Sensor assembly part and a base plate for a medical appliance and a method for manufacturing a sensor assembly part and a base plate

Disclosed is a base plate, a sensor assembly part and a method for manufacturing of a base plate or a sensor assembly part. The method comprising: positioning a coupling part; positioning an electrode assembly; providing one or more terminal elements; positioning the one or more terminal elements; securing the one or more terminal elements, by securing the distal part of each of the one or more terminal elements to the coupling part and positioning the proximal part of each of the one or more terminal elements to contact respective connection parts of the one or more electrodes, wherein after securing the one or more terminal elements, the terminal element bend of each of the one or more terminal elements forms a second angle, the second angle being less than the first angle.

The present disclosure relates to an ostomy system, devices thereof, method of manufacturing and method for monitoring an ostomy appliance. The ostomy appliance system comprises an ostomy appliance and an ostomy monitor device. In particular, the present disclosure relates to leakage classification and/or detection and monitoring of the operation of an ostomy appliance.

DETAILED DESCRIPTION

Throughout this disclosure, the words “stoma” and “ostomy” are used to denote a surgically created opening bypassing the intestines or urinary tract system of a person.

The words are used interchangeably, and no differentiated meaning is intended. The same applies for any words or phrases derived from these, e.g. “stomal”, “ostomies” etc. Also, the solid and liquid wastes emanating from the stoma may be referred to as both stomal “output,” “waste(s),” and “fluids” interchangeably. A subject having undergone ostomy surgery may be referred to as “ostomist” or “ostomate”—moreover, also as “patient” or “user”. However, in some cases “user” may also relate or refer to a health care professional (HCP), such as a surgeon or an ostomy care nurse or others. In those cases, it will either be explicitly stated, or be implicit from the context that the “user” is not the “patient” him- or herself.

In the following, whenever referring to proximal side or surface of a layer, an element, a device or part of a device, the referral is to the skin-facing side or surface, when a user wears the ostomy appliance. Likewise, whenever referring to the distal side or surface of a layer, an element, a device or part of a device, the referral is to the side or surface facing away from the skin, when a user wears the ostomy appliance. In other words, the proximal side or surface is the side or surface closest to the user, when the appliance is fitted on a user and the distal side is the opposite side or surface—the side or surface furthest away from the user in use.

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

The radial direction is defined as perpendicular to the axial direction. In some sentences, the words “inner” and “outer” may be used. These qualifiers should generally be perceived with respect to the radial direction, such that a reference to an “outer” element means that the element is farther away from a centre portion of the ostomy appliance than an element referenced as “inner”. In addition, “innermost” should be interpreted as the portion of a component forming a centre of the component and/or being adjacent to the centre of the component. In analogy, “outermost” should be interpreted as a portion of a component forming an outer edge or outer contour of a component and/or being adjacent to that outer edge or outer contour.

The use of the word “substantially” as a qualifier to certain features or effects in this disclosure is intended to simply mean that any deviations are within tolerances that would normally be expected by the skilled person in the relevant field.

The use of the word “generally” as a qualifier to certain features or effects in this disclosure is intended to simply mean—for a structural feature: that a majority or major portion of such feature exhibits the characteristic in question, and—for a functional feature or an effect: that a majority of outcomes involving the characteristic provide the effect, but that exceptionally outcomes do no provide the effect.

The present disclosure relates to an ostomy system and devices thereof, such as an ostomy appliance, a base plate for an ostomy appliance, a monitor device, and optionally one or more accessory devices. Further, methods related to the ostomy system and devices thereof are disclosed. An accessory device (also referred to as an external device) may be a mobile phone or other handheld device. An accessory device may be a personal electronic device, e.g. a wearable, such as a watch or other wrist-worn electronic device. An accessory device may be a docking station. The docking station may be configured to electrically and/or mechanically couple the monitor device to the docking station. The docking station may be configured for charging the monitor device and/or configured for transferring data between the monitor device and the docking station. The ostomy system may comprise a server device. The server device may be operated and/or controlled by the ostomy appliance manufacturer and/or a service centre.

The present disclosure provides an ostomy system and devices thereof, such as an ostomy appliance, a base plate for an ostomy appliance, a monitor device, and optionally one or more accessory devices which either alone or together facilitate reliable determination of the nature, severity and rapidness of moisture propagation in the adhesive material provided for attaching the base plate to the skin surface of a user. Depending on the nature of the pattern of moisture propagation in the adhesive, the ostomy system and devices thereof enable providing information to the user about the type of failure, and in turn enable providing an indication to the user of the severity and thus the remaining time frame for replacing the ostomy appliance without experiencing severe leakage and/or skin damage.

The ostomy appliance comprises a base plate and an ostomy pouch (also referred to as an ostomy bag). The ostomy appliance may be a colostomy appliance, an ileostomy appliance or a urostomy appliance. The ostomy appliance may be a two-part ostomy appliance, i.e. the base plate and the ostomy pouch may be releasably coupled e.g. with a mechanical and/or an adhesive coupling, e.g. to allow that a plurality of ostomy pouches can be utilized (exchanged) with one base plate. Further, a two-part ostomy appliance may facilitate correct application of the base plate to skin, e.g. to an improved user sight of the stomal region. The ostomy appliance may be a one-part ostomy appliance, i.e. the base plate and the ostomy pouch may be fixedly attached to each other. The base plate is configured for coupling to a user's stoma and/or skin surrounding the stoma, such as a peristomal skin area.

The ostomy appliance includes a base plate, such as a monolithic, one-piece base plate, e.g. integrated with a sensor assembly part, or a base plate and a separate sensor assembly part, such as a sensor assembly part to be subsequently applied to a base plate. For example, to allow an arbitrary base plate, such as a conventional base plate, to achieve the features as described herein. Features as described with respect to the base plate herein may be provided by a sensor assembly part to be applied to a base plate, e.g. by the user. A sensor assembly part may be adapted to adhere to an ostomy plate.

A disclosed method of attaching a base plate to a user's stoma and/or skin surrounding the stoma, such as the peristomal skin area, may comprise attaching a sensor assembly part to a base plate and attaching the base plate, e.g. together with the attached sensor assembly part, to the user's stoma and/or skin surrounding the stoma, such as the peristomal skin area. Alternatively, the method of attaching the base plate to the user's stoma and/or skin surrounding the stoma may comprise attaching the sensor assembly part to the user's stoma and/or skin surrounding the stoma and attaching the base plate to the user's stoma and/or skin surrounding the stoma above the attached sensor assembly part.

The base plate and/or the sensor assembly part may comprise a first adhesive layer, also denoted center adhesive layer. During use, the first adhesive layer adheres to the user's skin (peristomal area) and/or to additional seals, such as sealing paste, sealing tape and/or sealing ring. Thus, the first adhesive layer may be configured for attachment of the base plate and/or the sensor assembly part to the skin surface of a user. The first adhesive layer may have a stomal opening, such as a first adhesive stomal opening, with a center point.

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

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

The first adhesive layer may have a plurality of sensor point openings. A sensor point opening of the first adhesive layer is optionally configured to overlap a part of an electrode, e.g. to form a sensor point.

The sensor point openings of the first adhesive layer may comprise primary sensor point openings. The primary sensor point openings may comprise one or more primary first sensor point openings and one or more primary second sensor point openings, the primary first sensor point openings configured to overlap parts of an electrode and the primary second sensor point openings configured to overlap parts of another electrode different from the electrode at least partly overlapped by the primary first sensor point openings.

The sensor point openings of the first adhesive layer may comprise secondary sensor point openings. The secondary sensor point openings may comprise one or more secondary first sensor point openings and one or more secondary second sensor point openings, the secondary first sensor point openings configured to overlap parts of an electrode and the secondary second sensor point openings configured to overlap parts of another electrode different from the electrode at least partly overlapped by the secondary first sensor point openings.

The sensor point openings of the first adhesive layer may comprise tertiary sensor point openings. The tertiary sensor point openings may comprise one or more tertiary first sensor point openings and one or more tertiary second sensor point openings, the tertiary first sensor point openings configured to overlap parts of an electrode and the tertiary second sensor point openings configured to overlap parts of another electrode different from the electrode at least partly overlapped by the tertiary first sensor point openings.

The first adhesive layer may have a substantially uniform thickness. The first adhesive layer may have a thickness in the range from 0.1 mm to 1.5 mm, e.g. in the range from 0.2 mm to 1.2 mm.

The first adhesive layer may have a primary thickness in a primary part of the first adhesive layer, e.g. in a primary region within a primary radial distance or in a primary radial distance range from the center point of the stomal opening. The primary thickness may be in the range from 0.2 mm to 1.5 mm. such as about 1.0 mm. The primary radial distance may be in the range from 20 mm to 50 mm, such as in the range from 25 mm to 35 mm, e.g. 30 mm.

The first adhesive layer may have a secondary thickness in a secondary part of the first adhesive layer, e.g. in a secondary region outside a secondary radial distance or in a secondary radial distance range from the center point of the stomal opening. The secondary thickness may be in the range from 0.2 mm to 1.0 mm, such as about 0.5 mm. The secondary radial distance may be in the range from 20 mm to 50 mm, such as in the range from 25 mm to 35 mm, e.g. 30 mm.

The base plate and/or the sensor assembly part may comprise a second layer. The second layer may be a second adhesive layer, also denoted rim adhesive layer. The second layer may have a second radial extension that is larger than a first radial extension of the first adhesive layer at least in a first angular range of the base plate and/or the sensor assembly part. Accordingly, a part of a proximal surface of the second layer may be configured for attachment to the skin surface of a user. The part of a proximal surface of the second layer configured for attachment to the skin surface of a user is also denoted the skin attachment surface of the second adhesive layer. The second layer may have a stomal opening, such as a second layer stomal opening and/or a second adhesive stomal opening, with a center point.

The second adhesive layer may be made of a second composition. The second composition may comprise one or more polyisobutenes and/or styrene-isoprene-styrene. The second composition may comprise one or more hydrocoloids.

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

Different ratio of contents may change properties of the first and/or second adhesive layers. The second adhesive layer and the first adhesive layer may have different properties. The second adhesive layer (second composition) and the first adhesive layer (first composition) may have different ratios of polyisobutenes, styrene-isoprene-styrene, and/or hydrocolloids. For example, the second adhesive layer may provide a stronger attachment to the skin compared to attachment to the skin provided by the first adhesive layer. Alternatively or additionally, the second adhesive layer may be thinner than the first adhesive layer. Alternatively or additionally, the second adhesive layer may be less water and/or sweat absorbing than the first adhesive layer. Alternatively or additionally, the second adhesive layer may be less mouldable than the first adhesive layer. The second adhesive layer may provide a second barrier against leakage.

The second layer may have a substantially uniform thickness. The second layer may have a thickness in the range from 0.1 mm to 1.5 mm, e.g. in the range from 0.2 mm to 1.0 mm, such as 0.5 mm, 0.6 mm, or 0.7 mm.

The base plate and/or the sensor assembly part may comprise one or more electrodes, such as a plurality of electrodes, such as two, three, four, five, six, seven or more electrodes. The sensor assembly part may be applied to the base plate, such as to provide the base plate with the one or more electrodes.

The electrodes, e.g. some or all the electrodes, may be arranged between the first adhesive layer and the second adhesive layer. The electrodes may be arranged in an electrode assembly, e.g. an electrode layer. An electrode comprises a connection part for connecting the electrodes to other components and/or interface terminals. An electrode may comprise one or more conductor parts and/or one or more sensing parts. The electrode assembly may be arranged between the first adhesive layer and the second adhesive layer. The base plate and/or the sensor assembly part, e.g. the electrode assembly, may comprise a first electrode, a second electrode and optionally a third electrode. The base plate and/or the sensor assembly part, e.g. the electrode assembly, may comprise a fourth electrode and/or a fifth electrode. The base plate and/or the sensor assembly part, e.g. the electrode assembly, optionally comprises a sixth electrode. The base plate and/or the sensor assembly part, e.g. the electrode assembly, may comprise a ground electrode. The ground electrode may comprise a first electrode part. The first electrode part of the ground electrode may form a ground for the first electrode. The ground electrode may comprise a second electrode part. The second electrode part of the ground electrode may form a ground for the second electrode. The ground electrode may comprise a third electrode part. The third electrode part of the ground electrode may form a ground for the third electrode. The ground electrode may comprise a fourth electrode part. The fourth electrode part of the ground electrode may form a ground for the fourth electrode and/or the fifth electrode.

The ground electrode or electrode parts of the ground electrode may be configured as or form a (common) reference electrode for some or all of the other electrodes of the electrode assembly. The ground electrode may also be denoted reference electrode.

Two electrodes of the electrode assembly may form a sensor. The first electrode and the ground electrode (e.g. first electrode part of the ground electrode) may form a first sensor or first electrode pair. The second electrode and the ground electrode (e.g. second electrode part of the ground electrode) may form a second sensor or second electrode pair. The third electrode and the ground electrode (e.g. third electrode part of the ground electrode) may form a third sensor or third electrode pair. The fourth electrode and the ground electrode (e.g. fourth electrode part of the ground electrode) may form a fourth sensor or fourth electrode pair. The fifth electrode and the ground electrode (e.g. fifth electrode part of the ground electrode) may form a fifth sensor or fifth electrode pair.

The first electrode may form an open loop. The second electrode may form an open loop and/or the third electrode may form an open loop. The fourth electrode may form an open loop. The fifth electrode may form an open loop. Open loop electrode(s) enables electrode arrangement in few or a single electrode layer.

The electrode assembly may comprise a support layer, also denoted a support film. One or more electrodes may be formed, e.g. printed, on the proximal side of the support layer. One or more electrodes may be formed, e.g. printed, on the distal side of the support layer. The electrode assembly, such as the support layer of the electrode assembly, may have a stomal opening, such as an electrode assembly stomal opening and/or a support layer stomal opening, with a center point.

The support layer may comprise polymeric (e.g. polyurethane, PTFE, PVDF) and/or ceramic (e.g. alumina, silica) materials. In one or more exemplary base plates and/or sensor assembly parts, the support layer is made of thermoplastic polyurethane (TPU). The support layer material may be made of or comprise one or more of polyester, a thermoplastic elastomer (TPE), polyimide, polyimide, Ethylene-vinyl acetate (EVA), polyurea, and silicones.

The base plate and/or the sensor assembly part, such as the electrode assembly may comprise a masking element configured to insulate at least parts of the electrodes from the first adhesive layer of the base plate and/or of the sensor assembly part. The masking element may comprise one or more, such as a plurality of, sensor point openings. The sensor point openings may comprise primary sensor point openings and/or secondary sensor point openings. The sensor point openings may comprise tertiary sensor point opening(s). The sensor point openings may comprise quaternary sensor point opening(s) A sensor point opening of the masking element overlaps at least one electrode of the electrode assembly when seen in the axial direction, e.g. to form a sensor point. For example, a primary sensor point opening may overlap a part of the ground electrode and/or a part of the fourth electrode. A secondary sensor point opening may overlap a part of the fourth electrode and/or a part of the fifth electrode. A tertiary sensor point opening may overlap a part of the fifth electrode and/or a part of the ground electrode.

The masking element may comprise one or more, such as a plurality of, terminal openings. The masking element may comprise polymeric (e.g. polyurethane, PTFE, PVDF) and/or ceramic (e.g. alumina, silica) materials. In one or more exemplary base plates and/or sensor assembly parts, the masking element is made of or comprises thermoplastic polyurethane (TPU). In one or more exemplary base plates and/or sensor assembly parts, the masking element is made of or comprises polyester. The masking element material may be made of or comprise one or more of polyester, a thermoplastic elastomer (TPE), polyimide, polyimide, Ethylene-vinyl acetate (EVA), polyurea, and silicones.

The base plate and/or the sensor assembly part may comprise a first intermediate element. The first intermediate element may be arranged between the electrodes/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.

The base plate and/or the sensor assembly part may comprise a release liner. The release liner is a protective layer that protects adhesive layer(s) during transport and storage and is peeled off by the user prior to applying the base plate on the skin. The release liner may have a stomal opening, such as a release liner stomal opening, with a center point.

The base plate and/or the sensor assembly part may comprise a top layer. The top layer is a protective layer protecting the adhesive layer(s) from external strains and stress when the user wears the ostomy appliance. The electrodes, e.g. some or all the electrodes, may be arranged between the first adhesive layer and the top layer. The top layer may have a stomal opening, such as a top layer stomal opening, with a center point. The top layer may have a thickness in the range from 0.01 mm to 1.0 mm, e.g. in the range from 0.02 mm to 0.2 mm, such as 0.04 mm.

The base plate and/or the sensor assembly part comprises a monitor interface. The monitor interface may be configured for electrically and/or mechanically connecting the ostomy appliance (base plate/sensor assembly part) to the monitor device. The monitor interface may be configured for wirelessly connecting the ostomy appliance (base plate/sensor assembly part) to the monitor device. Thus, the monitor interface of the base plate and/or the sensor assembly part may be configured to electrically and/or mechanically couple the ostomy appliance and the monitor device.

The monitor interface of the base plate and/or of the sensor assembly part may comprise, e.g. as part of a first connector of the monitor interface, a coupling part for forming a mechanical connection, such as a releasable coupling between the monitor device and the base plate and/or the sensor assembly part. The coupling part may be configured to engage with a coupling part of the monitor device for releasably coupling the monitor device to the base plate and/or the sensor assembly part.

The monitor interface of the base plate and/or of the sensor assembly part may comprise, e.g. as part of a first connector of the monitor interface, a plurality of terminals, such as two, three, four, five, six, seven or more terminals, for forming electrical connections with respective terminals of the monitor device. The monitor interface may comprise a ground terminal element forming a ground terminal. The monitor interface may comprise 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 comprise a fourth terminal element forming a fourth terminal and/or a fifth terminal element forming a fifth terminal. The monitor interface optionally comprises a sixth terminal element forming a sixth terminal. The terminal elements of the monitor interface may contact respective electrodes of the base plate and/or of the sensor assembly part, such as of the electrode assembly. The first intermediate element may be arranged between the terminal elements and the first adhesive layer. The first intermediate element may cover or overlap terminal element(s) of the base plate and/or of the sensor assembly part when seen in the axial direction. Thus, the first adhesive layer may be protected or experience more evenly distributed mechanical stress from the terminal elements of the base plate and/or of the sensor assembly part, in turn reducing the risk of terminal elements penetrating or otherwise damaging the first adhesive layer. The first intermediate element may protect or mechanically and/or electrically shield the first adhesive layer from the terminal elements of the base plate and/or of the sensor assembly part.

A terminal element, such as the ground terminal element, the first terminal element, the second terminal element, the third terminal element, the fourth terminal element, the fifth terminal element and/or the sixth terminal element, may comprise a distal end and a proximal end. A terminal element, such as the ground terminal element, the first terminal element, the second terminal element, the third terminal element, the fourth terminal element, the fifth terminal element and/or the sixth terminal element, may comprise a distal part, a centre part, and/or a proximal part. The distal part may be between the distal end and the centre part. The proximal part may be between the proximal end and the centre part. A terminal element, such as the ground terminal element, the first terminal element, the second terminal element, the third terminal element, the fourth terminal element, the fifth terminal element and/or the sixth terminal element, may be gold plated copper.

The base plate may comprise a coupling ring or other coupling member for coupling an ostomy pouch to the base plate (two-part ostomy appliance). The center point may be defined as a center of the coupling ring.

The base plate and/or the sensor assembly part may have a stomal opening, e.g. with a center point. The stomal opening of the base plate and/or the sensor assembly part may be formed collectively of stomal opening(s) of the layers of the base plate and/or the sensor assembly part, such as of the top layer, the first adhesive layer, the second layer and/or the sensor assembly part. The stomal opening(s) of the layers of the base plate and/or the sensor assembly part, such as of the top layer, the first adhesive layer, the second layer and/or the sensor assembly part may be aligned to form the stomal opening of the base plate and/or the sensor assembly part. The stomal opening may be a through-going passage of the base plate and/or the sensor assembly part. The stomal opening may be arranged substantially in the center of the base plate and/or the sensor assembly part. The stomal opening(s) of the layers of the base plate and/or the sensor assembly part may be arranged substantially in the center of the respective layer. The stomal opening may be configured to receive a stoma of the user and/or the stomal opening may be configured to allow output from the stoma to pass through the stomal opening an into an ostomy pouch attached to the base plate. For example, the stomal opening may be configured to allow passage of output from a proximal side of the base plate and/or sensor assembly part to a distal side of the base plate and/or sensor assembly part. The size and/or shape of the stomal opening may typically be adjusted by the user or nurse before application of the ostomy appliance to accommodate the user's stoma. In one or more exemplary base plates and/or sensor assembly parts, the user forms the stomal opening during preparation of the base plate for application.

The monitor device comprises a processor and one or more interfaces, such as a first interface and/or a second interface. The monitor device may comprise a memory for storing ostomy data.

In one or more exemplary monitor devices, the processor is configured to apply a processing scheme, the first interface is connected to the processor and the memory, and the first interface is configured for collecting ostomy data from the base plate and/or the sensor assembly part coupled to the first interface. The ostomy data may comprise one or more, such as all, of first ostomy data from a first electrode pair of the base plate and/or of the sensor assembly part, second ostomy data from a second electrode pair of the base plate and/or of the sensor assembly part, and third ostomy data from a third electrode pair of the base plate and/or of the sensor assembly part. A second interface is connected to the processor. To apply a processing scheme may comprise one or more of obtain first parameter data based on the first ostomy data; obtain second parameter data based on the second ostomy data; and obtain third parameter data based on the third ostomy data. To apply a processing scheme may comprise determine an operating state of the base plate of the ostomy appliance based on one or more, such as all, of the first parameter data, the second parameter data and the third parameter data. The operating state may be indicative of a degree of radial erosion of the base plate, such as of the first adhesive layer, and/or an acute leakage risk for the ostomy appliance. The monitor device is configured to, in accordance with a determination that the operating state is a first operating state, transmit a first monitor signal comprising monitor data indicative of the first operating state of the base plate via the second interface; and/or in accordance with a determination that the operating state is a second operating state, transmit a second monitor signal comprising monitor data indicative of the second operating state of the base plate via the second interface.

In one or more exemplary monitor devices, the first operating state of the base plate corresponds to a situation wherein the first adhesive layer of the base plate and/or of the sensor assembly part has experienced a first degree of radial erosion, e.g. the first adhesive layer is eroded to a first radial distance of the first electrode pair but not to a second radial distance of the second electrode pair.

In one or more exemplary monitor devices, the second operating state of the base plate corresponds to a situation wherein the first adhesive layer of the base plate and/or of the sensor assembly part has experienced a second degree of radial erosion, e.g. the first adhesive layer is eroded to the second radial distance of the second electrode pair but not to a third radial distance of the third electrode pair.

To obtain first parameter data based on the first ostomy data may comprise determining one or more first parameters based on the first ostomy data. To obtain second parameter data based on the second ostomy data may comprise determining one or more second parameters based on the second ostomy data. To obtain third parameter data based on the third ostomy data may comprise determining one or more third parameters based on the third ostomy data. In one or more exemplary monitor devices, determination of an operating state may be based on one or more first parameters, such as first primary parameter and/or first secondary parameter of first parameter data. In one or more exemplary monitor devices, determination of an operating state may be based on one or more second parameters, such as second primary parameter and/or second secondary parameter of the second parameter data. In one or more exemplary monitor devices, determination of an operating state may be based on one or more third parameters, such as third primary parameter and/or third secondary parameter of the third parameter data. In one or more exemplary monitor devices, determination of an operating state may be based on one or more fourth parameters, such as fourth primary parameter and/or fourth secondary parameter of the fourth parameter data.

In one or more exemplary monitor devices, to determine an operating state of the base plate is based on a first criteria set based on the first parameter data and/or the second parameter data, wherein the operating state is determined to be the first operating state if the first criteria set is satisfied. The first criteria set may comprise one or more first criteria based on one or more of first parameter data, second parameter data and third parameter data. The first criteria set may comprise a first primary criterion based on the first parameter data. The first criteria set may comprise a first secondary criterion based on the second parameter data. The first criteria set may comprise a first tertiary criterion based on the third parameter data.

In one or more exemplary monitor devices, to determine an operating state of the base plate may be based on a first threshold set comprising one or a plurality of first threshold values. The first threshold set may comprise one or a plurality of threshold values, e.g. to be applied in the first criteria set. The first threshold set may comprise a first primary threshold value. The first threshold set may comprise a first secondary threshold value. The first threshold set may comprise a first tertiary threshold value.

The first criteria set may be given by(P_1_1<TH_1_1),(P_2_1>TH_1_2), and(P_3_1>TH_1_3),

wherein P_1_1 is a first primary parameter based on the first parameter data, TH_1_1 is a first primary threshold value, P_2_1 is a second primary parameter based on the second parameter data, TH_1_2 is a first secondary threshold value, P_3_1 is a third primary parameter based on the third parameter data, and TH_1_3 is a first tertiary threshold value, and wherein the first operating state is indicative of low degree of radial erosion on the base plate. The first threshold values (TH_1_1, TH_1_2 and TH_1_3) may be the same or different, e.g. depending on the electrode configuration of the base plate and/or the sensor assembly part. The first tertiary criterion (P_3_1<TH_1_3) may be omitted in the first criteria set.

The first primary parameter P_1_1 may be indicative of the resistance between the first electrode pair (first electrode and first electrode part of the ground electrode) of the base plate and/or the sensor assembly part.

The second primary parameter may be indicative of the resistance between the second electrode pair (second electrode and second electrode part of the ground electrode) of the base plate and/or the sensor assembly part.

The third primary parameter may be indicative of resistance between the third electrode pair (third electrode and third electrode part of the ground electrode) of the base plate and/or the sensor assembly part.

In one or more exemplary monitor devices, to determine an operating state of the base plate is based on a second criteria set based on the second parameter data and/or the third parameter data, wherein the operating state is determined to be the second operating state if the second criteria set is satisfied. The second criteria set may be based on the first parameter data.

The second criteria set may comprise one or more second criteria based on one or more of first parameter data, second parameter data and third parameter data. The second criteria set may comprise a second primary criterion based on the first parameter data. The second criteria set may comprise a second secondary criterion based on the second parameter data. The second criteria set may comprise a second tertiary criterion based on the third parameter data.

In one or more exemplary monitor devices, to determine an operating state of the base plate is based on a second threshold set comprising one or a plurality of second threshold values. The second threshold set may comprise one or a plurality of threshold values, e.g. to be applied in the second criteria set. The second threshold set may comprise a second primary threshold value. The second threshold set may comprise a second secondary threshold value. The second threshold set may comprise a second tertiary threshold value.

The second criteria set may be given by(P_1_1<TH_2_1),(P_2_1<TH_2_2), and(P_3_1>TH_2_3)

wherein P_1_1 is a first primary parameter based on the first parameter data and indicative of the resistance between the first electrode pair, TH_2_1 is a second primary threshold value, P_2_1 is a second primary parameter based on the second parameter data and indicative of the resistance between the second electrode pair, TH_2_2 is a second secondary threshold value, P_3_1 is a third primary parameter based on the third parameter data and indicative of the resistance between the third electrode pair, TH_2_3 is a second tertiary threshold value, and wherein the second operating state is indicative of medium degree of radial erosion on the base plate. The second threshold values (TH_2_1, TH_2_2 and TH_2_3) may be the same or different, e.g. depending on the electrode configuration of the base plate and/or the sensor assembly part. The second primary criterion (P_1_1<TH_2_1) and/or the second tertiary criterion (P_3_1>TH_2_3) may be omitted in the second criteria set.

In one or more exemplary monitor devices, to determine an operating state of the base plate is based on a default criteria set based on the first parameter data, wherein the operating state is determined to be the default operating state if the default criteria set is satisfied, and in accordance with a determination that the operating state is the default operating state, transmit a default monitor signal comprising monitor data indicative of the default operating state of the ostomy appliance.

The default criteria set may be given by(P_1_1>TH_D_1),(P_2_1>TH_D_2), and(P_3_1>TH_D_3)

wherein P_1_1 is a first primary parameter based on the first parameter data and indicative of the resistance between the first electrode pair, TH_D_1 is a default primary threshold value, P_2_1 is a second primary parameter based on the second parameter data and indicative of the resistance between the second electrode pair, TH_D_2 is a default secondary threshold value, P_3_1 is a third primary parameter based on the third parameter data and indicative of the resistance between the third electrode pair, TH_D_3 is a default tertiary threshold value, and wherein the default operating state is indicative of very low or no degree of radial erosion on the base plate. The default threshold values (TH_D_1, TH_D_2 and TH_D_3) may be the same or different, e.g. depending on the electrode configuration of the base plate and/or of the sensor assembly part.

In one or more exemplary monitor devices, to determine an operating state of the base plate is based on a third criteria set based on the third parameter data, wherein the operating state is determined to be the third operating state if the third criteria set is satisfied, and in accordance with a determination that the operating state is the third operating state, transmit a third monitor signal comprising monitor data indicative of the third operating state of the ostomy appliance.

In one or more exemplary monitor devices, the third operating state of the base plate corresponds to a situation wherein the first adhesive layer of the base plate and/or of the sensor assembly part has experienced a third degree of radial erosion, e.g. the first adhesive layer is eroded to the third radial distance of the third electrode pair.

The third criteria set may be given by(P_1_1<TH_3_1),(P_2_1<TH_3_2), and(P_3_1<TH_3_3)

wherein P_1_1 is a first primary parameter based on the first parameter data and indicative of the resistance between the first electrode pair, TH_3_1 is a third primary threshold value, P_2_1 is a second primary parameter based on the second parameter data and indicative of the resistance between the second electrode pair, TH_3_2 is a third secondary threshold value, P_3_1 is a third primary parameter based on the third parameter data and indicative of the resistance between the third electrode pair, TH_3_3 is a third tertiary threshold value, and wherein the third operating state is indicative of high degree of radial erosion on the base plate. The third threshold values (TH_3_1, TH_3_2 and TH_3_3) may be the same or different, e.g. depending on the electrode configuration of the base plate and/or of the sensor assembly part. The third primary criterion (P_1_1<TH_3_1) and/or the third secondary criterion (P_2_1<TH_3_2) may be omitted in the third criteria set.

In one or more exemplary monitor devices, the ostomy data comprises fourth ostomy data from a fourth electrode pair of the base plate and/or of the sensor assembly part. To apply a processing scheme may comprise to obtain fourth parameter data based on the fourth ostomy data, and determine an operating state of the base plate of the ostomy appliance based on the fourth parameter data. The monitor device may be configured to, in accordance with a determination that the operating state is a fourth operating state, transmit a fourth monitor signal comprising monitor data indicative of the fourth operating state of the ostomy appliance.

In one or more exemplary monitor devices, the fourth operating state of the base plate corresponds to a situation, wherein the fourth electrode pair detects fluid, such as output, between the distal surface of first adhesive layer and the skin of the user at a fourth radial distance, and thus there is a high risk of leakage from the ostomy appliance in the fourth operating state.

The fourth criteria set may be given by(P_4_1<TH_4_4)

wherein P_4_1 is a fourth primary parameter based on the fourth parameter data and indicative of the resistance between the fourth electrode pair and TH_4_4 is a fourth quaternary threshold value, and wherein the fourth operating state is indicative of high risk of leakage from the ostomy appliance.

The monitor device comprises a monitor device housing optionally made of a plastic material. The monitor device housing may be an elongate housing having a first end and a second end. The monitor device housing may have a length or maximum extension along a longitudinal axis in the range from 1 cm to 15 cm. The monitor device housing may have a width or maximum extension perpendicular to the longitudinal axis in the range from 0.5 cm to 3 cm. The monitor device housing may be curve-shaped.

The monitor device comprises a first interface. The first interface may be configured as an appliance interface for electrically and/or mechanically connecting the monitor device to the ostomy appliance. Thus, the appliance interface is configured to electrically and/or mechanically couple the monitor device and the ostomy appliance. The first interface may be configured as an accessory device interface for electrically and/or mechanically connecting the monitor device to an accessory device, such as a docking station. The first interface may be configured for coupling to a docking station of the ostomy system, e.g. for charging the monitor device and/or for data transfer between the monitor device and the docking station.

The first interface of the monitor device may comprise a plurality of terminals, such as two, three, four, five, six, seven or more terminals, for forming electrical connections with respective terminals and/or electrodes of the ostomy appliance. One or more terminals of the first interface may be configured for forming electrical connections with an accessory device, e.g. with respective terminals of a docking station. The first interface may comprise a ground terminal. The first interface may comprise a first terminal, a second terminal and optionally a third terminal. The first interface may comprise a fourth terminal and/or a fifth terminal. The first interface optionally comprises a sixth terminal. In one or more exemplary monitor devices, the first interface has M terminals, wherein M is an integer in the range from 4 to 8.

The first interface of the monitor device may comprise a coupling part for forming a mechanical connection, such as a releasable coupling between the monitor device and the base plate and/or the sensor assembly part. The coupling part and the terminals of the first interface form (at least part of) a first connector of the monitor device.

The monitor device comprises a power unit for powering the monitor device. The power unit may comprise a battery. The power unit may comprise charging circuitry connected to the battery and terminals of the first interface for charging the battery via the first interface, e.g. the first connector. The first interface may comprise separate charging terminal(s) for charging the battery.

The monitor device may comprise a sensor unit with one or more sensor. The sensor unit is connected to the processor for feeding sensor data to the processor. The sensor unit may comprise an accelerometer for sensing acceleration and provision of acceleration data to the processor. The sensor unit may comprise a temperature sensor for provision of temperature data to the processor.

The monitor device comprises a second interface connected to the processor. The second interface may be configured as an accessory interface for connecting, e.g. wirelessly connecting, the monitor device to one or more accessory devices. The second interface may comprise an antenna and a wireless transceiver, e.g. configured for wireless communication at frequencies in the range from 2.4 to 2.5 GHz. The wireless transceiver may be a Bluetooth transceiver, i.e. the wireless transceiver may be configured for wireless communication according to Bluetooth protocol, e.g. Bluetooth Low Energy, Bluetooth 4.0, Bluetooth 5. The second interface optionally comprises a loudspeaker and/or a haptic feedback element for provision of an audio signal and/or haptic feedback to the user, respectively.

In one or more exemplary ostomy systems, the monitor device forms an integrated part of the ostomy appliance, e.g. the monitor device may form an integrated part of a base plate and/or a sensor assembly part of the ostomy appliance.

The ostomy system may comprise a docking station forming an accessory device of the ostomy system. The docking station may be configured to electrically and/or mechanically couple the monitor device to the docking station.

The docking station may comprise a docking monitor interface. The docking monitor interface may be configured for electrically and/or mechanically connecting the monitor device to the docking station. The docking monitor interface may be configured for wirelessly connecting the monitor device to the docking station. The docking monitor interface of the docking station may be configured to electrically and/or mechanically couple the docking station and the monitor device.

The docking monitor interface of the docking station may comprise, e.g. as part of a first connector of the docking monitor interface, a coupling part for forming a mechanical connection, such as a releasable coupling between the monitor device and the docking station. The coupling part may be configured to engage with a coupling part of the monitor device for releasably coupling the monitor device to the docking station.

The docking monitor interface of the docking station may comprise, e.g. as part of a first connector of the docking monitor interface, a plurality of terminals, such as two, three, four, five, six, seven or more terminals, for forming electrical connections with respective terminals of the monitor device. The docking monitor interface may comprise a ground terminal. The docking monitor interface may comprise a first terminal and/or a second terminal. The docking station may comprise a third terminal. The docking monitor interface may comprise a fourth terminal and/or a fifth terminal. The docking monitor interface optionally comprises a sixth terminal.

Disclosed is a method for manufacturing a base plate or a sensor assembly part, such as a base plate or a sensor assembly part for an ostomy appliance, such as a base plate or a sensor assembly part as disclosed above.

The method comprises positioning a coupling part, such as base plate coupling part or a sensor assembly coupling part, e.g. a coupling part for the monitor interface of the base plate or the sensor assembly part. The coupling part defines a terminal interface region, such as a region wherein terminals, e.g. of the base plate and/or sensor assembly part, may connect, such as mechanically and/or electrically connect, with respective terminals of a monitor device.

The method further comprises positioning an electrode assembly, such as the electrode assembly as disclosed above. The electrode assembly has a distal side and a proximal side. The electrode assembly and/or the coupling part is positioned such that the distal side of the electrode assembly is facing the coupling part. The electrode assembly comprises a support layer and one or more electrodes provided, such as formed, on a proximal side of the support layer. Each of the one or more electrodes comprises a connection part.

The method comprises providing one or more terminal elements. Each of the one or more terminal elements comprises a terminal element bend, such as a proximal terminal element bend and/or a distal terminal element bend, between an end, such as a proximal end and/or a distal end, and a centre part of each of the one or more terminal elements. The terminal element bend forms a first angle, e.g. relative to the centre part of each respective one of the one or more terminal elements, e.g. relative to an axis along the centre part of each respective one of the one or more terminal elements. For example, the one or more terminal elements may be provided with a terminal element bend forming a first angle. For example, the method may comprise bending the one or more terminal elements to provide the terminal element bend, such as the proximal terminal element bend and/or the distal terminal element bend.

The one or more terminal elements may be recrystalized, e.g. heat treated, e.g. after providing the proximal terminal element bend and/or the distal terminal element bend.

The angle of a terminal element bend, such as a proximal terminal element bend and/or a distal terminal element bend, is defined relative to a straight terminal element, e.g. no bend has a 0 degrees angle and a U-shaped bend has a 180 degrees angle.

The method comprises positioning the one or more terminal elements such that a distal part of each of the one or more terminal elements extends into the terminal interface region and a proximal part of each of the one or more terminal elements extends to the proximal side of the electrode assembly. Each of the one or more terminal elements may comprise the terminal element bend forming the first angle while positioning the one or more terminal elements.

The method comprises securing the one or more terminal elements. The one or more terminal elements being secured by securing the distal part of each of the one or more terminal elements to the coupling part and positioning the proximal part of each of the one or more terminal elements to contact respective connection parts of the one or more electrodes. Securing the distal part to the coupling part may prevent axial movement of the terminal element in a proximal direction and/or in a distal direction.

After securing the one or more terminal elements, the terminal element bend of each of the one or more terminal elements forms a second angle, e.g. relative to the centre part of each respective one of the one or more terminal elements, e.g. relative to an axis along the centre part of each respective one of the one or more terminal elements. The second angle is less than the first angle. For example, securing the one or more terminal elements may be performed such that the terminal element bend of each of the one or more terminal elements forms the second angle. For example, securing the one or more terminal elements may be performed such that the terminal element bend of each of the one or more terminal elements is slightly straightened, e.g. such that the terminal element bend has a smaller angle after the one or more terminal elements are secured, i.e. the second angle, compared to before the one or more terminal elements are secured, i.e. the first angle. For example, the terminal element bend of each of the one or more terminal elements may be more straight, e.g. less bent, after securing the one or more terminal elements, compared to the terminal element bend provided to the one or more terminal elements.

Because the terminal element being deformed will have an elasticity, the terminal element being secured in a position wherein the terminal element bend forms a smaller angle than it did prior to securing the terminal element, the terminal element will provide a spring like force. To further emphasize this effect, the terminal element may be prone to work hardening. For example, the one or more terminal elements may be formed from a material supporting work hardening, such as metals, such as face centered cubic metals, such as copper, silver, gold, aluminium, lead, platinum and/or nickel.

Securing the terminal element may involve a degree of permanent deformation of the terminal element bend. However, even so, some degree of elastic deformation may still be present. Hence, the spring-like effect will remain.

A base plate for an ostomy appliance is also disclosed, such as a base plate manufactured by a method, such as the above-mentioned method. Also, a sensor assembly part for an ostomy appliance is disclosed, such as a sensor assembly part for being applied to a base plate, such as a sensor assembly part manufactured by a method, such as the previously disclosed method. The base plate and/or the sensor assembly part comprises a coupling part defining a terminal interface region; an electrode assembly having a distal side and a proximal side; and one or more terminal elements each comprising a terminal element bend between a proximal part and a distal part. The terminal interface region may be a region wherein terminals, e.g. of the base plate and/or sensor assembly part, may connect, such as mechanically and/or electrically connect, with respective terminals of a monitor device.

The distal side of the electrode assembly is facing the coupling part. The electrode assembly comprises a support layer and one or more electrodes provided on a proximal side of the support layer, each of the one or more electrodes comprising a connection part.

The distal part of each of the one or more terminal elements extends into the terminal interface region. The proximal part of each of the one or more terminal elements extends from the proximal side of the electrode assembly and contact respective connection parts of the one or more electrodes. The distal part of each of the one or more terminal elements are secured to the coupling part.

The terminal element bend may provide tension to reduce a distance between the proximal part and the distal part. For example, the terminal element bend is, e.g. after securing the one or more terminal elements, in a configuration wherein it provides tension to reduce the distance between the proximal part and the distal part, e.g. such as to allow for a reduction of a distance between the distal part and the proximal part of each of the one or more terminal elements, and/or to allow for a reduction of a distance between the coupling part and the connection parts of the electrode assembly.

The tension may provide, such as ensure, that contact between the proximal part of each of the one or more terminal elements and the connection parts of the one or more electrodes is maintained, even if the material between the coupling part and the electrodes, e.g. due to viscous flow of material, becomes thinner over time, i.e. distance between proximal and distal side decreases. This is in particular helpful where a viscous material, such as an adhesive, is provided between the coupling part and the electrode assembly.

Securing the one or more terminal elements may comprise applying a force to the centre part of the terminal elements in an axial direction, while securing the distal part of each of the one or more terminal elements to the coupling part and positioning the proximal part of each of the one or more terminal elements to contact the respective connection parts of the one or more electrodes. By applying a force while securing the distal part and positioning the proximal part of each of the one or more terminal elements, the one or more terminal elements may be secured in a position wherein the terminal element bend is slightly straightened to the second angle, such that it provides a tension to take up decreasing thickness of material between the electrodes and the coupling part. The force may be applied in a distal direction, e.g. towards the coupling part. Alternatively or additionally, the force may be applied in a proximal direction, e.g. away from the coupling part.

An angle of a terminal element bend is defined relative to a straight terminal element, e.g. no bend has a 0 degrees angle and a U-shaped bend has a 180 degrees angle.

The first angle may be more than 90 degrees, such as more than 95 degrees. The first angle may be between 95-175 degrees, such as between 95-155 degrees, such as between 95-135 degrees, such as between 95-115 degrees.

The second angle is less than the first angle. For example, the second angle may be less than 120 degrees, such as less than 100 degrees, such as less than 95 degrees. The second angle may be between 90-120 degrees, such as between 90-100 degrees, such as between 90-95 degrees.

The base plate and/or the sensor assembly part may comprise a first adhesive layer, such as the first adhesive layer as disclosed above. The first adhesive layer may have a distal side facing the proximal side of the electrode assembly. The proximal part of each of the one or more terminals may be located between the first adhesive layer and the electrode assembly. The method may comprise positioning a first adhesive layer with a distal side facing the proximal side of the electrode assembly. The first adhesive layer may be positioned after positioning the one or more terminal elements. For example, such that the proximal part of each of the one or more terminal elements is located between the first adhesive layer and the electrode assembly.

The base plate and/or the sensor assembly part may comprise a second adhesive layer, such as the second adhesive layer as disclosed above. The second adhesive layer may have a distal side facing the coupling part. The second adhesive layer may have a proximal side facing the distal side of the electrode assembly. The method may comprise positioning a second adhesive layer with a distal side facing the coupling part and a proximal side facing the distal side of the electrode assembly.

The base plate and/or the sensor assembly part may comprise a top layer, such as the top layer as disclosed above. The top layer may have a distal side facing the coupling part and a proximal side facing the distal side of the second adhesive layer and/or the electrode assembly. The method may comprise positioning a top layer with a distal side facing the coupling part and a proximal side facing the distal side of the second adhesive layer and/or the electrode assembly.

The coupling part may be attached to the top layer. For example, the coupling part may be positioned on the distal side of the top layer and optionally the coupling part may be fixed, such as glued, soldered, or welded, to the top layer.

The terminal element bend may be a proximal terminal element bend, such as a proximal terminal element bend between the proximal end and the centre part of each of the one or more terminal elements. For example, the each of the one or more terminal elements may comprise a proximal terminal element bend between the proximal end and the centre part of each of the one or more terminal elements. The proximal terminal element bend may form the first angle.

Alternatively or additionally, the terminal element bend may be a distal terminal element bend, such as a distal terminal element bend between the distal end and the centre part of each of the one or more terminal elements. For example, each of the one or more terminal elements may comprise a distal terminal element bend between the distal end and the centre part of each of the one or more terminal elements. The distal terminal element bend may form the first angle.

The one or more terminal elements may be inserted through one or more of the electrode assembly, the top layer and/or the second adhesive layer. For example, positioning the one or more terminal elements may comprise inserting the one or more terminal elements through the electrode assembly, the top layer and/or the second adhesive layer. For example, the one or more terminal elements may be used to penetrate the electrode assembly, the top layer and/or the second adhesive layer.

Using the terminal elements to penetrate layers may provide the advantage that specific tools are not needed to provide holes in the respective layers. This may, in particular, be an advantage if the layers to be penetrated comprise adhesive, because adhesive will have a tendency to stick to the tools, and thereby extensive cleaning or frequent exchange of the tools may be required. Using the terminal elements to penetrate the respective layers may prevent physical contact between production tools and layers, such as adhesive layers.

The one or more terminal elements may be inserted through the support layer of the electrode assembly. Inserting the one or more terminal elements may comprise inserting the one or more terminal elements through the support layer of the electrode assembly, such as inserting the one or more terminal elements through the support layer while not penetrating the one or more electrodes. A terminal element bend, such as the proximal terminal element bend may provide that the proximal part of the terminal elements electrically connect the respective connection parts of the one or more electrodes.

Alternatively, or additionally the one or more terminal elements may be inserted through the connection parts of the one or more electrodes. Inserting the one or more terminal elements may comprise inserting the one or more terminal elements through the respective connection parts of the one or more electrodes.

The distal part of each of the one or more terminal elements may contact a surface, such as a distal surface, of the coupling part. Securing the distal part of each of the one or more terminal elements to the coupling part may comprise positioning the distal part of each of the one or more terminal elements to contact a surface, such as a distal surface, of the coupling part. For example, each of the one or more terminal elements may be provided with a distal terminal element bend, e.g. to position the distal part of each of the one or more terminal elements to contact the surface of the coupling part. The method may comprise providing each of the one or more terminal elements with a distal terminal element bend e.g. to position the distal part of each of the one or more terminal elements to contact the surface of the coupling part. Positioning the distal part of each of the one or more terminal elements to contact a distal surface of the coupling part may facilitate a fastening of the coupling part towards the layers of the base plate and/or the sensor assembly part and/or facilitate that the proximal part of each of the one or more terminal elements may be forced, such as pushed or pulled, towards their respective connection parts by forcing, such as pushing or pulling, the coupling part in a distal direction.

The one or more terminal elements may be inserted from either side, such as from the distal side or from the proximal side. Inserting the one or more terminal elements may comprise inserting the one or more terminal elements from the proximal side of the electrode assembly. Inserting the one or more terminals elements may comprises inserting the one or more terminal elements from the distal side of the electrode assembly.

A terminal element bend, such as the proximal terminal element bend and/or the distal terminal element bend may be provided and/or formed prior to positioning the one or more terminal elements. Alternatively or additionally, a terminal element bend, such as the proximal terminal element bend and/or the distal terminal element bend may be provided and/or formed after positioning the one or more terminal elements.

The coupling part may be aligned with the connection parts of the one or more electrodes. For example, positioning the coupling part and/or positioning the electrode assembly may comprise aligning the coupling part with the connection part of the one or more electrodes. For example, the coupling part, such as the distal surface of the coupling part, may be positioned axially to the connection parts of the one or more electrodes.

FIG.1illustrates an exemplary ostomy system. The ostomy system1comprises an ostomy appliance2including a base plate4. The base plate4is adapted to support an ostomy pouch (not shown). Further, the ostomy system1comprises a monitor device6and an accessory device8(mobile telephone). The monitor device6is connectable to the base plate4via respective first connectors of the monitor device6and base plate4. The monitor device6is configured for wireless communication with the accessory device8. Optionally, the accessory device8is configured to communicate with a server device10of the ostomy system1, e.g. via network12. The server device10may be operated and/or controlled by the ostomy appliance manufacturer and/or a service centre. Ostomy data or parameter data based on the ostomy data are obtained from electrodes/sensors of the ostomy appliance2with the monitor device6. The monitor device6processes the ostomy data and/or parameter data based on the ostomy data to determine monitor data that are transmitted to the accessory device8. In the illustrated ostomy system, the accessory device8is a mobile phone, however the accessory device8may be embodied as another handheld device, such as a tablet device, or a wearable, such as a watch or other wrist-worn electronic device. Accordingly, the monitor device6is configured to determine and transmit monitor data to the accessory device8. The base plate4comprises a coupling member14in the form of a coupling ring16for coupling an ostomy pouch (not shown) to the base plate (two-part ostomy appliance). The base plate has a stoma-receiving opening18with a stoma center point. The size and/or shape of the stomal opening18is typically adjusted by the user or nurse before application of the ostomy appliance to accommodate the user's stoma.

The ostomy system1optionally comprises a docking station20forming an accessory device of the ostomy system1. The docking station20comprises a docking monitor interface including a first connector22configured for electrically and/or mechanically connecting the monitor device6to the docking station20. The docking monitor interface may be configured for wirelessly connecting the monitor device to the docking station. The docking station20comprises a user interface24for receiving user input and/or providing feedback to the user on the operational state of the docking station20. The user interface24may comprise a touch-screen. The user interface24may comprise one or more physical buttons and/or one or more visual indicators, such as light emitting diodes.

FIG.2is a schematic block diagram of an exemplary monitor device. The monitor device6comprises a monitor device housing100, a processor101and one or more interfaces, the one or more interfaces including a first interface102(appliance interface) and a second interface104(accessory interface). The monitor device6comprises a memory106for storing ostomy data and/or parameter data based on the ostomy data. The memory106is connected to the processor101and/or the first interface102.

The first interface102is configured as an appliance interface for electrically and/or mechanically connecting the monitor device6to the ostomy appliance, e.g. ostomy appliance2. The first interface102comprises a plurality of terminals for forming electrical connections with respective terminals of the ostomy appliance2(base plate4). The first interface102comprises a ground terminal108, a first terminal110, a second terminal112and a third terminal114. The first interface102optionally comprises a fourth terminal116and a fifth terminal118. The first interface102of the monitor device6comprises a coupling part120for forming a mechanical connection, such as a releasable coupling between the monitor device and the base plate. The coupling part120and the terminals108,110,112,114,116, and118of the first interface102form (at least part of) a first connector of the monitor device6.

The monitor device6comprises a power unit121for powering the monitor device and active components thereof, i.e. the power unit121is connected to the processor101, the first interface102, the second interface104, and memory106. The power unit comprises a battery and charging circuitry. The charging circuitry is connected to the battery and terminals of the first interface102for charging the battery via terminals of the first interface, e.g. terminals of the first connector.

The second interface104of monitor device is configured as an accessory interface for connecting the monitor device6to one or more accessory devices such as accessory device8. The second interface104comprises an antenna122and a wireless transceiver124configured for wireless communication with accessory device(s). Optionally, the second interface104comprises a loudspeaker126and/or a haptic feedback element128for provision of respective audio signal and/or haptic feedback to the user.

The monitor device6comprises a sensor unit140connected to the processor101. The sensor unit140comprises a temperature sensor for feeding temperature data to the processor and a G-sensor or accelerometer for feeding acceleration data to the processor101.

The processor101is configured to apply a processing scheme, and the first interface102is configured for collecting ostomy data from the base plate coupled to the first interface, the ostomy data comprising first ostomy data from a first electrode pair of the base plate, second ostomy data from a second electrode pair of the base plate, and third ostomy data from a third electrode pair of the base plate. The ostomy data may be stored in the memory106and/or processed in the processor101in order to obtain parameter data. The parameter data may be stored in the memory106. The processor101is configured to apply a processing scheme, wherein to apply a processing scheme comprises obtain first parameter data based on the first ostomy data; obtain second parameter data based on the second ostomy data; obtain third parameter data based on the third ostomy data. In other words, the processor101is configured to obtain first, second and third parameter data based on respective first, second and third ostomy data. To apply a processing scheme comprises to determine an operating state of the base plate of the ostomy appliance based on one or more, e.g. all, of the first parameter data, the second parameter data and the third parameter data, wherein the operating state is indicative of a degree of radial erosion of the base plate and/or acute leakage risk for the ostomy appliance. The monitor device6is configured to, in accordance with a determination that the operating state is a first operating state, transmit a first monitor signal comprising monitor data indicative of the first operating state of the base plate via the second interface; and in accordance with a determination that the operating state is a second operating state, transmit a second monitor signal comprising monitor data indicative of the second operating state of the base plate via the second interface.

FIG.3illustrates an exploded view of an exemplary base plate of an ostomy appliance. The base plate4comprises a first adhesive layer200. During use, a proximal surface of the first adhesive layer200adheres to the user's skin in the peristomal area and/or to additional seals, such as sealing paste, sealing tape and/or sealing ring. The base plate4optionally comprises a second adhesive layer202, also denoted rim adhesive layer. The base plate4comprises a plurality of electrodes arranged in an electrode assembly204. The electrode assembly204is arranged between the first adhesive layer200and the second adhesive layer202. The electrode assembly204comprises a support layer with electrodes formed on a proximal surface of the support layer. The base plate4comprises a release liner206that is peeled off by the user prior to applying the base plate4on the skin. The base plate4comprises a top layer208and a coupling ring209for coupling an ostomy pouch to the base plate4. The top layer208is a protective layer protecting the second adhesive layer202from external strains and stress during use.

The base plate4comprises a monitor interface. The monitor interface is configured for electrically and/or mechanically connecting the ostomy appliance (base plate4) to the monitor device. The monitor interface of the base plate comprises a coupling part210for forming a mechanical connection, such as a releasable coupling between the monitor device and the base plate. The coupling part210is configured to engage with a coupling part of the monitor device for releasably coupling the monitor device to the base plate4. Further, the monitor interface of the base plate4comprises a plurality of terminal elements respectively forming a plurality of terminals212for forming electrical connections with respective terminals of the monitor device. The coupling part210and the terminals212form a first connector211of the base plate4. The base plate4comprises a first intermediate element213on the proximal side of the electrode assembly. The first intermediate element213is arranged between the terminal elements forming terminals212and the first adhesive layer (not shown). The first intermediate element213covers the terminal elements forming terminals212of the base plate4when seen in the axial direction and protects the first adhesive layer from mechanical stress from the terminal elements of the base plate.

As previously described, some parts of the illustrated base plate4, may be provided as a separate assembly to be applied to an existing base plate, e.g. comprising one or more of the components as described, such as to provide a base plate like the base plate4as described. For example, a sensor assembly part700may be provided, e.g. comprising the electrode assembly204, the first connector211, the first intermediate element213, the first adhesive layer200and the release liner206. Additionally, the sensor assembly part700may also comprise the second adhesive layer202and/or the top layer208. It may be envisioned that the user may provide a hole in layers of the base plate whereto the sensor assembly part700is to be applied, to allow for the first connector211of the sensor assembly part700to protrude through layers of the base plate whereto the sensor assembly part700is applied. Alternatively, the sensor assembly part700may be applied to the base plate such that the first connector211is positioned outside the periphery of the base plate.

FIG.4illustrates an exploded view of an exemplary electrode assembly204of a base plate and/or a sensor assembly part. The electrode assembly204has a distal side204A and a proximal side204B. The electrode assembly comprises a support layer214with proximal surface214B and electrodes216including a ground electrode, a first electrode, a second electrode, a third electrode, a fourth electrode, and a fifth electrode, wherein each electrode has a respective connection part217for connecting the electrodes216to respective terminal elements of the monitor interface. The electrodes216are provided, such as formed, on a proximal side214B of the support layer214, e.g. the electrodes216may be positioned on the proximal side214B of the support layer. Further, electrode assembly204comprises a masking element218with proximal surface218B and configured to insulate electrode parts of electrodes216from the first adhesive layer of the base plate and/or of the sensor assembly part. The masking element218covers or overlap with parts of the electrodes216when seen in the axial direction.

FIG.5is a proximal view of proximal surfaces of parts of the base plate and/or the sensor assembly part without the first adhesive layer and the release liner. The base plate4and/or the sensor assembly part700comprises a first intermediate element213on the proximal side of the electrode assembly, i.e. between the electrode assembly204and the first adhesive layer (not shown). The first intermediate element213covers the terminal elements of the base plate4and/or of the sensor assembly part700when seen in the axial direction and protects the first adhesive layer from mechanical stress from the terminal elements of the base plate and/or the sensor assembly part.

FIG.6is a distal view of an exemplary electrode configuration220of electrodes216of the electrode assembly204. The electrode assembly204, such as the electrode configuration220of the electrode assembly204comprises a ground electrode222, a first electrode224, a second electrode226, a third electrode228, a fourth electrode230, and a fifth electrode232. The ground electrode222comprises a ground connection part222A and the first electrode224comprises a first connection part224A. The second electrode226comprises a second connection part226A and the third electrode228comprises a third connection part228A. The fourth electrode230comprises a fourth connection part230A and the fifth electrode232comprise a fifth connection part232A.

The fourth electrode230comprises fourth sensing parts230B. The fifth electrode232comprises fifth sensing parts232B.

The ground electrode222comprises a first electrode part234for forming a ground for the first electrode224. The ground electrode222comprises a second electrode part236for forming a ground for the second electrode226. The ground electrode222comprises a third electrode part238for forming a ground for the third electrode228. The ground electrode222comprises a fourth electrode part240for forming a ground for the fourth electrode230and the fifth electrode232. The fourth electrode part240of the ground electrode222comprises ground sensing parts222B

FIG.7is a distal view of an exemplary masking element. The masking element218optionally has a plurality of terminal openings including six terminal openings. The plurality of terminal openings comprises a ground terminal opening242, a first terminal opening244, a second terminal opening246, a third terminal opening248, a fourth terminal opening250, and a fifth terminal opening252. The terminal openings242,244,246,248,250,252of the masking element218are configured to overlap and/or be aligned with respective connection parts222A,224A,226A,228A,230A,232A of the electrodes of the electrode assembly.

The masking element218has a plurality of sensor point openings. The sensor point openings comprise primary sensor point openings shown within dotted line254, each primary sensor point opening configured to overlap a part of the ground electrode222and/or a part of the fourth electrode230. The primary sensor point openings254comprise, in the illustrated exemplary masking element, five primary first sensor point openings254A each configured to overlap a part of the ground electrode222. The primary sensor point openings254comprise, in the illustrated exemplary masking element, four primary second sensor point openings254B each configured to overlap a part of the fourth electrode230. The sensor point openings comprise secondary sensor point openings shown within dotted line256, each second sensor point opening configured to overlap a part of the fourth electrode230and/or a part of the fifth electrode232. The secondary sensor point openings256comprise, in the illustrated exemplary masking element, five secondary first sensor point openings256A each configured to overlap a part of the fifth electrode232. The secondary sensor point openings256comprise, in the illustrated exemplary masking element, four secondary second sensor point openings256B each configured to overlap a part of the fourth electrode230. The sensor point openings comprise tertiary sensor point openings shown within dotted line258, each tertiary sensor opening configured to overlap a part of the fifth electrode232and/or a part of the ground electrode222. The tertiary sensor point openings258comprise, in the illustrated exemplary masking element, five tertiary first sensor point openings258A each configured to overlap a part of the fifth electrode232. The tertiary sensor point openings258comprise, in the illustrated exemplary masking element, four tertiary second sensor point openings258B each configured to overlap a part of the ground electrode222.

FIG.8is a distal view of an exemplary first adhesive layer. The first adhesive layer200has a plurality of sensor point openings. The sensor point openings of the first adhesive layer comprise primary sensor point openings shown within dotted line260, each primary sensor point opening configured to overlap a part of the ground electrode222and/or a part of the fourth electrode230of the electrode assembly. The primary sensor point openings260comprise, in the illustrated exemplary first adhesive layer, five primary first sensor point openings260A each configured to overlap a part of the ground electrode222. The primary sensor point openings260comprise, in the illustrated exemplary first adhesive layer, four primary second sensor point openings260B each configured to overlap a part of the fourth electrode230. The sensor point openings of the first adhesive layer comprise secondary sensor point openings shown within dotted line262, each second sensor point opening configured to overlap a part of the fourth electrode230and/or a part of the fifth electrode232of the electrode assembly. The secondary sensor point openings262comprise, in the illustrated exemplary first adhesive layer, five secondary first sensor point openings262A each configured to overlap a part of the fifth electrode232. The secondary sensor point openings262comprise, in the illustrated exemplary first adhesive layer, four secondary second sensor point openings262B each configured to overlap a part of the fourth electrode230. The sensor point openings of the first adhesive layer comprise tertiary sensor point openings shown within dotted line264, each tertiary sensor opening configured to overlap a part of the fifth electrode232and/or a part of the ground electrode222of the electrode assembly. The tertiary sensor point openings264comprise, in the illustrated exemplary first adhesive layer, five tertiary first sensor point openings264A each configured to overlap a part of the fifth electrode232. The tertiary sensor point openings264comprise, in the illustrated exemplary first adhesive layer, four tertiary second sensor point openings264B each configured to overlap a part of the ground electrode222.FIG.9is a proximal view of the first adhesive layer ofFIG.8.

FIG.10is a more detailed distal view of a part of the base plate4and/or the sensor assembly part700. The base plate4and/or the sensor assembly part700comprises a monitor interface. The monitor interface comprises the first connector211. The first connector211comprises coupling part210configured to releasably couple the monitor device to the base plate and/or the sensor assembly part and thus forming a releasable coupling. The first connector211of the monitor interface comprises a plurality of terminals formed by respective terminal elements for forming respective electrical connections with respective terminals of the monitor device.

The plurality of terminals of the first connector211/monitor interface comprises a ground terminal element282forming a ground terminal282A, a first terminal element284forming a first terminal284A, a second terminal element286forming a second terminal286A, and a third terminal element288forming a third terminal288A. The monitor interface optionally comprises a fourth terminal element290forming a fourth terminal290A and/or a fifth terminal element292forming a fifth terminal292A. The terminal elements282,284,286,288,290,292contact respective connection parts222A,224A,226A,228A,230a,232A of electrodes222,224,226,228,230,232.

FIG.11shows a flow diagram of an exemplary method1100for manufacturing a base plate, such as a base plate4as disclosed in the previous figures, or for manufacturing a sensor assembly part, such as a sensor assembly part700as disclosed in the previous figures. For illustrations of the structural features of the base plate and/or sensor assembly part, reference is made to the other figures, in particularFIGS.3,4,13and14.

The method1100comprises positioning1102a coupling part210. The coupling part210defines a terminal interface region270. For example, the terminal interface region270may be a region surrounded by the coupling part210.

The method1100comprises positioning1104an electrode assembly204having a distal side204A and a proximal side204B. The electrode assembly204and/or the coupling part is positioned such that the distal side204A of the electrode assembly204is facing the coupling part210. The electrode assembly204comprises a support layer214and one or more electrodes216provided on a proximal side214B of the support layer214. Each of the one or more electrodes216comprises a connection part217.

The method1100comprises providing1106one or more terminal elements272, e.g. such as the terminal elements282,284,286,288,290,292ofFIG.10, each comprising a terminal element bend276A;276B between an end272A;272B and a centre part274C of each of the one or more terminal elements272. The terminal element bend276A;276B forms a first angle700A;700B. The first angle700A;700B may be an angle formed by the terminal element bend276A;276B prior to combining the terminal elements272with the coupling part210and layers204;208of the base plate and/or of the sensor assembly part.

The method1100comprises positioning1108the one or more terminal elements272such that a distal part274A of each of the one or more terminal elements extends into the terminal interface region270and a proximal part274B of each of the one or more terminal elements272extends to the proximal side of the electrode assembly204.

Positioning1108the one or more terminal elements272may comprise inserting the one or more terminal elements272through the electrode assembly204. The one or more terminal elements272may be inserted from the proximal side204B of the electrode assembly204. Alternatively, the one or more terminal elements272may be inserted from the distal side204A of the electrode assembly204. The one or more terminal elements272, such as a distal end272B or a proximal end272A of each of the one or more terminal elements272, may be used in inserting the one or more terminal elements272to penetrate the electrode assembly204. The one or more terminal elements272may be inserted through the support layer214of the electrode assembly204, such as without penetrating the electrodes216of the electrode assembly204. Alternatively, the one or more terminal elements272may be inserted through the respective connection parts217.

The method1100comprises securing1110the one or more terminal elements272.

Securing1110the one or more terminal elements272comprises securing the distal part274A of each of the one or more terminal elements272to the coupling part210. For example, securing the distal part274A of each of the one or more terminal elements272to the coupling part210may comprise positioning the distal part274A of each of the one or more terminal elements272to contact a surface, such as a distal surface, of the coupling part210. For example, the one or more terminal elements272may be bent such that the distal part274A of each of the one or more terminal elements272is contacting the surface of the coupling part210. Alternatively or additionally, the distal part274A may be secured to the coupling part210by engaging with a clamping element (not shown) of the coupling part210, e.g. the coupling part210may comprise a clamping element configured to secure, such as lock, the distal parts274A to the coupling part210.

Securing1110the one or more terminal elements272comprises positioning the proximal part274B of each of the one or more terminal elements272to contact respective connection parts217of the one or more electrodes216. Positioning the proximal part274B or each of the one or more terminal elements272and securing the distal part274A of each of the one or more terminal elements272to the coupling part210may be performed simultaneously, such as performed by the same action. For example, positioning the distal part274A of each of the one or more terminal elements272to contact the surface of the coupling part210may result in the proximal part274B of each of the one or more terminal elements272to contact respective connection parts217of the one or more electrodes216.

Securing1110the one or more terminal elements272may comprise applying a force to the centre part274C of the terminal elements272in an axial direction, e.g. in a distal direction, such as in a direction towards the coupling part210, while securing the distal part274A of each of the one or more terminal elements272to the coupling part210the one or more electrodes216. Securing1110the one or more terminal elements272may comprise applying a force to the centre part274C of the terminal elements272in an axial direction, e.g. in a proximal direction, such as in a direction towards the electrode assembly204, while positioning the proximal part274B of each of the one or more terminal elements272to contact the respective connection parts217of the one or more electrodes216.

After securing1110the one or more terminal elements272. The terminal element bend276A;276B of each of the one or more terminal elements272forms a second angle702A;702B. The second angle702A;702B is less than the first angle700A;700B. Thus, in securing1110the one or more terminal elements272the terminal element bend276A;276B has been slightly straightened to form a smaller angle, i.e. a smaller bend.

The method1100further comprises an optional step of positioning1112a first adhesive layer200. The first adhesive layer200comprises a distal side and a proximal side. The first adhesive layer200is positioned1112such that the distal side of the first adhesive layer200is facing the proximal side of the electrode assembly204. The first adhesive layer200may be positioned1112after positioning1108the one or more terminal elements272such that the proximal part274B of each of the one or more terminal elements272is located between the first adhesive layer200and the electrode assembly204.

The first adhesive layer200may be positioned1112together with a release liner206provided on the proximal side of the first adhesive layer200. The first adhesive layer200may be formed on the release liner206by scraping a thin layer of a first adhesive composition onto the release liner206to form the first adhesive layer200. The first adhesive layer200may be formed on the release liner prior to positioning1112the first adhesive layer200, e.g. with the release liner206.

The method1100provides that an electrical connection is provided from the distal side of the base plate4and/or of the sensor assembly part700to the electrodes216of the electrode assembly204being positioned on a proximal facing side of the electrode assembly204. The proximal position of the electrodes216may provide for better measuring of leakage and/or wear of the base plate and/or of the sensor assembly part. The method1100further provides that a tension is provided to the electrical connection between the one or more terminal elements272and the respective connection parts217of the electrodes216. Thereby, the electrical connection may be maintained even if the thickness of any of the intermediary material, such as the electrode assembly, should be reduced, e.g. due to creep.

FIG.12shows a flow diagram of an exemplary method1100′ for manufacturing a base plate, such as a base plate4as disclosed in the previous figures, or for manufacturing a sensor assembly part, such as a sensor assembly part700as disclosed in the previous figures. For illustrations of the structural features of the base plate4and/or the sensor assembly part700, reference is made to the other figures, in particularFIGS.3,4,13and14.

The method1100′ comprises the same steps as the method1100as explained in relation toFIG.11, namely, positioning1102a coupling part210, positioning1104an electrode assembly204, providing1106one or more terminal elements272, positioning1108the one or more terminal elements272, securing1110the one or more terminal elements272, and optionally positioning1112a first adhesive layer200. The additional steps of the method1100′ as described in the following are generally not mutually dependent, and hence may be individually applied and/or omitted.

The method1100′ comprises positioning1114a top layer208. The top layer208has a distal side and a proximal side. The top layer208is positioned1114such that the distal side of the top layer208is facing the coupling part and a proximal side facing the distal side of the electrode assembly204.

The method1100′ comprises positioning1116a second adhesive layer202. The second adhesive layer202has a distal side and a proximal side. The second adhesive layer is positioned1116such that the distal side of the second adhesive layer202is facing the coupling part and a proximal side of the second adhesive layer202is facing the distal side of the electrode assembly204. The second adhesive layer202may be positioned1116on the top layer208, e.g. after the top layer208is positioned1114. The second adhesive layer202may be positioned1116on the top layer208by scraping a thin layer of a second adhesive composition onto the top layer208to form the second adhesive layer202. Positioning1114the top layer208and positioning1116the second adhesive layer may be performed simultaneously.

The second adhesive layer202may be positioned1116prior to positioning1108the one or more terminal elements272and/or the top layer208may be positioned1114prior to positioning1108the one or more terminal elements272. Positioning1108the one or more terminal elements272may comprise inserting the one or more terminal elements272through the second adhesive layer202and/or the top layer208.

The one or more terminal elements272, such as a distal end or proximal end of each of the one or more terminal elements272, may be used in inserting the one or more terminal elements272to penetrate the electrode assembly202, the second adhesive layer202and/or the top layer208.

FIG.13schematically illustrates insertion of terminal elements272in manufacturing of a base plate4or sensor assembly part700, such as in an exemplary method, such as the method1100and/or1100′ ofFIGS.11and12.

A coupling part210, a top layer208and an electrode assembly204are positioned such that a distal side of the electrode assembly204is facing the coupling part210, and such that the top layer208is between the coupling part210and the electrode assembly204. A second adhesive layer (not shown) may be positioned between the top layer208and the electrode assembly204.

The terminal elements272have a distal end272A and a proximal end272B. The terminal elements272comprises a proximal terminal element bend276B between a proximal end272B and a centre part274C of each of the terminal elements272.

InFIG.13a, terminal elements272are positioned such that the distal part274A of each of the terminal elements272extends into a terminal interface region270defined by the coupling part210. The proximal part274B of each of the terminal elements272extends to the proximal side of the electrode assembly204. The terminal elements272may be inserted through the electrode assembly from the proximal side towards the distal side of the base plate4and/or of the sensor assembly part700. The terminal elements272may be inserted by penetrating the electrode assembly204and the top layer208with the distal end272A of the terminal elements272from the proximal side to the distal side of the base plate4and/or of the sensor assembly part700.

The terminal elements272may be extending through respective connection parts of the electrodes of the electrode assembly204. Alternatively, the terminal elements272may be extending through the electrode assembly204without extending though electrodes or connection parts of electrodes, e.g. the terminal elements272may be extending through a support layer of the electrode assembly204without extending though electrodes or connection parts of electrodes.

The coupling part210comprises guide holes278for receiving terminal elements272being inserted through the coupling part210from the proximal side. The guide holes278may facilitate the positioning of the terminal elements272.

After positioning the terminal elements272, the terminal elements272are secured, as illustrated inFIG.13b. The terminal elements272are secured by securing the distal part274A of each of the terminal elements272to the coupling part210and positioning the proximal part274B of each of the terminal elements272to contact respective connection parts of the electrodes of the electrode assembly204. The terminal elements272are provided with distal terminal element bends276A, and the terminal elements272are being pressed, such that the proximal terminal element bend276B forms a second angle being less than a first angle formed by the proximal terminal element bend276B, e.g. prior to securing the terminal elements272, as illustrated inFIG.13a.

The distal terminal element bends276A is provided by positioning a distal staple element602on the distal side of the coupling part210. The distal staple element602comprises curvatures such that upon movement of the terminal elements272in a distal direction, the distal ends272A of the terminal elements272are guided in a direction perpendicular to the distal direction. Thereby, the terminal elements272are provided with distal terminal element bends276A. Thereby, the terminal elements272may be secured to the coupling part210.

A proximal staple element604, acting on the proximal side of the base plate4and/or of the sensor assembly part700, is configured to provide pressure to the terminal elements272from the proximal side, e.g. to press the proximal part274B of each of the terminal elements272towards the coupling part210, such as in a distal direction. The distal staple element602provides a counter force. The distal part274A and the proximal part274B of each of the terminal elements272are pressed towards each other by the distal staple element602and the proximal staple element604. Thus, the proximal staple element604provides that the distal ends272A of the terminal elements272are moving in the distal direction, such that the distal ends272A of the terminal elements272are guided by the distal staple element602, such that the terminal elements272are provided with distal terminal element bends276A, and are secured to the coupling part210. Thereby, the coupling part210, the top layer208and the electrode assembly204are clamped between the proximal parts274B and distal parts274A of the terminal elements272.

Furthermore, the proximal staple element604provides that the proximal terminal element bends276B are flattened, such that upon securing the distal part274A of each of the terminal elements272to the coupling part210, the proximal terminal element bend forms an angle that is smaller than the initial angle formed by the proximal terminal element bend. Thereby, the terminal element bend276B is in a configuration wherein it provides tension to reduce a distance between the proximal part274B and the distal part274A of each of the terminal elements272, such as if the thickness of the material being clamped between the proximal part274B and the distal part274A would be reduced.

It will be understood that although not specifically exemplified, the terminal elements272could be inserted from the distal side, and the terminal elements272could in such an example be provided with a distal terminal element bend276A prior to securing the terminal element272forming a first angle before securing the terminal elements272and a second angle smaller than the first angle after securing the terminal elements272. Thereby the distal terminal element bend276A would be in a configuration wherein it provides tension to reduce a distance between the proximal part274B and the distal part274A, such as if the thickness of the material being clamped between the proximal part274B and the distal part274A would be reduced.

FIG.14schematically illustrates an exemplary terminal element272, such as the terminal element as discussed in relation toFIG.13. The terminal element272have a distal end272A and a proximal end272B. The terminal element272have a distal part274A, a proximal part274B and a centre part274C.

FIG.14aillustrates the terminal element272prior to securing the terminal element272.

The terminal element272comprises a proximal terminal element bend276B between the proximal end272B and a centre part274C. As seen inFIG.14a, the proximal terminal element bend276B forms a first angle700B prior to securing the terminal element272. The first angle700B is approximately 120 degrees.

In the situation illustrated inFIG.14a, the terminal element272does not comprises a distal terminal element bend. Hence, a first angle700A formed by the distal terminal element bend is 0 degrees.

FIG.14billustrates the terminal element272after securing the terminal element272. The proximal terminal element bend276B forms a second angle702B after securing the terminal element272. The second angle702B is approximately 90 degrees. Thus, the second angle702B, as illustrated inFIG.14b, is smaller than the first angle700B formed by the proximal terminal element bend276B prior to securing the terminal element272, as illustrated inFIG.14a.

In securing the terminal element272, the terminal element272has been provided with a distal terminal element bend276A. The distal terminal element bend276A forms a second angle702A after securing the terminal element272.

FIG.15schematically illustrates a base plate4and/or a sensor assembly part700comprising a coupling part210. The coupling part defines a terminal interface region270. The base plate4and/or the sensor assembly part700comprises an electrode assembly204having a distal side and a proximal side. The distal side of the electrode assembly204is facing the coupling part210. Terminal elements272extends through the electrode assembly204. Each of the terminal elements have a distal part274A extending into the terminal interface region270and a proximal part274B extending to the proximal side of the electrode assembly204. The terminal elements272comprises terminal element bends276A;276B between the proximal part274B and the distal part274A. The terminal elements272comprises a distal terminal element bend276A between the distal part274A and a centre part274C of the terminal element272. The terminal elements272comprises a proximal terminal element bend276B between the proximal part274A and the centre part274C of the terminal element272. The proximal part274B of each of the terminal elements272are electrically connected to respective connection parts of electrodes of the electrode assembly204. The distal part274A of each of the terminal elements contact a distal surface of the coupling part210, e.g. in order to secure the terminal elements272.

The base plate4and/or the sensor assembly part700comprises a top layer208. The top layer208has a distal side facing the coupling part210and a proximal side facing the distal side of the electrode assembly204. The terminal elements272are extending through the top layer208. If the base plate and/or the sensor assembly part had a second adhesive layer, as described in relation to other figures, the proximal side of the top layer208could face the second adhesive layer.

The base plate and/or of the sensor assembly part as illustrated inFIG.15may be provided by the steps as explained in relation toFIG.13. Hence,FIG.15may be followingFIG.13b.

FIG.16schematically illustrates a base plate4and/or the sensor assembly part700, such as the base plate4and/or the sensor assembly part700as illustrated inFIG.15, with the addition as compared toFIG.15, that a first adhesive layer200has been added. The first adhesive layer200has a distal side facing the proximal side of the electrode assembly204. The proximal part274B of each of the terminal elements272are located between the first adhesive layer200and the electrode assembly204. Thus, the first adhesive layer200may have been added to the base plate4and/or the sensor assembly part700after the terminal elements272have been positioned and secured.

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

The use of the terms “first”, “second”, “third” and “fourth”, “primary”, “secondary”, “tertiary” etc. does not imply any particular order, but are included to identify individual elements. Moreover, the use of the terms “first”, “second”, “third” and “fourth”, “primary”, “secondary”, “tertiary” etc. does not denote any order or importance, but rather the terms “first”, “second”, “third” and “fourth”, “primary”, “secondary”, “tertiary” etc. are used to distinguish one element from another. Note that the words “first”, “second”, “third” and “fourth”, “primary”, “secondary”, “tertiary” etc. are used here and elsewhere for labelling purposes only and are not intended to denote any specific spatial or temporal ordering. Furthermore, the labelling of a first element does not imply the presence of a second element and vice versa.

Embodiments of the present disclosure is set out in the following items:

1. Method for manufacturing a base plate or a sensor assembly part for an ostomy appliance, the method comprising:positioning a coupling part, the coupling part defining a terminal interface region;positioning an electrode assembly having a distal side and a proximal side, wherein the electrode assembly is positioned such that the distal side of the electrode assembly is facing the coupling part, the electrode assembly comprises a support layer and one or more electrodes provided on a proximal side of the support layer, each of the one or more electrodes comprising a connection part;providing one or more terminal elements each comprising a terminal element bend between an end and a centre part of each of the one or more terminal elements, the terminal element bend forming a first angle;positioning the one or more terminal elements such that a distal part of each of the one or more terminal elements extends into the terminal interface region and a proximal part of each of the one or more terminal elements extends to the proximal side of the electrode assembly;securing the one or more terminal elements, by securing the distal part of each of the one or more terminal elements to the coupling part and positioning the proximal part of each of the one or more terminal elements to contact respective connection parts of the one or more electrodes,

wherein after securing the one or more terminal elements, the terminal element bend of each of the one or more terminal elements forms a second angle, the second angle being less than the first angle.

2. Method according to item 1 comprising positioning a first adhesive layer with a distal side facing the proximal side of the electrode assembly, wherein the first adhesive layer is positioned after positioning the one or more terminal elements such that the proximal part of each of the one or more terminal is located between the first adhesive layer and the electrode assembly.

3. Method according to any of items 1 or 2 comprising positioning a second adhesive layer with a distal side facing the coupling part and a proximal side facing the distal side of the electrode assembly.

4. Method according to any of items 1-3 comprising positioning a top layer with a distal side facing the coupling part and a proximal side facing the distal side of the electrode assembly.

5. Method according to any of the preceding items, wherein the terminal element bend is a proximal terminal element bend between a proximal end and the centre part of each of the one or more terminal elements.

6. Method according to any of the preceding items, wherein securing the distal part of each of the one or more terminal elements to the coupling part comprises positioning the distal part of each of the one or more terminal element to contact a distal surface of the coupling part.

7. Method according to item 6, wherein securing the distal part of each of the one or more terminal elements to the coupling part comprises providing each of the one or more terminal elements with a distal terminal element bend to position the distal part of each of the one or more terminal elements to contact the distal surface of the coupling part.

8. Method according to any of the preceding items, wherein securing the one or more terminal elements comprises applying a force to the centre part of the terminal elements in an axial direction while securing the distal part of each of the one or more terminal elements to the coupling part and positioning the proximal part of each of the one or more terminal elements to contact the respective connection parts of the one or more electrodes.

9. Method according to any of the preceding items, wherein the first angle is between 95-175 degrees

10. Method according to any of the preceding items, wherein the second angle is between 90-120 degrees.

11. Method according to any of the preceding items, wherein the coupling part is positioned axially to the connection parts of the one or more electrodes.

12. Sensor assembly part for an ostomy appliance, the sensor assembly part comprising:a coupling part defining a terminal interface region;an electrode assembly having a distal side and a proximal side, the distal side of the electrode assembly is facing the coupling part, the electrode assembly comprises a support layer and one or more electrodes provided on a proximal side of the support layer, each of the one or more electrodes comprising a connection part;one or more terminal elements each comprising a terminal element bend between a proximal part and a distal part, the distal part of each of the one or more terminal elements extends into the terminal interface region and the proximal part of each of the one or more terminal elements extends from the proximal side of the electrode assembly and contact respective connection parts of the one or more electrodes, the distal part of each of the one or more terminal elements are secured to the coupling part;
wherein the terminal element bend is in a configuration wherein it provides tension to reduce a distance between the proximal part and the distal part.

13. Sensor assembly part according to item 12 comprising a first adhesive layer with a distal side facing the proximal side of the electrode assembly, and wherein the proximal part of each of the one or more terminal is located between the first adhesive layer and the electrode assembly.

14. Sensor assembly part according to any of items 12 or 13 comprising a second adhesive layer with a distal side facing the coupling part and a proximal side facing the distal side of the electrode assembly.

15. Sensor assembly part according to any of items 12-14 comprising a top layer with a distal side facing the coupling part and a proximal side facing the distal side of the electrode assembly.

16. Sensor assembly part according to any of items 12-15, wherein the distal part of each of the one or more terminal elements contact a distal surface of the coupling part.

17. Base plate for an ostomy appliance, the base plate comprising:a coupling part defining a terminal interface region;an electrode assembly having a distal side and a proximal side, the distal side of the electrode assembly is facing the coupling part, the electrode assembly comprises a support layer and one or more electrodes provided on a proximal side of the support layer, each of the one or more electrodes comprising a connection part;one or more terminal elements each comprising a terminal element bend between a proximal part and a distal part, the distal part of each of the one or more terminal elements extends into the terminal interface region and the proximal part of each of the one or more terminal elements extends from the proximal side of the electrode assembly and contact respective connection parts of the one or more electrodes, the distal part of each of the one or more terminal elements are secured to the coupling part;
wherein the terminal element bend is in a configuration wherein it provides tension to reduce a distance between the proximal part and the distal part.

18. Base plate according to item 17 comprising a first adhesive layer with a distal side facing the proximal side of the electrode assembly, and wherein the proximal part of each of the one or more terminal is located between the first adhesive layer and the electrode assembly.

19. Base plate according to any of items 17 or 18 comprising a second adhesive layer with a distal side facing the coupling part and a proximal side facing the distal side of the electrode assembly.

20. Base plate according to any of items 17-19 comprising a top layer with a distal side facing the coupling part and a proximal side facing the distal side of the electrode assembly.

21. Base plate according to any of items 17-20, wherein the distal part of each of the one or more terminal elements contact a distal surface of the coupling part.

LIST OF REFERENCES

100monitor device housing

108ground terminal of monitor device

110first terminal of monitor device

112second terminal of monitor device

114third terminal of monitor device

116fourth terminal of monitor device

118fifth terminal of monitor device

128haptic feedback element

200A distal surface of first adhesive layer

200B proximal surface of first adhesive layer

202A distal surface of second adhesive layer

202B proximal surface of second adhesive layer

204A distal surface of electrode assembly

204B proximal surface of electrode assembly

206A distal surface of the release liner

206B proximal surface of the release liner

208A distal surface of the top layer

208B proximal surface of the top layer

210coupling part of first connector

212terminals of first connector

213first intermediate element

213A distal surface of first intermediate element

213B proximal surface of first intermediate element

214support layer of electrode assembly

214A distal surface of support layer

214B proximal surface of support layer

216electrodes of electrode assembly

218A distal surface of masking element

218B proximal surface of masking element

222A ground connection part

222B ground sensing part

224A first connection part

226A second connection part

228A third connection part

230A fourth connection part

230B fourth sensing part

232A fifth connection part

232B fifth sensing part

234first electrode part of the ground electrode

236second electrode part of the ground electrode

238third electrode part of the ground electrode

240fourth electrode part of the ground electrode

242ground terminal opening

244first terminal opening

246second terminal opening

248third terminal opening

250fourth terminal opening

252fifth terminal opening

254primary sensor point openings of masking element

254A primary first sensor point opening

254B primary second sensor point opening

256secondary sensor point openings of masking element

256A secondary first sensor point opening

256B secondary second sensor point opening

258tertiary sensor point openings of masking element

258A tertiary first sensor point opening

258B tertiary second sensor point opening

260primary sensor point openings of first adhesive layer

260A primary first sensor point opening

260B primary second sensor point opening

262secondary sensor point openings of first adhesive layer

262A secondary first sensor point opening

262B secondary second sensor point opening

264tertiary sensor point openings of first adhesive layer

264A tertiary first sensor point opening

264B tertiary second sensor point opening

270terminal interface region

272A distal end of terminal element(s)

272B proximal end of terminal element(s)

274A distal part of terminal element(s)

274B proximal part of terminal element(s)

276A distal terminal element bend

276B proximal terminal element bend

282ground terminal element

282A ground terminal

284first terminal element

284A first terminal

286second terminal element

286A second terminal

288third terminal element

288A third terminal

290fourth terminal element

290A fourth terminal

292fifth terminal element

292A fifth terminal

700sensor assembly part

700A first angle of distal terminal element bend

700B first angle of proximal terminal element bend

702A second angle of distal terminal element bend

702B second angle of proximal terminal element bend

1102positioning coupling part

1112positioning first adhesive

1114positioning top layer

1116positioning second adhesive layer

M number of terminals in the first interface of the monitor device