Patent Description:
<CIT> relates to systems and methods for providing comprehensive care for stoma patients. The system includes a sensor device for detecting a fill level of an ostomy bag fitted over and around a stoma and is configured to sense one or more parameters of an effluent received in the bag and to communicate the measurements to a stoma care management software application.

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/monitor device. 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/monitor device. 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.

A 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.

An ostomy system comprising an ostomy appliance and a monitor device, the ostomy appliance comprising a base plate is disclosed, wherein the monitor device is a monitor device as described herein.

An ostomy system comprising a monitor device and an ostomy appliance comprising a base plate is disclosed, the base plate having a first adhesive layer with a proximal side configured for attachment of the base plate to the skin surface of a user, the first adhesive layer having a stomal opening, such as a first adhesive stomal opening, with a center point, the monitor device comprising a processor and a sensor unit comprising a first sensor with a first sensor surface accommodated in a monitor device housing, the monitor device housing having a sensor opening in a proximal surface of the monitor device, the sensor opening forming at least a part of a sensor path from surroundings of the proximal surface to the first sensor surface.

Also disclosed is a monitor device for an ostomy appliance of an ostomy system, the monitor device comprising a processor and a sensor unit comprising a first sensor with a first sensor surface accommodated in a monitor device housing, the monitor device housing having a sensor opening in a proximal surface of the monitor device, the proximal surface configured for facing the skin of a user during use, the sensor opening forming at least a part of a sensor path from surroundings of the proximal surface to the first sensor surface.

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 may facilitate reliable monitoring of the ostomy appliance.

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.

A base plate and/or a sensor assembly part for an ostomy appliance is disclosed, the base plate and/or the sensor assembly part comprising a first adhesive layer with a proximal side configured for attachment of the base plate and/or the sensor assembly part to the skin surface of a user, the first adhesive layer having a stomal opening, such as a first adhesive stomal opening, with a center point; and a plurality of electrodes including a ground electrode, a first electrode, and a optionally a second electrode, the ground electrode comprising a ground connection part, the first electrode comprising a first connection part, and the second electrode comprising a second connection part, wherein the ground electrode forms a ground for the first electrode and/or the second electrode.

The base plate and/or the sensor assembly part comprises a first 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 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 or is at least prepared for forming a stomal opening, such as a first adhesive stomal opening, with a center point.

The base plate and/or sensor assembly part may comprise one or more electrodes having sensing parts. A base plate and/or sensor assembly part with one or more electrodes, such as two electrodes or three electrodes, having sensing parts with contact to the first adhesive layer allows for determining erosion/swelling properties or characteristics of the first adhesive layer and/or determining a degree of erosion and/or swelling of the first adhesive layer.

It is an advantage of the present disclosure that an optimum or improved use of an ostomy appliance is provided. In particular, the present disclosure facilitates that a base plate is not changed too early (leading to increased cell-stripping from the skin and increased risk of skin damage and further leading to increased costs and/or material waste) nor too late (leading to adhesive failure, leakage and/or skin damage from the aggressive output). Accordingly, the user or a health care professional is able to monitor and plan the use of the ostomy appliance.

The present disclosure provides a simple, efficient, and easy-to-use ostomy appliance system with a high degree of comfort for a user.

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-butadienestyrene 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 <NUM>% to <NUM>% 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 <NUM> - <NUM>% 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 <NUM>-<NUM>% hydrocolloids. A preferred hydrocolloid is carboxymethyl cellulose (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 configured to overlap a (sensing) 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 (sensing) parts of an electrode and the primary second sensor point openings configured to overlap (sensing) 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 (sensing) parts of an electrode and the secondary second sensor point openings configured to overlap (sensing) 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 (sensing) parts of an electrode and the tertiary second sensor point openings configured to overlap (sensing) 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 <NUM> to <NUM>, e.g. in the range from <NUM> to <NUM>, such as <NUM> or <NUM>.

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 <NUM> to <NUM>. such as about <NUM>. The primary radial distance may be in the range from <NUM> to <NUM>, such as in the range from <NUM> to <NUM>, e.g. <NUM>.

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 <NUM> to <NUM>, such as about <NUM>. The secondary radial distance may be in the range from <NUM> to <NUM>, such as in the range from <NUM> to <NUM>, e.g. <NUM>.

The base plate may comprise a second layer. The second layer may be an 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. 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 hydrocolloids. 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 styrenebutadiene-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 <NUM>% to <NUM>% 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 <NUM> - <NUM>% 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 <NUM>-<NUM>% hydrocolloids. A preferred hydrocolloid is carboxymethyl cellulose (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 moldable 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 <NUM> to <NUM>, e.g. in the range from <NUM> to <NUM>, such as <NUM>, <NUM>, or <NUM>.

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/terminal elements. An electrode may comprise one or more conductor parts and/or one or more sensing parts. A conductor part may be considered part of an electrode connecting two or more sensing parts. A sensing part may be considered a part of the electrode being suitable for receiving an input, e.g. from a liquid, e.g. output resulting from a leakage. The suitability may arise from its shape, said shape potentially being circular, oval, or rectangular. Thus, the conductor part conducts a signal arising from the sensing part. Thereby, an electrode may comprise alternating conductor parts and 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 or reference 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 or reference 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 or reference 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 or reference 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.

The electrodes are electrically conductive and may comprise one or more of metallic (e.g. silver, copper, gold, titanium, aluminium, stainless steel), ceramic (e.g. ITO), polymeric (e.g. PEDOT, PANI, PPy), and carbonaceous (e.g. carbon black, carbon nanotube, carbon fibre, graphene, graphite) materials.

The ground electrode may comprise a first electrode part and a second electrode part, the first electrode part forming the ground for the first electrode and the second electrode part forming the ground for the second electrode. The first electrode part may form a closed loop.

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.

An electrode may comprise a sensing part or a plurality of sensing parts, i.e. the part(s) of an electrode that are used for sensing. The first electrode may comprise a first sensing part. The first sensing part may contact the first adhesive layer and is optionally arranged at least partly annularly around the stomal opening. The first electrode may comprise a first conductor part insulated from the first adhesive layer, e.g. by a masking element arranged between the first conductor part and the first adhesive layer. The first sensing part may extend at least <NUM> degrees around the stomal opening, such as at least <NUM> degrees around the stomal opening. The first sensing part of the first electrode may be arranged at a first ground distance from the first electrode part of the ground electrode. The first ground distance may be less than <NUM>, such as less than <NUM>, e.g. about <NUM>.

The second electrode may comprise a second sensing part. The second sensing part may contact the first adhesive layer. The second sensing part may be arranged at least partly annularly around the stomal opening. The second sensing part may extend at least <NUM> degrees around the stomal opening, such as at least <NUM> degrees around the stomal opening. The second sensing part of the second electrode may be arranged at a second ground distance from the second electrode part of the ground electrode. The second ground distance may be less than <NUM>, such as less than <NUM>, e.g. about <NUM>.

The first sensing part may be arranged at a first radial distance from the center point and the second sensing part may be arranged at a second radial distance from the center point. The second radial distance may be larger than the first radial distance. The second electrode may comprise a second conductor part insulated from the first adhesive layer, e.g. by a masking element arranged between the second conductor part and the first adhesive layer. The first radial distance may vary as a function of an angular position with respect to a zero direction from the center point. The second radial distance may vary as a function of an angular position with respect to a zero direction from the center point. The zero direction may be defined as the vertical upward direction when the base plate is in its intended wearing position on an upstanding user.

The first radial distance may be in the range from <NUM> to <NUM>, such as in the range from <NUM> to <NUM>, e.g. about <NUM>. The second radial distance may be in the range from <NUM> to <NUM>, such as in the range from <NUM> to <NUM>, e.g. about <NUM>.

The base plate and/or the sensor assembly part may comprise a third electrode comprising a third connection part. The ground electrode may form a ground for the third electrode. The ground electrode may comprise a third electrode part, the third electrode part forming the ground for the third electrode. The third electrode may comprise a third conductor part insulated from the first adhesive layer, e.g. by a masking element arranged between the third conductor part and the first adhesive layer. The third electrode may comprise a third sensing part, the third sensing part contacting the first adhesive layer. The third sensing part may be arranged at least partly annularly around the stomal opening. The third sensing part may be arranged at a third radial distance from the center point. The third radial distance may be larger than the first radial distance and/or larger than the second radial distance. The third radial distance may be in the range from <NUM> to <NUM>. such as in the range from <NUM> to <NUM>, e.g. about <NUM>. The third sensing part may extend at least <NUM> degrees around the stomal opening, such as at least <NUM> degrees around the stomal opening. The third sensing part of the third electrode may be arranged at a third ground distance from the third electrode part of the ground electrode. The third ground distance may be less than <NUM>, such as less than <NUM>, e.g. about <NUM>. A base plate with a ground electrode, a first electrode, a second electrode, and a third electrode allows for a failsafe base plate in case e.g. the first electrode is cut or otherwise destroyed during preparation of the base plate.

The base plate and/or the sensor assembly part may comprise a fourth electrode comprising a fourth connection part. The ground electrode may form a ground for the fourth electrode. The ground electrode may comprise a fourth electrode part, the fourth electrode part forming the ground for the fourth electrode. The fourth electrode may comprise one or a plurality of fourth sensing parts, such as at least five fourth sensing parts. The fourth sensing parts may be distributed around the stomal opening or a center point thereof. The fourth sensing parts may be arranged at respective fourth radial distances from the center point. The fourth radial distance(s) may be larger than the third radial distance. The fourth radial distance(s) may be in the range from <NUM> to <NUM>, such as about <NUM>.

The base plate and/or the sensor assembly part may comprise a fifth electrode comprising a fifth connection part. The ground electrode may form a ground for the fifth electrode. The ground electrode may comprise a fifth electrode part, the fifth electrode part forming the ground for the fifth electrode. The fifth electrode may comprise one or a plurality of fifth sensing parts, such as at least five fifth sensing parts. The fifth sensing parts may be distributed around the stomal opening or a center point thereof. The fifth sensing parts may be arranged at respective fifth radial distances from the center point. The fifth radial distance may be larger than the third radial distance. The fifth radial distance may be equal to or larger than the fourth radial distance. The fifth radial distance(s) may be in the range from <NUM> to <NUM>, such as about <NUM>.

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 base plate and/or the sensor assembly part may comprise a second adhesive layer, wherein the plurality of electrodes is arranged between the first adhesive layer and the second adhesive 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. Thus, one or more electrodes may be arranged between the support layer and the first adhesive 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), polyamide, polyimide, Ethylene-vinyl acetate (EVA), polyurea, and silicones.

Exemplary thermoplastic elastomers of the support layer are styrenic block copolymers (TPS, TPE-s), thermoplastic polyolefin elastomers (TPO, TPE-o), thermoplastic Vulcanizates (TPV, TPE-v), thermoplastic polyurethanes (TPU), thermoplastic copolyester (TPC, TPE-E), and thermoplastic polyamides (TPA, TPE-A).

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 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 (sensing) part of the ground electrode and/or a (sensing) part of the fourth electrode. A secondary sensor point opening may overlap a (sensing) part of the fourth electrode and/or a (sensing) part of the fifth electrode. A tertiary sensor point opening may overlap a (sensing) part of the fifth electrode and/or a (sensing) part of the ground electrode.

The masking element may comprise one or more, such as a plurality of, terminal openings. A terminal opening may overlap with one or more connection parts of electrodes. In one or more exemplary base plates and/or sensor assembly parts, each terminal opening overlaps with a single connection part of an electrode.

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), polyamide, polyimide, Ethylene-vinyl acetate (EVA), polyurea, and silicones.

Exemplary thermoplastic elastomers of the masking element are styrenic block copolymers (TPS, TPE-s), thermoplastic polyolefin elastomers (TPO, TPE-o), thermoplastic Vulcanizates (TPV, TPE-v), thermoplastic polyurethanes (TPU), thermoplastic copolyester (TPC, TPE-E), and thermoplastic polyamides (TPA, TPE-A).

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 <NUM> to <NUM>, e.g. in the range from <NUM> to <NUM>, such as <NUM>. The top layer may have a stomal opening with a center point.

The base plate and/or the sensor assembly part may comprise a monitor interface. The monitor interface may be configured for electrically and/or mechanically connecting the ostomy appliance (base plate and/or sensor assembly part) to the monitor device. The monitor interface may be configured for wirelessly connecting the ostomy appliance (base plate and/or 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 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 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 (connection parts) of the base plate and/or 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 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 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 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. The proximal end/proximal part of a terminal element may contact a connection part of an electrode. 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 has a stomal opening 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 is typically 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, the user forms the stomal opening during preparation of the base plate for application.

An ostomy system comprising a monitor device and an ostomy appliance comprising a base plate is disclosed. The ostomy appliance may comprise a sensor assembly part, e.g. as disclosed above. For example, the base plate may be fitted with a sensor assembly part. The base plate has a first adhesive layer with a proximal side configured for attachment of the base plate to the skin surface of a user. The first adhesive layer has a stomal opening with a center point. The monitor device comprises a processor and a sensor unit comprising a first sensor with a first sensor surface accommodated in a monitor device housing. The monitor device housing has a sensor opening in a proximal surface of the monitor device. The sensor opening forming at least a part of a sensor path from surroundings of the proximal surface to the first sensor surface.

Also disclosed is a monitor device for an ostomy appliance of an ostomy system. The monitor device comprises a processor and a sensor unit comprising a first sensor with a first sensor surface accommodated in a monitor device housing. The monitor device housing has a sensor opening in a proximal surface of the monitor device. The proximal surface is configured for facing the skin of a user during use. The sensor opening forms at least a part of a sensor path from surroundings of the proximal surface to the first sensor surface.

The present disclosure allows for a monitor device that is able to obtain reliable and stable measurements of parameters considered relevant for monitoring an ostomy appliance, such as temperature and/or humidity. The position of the sensor opening reduces the risk of dirt, dust, lint, etc. clogging or blocking the sensor opening in turn increasing durability of the monitor device and increasing the accuracy of the parameters measured.

Further, the present disclosure allows for temperature and humidity measurements locally and close to the skin of a user with reduced influence from ambient factors, such as ambient temperature, wind speed, etc..

The monitor device comprises a processor. The processor controls the operation of the monitor device including collection and processing of ostomy data from the base plate of the ostomy appliance, processing of, such as storing, sensor data from sensor unit, and generation/transmission of monitor data to accessory devices.

The monitor device comprises a memory for storing ostomy data and/or parameter data based on the ostomy data. The processor may be configured for processing and storing sensor data in the memory.

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 <NUM> to <NUM>. The monitor device housing may have a width or maximum extension perpendicular to the longitudinal axis in the range from <NUM> to <NUM>, such as from <NUM> to <NUM>. The monitor device housing may be curve-shaped.

The monitor device housing may have a plurality of sensor openings, e.g. a plurality of sensor openings for a sensor and/or a sensor opening for each of a plurality of sensors. The monitor device may comprise one or more sensor openings in a distal surface of the monitor device. The monitor device may comprise one or more sensor openings in a side surface of the monitor device. The monitor device may comprise one or more sensor openings in an end surface of the monitor device.

The sensor opening in the proximal surface is arranged at a sensor opening distance from the first end. The sensor opening distance, also denoted D_S, may be in the range from <NUM> to <NUM>, such as from <NUM> to <NUM>, where L is the length of the monitor device housing. The sensor opening distance may be in the range from <NUM> to <NUM>.

The monitor device housing comprises or forms a sensor path from surroundings of the proximal surface to the first sensor surface. The sensor path translates temperature and/or humidity at the proximal surface of the monitor device/monitor device housing to the first sensor surface. The sensor opening forms a part of the sensor path and has a cross-sectional area optionally in the range from <NUM><NUM> to <NUM><NUM>. The sensor opening may be a circular sensor opening with a diameter in the range from <NUM> to <NUM>, e.g. from <NUM> to <NUM>.

The monitor device comprises a sensor unit with one or more sensors including a first sensor. The sensor unit is connected to the processor for feeding sensor data to the processor. The sensor unit may comprise a humidity sensor for provision of humidity data to the processor. Thus, the sensor data may comprise humidity data. For example, the first sensor may be a humidity sensor for provision of humidity data to the processor. Thus, the present disclosure enables humidity detection near the skin of a user and/or on the distal side of the base plate, which in turn can be used for a more accurate estimation of base plate operation state.

The sensor unit may comprise a temperature sensor for provision of temperature data to the processor. Thus, the sensor data may comprise temperature data. For example, the first sensor may be a temperature sensor for provision of temperature data to the processor. Thus, the present disclosure enables temperature detection near the skin of a user and/or on the distal side of the base plate, which in turn can be used for a more accurate estimation of base plate operation state.

The first sensor may be a combined humidity and temperature sensor for provision of humidity and temperature data to the processor.

The sensor unit of the monitor device may comprise a second sensor, e.g. an accelerometer for provision of acceleration data to the processor. The sensor unit of the monitor device may comprise a third sensor, e.g. a gyroscope for provision of gyroscope data to the processor. The sensor unit of the monitor device may comprise a fourth sensor, e.g. a magnetometer for provision of magnetometer data to the processor.

The processor is configured for processing ostomy data obtained from the base plate and generate or determine monitor data that are transmitted to an accessory device. The monitor data may comprise sensor data obtained from the sensor unit.

The monitor device comprises a first interface for connecting the monitor device to the base plate. The first interface may be arranged in the proximal surface of the monitor device housing. The first interface may be arranged within a first interface distance from the first end. The first interface distance may be less than <NUM>, such as less than <NUM>, where L is the length of the monitor device housing.

The monitor device may comprise a sealing element forming a seal between the first sensor and a housing part of the monitor device housing. The sealing element may be an O-ring, e.g. made of a rubber material. The sealing element may encircle the first sensor surface to expose the first sensor surface (membrane) to the sensor path while providing a closed cavity of the monitor device, the closed cavity accommodating PCB, processor, and other electronic circuitry. A glue may form the sealing element.

The ostomy system enables a reliable and accurate measurement of different parameters relevant for monitoring of the ostomy appliance. In the ostomy system, a distance between the proximal surface of the monitor device and a distal surface of the base plate, in a coupled state, is in the range from <NUM> to <NUM>, such as in the range from <NUM> to <NUM>. In the coupled state, the monitor device is attached to the base plate and arranged in its intended position during use of the ostomy system.

The monitor device comprises a first interface connected to the processor. 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 <NUM> to <NUM>.

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. 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 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 <NUM> to <NUM>. 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 <NUM>, Bluetooth <NUM>. 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. The processor may be configured to transmit monitor data, as a wireless monitor signal via the antenna and the wireless transceiver.

The ostomy system may comprise a docking station forming an alternative or additional 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.

<FIG> illustrates an exemplary ostomy system. The ostomy system <NUM> comprises an ostomy appliance <NUM> including a base plate <NUM>. The base plate <NUM> is adapted to support an ostomy pouch (not shown). Further, the ostomy system <NUM> comprises a monitor device <NUM> and an accessory device <NUM> (mobile telephone). The base plate <NUM> and the monitor device <NUM> are in a coupled state, and the monitor device <NUM> is connectable to the base plate <NUM> via respective first connectors of the monitor device <NUM> and base plate <NUM>. The monitor device <NUM> is configured for wireless communication with the accessory device <NUM>. Optionally, the accessory device <NUM> is configured to communicate with a server device <NUM> of the ostomy system <NUM>, e.g. via network <NUM>. The server device <NUM> may 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 appliance <NUM> with the monitor device <NUM>. The monitor device <NUM> processes the ostomy data and/or parameter data based on the ostomy data to determine monitor data that are transmitted to the accessory device <NUM>. The monitor data may include sensor data of the monitor device. In the illustrated ostomy system, the accessory device <NUM> is a mobile phone, however the accessory device <NUM> may 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 device <NUM> is configured to determine and transmit monitor data to the accessory device <NUM>. The base plate <NUM> comprises a coupling member <NUM> in the form of a coupling ring <NUM> for coupling an ostomy pouch (not shown) to the base plate (two-part ostomy appliance). The base plate <NUM> has a stomal opening <NUM> with a center point <NUM>. The size and/or shape of the stomal opening <NUM> is typically adjusted by the user or nurse before application of the ostomy appliance to accommodate the user's stoma.

The ostomy system <NUM> optionally comprises a docking station <NUM> forming an accessory device of the ostomy system <NUM>. The docking station <NUM> comprises a docking monitor interface including a first connector <NUM> configured for electrically and/or mechanically connecting the monitor device <NUM> to the docking station <NUM>. The docking monitor interface may be configured for wirelessly connecting the monitor device to the docking station. The docking station <NUM> comprises a user interface <NUM> for receiving user input and/or providing feedback to the user on the operational state of the docking station <NUM>. The user interface <NUM> may comprise a touch-screen. The user interface <NUM> may comprise one or more physical buttons and/or one or more visual indicators, such as light emitting diodes.

<FIG> is a schematic block diagram of an exemplary monitor device. The monitor device <NUM> comprises a monitor device housing <NUM>, a processor <NUM>, and one or more interfaces, the one or more interfaces including a first interface <NUM> (appliance interface) and a second interface <NUM> (accessory interface). The monitor device <NUM> comprises a memory <NUM> for storing ostomy data and/or parameter data based on the ostomy data. The memory <NUM> is connected to the processor <NUM> and/or the first interface <NUM>.

The first interface <NUM> is configured as an appliance interface for electrically and/or mechanically connecting the monitor device <NUM> to the ostomy appliance, e.g. ostomy appliance <NUM>. The first interface <NUM> comprises a plurality of terminals for forming electrical connections with respective terminals of the ostomy appliance <NUM> (base plate <NUM>). The first interface <NUM> comprises a ground terminal <NUM>, a first terminal <NUM>, a second terminal <NUM> and a third terminal <NUM>. The first interface <NUM> optionally comprises a fourth terminal <NUM> and a fifth terminal <NUM>. The first interface <NUM> of the monitor device <NUM> comprises a coupling part <NUM> for forming a mechanical connection, such as a releasable coupling between the monitor device and the base plate. The coupling part <NUM> and the terminals <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, and <NUM> of the first interface <NUM> form (at least part of) a first connector of the monitor device <NUM>.

The monitor device <NUM> comprises a power unit <NUM> for powering the monitor device and active components thereof, i.e. the power unit <NUM> is connected to the processor <NUM>, the first interface <NUM>, the second interface <NUM>, and memory <NUM>. The power unit comprises a battery and charging circuitry. The charging circuitry is connected to the battery and terminals of the first interface <NUM> for charging the battery via terminals of the first interface, e.g. terminals of the first connector.

The second interface <NUM> of monitor device is configured as an accessory interface for connecting the monitor device <NUM> to one or more accessory devices such as accessory device <NUM>. The second interface <NUM> comprises an antenna <NUM> and a wireless transceiver <NUM> configured for wireless communication with accessory device(s). Optionally, the second interface <NUM> comprises a loudspeaker <NUM> and/or a haptic feedback element <NUM> for provision of respective audio signal and/or haptic feedback to the user.

The monitor device <NUM> comprises a sensor unit <NUM> connected to the processor <NUM> for provision of sensor data <NUM> to the processor <NUM>. The sensor unit <NUM> comprises a first sensor <NUM> being a temperature and/or a humidity sensor for feeding temperature and/or humidity data as sensor data <NUM> to the processor <NUM>. Further, the sensor unit <NUM> comprises a second sensor <NUM> being an accelerometer for feeding acceleration data as sensor data <NUM> to the processor <NUM>. The processor <NUM> receives and stores sensor data <NUM> comprising temperature data, humidity data, and/or acceleration data, in the memory <NUM> and/or transmits the sensor data as part of monitor data via second interface <NUM>.

The monitor device <NUM> is configured to obtain ostomy data from the base plate coupled to the first interface <NUM>. The ostomy data may be stored in the memory <NUM> and/or processed in the processor <NUM> in order to obtain parameter data.

<FIG> illustrates an exploded view of an exemplary base plate of an ostomy appliance. The base plate <NUM> comprises a first adhesive layer <NUM> with a stomal opening 18A. During use, a proximal surface of the first adhesive layer <NUM> adheres to the user's skin in the peristomal area and/or to additional seals, such as sealing paste, sealing tape and/or sealing ring. The base plate <NUM> optionally comprises a second adhesive layer <NUM> with a stomal opening 18B. The base plate <NUM> comprises a plurality of electrodes arranged in an electrode assembly <NUM>. The electrode assembly <NUM> is arranged between the first adhesive layer <NUM> and the second adhesive layer <NUM>. The electrode assembly <NUM> comprises a support layer with stomal opening 18C and electrodes formed on a proximal surface of the support layer. The base plate <NUM> comprises a release liner <NUM> that is peeled off by the user prior to applying the base plate <NUM> on the skin. The base plate <NUM> comprises a top layer <NUM> with a stomal opening 18D and a coupling ring <NUM> for coupling an ostomy pouch to the base plate <NUM>. The top layer <NUM> is a protective layer protecting the second adhesive layer <NUM> from external strains and stress during use.

The base plate <NUM> comprises a monitor interface. The monitor interface is configured for electrically and/or mechanically connecting the ostomy appliance (base plate <NUM>) to the monitor device. The monitor interface of the base plate comprises a coupling part <NUM> for forming a mechanical connection, such as a releasable coupling between the monitor device and the base plate. The coupling part <NUM> is configured to engage with a coupling part of the monitor device for releasably coupling the monitor device to the base plate <NUM>. Further, the monitor interface of the base plate <NUM> comprises a plurality of terminal elements respectively forming a plurality of terminals <NUM> for forming electrical connections with respective terminals of the monitor device. The coupling part <NUM> and the terminals <NUM> form a first connector <NUM> of the base plate <NUM>. The base plate <NUM> comprises a first intermediate element <NUM> on the proximal side of the electrode assembly. The first intermediate element <NUM> is arranged between the terminal elements forming terminals <NUM> and the first adhesive layer (not shown). The first intermediate element <NUM> covers the terminal elements forming terminals <NUM> of the base plate <NUM> when 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 plate <NUM>, 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 plate <NUM> as described. For example, a sensor assembly part may be provided, e.g. comprising the electrode assembly <NUM>, the first connector <NUM>, the first intermediate element <NUM>, the first adhesive layer <NUM> and the release liner <NUM>. Additionally, the sensor assembly part may also comprise the second adhesive layer <NUM> and/or the top layer <NUM>. It may be envisioned that the user may provide a hole in layers of the base plate whereto the sensor assembly part is to be applied, to allow for the first connector <NUM> of the sensor assembly part to protrude through layers of the base plate whereto the sensor assembly part is applied. Alternatively, the sensor assembly part may be applied to the base plate such that the first connector <NUM> is positioned outside the periphery of the base plate.

<FIG> illustrates an exploded view of an exemplary electrode assembly <NUM> of a base plate and/or a sensor assembly part. The electrode assembly <NUM> has a distal side 204A and a proximal side 204B. The electrode assembly <NUM> comprises a support layer <NUM> with proximal surface 214B and electrodes <NUM> arranged on the proximal side of the support layer <NUM> and including a ground electrode, a first electrode, a second electrode, a third electrode, a fourth electrode, and a fifth electrode, wherein each electrode has a respective connection part <NUM> for connecting the electrodes <NUM> to respective terminal elements of the monitor interface. The electrodes <NUM> are positioned and/or formed on a proximal side 214B of the support layer <NUM>. Further, electrode assembly <NUM> comprises a masking element <NUM> with proximal surface 218B and configured to insulate electrode parts of electrodes <NUM> from the first adhesive layer of the base plate and/or the sensor assembly part. The masking element <NUM> covers or overlap with parts of the electrodes <NUM> when seen in the axial direction.

<FIG> is a proximal view of proximal surfaces of base plate parts of the base plate without the first adhesive layer and the release liner. The base plate <NUM> comprises a first intermediate element <NUM> on the proximal side of the electrode assembly, i.e. between the electrode assembly <NUM> and the first adhesive layer (not shown). The first intermediate element <NUM> covers the terminal elements of the base plate <NUM> when seen in the axial direction and protects the first adhesive layer from mechanical stress from the terminal elements of the base plate.

<FIG> is a distal view of an exemplary electrode configuration <NUM> of electrodes <NUM> of the electrode assembly <NUM>. The electrode assembly <NUM>, such as the electrode configuration <NUM> of the electrode assembly <NUM> comprises a ground electrode <NUM>, a first electrode <NUM>, a second electrode <NUM>, a third electrode <NUM>, a fourth electrode <NUM>, and a fifth electrode <NUM>. The ground electrode <NUM> comprises a ground connection part 222A and the first electrode <NUM> comprises a first connection part 224A. The second electrode <NUM> comprises a second connection part 226A and the third electrode <NUM> comprises a third connection part 228A. The fourth electrode <NUM> comprises a fourth connection part 230A and the fifth electrode <NUM> comprise a fifth connection part 232A.

The fourth electrode <NUM> comprises fourth sensing parts 230B. The fifth electrode <NUM> comprises fifth sensing parts 232B.

The ground electrode <NUM> comprises a first electrode part <NUM> for forming a ground or reference for the first electrode <NUM>. The ground electrode <NUM> comprises a second electrode part <NUM> for forming a ground or reference for the second electrode <NUM>. The ground electrode <NUM> comprises a third electrode part <NUM> for forming a ground or reference for the third electrode <NUM>. The masking element <NUM> is arranged proximal to the electrodes <NUM>, <NUM>, <NUM>, <NUM> covering and insulating parts of the electrodes from the first adhesive and forming respective conductor parts of the electrodes <NUM>, <NUM>, <NUM>, <NUM>. The parts of the electrodes <NUM>, <NUM>, <NUM>, <NUM> not covered by the masking element <NUM> contacts the first adhesive layer and form sensing parts 224B, 226B, 228B of electrodes <NUM>, <NUM>, <NUM>, respectively. Further, the electrode parts <NUM>, <NUM>, <NUM> form sensing parts of the ground electrode <NUM>.

The first sensing part 224B extends circularly at least <NUM> degrees around the stomal opening at a first radial distance R1 from the center point <NUM>. The first radial distance R1 is <NUM>. The first electrode part <NUM> is arranged on the inside of the first sensing part (i.e. closer to the center point) and extends circularly at least <NUM> degrees around the stomal opening at a first ground distance RG1 from the first sensing part (radially from the center point). The first ground distance RG1 between sensing part of first electrode and first electrode part is about <NUM>.

The second sensing part 226B extends circularly at least <NUM> degrees around the stomal opening at a second radial distance R2 from the center point <NUM>. The second radial distance R2 is <NUM>. The second electrode part <NUM> is arranged on the inside of the second sensing part 226B (i.e. closer to the center point) and extends circularly at least <NUM> degrees around the stomal opening at a second ground distance RG2 from the second sensing part 226B (radially from the center point). The second ground distance RG2 between sensing part of second electrode and second electrode part is about <NUM>.

The third sensing part 228B extends circularly at least <NUM> degrees around the stomal opening at a third radial distance R3 from the center point <NUM>. The third radial distance R3 is about <NUM>. The third electrode part <NUM> is arranged on the inside of the third sensing part 228B (i.e. closer to the center point) and extends circularly at least <NUM> degrees around the stomal opening at a third ground distance RG3 from the third sensing part 228B (radially from the center point). The third ground distance RG3 between sensing part of third electrode and third electrode part is about <NUM>.

The ground electrode <NUM> comprises a fourth electrode part <NUM> for forming a ground or reference for the fourth electrode <NUM> and the fifth electrode <NUM>. The fourth electrode part <NUM> of the ground electrode <NUM> extends at least <NUM> degrees around the stomal opening and comprises ground sensing parts 222B. The fourth sensing parts 230B, fifth sensing parts 232B, and ground sensing parts of the fourth electrode part <NUM> are circularly distributed around the center point <NUM> at a leakage radius from the center point. The fourth sensing parts 230B, fifth sensing parts 232B, and ground sensing parts of the fourth electrode part may have a radial extension larger than <NUM>, such as in the range from <NUM> to <NUM>, e.g. about <NUM>. The fourth sensing parts 230B, fifth sensing parts 232B, and ground sensing parts of the fourth electrode part <NUM> may have a circumferential extension (perpendicular to the radial extension) larger than <NUM>, such as in the range from <NUM> to <NUM>, e.g. about <NUM>.

<FIG> is a distal view of an exemplary masking element. The masking element <NUM> optionally has a plurality of terminal openings including six terminal openings. The plurality of terminal openings comprises a ground terminal opening <NUM>, a first terminal opening <NUM>, a second terminal opening <NUM>, a third terminal opening <NUM>, a fourth terminal opening <NUM>, and a fifth terminal opening <NUM>. The terminal openings <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> of the masking element <NUM> are configured to overlap and/or be aligned with respective connection parts 222A, 224A, 226A, 228A, 230A, 232A of the electrodes of the electrode assembly.

The masking element <NUM> has a plurality of sensor point openings. The sensor point openings comprise primary sensor point openings shown within dotted line <NUM>, each primary sensor point opening configured to overlap a part of the ground electrode <NUM> and/or a part of the fourth electrode <NUM>. The primary sensor point openings <NUM> comprise, in the illustrated exemplary masking element, five primary first sensor point openings 254A each configured to overlap a part of the ground electrode <NUM>. The primary sensor point openings <NUM> comprise, in the illustrated exemplary masking element, four primary second sensor point openings 254B each configured to overlap a part of the fourth electrode <NUM>. The sensor point openings comprise secondary sensor point openings shown within dotted line <NUM>, each second sensor point opening configured to overlap a part of the fourth electrode <NUM> and/or a part of the fifth electrode <NUM>. The secondary sensor point openings <NUM> comprise, in the illustrated exemplary masking element, five secondary first sensor point openings 256A each configured to overlap a part of the fifth electrode <NUM>. The secondary sensor point openings <NUM> comprise, in the illustrated exemplary masking element, four secondary second sensor point openings 256B each configured to overlap a part of the fourth electrode <NUM>. The sensor point openings comprise tertiary sensor point openings shown within dotted line <NUM>, each tertiary sensor opening configured to overlap a part of the fifth electrode <NUM> and/or a part of the ground electrode <NUM>. The tertiary sensor point openings <NUM> comprise, in the illustrated exemplary masking element, five tertiary first sensor point openings 258A each configured to overlap a part of the fifth electrode <NUM>. The tertiary sensor point openings <NUM> comprise, in the illustrated exemplary masking element, four tertiary second sensor point openings 258B each configured to overlap a part of the ground electrode <NUM>.

<FIG> is a distal view of an exemplary first adhesive layer. The first adhesive layer <NUM> has a plurality of sensor point openings. The sensor point openings of the first adhesive layer comprise primary sensor point openings shown within dotted line <NUM>, each primary sensor point opening configured to overlap a part of the ground electrode <NUM> and/or a part of the fourth electrode <NUM> of the electrode assembly. The primary sensor point openings comprise, in the illustrated exemplary first adhesive layer, five primary first sensor point openings 260A each configured to overlap a part of the ground electrode <NUM>. The primary sensor point openings comprise, in the illustrated exemplary first adhesive layer, four primary second sensor point openings 260B each configured to overlap a part of the fourth electrode <NUM>. The sensor point openings of the first adhesive layer comprise secondary sensor point openings shown within dotted line <NUM>, each second sensor point opening configured to overlap a part of the fourth electrode <NUM> and/or a part of the fifth electrode <NUM> of the electrode assembly. The secondary sensor point openings comprise, in the illustrated exemplary first adhesive layer, five secondary first sensor point openings 262A each configured to overlap a part of the fifth electrode <NUM>. The secondary sensor point openings comprise, in the illustrated exemplary first adhesive layer, four secondary second sensor point openings 262B each configured to overlap a part of the fourth electrode <NUM>. The sensor point openings of the first adhesive layer comprise tertiary sensor point openings shown within dotted line <NUM>, each tertiary sensor opening configured to overlap a part of the fifth electrode <NUM> and/or a part of the ground electrode <NUM> of the electrode assembly. The tertiary sensor point openings comprise, in the illustrated exemplary first adhesive layer, five tertiary first sensor point openings 264A each configured to overlap a part of the fifth electrode <NUM>. The tertiary sensor point openings comprise, in the illustrated exemplary first adhesive layer, four tertiary second sensor point openings 264B each configured to overlap a part of the ground electrode <NUM>. <FIG> is a proximal view of the first adhesive layer of <FIG>.

<FIG> is a more detailed distal view of a part of the base plate <NUM>. Monitor interface of the base plate comprises the first connector <NUM>. The first connector <NUM> comprises coupling part <NUM> configured to releasably couple the monitor device to the base plate and thus forming a releasable coupling. The first connector <NUM> of 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 connector <NUM> of the monitor interface comprises a ground terminal element <NUM> forming a ground terminal 282A, a first terminal element <NUM> forming a first terminal <NUM>, a second terminal element <NUM> forming a second terminal 286A, and optionally a third terminal element <NUM> forming a third terminal 288A. The monitor interface optionally comprises a fourth terminal element <NUM> forming a fourth terminal 290A and/or a fifth terminal element <NUM> forming a fifth terminal 292A. The terminal elements <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> contact respective connection parts 222A, 224A, 226A, 228A, 230a, 232A of electrodes <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>.

The position of the first connector on the base plate, 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.

<FIG> is a perspective view of monitor device <NUM> and base plate <NUM>. The monitor device <NUM> comprises monitor device housing <NUM> with proximal surface <NUM> configured for facing the skin of a user during use. The monitor device <NUM> has first interface <NUM> and a sensor opening <NUM> in the proximal surface <NUM>, the sensor opening <NUM> forming at least a part of a sensor path from surroundings of the proximal surface to a first sensor surface of first sensor. The sensor opening <NUM> is generally circular or oval with a diameter of about <NUM>. Such diameter has shown to provide effective translation of humidity and/or temperature while still protecting the first sensor surface from dirt, dust, lint, etc..

The monitor device housing <NUM> is an elongate housing having a first end <NUM> and a second end <NUM> with a length L in the range from <NUM> to <NUM> along longitudinal axis X, and a width W perpendicular to the longitudinal axis X in the range from <NUM> to <NUM>.

The sensor opening <NUM> in the proximal surface is arranged at a sensor opening distance from the first end <NUM>. The sensor opening distance D_S is from <NUM> to <NUM>, such as about <NUM> as in <FIG>, where L is the length of the monitor device housing.

<FIG> show cross-section perpendicular to the longitudinal axis of the monitor device <NUM> coupled to the base plate <NUM>. The monitor device housing comprises a first housing part <NUM>, a second housing part <NUM>, and optionally third housing part <NUM>. The monitor device <NUM> comprises first sensor <NUM> being a combined temperature and humidity sensor. The first sensor <NUM> has first sensor surface <NUM> and the monitor device housing forms a sensor path <NUM> (indicated with dotted line) from surroundings <NUM> of the proximal surface <NUM> to the first sensor surface <NUM>. The sensor path <NUM> translates temperature and/or humidity at the proximal surface <NUM> of the monitor device/monitor device housing to the first sensor surface <NUM> via sensor opening <NUM> in the proximal surface <NUM> and sensor opening <NUM> in the first housing part <NUM>. The sensor opening <NUM> forms a part of the sensor path <NUM> and has a cross-sectional area of about <NUM><NUM>. The monitor device <NUM> comprises a sealing element <NUM> forming a seal between the first sensor <NUM> and the first housing part <NUM> of the monitor device housing. The sealing element <NUM> is an O-ring made of a rubber material. The sealing element <NUM> encircles the first sensor surface <NUM> to expose the first sensor surface (membrane) to the sensor path <NUM> while providing a closed cavity <NUM> of the monitor device, the closed cavity accommodating PCB, processor, and other electronic circuitry of the monitor device. The distance between the proximal surface <NUM> of the monitor device <NUM> and distal surface <NUM> of the base plate <NUM> in the coupled state is in the range from <NUM> to <NUM>.

Although particular features have been shown and described, it will be understood that they are not intended to limit the claimed invention, and it will be made obvious to those skilled in the art that various changes and modifications may be made without departing from the scope of the claimed invention. The specification and drawings are accordingly to be regarded in an illustrative rather than restrictive sense.

Claim 1:
A monitor device (<NUM>) for an ostomy appliance (<NUM>) of an ostomy system (<NUM>), the monitor device (<NUM>) comprising a processor (<NUM>) and a sensor unit (<NUM>), characterized in that the sensor unit (<NUM>) comprises a first sensor (<NUM>) with a first sensor surface (<NUM>) accommodated in a monitor device housing (<NUM>, <NUM>), the monitor device housing (<NUM>, <NUM>) having a sensor opening (<NUM>) in a proximal surface (<NUM>) of the monitor device (<NUM>), the proximal surface (<NUM>) configured for facing the skin of a user during use, the sensor opening (<NUM>) forming at least a part of a sensor path (<NUM>) from surroundings of the proximal surface (<NUM>) to the first sensor surface (<NUM>).