6 electrodes and / or Figure 7 (Sensor point opening).

[0137] In one or more exemplary methods, the monitor data may include first local monitor data and second local monitor data, the first local monitor data indicating the presence of fluid at a first location proximal to the first adhesive layer of the substrate or in a first region proximal to the first adhesive layer of the substrate, and the second local monitor data indicating the presence of fluid at a second location proximal to the first adhesive layer of the substrate or in a second region proximal to the first adhesive layer of the substrate. For example, parameter data may include first parameter data indicating the presence of fluid in the first region and / or primary sensing region. For example, parameter data may include second parameter data indicating the presence of fluid in the second region and / or secondary sensing region. For example, parameter data may include third parameter data indicating the presence of fluid in the third region and / or tertiary sensing region.

[0138] In one or more exemplary methods, determining the operational status of an ostomy appliance / ostomy system based on monitor data includes: determining one or more moisture pattern types based on monitor data, such as ostomy data and / or parameter data (e.g., first parameter data and optional second parameter data), such as measurements obtained through electrodes, such as measurements of resistance, capacitance, and / or inductance, such as timing information, for example, a first primary sensing area (and / or a first zone) and an optional second primary sensing area (and / or a second zone), including monitor data, such as ostomy data and / or parameter data (e.g., first parameter data and optional second parameter data), including measurements obtained through electrodes, such as measurements of resistance, capacitance, and / or inductance, including timing information. The moisture pattern type may optionally indicate the risk of leakage of the ostomy appliance and / or the risk of skin damage to the user of the ostomy system. In one or more exemplary methods, determining the operational status of an ostomy appliance based on monitor data includes: determining one or more moisture pattern types based on first parameter data (and optional second parameter data and optional third parameter).

[0139] In one or more exemplary methods, determining one or more moisture pattern types may include selecting a moisture pattern type from a set of predefined moisture pattern types. This set of predefined moisture pattern types may include a number of K moisture pattern types, such as at least three, at least four, or at least five moisture pattern types. The number of moisture pattern types K may be in the range of four to twenty.

[0140] In one or more exemplary methods, the method includes: determining whether an operating state meets a first-level indicator, and setting the operating state to a first-level operating state based on the determination that the first-level indicator is met. The first-level indicator may include one or more indicators, such as a first indicator, a second indicator, and a third indicator. In one or more exemplary methods, the first-level indicator can be met if the resistance between the electrodes of an electrode pair of an electrode assembly (e.g., the outermost electrode pair) is below a threshold value.

[0141] In one or more exemplary methods, determining the operational status of an ostomy appliance based on monitor data includes: determining the operational status based on one or more moisture pattern types, such as determining the operational status as a first-level moisture pattern type. Several different moisture pattern types can reflect the same operational status. In other words, determining the operational status of an ostomy appliance / ostomy system / baseplate may include determining the moisture pattern type based on monitor data and reflecting the operational status using the moisture pattern type.

[0142] The international patent application number PCT / DK2018 / 050396 assigned to the applicant discloses an example of determining the operational status of an ostomy appliance / ostomy system.

[0143] In one or more exemplary methods, the interface includes one or more of an audio interface, a visual interface (such as a display), and a transceiver module.

[0144] In one or more exemplary methods, conveying an instruction via a display includes: displaying a user interface on a visual interface (e.g., a display) of an accessory device, the user interface including one or more user interface objects representing the instruction, such as multiple first-level user interface objects representing a first-level operational state within a first time period and multiple second user interface objects representing a first-level operational state within a second time period. The user interface objects may represent one or more determined moisture mode types, such as a first moisture mode type, a second moisture mode type, and / or a third moisture mode type.

[0145] User interface objects may include one or more visual indicators representing the operational status within a given time period, such as a first visual indicator, a second visual indicator, and / or a third visual indicator. The visual indicators may be text prompts that indicate the operational status of the ostomy apparatus and / or the possible causes of the operation to the user.

[0146] In one or more exemplary methods / apparatus, conveying instructions includes notifying a user via an interface, such as by displaying a notification on the apparatus's display (e.g., the lock screen and / or home screen). The notification may include an operational status or associated user interface object representing a given time period. The notification may include a notification indicator for opening an application related to the stoma device. The method may include: detecting input to the notification indicator; opening the application related to the stoma device in response to the input; and displaying an operational status or associated user interface object representing a given time period on the apparatus's display in response to the opening of the application.

[0147] The memory can be configured to store monitor data and / or operational status. The interface is configured to convey instructions to the user via an interface, such as an audio interface, a visual interface, and / or a transceiver module. The audio interface includes, for example, a speaker and / or a microphone. The visual interface includes, for example, a display, such as a touch-sensitive display. The transceiver module includes, for example, an antenna and / or a radio transceiver.

[0148] The processor can be configured to instruct the interface to display a user interface that includes multiple user interface objects.

[0149] The auxiliary device may include a user application configured to convey instructions via an interface. The user application may be a dedicated ostomy application that assists the user in monitoring the internal leakage status of the ostomy appliance / ostomy system and thereby reducing the likelihood of serious leaks reaching the user's clothing.

[0150] Figure 1 An exemplary ostomy system is illustrated. The ostomy system 1 includes an ostomy appliance 2, which includes a base plate 4 and an ostomy bag (not shown). Additionally, the ostomy system 1 includes a monitoring device 6 and an auxiliary device 8 (mobile device). The monitoring device 6 is connectable to or connected to the electrode assembly / base plate 4 via a corresponding first connector of the monitoring device 6 and the base plate 4. The monitoring device 6 is configured to wirelessly communicate with the auxiliary device 8, i.e., the monitoring device is wirelessly connected or can be wirelessly connected to the auxiliary device. Optionally, the auxiliary device 8 is configured to communicate, for example, with a server device 10 of the ostomy system 1 via a network 12. The server device 10 may be operated and / or controlled by the ostomy appliance manufacturer and / or service center. Ostomy data or parametric data based on the ostomy data is obtained from the electrodes / sensors of the ostomy appliance 2 having the monitoring device 6. The monitoring device 6 processes the ostomy data and / or the parametric data based on the ostomy data to determine the monitoring data to be sent to the auxiliary device 8. In the demonstrated stoma system, the accessory device 8 is a mobile phone, but it can be implemented as another handheld device, such as a tablet or a wearable device, such as a watch or other wrist-worn electronic device. Therefore, the monitoring device 6 is configured to determine monitor data and transmit it to the accessory device 8, and the accessory device 8 is configured to obtain, for example, receive monitor data from the monitoring device. The base plate 4 includes a connecting member 14 in the form of a connecting ring 16 for attaching a stoma bag (not shown) to the base plate (a two-piece stoma 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 nurse to fit the user's stoma before the stoma appliance is applied.

[0151] The stoma system 1 optionally includes a docking station 20 forming an accessory device of the stoma system 1. The docking station 20 includes a monitor expansion interface comprising a first connector 22 configured to electrically and / or mechanically connect a monitor device 6 to the docking station 20. The monitor expansion interface can be configured to wirelessly connect a monitor device to the docking station. The docking station 20 includes a user interface 24 for receiving user input and / or providing feedback to the user regarding the operational status of the docking station 20. The user interface 24 may include a touchscreen. The user interface 24 may include one or more physical buttons and / or one or more visual indicators, such as light-emitting diodes.

[0152] Figure 2 This is a schematic block diagram of an exemplary monitoring device. The monitoring device 6 includes monitoring device housings 100 and 101 and one or more interfaces, including a first interface 102 (instrument interface) and a second interface 104 (accessory interface). The monitoring device 6 includes a memory 106 for storing ostomy data and / or parameter data based on the ostomy data. The memory 106 is connected to the processor 101 and / or the first interface 102.

[0153] The first interface 102 is configured to electrically and / or mechanically connect the monitor device 6 to an ostomy appliance, such as the appliance interface of the ostomy appliance 2. The first interface 102 includes a plurality of terminals to form electrical connections with corresponding terminals of the ostomy appliance 2 (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. Optionally, the first interface 102 includes a fourth terminal 116 and a fifth terminal 118. The first interface 102 of the monitor device 6 includes a coupling portion 120 for forming a mechanical connection, such as a releasable connection, between the monitor device and the base plate. The coupling portion 120 and terminals 108, 110, 112, 114, 116, and 118 of the first interface 102 form at least a portion of a first connector for the monitor device 6.

[0154] The monitor device 6 includes a power supply unit 121 for supplying power to the monitor device and its active components. Specifically, the power supply unit 121 is connected to the processor 101, the first interface 102, the second interface 104, and the memory 106. The power supply unit includes a battery and a charging circuit system. The charging circuit system is connected to the battery and terminals of the first interface 102 to charge the battery via terminals of the first interface, such as terminals of the first connector.

[0155] The second interface 104 of the monitor device is configured as an accessory interface for connecting the monitor device 6 to one or more accessory devices, such as accessory device 8. The second interface 104 includes an antenna 122 and a wireless transceiver 124 configured for wireless communication with the accessory devices(s). Optionally, the second interface 104 includes a speaker 126 and / or a haptic feedback element 128 for providing appropriate audio signals and / or haptic feedback to the user.

[0156] The monitoring device 6 includes a sensor unit 140 connected to the processor 101. The sensor unit 140 includes a temperature sensor for feeding temperature data to the processor, and a G-sensor or accelerometer for feeding acceleration data to the processor 101.

[0157] Monitoring device 6 / Processor 101 The processor is configured to acquire instrument data, such as stoma data or parametric data based on stoma data, via terminals 108, 110, 112, 114, 116, and 118 of the first interface 102, based on instrument measurements. The processor is configured to determine monitor data based on the instrument data. The monitoring device 6 / processor 101 is configured to wirelessly transmit monitor data to the auxiliary device 8 via the second interface 104.

[0158] Figure 3 An exploded view of an exemplary base plate of an ostomy device is shown. The base plate 4 includes a first adhesive layer 200. During use, the proximal surface of the first adhesive layer 200 adheres to the peristaltic area of ​​the user's skin and / or to additional sealants, such as sealant, 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 in an electrode assembly 204. The electrode assembly 204 is disposed between the first adhesive layer 200 and the second adhesive layer 202. The electrode assembly 204 includes a support layer in which electrodes are formed on the proximal surface of the support layer. The base plate 4 includes a release liner 206 that the user peels off before applying the base plate 4 to the skin. The base plate 4 includes a top layer 208 and a connecting ring 209 for attaching an ostomy bag to the base plate 4. The top layer 208 is a protective layer that protects the second adhesive layer 202 from external strain and stress during use.

[0159] The base plate 4 includes a monitor interface. The monitor interface is configured to electrically and / or mechanically connect an ostomy appliance (base plate 4) to a monitor device. The monitor interface of the base plate includes a coupling portion 210 for forming a mechanical connection, such as a releasable connection, between the monitor device and the base plate. The coupling portion 210 is configured to engage with a coupling portion of the monitor device to releasably connect the monitor device to the base plate 4. Further, the monitor interface of the base plate 4 includes a plurality of terminal elements, each forming a plurality of terminals 212 for forming an electrical connection with a corresponding 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 forming the terminals 212 and a first adhesive layer (not shown). When viewed in the axial direction, the first intermediate element 213 covers the terminal elements of the terminal 212 forming the base plate 4 and protects the first adhesive layer from the mechanical stress of the terminal elements from the base plate.

[0160] Figure 4 An exploded view of an exemplary electrode assembly 204 of the base plate is shown. The electrode assembly 204 includes a support layer 214 having a proximal surface 214B and a plurality of electrodes 216 disposed proximal to the support layer 214, including a ground electrode, a first electrode, a second electrode, a third electrode, a fourth electrode, and a fifth electrode, wherein each electrode has a corresponding connection portion for connecting the electrode to a corresponding terminal element of a monitor interface. Additionally, the electrode assembly 204 includes a masking element 218 having a proximal surface 218B and configured to insulate the electrode portions of the electrodes 216 from a first adhesive layer of the base plate. Viewed in the axial direction, the masking element 218 covers or overlaps with a portion of the electrodes 216.

[0161] Figure 5 This is a near-side view of the near-side surface of the base plate portion 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). When viewed in the axial direction, the first intermediate element 213 covers the terminal elements of the base plate 4 and protects the first adhesive layer from the mechanical stresses emanating from the terminal elements of the base plate.

[0162] Figure 6This is a remote view of an exemplary electrode configuration 220 for electrode 216 of electrode assembly 204. 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. Ground electrode 222 includes a ground connection portion 222A, and the first electrode 224 includes a first connection portion 224A. The second electrode 226 includes a second connection portion 226A, and the third electrode 228 includes a third connection portion 228A. The fourth electrode 230 includes a fourth connection portion 230A, and the fifth electrode 232 includes a fifth connection portion 232A.

[0163] The fourth electrode 230 includes a plurality of fourth sensing units 230B. The fifth electrode 232 includes a plurality of fifth sensing units 232B.

[0164] Grounding electrode 222 includes a first electrode portion 234 for grounding the first electrode 224. Grounding electrode 222 includes a second electrode portion 236 for grounding the second electrode 226. Grounding electrode 222 includes a third electrode portion 238 for grounding the third electrode 228. Grounding electrode 222 includes a fourth electrode portion 240 for grounding the fourth electrode 230 and the fifth electrode 232. The fourth electrode portion 240 of grounding electrode 222 includes a plurality of ground sensing portions 222B.

[0165] Figure 7 This is a rear view of an exemplary masking element. The masking element 218 optionally has a plurality of terminal openings (including six terminal openings). The plurality of terminal openings 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, and 252 of the masking element 218 are configured to overlap and / or align with corresponding connections 222A, 224A, 226A, 228A, 230A, and 232A of the electrodes of the electrode assembly.

[0166] The masking element 218 has a plurality of sensing point openings. These sensor point openings include primary sensor point openings shown within dashed lines 254, each primary sensor point opening configured to overlap with a portion of the ground electrode 222 and / or a portion of the fourth electrode 230. In the illustrated exemplary masking element, the primary sensor point openings 254 include five primary first sensor point openings 254A, each primary first sensor point opening configured to overlap with a portion of the ground electrode 222. In the illustrated exemplary masking element, the primary sensor point openings 254 include four primary second sensor point openings 254B, each primary second sensor point opening configured to overlap with a portion of the fourth electrode 230. These sensor point openings include secondary sensor point openings shown within dashed lines 256, each second sensor point opening configured to overlap with a portion of the fourth electrode 230 and / or a portion of the fifth electrode 232. In the illustrated exemplary masking element, the secondary sensor point openings 256 include five secondary first sensor point openings 256A, each secondary first sensor point opening configured to overlap with a portion of the fifth electrode 232. In the illustrated exemplary masking element, the secondary sensor point opening 256 includes four secondary second sensor point openings 256B, each configured to overlap a portion of the fourth electrode 230. These sensor point openings include tertiary sensor point openings shown within dashed lines 258, each configured to overlap a portion of the fifth electrode 232 and / or a portion of the ground electrode 222. In the illustrated exemplary masking element, the tertiary sensor point opening 258 includes five tertiary first sensor point openings 258A, each configured to overlap a portion of the fifth electrode 232. In the illustrated exemplary masking element, the tertiary sensor point opening 258 includes four tertiary second sensor point openings 258B, each configured to overlap a portion of the ground electrode 222.

[0167] Figure 8This is a distal view of an exemplary first adhesive layer. The first adhesive layer 200 has a plurality of sensing point openings. The sensing point openings of the first adhesive layer include primary sensing point openings shown within dashed lines 260, each primary sensing point opening being configured to overlap with a portion of the ground electrode 222 and / or a portion of the fourth electrode 230 of the electrode assembly. In the illustrated exemplary first adhesive layer, the primary sensor point openings 260 include five primary first sensor point openings 260A, each primary first sensor point opening being configured to overlap with a portion of the ground electrode 222. In the illustrated exemplary first adhesive layer, the primary sensor point openings 260 include four primary second sensor point openings 260B, each primary second sensor point opening being configured to overlap with a portion of the fourth electrode 230. The sensing point openings of the first adhesive layer include secondary sensing point openings shown within dashed lines 262, each secondary sensing point opening being configured to overlap with a portion of the fourth electrode 230 and / or a portion of the fifth electrode 232 of the electrode assembly. In the illustrated exemplary first adhesive layer, the secondary sensor point opening 262 includes five secondary first sensor point openings 262A, each configured to overlap a portion of the fifth electrode 232. In the illustrated exemplary first adhesive layer, the secondary sensor point opening 262 includes four secondary second sensor point openings 262B, each configured to overlap a portion of the fourth electrode 230. The sensing point openings of the first adhesive layer include tertiary sensing point openings shown within dashed lines 264, each configured to overlap a portion of the fifth electrode 232 of the electrode assembly and / or a portion of the ground electrode 222. In the illustrated exemplary first adhesive layer, the tertiary sensor point opening 264 includes five tertiary first sensor point openings 264A, each configured to overlap a portion of the fifth electrode 232. In the exemplary first adhesive layer shown, the tertiary sensor point opening 264 includes four tertiary second sensor point openings 264B, each of which is configured to overlap a portion of the ground electrode 222. Figure 9 yes Figure 8 A near-side view of the first adhesive layer.

[0168] Figure 10 This is a more detailed rear view of a portion 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 monitoring device to the base plate, thereby forming a releasable connection. The first connector 221 / monitor interface includes a plurality of terminals formed by corresponding terminal elements for forming corresponding electrical connections with corresponding terminals of the monitoring device.

[0169] The plurality of 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, and 292 contact the electrodes 222, 224, 226, 228, 230, and 232 with corresponding connection portions 222A, 224A, 226A, 228A, 230a, and 232A.

[0170] The position of the first connector on the base plate, the number of terminals, and the position of the terminals in the connecting part can be adapted to the electrode configuration used in the electrode assembly of the base plate.

[0171] Figure 11 This is a block diagram illustrating an exemplary accessory device 400 according to this disclosure. The accessory device 400 forms part of an ostomy system and is capable of supporting monitoring of the operational status of the ostomy system / ostomy appliance / plate placed on the user's skin. The accessory device 400 includes a memory 401; a processor 402 coupled to the memory 401; and an interface 403 coupled to the processor 402.

[0172] Peripheral devices (such as memory 401 and / or interface 403) can be operatively and communicatively connected to processor 402 via a bus to transmit data. Processor 402 may be a central processing unit (CPU), but other suitable microprocessors are also envisioned.

[0173] Interface 403 is configured to connect an accessory device to a monitoring device of the ostomy system, and the interface includes a transceiver module 403A connected to processor 402.

[0174] Interface 403 can be configured to communicate with one or more devices of an ostomy system. These devices include monitoring devices and / or ostomy instruments configured to be placed on the user's skin surface and / or any additional seal. Interface 403 may include a display 403B as a visual interface for the user. Interface 403 is configured to establish a wireless connection between the monitoring devices and auxiliary devices.

[0175] Interface 403 is configured to obtain monitor data from a monitoring device, such as receiving or retrieving monitor data. This monitor data may indicate the status of the stoma device, the monitoring device, and the connection between the stoma device and the monitoring device, such as the status of the proximal side (pointing towards the skin surface) of the first adhesive layer of the stoma device. In one or more exemplary auxiliary devices, the monitor data includes device data, such as stoma data, obtained from the stoma device via interface 403.

[0176] The processor 402 can be configured to determine the operational status of ostomy instruments based on monitor data.

[0177] The processor 402 is configured to determine the operational status of the stoma system, for example, within a first time period after a first event, based on monitor data; to transmit a first-level instruction via the interface, based on the operational status of the first time period as a first-level operational status; to determine the operational status of the stoma system, for example, within a second time period after the first time period or after a second event, based on the monitor data; and to transmit a second instruction, different from the first-level instruction, via the interface, based on the operational status of the second time period as a first-level operational status.

[0178] The accessory device's display can be configured to detect touch (e.g., the display is a touch-sensitive display), and input includes contact on the touch-sensitive display. The touch-sensitive display provides an input and output interface between the accessory device and the user. The accessory device's processor can be configured to receive electrical signals from and / or send electrical signals to the touch-sensitive display. The touch-sensitive display is configured to display visual output to the user. Visual output (such as user interface objects displayed on the display) may optionally include graphics, text, icons, video, and any combination thereof (collectively, "graphics"). For example, some or all of the visual output may be considered to correspond to a user interface object.

[0179] The processor of the auxiliary device can be configured to display one or more user interfaces, such as a user interface screen, on a display, including a first user interface and / or a second user interface. The first user interface may be associated with a first time period, and / or the second user interface may be associated with a second time period. A user interface may include one or more user interface objects. For example, the first user interface may include a first-level user interface object and / or a first-level user interface object. The second user interface may include one or more second user interface objects, such as a second-level user interface object and / or a second-level user interface object. The user interface objects (such as the first-level user interface object and / or the second user interface object) may represent / indicate the operating status of the baseboard during a certain time period.

[0180] The accessory device 400 is optionally configured to receive user input indicating a first event via interface 403.

[0181] The stoma device optionally includes a stoma bag and a base plate, the base plate including a first adhesive layer having a proximal side, and one or more electrodes configured to measure electrical properties at or in the first adhesive layer, and in the accessory device 400, obtaining monitor data includes obtaining stoma data representing electrical properties.

[0182] In the auxiliary device 400, the first time period has a length of less than 15 minutes. The length of the first time period can be less than 10 minutes, for example, in the range of 1 second to 5 minutes, such as 2 minutes, 3 minutes, or 4 minutes. In one or more exemplary methods, the first time period has a length of less than 1 minute, for example, in the range of 15 seconds to 45 seconds. A relatively short first time period (e.g., less than 1 minute) may be sufficient to detect possible erroneous manipulation without causing delay to the user during the application routine.

[0183] In the auxiliary device 400, the first-level operating state can indicate the presence of liquid or fluid, such as discharge, mucus, water and / or sweat, on the proximal side of the base plate.

[0184] In one or more exemplary accessories, interface 403 includes display 403B, and wherein conveying a first-level instruction includes displaying a first-level user interface object on the display. The first-level user interface object may indicate that an ostomy appliance is wet-installed.

[0185] The term "user interface" here refers to a graphical representation of a collection of user interface objects. A user interface comprises one or more user interface objects. A user interface may be referred to as a user interface screen or a graphical user interface.

[0186] User interface objects (UI objects) refer here to graphical representations of objects displayed on the display of an accessory device. UI objects can be user-interactive or selectable via user input. For example, images (e.g., icons), buttons, and text (e.g., hyperlinks) may each optionally constitute a UI object. UI objects can form part of a widget. A widget can be considered a miniature application that can be used by and created by a user. UI objects may include prompts, application launch icons, and / or action menus. Input, such as a first input and / or a second input, may include touch (e.g., tap, pressure touch, long press) and / or contact movement (e.g., swipe gestures, such as for toggling). Contact movement can be detected, for example, on a touch-sensitive surface on the display of the accessory device. Therefore, the display may be a touch-sensitive display. Input, such as a first input and / or a second input, may include lifting off. Input, such as a first input and / or a second input, may include touching and moving, and then lifting off.

[0187] In the accessory device 400, conveying a second-level indication may optionally include displaying a second user interface object on the accessory device's display indicating a possible discharge leak.

[0188] In the auxiliary device 400, the auxiliary device 400 is optionally configured to transmit a first secondary instruction via an interface based on whether the operation state during a first time period is a first secondary operation state.

[0189] The first and second level operating states can indicate incorrect connections between the stoma device and the monitoring device. In other words, the auxiliary device can be configured to determine if there is a connection error between the monitoring device and the stoma device / sensor assembly, and based on the determination of the connection error, to convey a first and second level indication via an interface. The first and second level indication can represent the first and second level operating states.

[0190] In the auxiliary device 400, conveying first and second-level instructions may optionally include displaying a first and second-level user interface object on a display indicating an erroneous connection between the monitoring device and the ostomy instrument.

[0191] Processor 402 is optionally configured to perform Figure 12A and Figure 12B Any operations disclosed in the document.

[0192] Processor 402 may optionally be configured to perform Figure 12A and Figure 12BAny operation disclosed herein (e.g., any one or more of S504, S506, S508, S508A, S508B, S510, S512, S514, S514A, S514B, S516, S518, S520, S520A, S520B, S522, S522A, S522B). The operation of the auxiliary device 400 may be implemented in the form of executable logic routines (e.g., lines of code, software programs, etc.) stored on a non-transitory computer-readable medium (e.g., memory 401) and executed by processor 402.

[0193] Furthermore, the operation of the auxiliary device 400 can be considered as a method configured to be performed by the auxiliary device 400. Moreover, although the described functions and operations can be implemented in software, such functions can also be implemented by dedicated hardware or firmware, or some combination of hardware, firmware and / or software.

[0194] Memory 401 can be one or more of the following: a buffer, flash memory, hard disk drive, removable media, volatile memory, non-volatile memory, random access memory (RAM), or other suitable means. In a typical arrangement, memory 401 may include non-volatile memory for long-term data storage and volatile memory used as system memory for processor 402. Memory 401 can exchange data with processor 402 via a data bus. Control lines and an address bus may also exist between memory 401 and processor 402. Figure 4 (Not shown in the image). Memory 401 is considered a non-transitory computer-readable medium.

[0195] Figure 12A and Figure 12B A flowchart of an exemplary method 500 for monitoring an ostomy system is shown. The ostomy system includes a monitoring device, and an ostomy appliance includes a base plate configured to be placed on the surface of a user's skin. Method 500 is a method for monitoring an ostomy system performed in an accessory device, the ostomy system including the monitoring device and the ostomy appliance including the base plate configured to be placed on the surface of a user's skin, the accessory device including an interface configured to communicate with at least the monitoring device of the ostomy system. Method 500 includes: obtaining monitor data from the monitoring device S502, the monitor data indicating the status of the ostomy system; and determining, based on the monitor data, the operational status of the ostomy system S504, such as the operational status of the base plate, during a first time period after a first event.

[0196] Method 500 optionally includes: determining whether the operation state of the first time period S506 is a first-level operation state; and, based on whether the operation state of the first time period is the first-level operation state OS_1_1, conveying a first-level instruction S508 via the interface. Conveying the first-level instruction S508 optionally includes displaying a first-level user interface object S508A on the display of the auxiliary device. Conveying the first-level instruction S508 optionally includes outputting a first-level audio output S508C. Therefore, the chances of the user noticing the first-level instruction can be increased, which may be important shortly after the application of the ostomy instrument. Furthermore, the need for confidentiality of notification may not be important during the first time period, as the user has just applied a new ostomy instrument and is therefore in a private situation under any circumstances.

[0197] The first-level operating status can optionally indicate the presence of liquid or fluid, such as water, excrement, sweat, and / or mucus, on the proximal side of the baseplate. The first-level user interface object can indicate maloperation of the stoma device, such as during baseplate application, or indicate wet installation of the stoma device. Wet installation should be understood as the presence of liquid, such as water, sweat, mucus, and / or excrement, between the first adhesive layer / electrode assembly of the baseplate and the user's skin during and / or shortly thereafter (i.e., within the first time period).

[0198] Method 500 includes: determining, based on the monitor data, the operational status of the S510 stoma system, for example, during a second time period after a first time period and / or after a second event; optionally, determining whether the operational status of the second time period is a first-level operational status; and, based on whether the operational status of the second time period is a first-level operational status, conveying via the interface a second-level indication, different from the first-level indication, of S514. Conveying the second-level indication of S514 optionally includes displaying a second-level user interface object of S514A on a display of an auxiliary device.

[0199] In method 500, the operational status of the stoma system may include the operational status of the baseplate, which may optionally indicate the adhesive properties of the baseplate and / or the presence of fluid (e.g., one or more of discharge, water, sweat, and mucus) on the proximal side or proximal surface of the first adhesive layer. In method 500, the operational status of the stoma system may include the operational status of the stoma apparatus and / or the operational status of the connection between the stoma apparatus and the monitoring device.

[0200] The first event can be a connection event where the monitoring device connects to the ostomy instrument. This connection event can be detected by the monitor, and a connection indicator (such as a connection timestamp) can be included in the monitoring device. The first event can also be an application event where the ostomy instrument is applied to the user's skin. Alternatively, the first event can be a connection event where the monitoring device connects to an accessory device. This connection event can be detected by the accessory device. Finally, the first event can be a user input event indicating the first event, i.e., when user input is detected by the accessory device, for example, on a user interface object on a touch-sensitive display.

[0201] In method 500, the end of the first time period can trigger or become the start of the second time period. In other words, the first and second time periods can be separate and non-overlapping. In one or more exemplary methods, a second event can trigger or become the start of the second time period. The second event can be a user input event indicating the second event, i.e., when user input is detected on a user interface object on an auxiliary device, such as a touch-sensitive display. The second event can be a time following the user input event indicating the second event, for example, 30 seconds after informing the user that the ostomy system is ready for use (i.e., the application routine is complete). Monitor data can indicate the physical condition of the baseplate, such as the dynamic internal state of the baseplate. Monitor data can indicate the presence of moisture at the baseplate / first adhesive layer and / or the first adhesive layer, such as the presence of moisture between the first adhesive layer and the user's skin.

[0202] Method 500 may optionally include receiving user input indicating the first event via the interface (e.g., via a touch-sensitive display), such as by having a user tap a user interface object of the user interface.

[0203] In method 500, the stoma device includes a base plate having a first adhesive layer having a proximal side, and one or more electrodes configured to measure electrical properties at or in the first adhesive layer, wherein obtaining monitor data optionally includes obtaining stoma data representing measurements of electrical properties in S502A.

[0204] In one or more exemplary methods for monitoring a stoma system, a first time period has a length of less than 15 minutes. The length of the first time period can be less than 10 minutes, for example, in the range of 1 second to 5 minutes, such as 2 minutes, 3 minutes, or 4 minutes. In one or more exemplary methods, the first time period has a length of less than 1 minute, for example, in the range of 15 seconds to 45 seconds. A relatively short first time period (e.g., less than 1 minute) may be sufficient to detect potential erroneous manipulation without causing delay to the user during the application of the routine.

[0205] This method may include, for example, determining an S508B first-level indication based on the first time or the start of a first time period after a first event. The first-level user object may indicate one or more of the following: a first time, a first-level operating state, a reason for the first-level operating state, and a recommended action. The first-level user object may include first-level text. Examples of first-level text may be: "Liquid has been detected between the baseplate and your skin, possibly due to misuse of your baseplate," "Your skin is wet; please replace your baseplate and ensure your skin is properly dry or clean," or "Liquid was detected 10 seconds after application due to wet installation of your baseplate; please replace it." Determining the S508B first-level indication may include selecting a first-level user interface object from a set of user interface objects.

[0206] In method 500, conveying the second-level indication of S514 may optionally include displaying a second-level user interface object of S514A, for example, indicating a possible discharge leak, on the display of the accessory device.

[0207] This method may include, for example, determining an S514B second-level indication based on a second time or the start of a second time period following a second event. The second-level user object may indicate one or more of the following: a second time, a first-level operational state, the cause of the first-level operational state, and a recommended action. The second-level user object may include second-level text. Examples of second-level text may be "Liquid has been detected between the baseplate and your skin, indicating a high risk of leakage," or "Check your baseplate; a leak may occur immediately."

[0208] Second-level user objects can be divided into multiple second-level user interface objects. Determining a second-level indicator can include selecting a second-level user interface object from a set of user interface objects.

[0209] Method 500 optionally includes: determining whether the operating state of the first time period S518 is a first-level operating state, and, based on the operating state being the first-level operating state OS_1_2 during the first time period, conveying a first-level indication S520 via an interface. The first-level operating state may indicate erroneous operation of the monitoring device during the connection of the stoma device / electrode assembly, and / or indicate an incorrect connection between the stoma device and the monitoring device. In method 500, conveying the first-level indication S520 optionally includes displaying a first-level user interface object S520A on the display of the auxiliary device. The first-level user interface object may indicate, for example, an incorrect connection between the monitoring device and the stoma device due to the presence of liquid in the connection between the monitoring device and the stoma device, for example, including first-level text such as "The connection between the monitoring device and the stoma device is wet; please keep the connection dry."

[0210] Method 500 may optionally include: determining whether the operation state of the second time period S522 is the first secondary operation state OS_1_2. Method 500 may optionally include: based on whether the operation state during the second time period is the first secondary operation state, conveying a second secondary instruction S524 via an interface. The second secondary instruction may be different from the first secondary instruction. Conveying the second secondary instruction S524 via the interface may include displaying a second secondary user interface object, for example, different from the first secondary user interface object. The second secondary user interface object may indicate that water has entered the connection between the monitoring device and the ostomy apparatus during the second time period. For example, the second secondary user interface object may include second secondary text, such as "Water entered the connection after application; please clean and dry the connection."

[0211] Figure 13 An exemplary user interface is shown for conveying the operational status of an ostomy system during a first time period via an accessory device, such as a visual interface or display of the accessory device.

[0212] The first user interface 600 is optionally displayed during a first time period following the first event. The first user interface 600 includes a first-level user interface object 602 displayed based on the determination that the operation status during the first time period is a first-level operation status. The first-level user interface object 602 may optionally include, for example, first-level text based on and / or including the first time (10 seconds) at which the operation status was determined, the reason for the operation status (wet installation), and the recommended action (replace), such as "Due to your baseplate being wet installed, liquid was detected 10 seconds after application; please replace."

[0213] The first user interface 600 may optionally include a first-level user interface object 604 displayed based on the determination that the operation status within the first time period is a first-level operation status. The first-level user interface object 604 may optionally include first-level text, such as "The connection between the monitoring device and the stoma apparatus is wet. Please keep the connection dry."

[0214] The auxiliary device is configured to dynamically change the visual appearance of the first user interface 600 according to the operating status of the ostomy system, such as the operating status of the base plate.

[0215] Figure 14 An exemplary user interface is shown for conveying the operational status of the ostomy system during a second time period via an accessory device, such as a visual interface or display of the accessory device.

[0216] The second user interface 700 is optionally displayed during a first time period following the first event. The second user interface 700 includes a second-level user interface object 702 displayed based on the determination that the operation status during the second time period is a first-level operation status. The second-level user interface object 702 is different from the first-level user interface object and optionally includes second first-level text, such as "Check your baseboard, a leak may occur soon".

[0217] The second user interface 700 may optionally include a second-level user interface object 704 displayed based on the determination of the operating state during the second time period as a first-level operating state, such as when fluid is detected in the connection between the monitoring device and the ostomy appliance. The second-level user interface object 704 may optionally include second-level text, such as "Water ingress occurred in the connection after application; please clean and dry the connection."

[0218] The auxiliary device is configured to dynamically change the visual appearance of the second user interface 700 according to the operating status of the ostomy system, such as the operating status of the base plate.

[0219] Monitor data can be viewed as an indication of the operational status of an ostomy system / instrument. The visual appearance of visual indicators indicates the operational status of ostomy instruments, such as the type of moisture pattern determined by auxiliary devices.

[0220] The accessory can be configured to provide services in user applications running on the processor. Figure 13 and Figure 14 User interfaces 600 and 700. The auxiliary device may include a user application configured to convey instructions via the interface. The user application may be a dedicated ostomy application that assists the user in monitoring the internal operating status of the ostomy device, thereby reducing the possibility of serious leakage reaching the user's clothing.

[0221] The use of the terms "first," "second," "third," and "fourth," "level one," "level two," and "level three," etc., does not imply any particular order, but is included to identify independent elements. Furthermore, the use of the terms "first," "second," "third," and "fourth," "level one," "level two," and "level three," etc., does not indicate any order or importance; rather, it is used to distinguish one element from another. It should be noted that the terms "first," "second," "third," and "fourth," "level one," "level two," and "level three," etc., are used here and elsewhere for labelling purposes only and are not intended to indicate any particular spatial or temporal order.

[0222] Furthermore, marking the first element does not imply the existence of the second element, and vice versa.

[0223] Understandable. Figures 1 to 14 This includes modules or operations shown in solid lines and modules or operations shown in dashed lines. Modules or operations included in solid lines are those included in the most broadly exemplary embodiments. Modules or operations included in dashed lines are exemplary embodiments that may be included in, or part of, the modules or operations of the solid-lined exemplary embodiments, or other modules or operations that may be employed besides those of the solid-lined exemplary embodiments. It should be understood that these operations do not need to be performed in the order presented. Furthermore, it should be understood that not all operations need to be performed. Exemplary operations can be performed in any order and in any combination.

[0224] Note that the word "including" does not necessarily exclude the presence of other elements or steps besides those listed.

[0225] Note that the words "one" or "a type" preceding an element do not preclude the existence of multiple such elements.

[0226] It should be further noted that no reference numerals in the drawings limit the scope of the claims, exemplary embodiments may be implemented at least in part by hardware and software, and several “apparatus”, “units” or “devices” may be represented by the same hardware.

[0227] The various exemplary methods, apparatuses, and systems described herein are described in the general context of the method steps and procedures. These can be implemented, on the one hand, by computer program products embodied in computer-readable media, including computer-executable instructions such as program code executed by a computer in a networked environment. Computer-readable media can include removable and non-removable storage devices, including but not limited to: read-only memory (ROM), random access memory (RAM), optical disc (CD), digital versatile optical disc (DVD), etc. Typically, program modules can include routines, programs, objects, components, data structures, etc., that perform a specific task or implement a specific abstract data type. Computer-executable instructions, associated data structures, and program modules represent examples of program code for performing the steps of the methods disclosed herein. A particular sequence of such executable instructions or associated data structures represents examples of corresponding actions for implementing the functions described in these steps or procedures.

[0228] Although specific features have been shown and described, it should be understood that they are not intended to limit the claimed invention, and various changes and modifications will be apparent to those skilled in the art without departing from the spirit and scope of the claimed invention. Accordingly, the specification and drawings should be considered illustrative rather than restrictive. The claimed invention is intended to cover all alternatives, modifications, and equivalents.

[0229] List of reference numerals

[0230] 1. Ostomy System

[0231] 2. Ostomy instruments

[0232] 4. Base plate

[0233] 6. Monitoring devices

[0234] 8. Auxiliary devices

[0235] 10 server devices

[0236] 12 Network

[0237] 14 Connecting components

[0238] 16 Connecting ring

[0239] 18, 18A, 18B, 18C, 18D: Stoma Reception Openings

[0240] 19. Opening center

[0241] 20 Docks

[0242] 22 First Connector

[0243] 24. Dock User Interface

[0244] 100 Monitoring device housing

[0245] 101 processor

[0246] 102 First Interface

[0247] 104 Second Interface

[0248] 106 Memory

[0249] 108 Grounding terminal of monitoring device

[0250] The first terminal of the 110 monitoring device

[0251] 112 The second terminal of the monitoring device

[0252] 114 The third terminal of the monitoring device

[0253] 116 The fourth terminal of the monitoring device

[0254] The fifth terminal of the 118 monitoring device

[0255] 120 Connecting part

[0256] 121 Power Supply Unit

[0257] 122 antenna

[0258] 124 Wireless Transceiver

[0259] 126 speakers

[0260] 128 haptic feedback elements

[0261] 140 sensor units

[0262] 200 First adhesive layer

[0263] 200A Distal surface of the first adhesive layer

[0264] 200B Proximal surface of the first adhesive layer

[0265] 202 Second adhesive layer

[0266] 202A The distal surface of the second adhesive layer

[0267] 202B Proximal surface of the second adhesive layer

[0268] 204 Electrode Assembly

[0269] 204A electrode assembly distal surface

[0270] 204B electrode assembly proximal surface

[0271] 206 Release Lining

[0272] 206A Release Liner Distal Surface

[0273] 206B Release Liner Proximal Surface

[0274] 208 Top Floor

[0275] 208A Top Layer Far Surface

[0276] 208B Top Layer Proximal Surface

[0277] 209 Connecting Ring

[0278] 210 Connecting part of the first connector

[0279] 211 First Connector

[0280] 212 Terminals of the first connector

[0281] 213 First intermediate element

[0282] 213A The distal surface of the first intermediate element

[0283] 213B Proximal surface of the first intermediate element

[0284] 214 Support layer of electrode assembly

[0285] 214A support layer distal surface

[0286] 214B support layer proximal surface

[0287] 216 Electrode assembly electrodes

[0288] 218 Masking elements

[0289] 218A Masking Element's Far Side

[0290] 218B Masking Element Proximal Surface

[0291] 220 Electrode Configuration

[0292] 222 Grounding electrode

[0293] 222A Grounding Connection

[0294] 222B Grounding Sensing Unit

[0295] 224 First Electrode

[0296] 224A First Connecting Part

[0297] 226 Second Electrode

[0298] 226A Second Connection Part

[0299] 228 Third Electrode

[0300] 228A Third Connection Part

[0301] 230 Fourth Electrode

[0302] 230A Fourth Connection Section

[0303] 230B Fourth Sensor Unit

[0304] 232 Fifth Electrode

[0305] 232A Fifth Connection Part

[0306] 232B Fifth Sensor Unit

[0307] 234 First electrode section of the grounding electrode

[0308] 236 Second electrode section of grounding electrode

[0309] 238 Third electrode section of the grounding electrode

[0310] 240 The fourth electrode section of the grounding electrode

[0311] 242 Grounding terminal opening

[0312] 244 First terminal opening

[0313] 246 Second terminal opening

[0314] 248 Third terminal opening

[0315] 250 Fourth terminal opening

[0316] 252 Fifth terminal opening

[0317] 254. Primary sensor point opening of the masking element.

[0318] 254A First-level sensor point opening

[0319] 254B First-level second sensor point opening

[0320] 256. Secondary sensor point opening of the masking element.

[0321] 256A Second-level first sensor point opening

[0322] 256B Secondary Second Sensor Point Opening

[0323] 258 Three-level sensor point openings of masking elements

[0324] 258A Level 3 First Sensor Point Opening

[0325] 258B Level 3 Second Sensor Point Opening

[0326] 260 First adhesive layer primary sensor point opening

[0327] 260A First-level sensor point opening

[0328] 260B First-level second sensor point opening

[0329] 262 Secondary sensor point opening in the first adhesive layer

[0330] 262A Secondary First Sensor Point Opening

[0331] 262B Secondary Second Sensor Point Opening

[0332] 264 Three-level sensor point openings in the first adhesive layer

[0333] 264A Level 3 First Sensor Point Opening

[0334] 264B Level 3 Second Sensor Point Opening

[0335] 282 Grounding terminal element

[0336] 282A Grounding Terminal

[0337] 284 First terminal element

[0338] 284A First Terminal

[0339] 286 Second terminal element

[0340] 286A Second Terminal

[0341] 288 Third Terminal Component

[0342] 288A Third Terminal

[0343] 290 Fourth terminal component

[0344] 290A Fourth Terminal

[0345] 292 Fifth terminal component

[0346] 292A Fifth Terminal

[0347] 400 Auxiliary devices

[0348] 401 Accessory Memory

[0349] 402 Accessory Processor

[0350] 403 Auxiliary Device Interface

[0351] 500 A method for monitoring a stoma system performed in an auxiliary device

[0352] S502 obtains monitor data from the monitoring device.

[0353] S502A obtains ostomy data representing electrical characteristic measurements.

[0354] S504 determines the operational status of the ostomy system based on monitor data.

[0355] S506 Determine whether the operation status of the first time period is the first-level operation status.

[0356] The S508 transmits first-level instructions via an interface.

[0357] The S508A displays the first-level user interface object on the monitor of the auxiliary device.

[0358] S508B Determines First-Level Instruction

[0359] S508C outputs the first-level audio signal

[0360] S510 determines the operational status of the ostomy system during the second time period based on monitor data.

[0361] S512 determines whether the operation status of the second time period of S512 is the first-level operation status.

[0362] The S514 transmits second-level instructions, which are different from the first-level instructions, via an interface.

[0363] The S514A displays the second-level user interface object on the monitor of the auxiliary device.

[0364] S514B Determines Secondary Level Instructions

[0365] The S516 receives user input indicating the first event via an interface.

[0366] S518 Determine whether the operation status of the first time period is a first or second level operation status.

[0367] The S520 transmits first and second level instructions via an interface.

[0368] The S520A displays the first and second level user interface objects on the monitor of the auxiliary device.

[0369] S520A determines first and second level instructions

[0370] S522 Determine whether the operation status of the second time period is a first or second level operation status.

[0371] S524 transmits second and third-level instructions via interface.

[0372] S524A displays second and third-level user interface objects.

[0373] S524 Determine the second and second level instructions

[0374] 600 First User Interface

[0375] 602 First-level user interface object

[0376] 604 First and second level user interface objects

[0377] 700 Second User Interface

[0378] 702 Second-level user interface object

[0379] 704 Second-level user interface object

Claims

1. A method for monitoring a stoma system performed in an accessory device, the stoma system comprising a monitoring device and a stoma appliance, the stoma appliance comprising a base plate configured to rest on the surface of a user's skin, wherein, The auxiliary device includes an interface configured to communicate with at least the monitoring device of the stoma system, the method comprising: Monitor data is obtained from the monitoring device, and the monitor data indicates the status of the stoma system; The operational status of the stoma system during the first time period following the first event is determined based on the monitor data. Based on the operation status of the first time period as the first level operation status, the first level instruction is conveyed through the interface; Based on the monitor data, determine the operational status of the stoma system during a second time period following the first time period; and Based on the operation status of the second time period as the first level operation status, a second instruction different from the first level instruction is conveyed through the interface.

2. The method according to claim 1, wherein, The method includes receiving user input indicating the first event via the interface.

3. The method according to any one of claims 1 to 2, wherein, The stoma device includes a base plate having a first adhesive layer on a proximal side and one or more electrodes configured to measure electrical properties at or in the first adhesive layer, wherein obtaining the monitor data includes obtaining stoma data representing measurements of the electrical properties.

4. The method according to any one of claims 1 to 2, wherein, The first time period has a length of less than 15 minutes.

5. The method according to any one of claims 1 to 2, wherein, The first level of operation indicates the presence of liquid on the proximal side of the base plate.

6. The method according to any one of claims 1 to 2, wherein, Conveying the first-level instruction includes displaying a first-level user interface object on the display of the accessory device, indicating that the ostomy instrument is wet-installed.

7. The method according to any one of claims 1 to 2, wherein, Conveying the second instruction includes displaying a second user interface object on the display of the accessory device that indicates a possible leakage of discharge.

8. The method according to any one of claims 1 to 2, wherein, Based on the operation status during the first time period, which indicates a first-level or second-level operation status indicating an incorrect connection between the stoma instrument and the monitoring device, the first-level or second-level indication is conveyed via the interface.

9. The method according to claim 8, wherein, The first secondary indication is conveyed by displaying a first secondary user interface object on the display of the accessory device that indicates an erroneous connection between the monitoring device and the ostomy instrument.

10. An accessory device for an ostomy system, the ostomy system comprising ostomy instruments, a monitoring device, and an accessory device, the accessory device comprising: processor; The memory connected to the processor, and An interface configured to connect the auxiliary device to the monitoring device, the interface including a transceiver module connected to the processor. The auxiliary device is configured to: Monitor data is obtained from the monitoring device connected to the accessory device, the monitor data indicating the status of the stoma system; The operational status of the stoma system during the first time period following the first event is determined based on the monitor data. Based on the operation status of the first time period as the first level operation status, the first level instruction is conveyed through the interface; Based on the monitor data, determine the operational status of the stoma system during a second time period following the first time period; and Based on the operation status of the second time period as the first level operation status, a second instruction different from the first level instruction is conveyed through the interface.

11. The auxiliary device according to claim 10, wherein, The accessory device is configured to receive user input indicating the first event via the interface.

12. The auxiliary device according to any one of claims 10 to 11, wherein, The stoma device includes a stoma bag and a base plate, the base plate including a first adhesive layer having a proximal side, and one or more electrodes configured to measure electrical properties at or in the first adhesive layer, wherein obtaining the monitor data includes obtaining stoma data representing measurements of the electrical properties.

13. The auxiliary device according to any one of claims 10 to 11, wherein, The first time period has a length of less than 15 minutes.

14. The auxiliary device according to any one of claims 10 to 11, wherein, The first level of operation indicates the presence of fluid on the proximal side of the base plate of the stoma device.

15. The auxiliary device according to any one of claims 10 to 11, wherein, The interface includes a display, and wherein conveying the first level instruction includes displaying a first level user interface object on the display indicating that the ostomy device is wet-installed.

16. The auxiliary device according to any one of claims 10 to 11, wherein, Conveying the second instruction includes displaying a second user interface object on the display of the accessory device that indicates a possible discharge leak.

17. The auxiliary device according to any one of claims 10 to 11, wherein, The auxiliary device is configured to transmit a first-level indication via the interface based on the operating status during the first time period, indicating a first-level operational state of erroneous connection between the stoma device and the monitoring device.

18. The auxiliary device according to claim 17, wherein, The first secondary indication is conveyed by displaying a first secondary user interface object on the display of the accessory device that indicates an erroneous connection between the monitoring device and the ostomy instrument.

19. A computer-readable storage medium storing one or more programs, said programs including instructions that, when executed by an accessory device having an interface, a memory, and a processor, cause said accessory device to operate according to any one of claims 1 to 9.

20. An ostomy system comprising an ostomy appliance, a monitoring device, and an accessory device according to any one of claims 10 to 18.

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