Base plate for an ostomy appliance

Abstract

A base plate (10) for an ostomy appliance is disclosed. The base plate has a proximal surface and a distal surface. The base plate comprises a first adhesive layer (110) having a proximal side comprising a proximal surface (111) and a distal side comprising a distal surface (112), an electrode assembly (120) comprising one or more electrodes (120'), and a top film (100) having a proximal surface and a distal surface. The top film is arranged on the distal side of the first adhesive layer. The electrode assembly is arranged on the proximal surface of the top film. The distal surface of the top film is the distal surface of the base plate.

Description

[0001] This disclosure relates to a base plate for an ostomy device, the base plate including an adhesive layer, a top membrane, and an electrode assembly; and to a method of manufacturing such a base plate. In particular, this disclosure relates to a base plate having sensing devices and improved flexibility and elasticity. Attached Figure Description

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

[0003] Figure 1 An exploded view of the base plate according to an embodiment of the present invention is shown.

[0004] Figure 2 A cross-sectional view of a portion of the base plate according to an embodiment of the present invention is shown.

[0005] Figure 3 An exploded cross-sectional view of the base plate according to an embodiment of the present invention is shown.

[0006] Figure 4 An exemplary ostomy system is demonstrated, and

[0007] Figure 5 A schematic block diagram of an exemplary monitoring device is shown. Detailed Implementation

[0008] In the following description, various exemplary embodiments and details are illustrated with reference to the accompanying drawings, where applicable. It should be noted that the drawings may or may not be drawn to scale, and the same reference numerals are used throughout all drawings to denote elements having similar structures or functions. It should also be noted that the drawings are intended only to facilitate the description of embodiments. They are not intended as an exhaustive description of the invention or a limitation on its scope. Furthermore, the illustrated embodiments are not necessarily to have all the aspects or advantages shown. Aspects or advantages described in connection with a particular embodiment are not necessarily limited to that embodiment and may be practiced in any other embodiment even if not so shown or so explicitly described.

[0009] Throughout this disclosure, the terms “ostomy” and “ostomy procedure” are used to refer to an opening created surgically around a person’s intestinal or urinary tract system. These terms are used interchangeably and do not have distinguishing meanings. This also applies to any words or phrases derived from these terms, such as “ostomy,” “ostomy procedure,” etc. Furthermore, solid and liquid waste draining from a stoma can be used interchangeably as stoma “excretion,” “waste,” “liquid,” and “fluid.” A subject undergoing an ostomy procedure may be referred to as an “ostomy patient” or “ostomy person,” and also as a “patient” or “user.” However, in some cases, “user” may also refer to or refer to a healthcare professional (HCP), such as a surgeon or ostomy care nurse or other personnel. In these cases, it will be explicitly stated or implied from the context that the “user” is not the “patient” himself or her.

[0010] In the following text, whenever a layer, element, device, or part of a device is referred to as the proximal side or surface, it refers to the side or surface facing the skin when the user wears the ostomy appliance. Similarly, whenever a layer, element, device, or part of a device is referred to as the distal side or surface, it refers to the side or surface facing away from the skin when the user wears the ostomy appliance. In other words, the proximal side or surface is the side or surface closest to the user when the appliance is fitted to the user, and the distal side is the opposite side or surface, that is, the side or surface furthest from the user during use.

[0011] When a user wears the device, the axial direction is defined as the direction of the stoma. Therefore, the axial direction is approximately perpendicular to the user's skin or abdominal surface.

[0012] The radial direction is defined as perpendicular to the axial direction. In some statements, the terms "inner" and "outer" may be used. These qualifiers should generally be understood with reference to the radial direction, such that referring to an "outer" element means that the element is further away from the center of the stomatal instrument than an element referred to as "inner." Furthermore, "innermost" should be interpreted as the part forming the center of the component and / or the portion adjacent to the center of the component. Similarly, "outermost" should be interpreted as the outer edge or outer contour of the component forming the component and / or the portion adjacent to that outer edge or outer contour.

[0013] The use of the word “substantially” in this disclosure as a modifier for certain characteristics or effects is intended to simply indicate that any deviations are within tolerances typically expected by those skilled in the art.

[0014] This disclosure provides a substrate including an adhesive, an electrode assembly, and a top film, as well as a method for manufacturing, for example, the substrate.

[0015] In a first aspect of the invention, a base plate for an ostomy apparatus is disclosed. The base plate has a proximal surface and a distal surface. The base plate includes a first adhesive layer, an electrode assembly, and a top membrane. The first adhesive layer has a proximal side including the proximal surface and a distal side including the distal surface. The electrode assembly includes one or more electrodes. The top membrane has a proximal surface and a distal surface. The top membrane is disposed on the distal side of the first adhesive layer. The electrode assembly is disposed on the proximal surface of the top membrane. The distal surface of the top membrane is the distal surface of the base plate.

[0016] By providing an electrode assembly, the baseplate provides a sensing device (sensor), such as a means for detecting the adhesive properties of the first adhesive layer and / or the presence of stoma discharge propagating at the interface between the first adhesive layer and the skin surface of a user wearing the baseplate. According to a first aspect of the invention, the sensor is provided by providing an electrode assembly comprising one or more electrodes forming the sensor. A monitoring device may be coupled to the one or more electrodes of the electrode assembly, whereby the monitoring device can monitor changes in certain electrical quantities (e.g., resistance, conductance, or capacitance) to determine the condition or "health" of the baseplate (e.g., adhesive properties, or the presence of leakage propagating at the interface between the skin and the baseplate). The baseplate is configured to adhere to the user's skin surface via the first adhesive layer, such as the skin surface around the stoma. In an embodiment, the baseplate further includes a stoma pocket for collecting discharge from the stoma.

[0017] The invention also discloses an ostomy system and apparatus, including an ostomy appliance, a base plate for the ostomy appliance, a sensor patch applied to the base plate, a monitoring device, and optionally one or more auxiliary devices. Furthermore, methods related to the ostomy system and apparatus are disclosed. The auxiliary device (also referred to as an external device) may be a mobile phone or other handheld device. In embodiments, the auxiliary device is a personal electronic device, such as a wearable device, such as a watch or other wrist-worn electronic device. The auxiliary device may be a docking station. In embodiments, the docking station may be configured to electrically and / or mechanically connect the monitoring device to the docking station. In embodiments, the docking station may be configured to charge the battery of the monitoring device and / or be configured to transfer data between the monitoring device and the docking station. The ostomy system may include a server device. In embodiments, the server device may be operated and / or controlled by an ostomy appliance manufacturer and / or service center.

[0018] A stoma system and apparatus of the same are also disclosed, including stoma appliances, a base plate of the stoma appliance, a sensor patch for application to the base plate, a monitoring device, and optionally one or more auxiliary devices, which, individually or together, facilitate the reliable determination of the nature, severity, and speed of moisture spread in the adhesive material provided for attaching the base plate and / or sensor patch to the user's skin surface. Depending on the nature of the moisture spread pattern in the adhesive, the stoma system and apparatus of the same can provide the user with information about the type of failure and, consequently, an indication of the severity and, therefore, the remaining timeframe for replacing the stoma appliance without serious leakage and / or skin damage. Determining the moisture pattern type or angular leakage pattern can help reduce the risk of leakage of the stoma appliance to the user. Furthermore, determining the moisture pattern type and operational status classification and / or leakage pattern of the stoma appliance can further help reduce the risk of skin damage to the user.

[0019] In embodiments, the stoma device includes a base plate and a stoma bag (also referred to as a stoma pouch). The stoma device can be a colostomy device, an ileostomy device, or a urostomy device. In embodiments, the stoma device can be a two-piece stoma device, i.e., the base plate and the stoma bag are releasably coupled, for example by mechanical and / or adhesive bonding, to allow one base plate to be used (interchangeable) with multiple stoma bags. Furthermore, a two-piece stoma device can facilitate proper application of the base plate to the skin, for example, to obtain the user's observation of improvement in the stoma area. In embodiments, the stoma device can be a one-piece stoma device, i.e., the base plate and the stoma bag can be securely attached to each other. The base plate is configured to attach to the user's stoma and / or the skin around the stoma, such as the peristaltic skin area.

[0020] In embodiments, the ostomy appliance includes: for example, a base plate integrated with a sensor assembly, such as an integral one-piece base plate; or a separate sensor assembly, such as a sensor assembly subsequently applied to the base plate. In other examples, the sensor assembly is a sensor patch for application to a base plate, such as a proximal surface of the base plate. Thus, any base plate, such as a conventional / general-purpose base plate, can achieve the features described herein.

[0021] Features described herein regarding the sensing / monitoring capabilities of the baseplate can be provided, for example, by the user applying the sensor assembly of the sensor patch to the baseplate, or vice versa. In embodiments, the sensor patch is adapted to adhere to a universal baseplate. Therefore, in embodiments, the features disclosed herein can also be provided in the sensor patch on the proximal surface to which it is to be adhered. In embodiments, a method for attaching a baseplate having sensing capabilities (e.g., by providing the sensor patch) to a user's stoma and / or peristaltic skin, such as a peristaltic skin region, includes attaching the sensor patch to the baseplate and attaching the baseplate, i.e., together with the attached sensor patch, to the user's stoma and / or peristaltic skin, such as a peristaltic skin region. Alternatively, a method for attaching a base plate to a user’s stoma and / or the skin around the stoma includes: attaching a sensor patch to the user’s stoma and / or the skin around the stoma, and attaching the base plate to the user’s stoma and / or the skin around the stoma above the attached sensor patch, i.e. on the distal surface of the sensor patch.

[0022] In an embodiment, the first adhesive layer is made of a first composition. The first composition may include one or more polyisobutylenes and / or styrene-isoprene-styrene. The first composition may include one or more hydrocolloids. The first composition may include 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 elastomer substrate and one or more water-soluble or water-swellable hydrocolloids. The first composition may include one or more polybutenes, one or more styrene copolymers, one or more hydrocolloids, or any combination thereof. The combination of the adhesive properties of polybutene and the absorption properties of hydrocolloids makes the first composition suitable for use in ostomy devices. The styrene copolymer may be, for example, a styrene-butadiene-styrene block copolymer or a styrene-isoprene-styrene block copolymer. Preferably, one or more styrene-isoprene-styrene (SIS) block copolymers are used. The amount of the styrene block copolymer may be 5% to 20% of the total adhesive composition. The butene component is suitably a conjugated butadiene polymer selected from polybutadiene and polyisoprene. Polybutene is preferably present in an amount of 35%-50% of the total adhesive composition. Preferably, the polybutene is polyisobutylene (PIB). The hydrocolloid suitable for incorporation into the first composition is selected from natural, semi-synthetic, and synthetic hydrocolloids. In examples, the first composition may include 20%-60% hydrocolloid. A preferred hydrocolloid is carboxymethyl cellulose (CMC). The first composition may optionally contain other components, such as fillers, tackifiers, plasticizers, and other additives.

[0023] The first adhesive layer may have a substantially uniform thickness. The thickness of the first adhesive layer may be in the range of 0.1 mm to 1.5 mm, for example, in the range of 0.2 mm to 1.2 mm, such as 0.8 mm or 1.0 mm. The first adhesive layer may have a main thickness in the main portion of the first adhesive layer, for example, in the main region within or within the main radial distance from the center point of the stoma opening in the base plate. The main thickness may be in the range of 0.2 mm to 1.5 mm, for example, about 1.0 mm. The main radial distance may be in the range of 20 mm to 50 mm, for example, in the range of 25 mm to 35 mm, such as 30 mm. The first adhesive layer may have a secondary thickness in the secondary portion of the first adhesive layer, for example, in the secondary region outside or within the secondary radial distance from the center point of the stoma opening. The secondary thickness may be in the range of 0.2 mm to 1.0 mm, for example, about 0.5 mm. The secondary radial distance may be in the range of 20 mm to 50 mm, for example, in the range of 25 mm to 35 mm, such as 30 mm.

[0024] In one embodiment, the base plate includes a second layer. In another embodiment, the second layer is an adhesive layer. In another embodiment, the second layer is disposed distal to the first adhesive layer. In another embodiment, the second layer includes a proximal surface and a distal surface. In another embodiment, the proximal surface adheres to or contacts the distal surface of the first adhesive layer. In another embodiment, the second layer has a second radial extension greater than the first radial extension of the first adhesive layer at least within a first corner of the base plate. Accordingly, a portion of the proximal surface of the second layer may be configured to adhere to the user's skin surface. This portion of the proximal surface of the second layer configured to adhere to the user's skin surface is also referred to as the skin-adhesive surface of the second adhesive layer. The second layer may have an ostomy opening with a central point, such as a second-layer ostomy opening and / or a second adhesive ostomy opening.

[0025] In embodiments, the second adhesive layer is made of a second composition. In embodiments, the second composition comprises one or more polyisobutylenes and / or styrene-isoprene-styrene. In embodiments, the second composition comprises one or more hydrocolloids. In embodiments, the second composition comprises one or more water-soluble or water-swellable hydrocolloids. In embodiments, the second composition is a pressure-sensitive adhesive composition suitable for medical purposes, comprising a rubbery elastomer substrate and one or more water-soluble or water-swellable hydrocolloids. In embodiments, the second composition comprises one or more polybutenes, one or more styrene copolymers, one or more hydrocolloids, or any combination thereof. The combination of the viscous properties of polybutene and the absorbent properties of the hydrocolloids makes the second composition suitable for use in ostomy devices. For example, the styrene copolymer may be a styrene-butadiene-styrene block copolymer or a styrene-isoprene-styrene block copolymer. Preferably, one or more styrene-isoprene-styrene (SIS) block copolymers are used. The amount of the 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 and polyisoprene. Polybutene is preferably present in an amount of 35%-50% of the total adhesive composition. Preferably, the polybutene is polyisobutylene (PIB). The hydrocolloid suitable for incorporation into the second composition is selected from natural hydrocolloids, semi-synthetic hydrocolloids, and synthetic hydrocolloids. The second composition may contain 20%-60% hydrocolloid. A preferred hydrocolloid is carboxymethyl cellulose (CMC). Optionally, the second composition may contain other components, such as fillers, tackifiers, plasticizers, and / or other additives.

[0026] Different ratios of inclusions can alter the properties of the first and / or second adhesive layers. In embodiments, the second adhesive layer and the first adhesive layer have different properties. In embodiments, the second adhesive layer (second composition) and the first adhesive layer (first composition) contain different ratios of polyisobutylene, styrene-isoprene-styrene, and / or hydrocolloids. For example, the second adhesive layer may provide stronger skin adhesion compared to the first adhesive layer. Alternatively or additionally, the second adhesive layer may be thinner than the first adhesive layer. Alternatively or additionally, the second adhesive layer may have lower water absorption and / or sweat absorption than the first adhesive layer. Alternatively or additionally, the second adhesive layer may have lower moldability than the first adhesive layer. In embodiments, the second adhesive layer provides a second leak-proof barrier.

[0027] The second layer can have a substantially uniform thickness. The thickness of the second layer can be in the range of 0.1 mm to 1.5 mm, for example, in the range of 0.2 mm to 1.0 mm, such as 0.5 mm, 0.6 mm, or 0.7 mm.

[0028] Providing a baseplate with sensing capabilities, such as through an integrated sensor assembly or through a sensor patch including the sensor assembly, enables optimal or improved use of ostomy appliances. Specifically, it facilitates that the baseplate is not replaced too late (leading to adhesive failure, leakage, and / or skin damage), or at least facilitates that the user is informed of a leakage that is about to occur, is occurring, or has already occurred. Accordingly, the user or healthcare professional can monitor and plan the use of the ostomy appliance.

[0029] In embodiments, the electrode assembly of the substrate includes one or more electrodes, such as multiple electrodes, such as two, three, four, five, six, seven, or more electrodes. According to a first aspect of the invention, the electrode assembly of the substrate, and therefore one or more electrodes, is arranged, for example, formed, for example, printed on the proximal surface of the top film. In embodiments, the electrode assembly and the top film combine to form a sensor assembly of the substrate. In embodiments, the one or more (e.g., two or more) electrodes of the electrode assembly form one or more sensors configured to detect changes in the resistance, conductance, and / or capacitance of the first adhesive layer, and / or to detect short circuits, such as short circuits caused by liquid paths between two or more electrodes of the electrode assembly.

[0030] In an embodiment, the electrode assembly of the base plate includes electrodes for connecting (multiple) electrodes to other components and / or interface terminals / terminal elements, such as for connecting electrodes to a monitoring device. In an embodiment, the electrode includes one or more conductor portions and / or one or more sensing portions. A conductor portion can be considered the part of the electrode that connects two or more sensing portions and / or connects the sensing portion of a corresponding electrode to the connector portion. A sensing portion can be considered the part of the electrode adapted to sense, for example, liquids (such as liquid contents), and / or discharges (such as discharges generated by a leak or impending leak). The sensing portion can be adapted to sense, for example, by its shape, which may be circular, elliptical, or rectangular. Thus, the conductor portion can conduct signals generated by the sensing portion. In an embodiment, the electrode includes alternating conductor portions and sensing portions. The electrode assembly may include a first electrode, a second electrode, and optionally a third electrode. The electrode assembly may include a fourth electrode and / or a fifth electrode. The electrode assembly may optionally include a sixth electrode. In an embodiment, the electrode assembly includes a ground electrode. The ground electrode may include a first electrode portion. In an embodiment, the first electrode portion of the ground electrode forms a ground or reference for the first electrode. In an embodiment, the first electrode portion forms a closed loop. The ground electrode may include a second electrode portion. In an embodiment, the second electrode portion of the ground electrode forms a ground or reference for the second electrode. The ground electrode may include a third electrode portion. In an embodiment, the third electrode portion of the ground electrode forms a ground or reference for the third electrode. The ground electrode may include a fourth electrode portion. In an embodiment, the fourth electrode portion of the ground electrode forms a ground or reference for the fourth electrode and / or the fifth electrode. In an embodiment, the ground electrode is configured as or forms a (common) reference electrode for some or all of the other electrodes in the electrode assembly.

[0031] In one embodiment, the first adhesive layer includes a plurality of sensor point openings. In another embodiment, the sensor point openings of the first adhesive layer are configured to overlap with a portion (sensing portion) of the electrodes of the electrode assembly, for example, to form sensor points. In another embodiment, the sensor point openings extend completely through the first adhesive layer to expose at least a portion of the electrode assembly to the surrounding environment, thereby providing a means for determining a short circuit between the first and second electrodes, indicating the presence of liquid, such as excrement, on the proximal surface of the baseplate. Therefore, in this embodiment, the sensor point openings provide a means for detecting the presence of liquid on the proximal surface of the baseplate by monitoring the voltage across the two electrodes of the electrode assembly. The presence of liquid on the proximal surface of the baseplate can indicate the propagation of excrement at the interface between the proximal surface of the baseplate and the user's peristaltic skin surface. In another embodiment, the first adhesive layer includes at least 10 sensor point openings, for example, 20 to 50 sensor point openings, to provide appropriate leakage detection around the user's stoma. In another embodiment, the sensor point openings have a diameter of at least 1 mm, for example, between 1.0 mm and 4.0 mm.

[0032] The electrode assembly has one or more electrodes that are conductive and may include one or more of the following: metallic materials (e.g., silver, copper, gold, titanium, aluminum, stainless steel, etc.), ceramic materials (e.g., ITO, etc.), polymeric materials (e.g., PEDOT, PANI, PPy, etc.), and carbonaceous materials (e.g., carbon black, carbon nanotubes, carbon fibers, graphene, graphite, etc.). In embodiments, the electrodes may be filamentary electrodes or one-dimensional electrodes, similar to wires or filaments. In embodiments, the width and / or thickness of the electrodes may be much smaller than their length. In embodiments, the width and / or thickness of the electrodes may be up to 50 times smaller than the length of the electrodes. In embodiments, the width of the electrodes may be less than 3 mm, while the length may be greater than 100 mm. In a preferred embodiment, the electrodes of the electrode assembly are printed on a top film, wherein the electrode assembly includes, for example, conductive traces of conductive ink (e.g., silver ink or carbon ink suitable for printing on a surface). Therefore, in embodiments, the electrode assembly includes, for example, (hardened / cured) conductive ink. In embodiments, conductive ink is generated by infusing graphite, silver, or other conductive materials into the ink.

[0033] In embodiments, a top film, and generally a film, refers to a coherent flexible and / or elastic sheet that significantly covers the entire surface or side of an object (such as a first adhesive layer). The top film of the substrate serves at least two purposes: it provides protection for the first adhesive layer and provides a substrate for the electrode assembly. Thus, the top film can be referred to as a protective top film. Specifically, the top film protects the first adhesive layer from dirt and external stresses and strains, such as those caused by manipulation. Further, the top film provides a degree of stiffness / rigidity to the first adhesive layer, thereby facilitating manipulation, for example, when the substrate is applied to a skin surface. In the art, a top film can also be referred to as a backing layer. In embodiments, the distal and / or proximal surfaces of the top film are non-adhesive. In embodiments, the distal and / or proximal surfaces of the top film are adhesive.

[0034] In embodiments, the top film is flexible and / or elastic. In preferred embodiments, the top film is both flexible and elastic. In embodiments, the top film is made of a polymeric material. In preferred embodiments, the top film is made of polyurethane (PU), such as thermoplastic polyurethane (TPU).

[0035] In alternative embodiments, the topcoat material may be made of or include one or more of the following: PTFE, PVDF, polyester (e.g., PET), thermoplastic elastomer (TPE), polyamide, polyimide, ethylene-vinyl acetate (EVA), polyurea, and / or silicone. Exemplary thermoplastic elastomers (TPEs) for the topcoat include styrene block copolymers (TPS, TPE-s), thermoplastic polyolefin elastomers (TPO, TPE-o), thermoplastic vulcanizates (TPV, TPE-v), thermoplastic polyurethanes (TPU), thermoplastic copolyesters (TPC, TPE-E), and thermoplastic polyamides (TPA, TPE-A).

[0036] (T)PU film is a preferred material for topcoats because its high flexibility and elasticity allow for a substrate that is equally flexible and elastic. Furthermore, (T)PU belongs to the group of materials suitable for substrates used for printed electrodes; that is, (T)PU is a substrate suitable for electrode printing processes, thereby allowing printed electrodes (conductive traces) to be formed on the surface of the (T)PU film.

[0037] In the embodiments, the thickness of the top membrane is between 20 μm and 60 μm, particularly between 35 μm and 50 μm, for example, 42 μm. Thicknesses within the indicated range, such as 42 μm, have been found suitable for the base plate of stoma instruments, specifically because the indicated thickness provides the base plate with appropriate rigidity for easy manipulation while reducing skin damage.

[0038] In an example where the first adhesive layer, electrode assembly, and top membrane are disposed in a sensor patch for attachment to a baseplate, the top membrane can be thinner, for example, between 20 μm and 50 μm, particularly between 25 μm and 35 μm, such as 30 μm. Thicknesses within the indicated range (25 μm to 35 μm, specifically 30 μm) have been found suitable for sensor patches for attachment to baseplates of ostomy devices. Since the thickness of the top membrane affects at least the flexibility of the product (e.g., sensor patch or baseplate), a thickness appropriate for the intended use must be carefully selected so that the product (sensor patch or baseplate) is neither too rigid when adhered to the user's skin surface (leading to an increased risk of leakage or skin irritation) nor too flexible during manipulation (thus reducing manageability). In the case of a sensor patch for attachment to a baseplate of an ostomy device, it is envisioned that a particularly rigid sensor patch is less important, as the combined stiffness of the sensor patch when adhered to the baseplate provides appropriate stiffness to the user during the application of the sensor patch to the skin surface of the baseplate. Conversely, providing a relatively thin top film for the sensor patch offers a more flexible and resilient product, allowing the user to more easily manipulate the sensor patch. This enables the sensor patch to be stretched and manipulated as needed to adhere to the proximal adhesive surface of the substrate before being applied to the skin surface. Furthermore, the thinner top film of the sensor patch (relative to the thickness of the top film of the universal substrate) provides a less stiff device when adhered to the universal substrate (where both the thickness of the top film of the sensor patch and the thickness of the top film of the substrate contribute to the stiffness of the assembled device).

[0039] According to a first aspect of the invention, the top film of the substrate has a proximal surface and a distal surface. The top film is disposed on the distal side of the first adhesive layer, for example, on the distal surface of the first adhesive layer. In other words, the proximal surface of the top film may face the distal surface of the first adhesive layer. When referring to the case where the proximal surface of the top film is disposed on the distal surface of the first adhesive layer, it should be understood that the electrode assembly is disposed on the proximal surface of the top film, thereby sandwiched between the top film and the first adhesive layer. Thus, in embodiments, the electrode assembly, such as one or more electrodes of the electrode assembly, has a distal surface disposed on the proximal surface of the top film and a proximal surface disposed on / facing the distal surface of the first adhesive layer. However, since the extent / coverage of the electrodes of the electrode assembly on the proximal surface of the top film is negligible, for the sake of simplicity, the mention of the distal / proximal surfaces of the electrodes is omitted.

[0040] According to a first aspect of the invention, an electrode assembly of a substrate is disposed on a proximal surface of a top film. Thus, the electrodes of the electrode assembly face the distal surface of a first adhesive layer. In an embodiment, at least a portion of the electrodes of the electrode assembly are in direct contact with the distal surface of the first adhesive layer, and therefore in direct contact with the first adhesive layer. In an embodiment, "disposing the electrode assembly on a proximal surface of the top film" means that the electrodes of the electrode assembly are formed (e.g., printed) on the proximal surface of the top film. Therefore, the electrodes of the electrode assembly are in contact with the proximal surface of the top film. Thus, the top film can be considered as a substrate or support for the electrode assembly.

[0041] According to a first aspect of the invention, the distal surface of the top membrane is the distal surface of the base plate. In other words, the distal surface of the top membrane itself forms the distal surface of the base plate. Therefore, the electrode assembly is provided on the proximal surface of the top membrane, and the distal surface of the top membrane is the distal surface of the entire base plate, with the top membrane forming part of the entire base plate. Thus, the top membrane also serves as a support for the one or more electrodes of the electrode assembly and a protective film for the entire distal side of the base plate.

[0042] Therefore, it is advantageous that the substrate comprises only one continuous film, as previously defined, on the distal side of the first adhesive layer. Providing only one film on the distal side of the first adhesive layer of the substrate allows for a thin, flexible, and resilient substrate. Furthermore, compared to providing an intermediate film (such as an intermediate support film supporting an electrode assembly) disposed between the proximal surface of the top film and the distal surface of the first adhesive layer, the cost associated with the substrate can be reduced. Further, the thus reduced complexity of the substrate lowers the complexity of manufacturing such a substrate.

[0043] In one embodiment, the base plate comprises a first adhesive layer, an electrode assembly, and a top membrane. In another embodiment, the electrode assembly includes an interface, such as one allowing electrical and / or mechanical connection to a monitoring device. In yet another embodiment, the base plate further comprises a release liner disposed on the proximal surface of the first adhesive layer. This release liner is configured to separate / peel off from the base plate before it is adhered to the user's skin surface. Therefore, the release liner acts as a protective barrier and does not form part of the base plate during use; that is, it does not form part of the base plate when the proximal surface of the first adhesive layer adheres to the user's skin surface.

[0044] In this embodiment, the top film is the only polymer layer of the base plate. In this embodiment, the top film is the only flexible and elastic membrane material disposed distal to the first adhesive layer. Therefore, in this embodiment, the base plate comprises one and only one polymer membrane material distal to the first adhesive layer. Thus, as described above, the provided feature is that the base plate is thin and flexible, and the associated costs are reduced.

[0045] In an embodiment, the one or more electrodes of the electrode assembly are conductive traces, such as conductive traces printed on the proximal surface of the top film. A conductive trace refers to a conductive path created by a printing process, wherein conductive ink (e.g., silver) is deposited on a substrate, such as the proximal surface of the top film according to an embodiment of the invention, according to a predefined pattern, based on the desired capabilities and characteristics of the electrode assembly. In an embodiment, the electrode assembly comprises one or more conductive traces (e.g., multiple conductive traces) and a monitor interface that allows connection to a monitor device.

[0046] In one embodiment, at least a portion of the electrode assembly contacts the distal surface of the first adhesive layer. In another embodiment, the entire electrode assembly contacts the distal surface of the first adhesive layer and / or is in complete contact with the proximal surface of the top film. According to a first aspect of the invention, the distal surface of the top film is the distal surface of the substrate. Therefore, by arranging the electrode assembly such that at least a portion of the electrode assembly contacts the distal surface of the first adhesive layer and the proximal surface of the top film, there is no space for any additional film / sheet covering the entire distal / surface of the first adhesive layer. Therefore, according to the previous definition, the only film covering the entire distal side is the top film. Therefore, the substrate includes one and only one continuous film covering the entire distal side of the first adhesive layer, such as one and only one polymer film. In one embodiment, at least a portion of the electrode assembly, such as at least a portion of one or more electrodes, is masked to the first adhesive layer by a masking layer, which will also be referred to as a reinforcing layer in the following discussion. The masking layer may be arranged according to a predefined pattern, thereby exposing certain portions of the electrode assembly to the distal surface of the first adhesive layer. Therefore, the masking layer does not cover the entire distal side / surface of the first adhesive layer and is thus not considered a membrane material according to the previously defined specifications. In an embodiment, the masking layer includes sensor point openings corresponding to / aligned with sensor point openings in the first adhesive layer to expose the electrodes through the first adhesive layer to the surrounding environment.

[0047] In this embodiment, the proximal surface of the top membrane is in contact with the distal surface of the first adhesive layer. Therefore, in this embodiment, the top membrane (including the electrode assembly disposed on its proximal surface) is disposed on the distal surface of the first adhesive layer. Thus, as discussed above, there is no space for any additional film / sheet to cover the entire distal / surface of the first adhesive layer.

[0048] In an embodiment, the base plate further includes a flexible reinforcing layer disposed distal to the first adhesive layer. In an embodiment, the flexible reinforcing layer (e.g., the masking layer described above) is bonded to the top membrane, such as to a surface of the top membrane, such as to a proximal and / or distal surface of the top membrane. Bonding means that in the bonded area, the reinforcing layer and the top membrane move / stretch together during stretching. Therefore, bonding provides that the reinforcing layer can withstand loads (stretching) applied to the base plate, thereby mitigating the effects of loads that could cause the top membrane and / or electrodes disposed thereon (e.g., fracture or plastic deformation).

[0049] Typically, depending on the properties of the top film and / or the first adhesive layer, the elasticity of the top film and / or the first adhesive layer can exceed the elasticity of the one or more electrodes (conductive traces) of the electrode assembly. In other words, one or more electrodes (especially during printing) can be less elastic than the top film and / or the first adhesive layer. Therefore, there is a risk of overstretching and thus breaking the electrodes during substrate manipulation. However, by providing a flexible reinforcing layer in the substrate, such as a surface bonded to the top film, the elasticity of the top film and / or the first adhesive layer can be reduced to a level that inhibits electrode overstretching or significantly reduces the risk. Therefore, in an embodiment, the elasticity of the reinforcing layer is less than the elasticity of the one or more electrodes of the electrode assembly, and / or the elasticity of the top film, and / or the elasticity of the first adhesive layer. Thus, the reinforcing layer acts as a limiting element in terms of substrate elasticity, thereby reducing the overall elasticity of at least a region of the substrate, preventing the electrodes of the substrate from being overstretched and breaking. In other words, in an embodiment, the reinforcing layer is configured to inhibit overstretching of the one or more electrodes of the electrode assembly. Furthermore, providing a reinforcing layer can protect the substrate, such as the first adhesive layer, from tearing, for example, at the edge portions of the substrate. Therefore, in an embodiment, a reinforcing layer is disposed in the edge portion of the base plate, for example, in a particularly exposed area of ​​the edge. Thus, in an embodiment, the reinforcing layer is arranged according to a predefined pattern. In an embodiment, the predefined pattern is designed to suppress overstretching of one or more electrodes, and / or electrically insulate at least a portion of one or more electrodes from / mask at least a portion of one or more electrodes to the first adhesive layer, and / or reinforce the edge portion of the base plate.

[0050] Elasticity refers to a material's ability to return to its original shape after a load, such as a uniaxial load, is removed (also known as elastic deformation). High elasticity, compared to low elasticity, means that the material can be stretched to a great extent before fracturing and / or undergoing plastic deformation. In embodiments, elasticity can be represented by Young's modulus E, typically expressed as:

[0051]

[0052] Where σ(ε) is the tensile stress, and ε is the engineering tensile strain of the elastic part of the physical stress-strain curve, where F is the force applied to the stretched object, L0 is the original length of the object, A is the actual cross-sectional area (equal to the area of ​​the cross section perpendicular to the applied force), and ΔL is the change in the length of the object.

[0053] In one embodiment, the base plate comprises a first adhesive layer, an electrode assembly, a reinforcing layer, and a top film. Optionally, the base plate further includes a release liner.

[0054] In an embodiment, the Young's modulus of the reinforcing layer is greater than that of the top film and / or the electrode assembly and / or the first adhesive layer. Therefore, a greater force is required to stretch, deform, and / or break the reinforcing layer compared to the top film and / or the one or more electrodes disposed thereon. Consequently, the reinforcing layer can withstand greater forces, thereby defining the stretching of the top film and thus the electrode assembly disposed thereon. Thus, the reinforcing layer is configured to withstand loads applied to the base plate, rather than the electrodes, top film, or first adhesive layer doing so.

[0055] In an embodiment, the ultimate tensile strength of the reinforcing layer is greater than the ultimate tensile strength of the top membrane and / or the one or more electrodes of the electrode assembly. Ultimate tensile strength refers to the force required to break a given material. Therefore, by providing a reinforcing layer with an ultimate tensile strength greater than that of the top membrane and / or the one or more electrodes, it is ensured that external loads (e.g., user-operated base plates) will not accidentally cause the electrodes of the electrode assembly disposed on the top membrane to break. Instead, by withstanding the load, the reinforcing layer prevents one or more electrodes from breaking.

[0056] In this embodiment, the thickness of the reinforcing layer is greater than the thickness of the top membrane. Therefore, the elasticity of the reinforcing layer can be manipulated by providing a fixed thickness rather than selecting different materials. In this embodiment, the thickness of the reinforcing layer varies, causing its load-bearing capacity to vary on the base plate.

[0057] In an embodiment, the top membrane itself has an elongation at break between 500% and 600%, for example, 510% to 560%, or for example, 540% to 560%. Here, the elongation at break of the top membrane is related to the top membrane when separated from other parts. Therefore, the elongation at break described herein is consistent with the top membrane before it is arranged in the base plate of the ostomy device. It should be noted that additional parts, such as the first adhesive layer or reinforcing layer described below, and the adhesion between them, may reduce the elongation of the top membrane. Providing a top membrane with an elongation at break between 500% and 600% provides a very resilient and flexible base plate when separated. However, an elongation at break between 500% and 600% increases the risk of electrode breakage in the electrode assembly, as the stretchability of the electrodes is significantly reduced due to their conductivity and printing method. Therefore, by introducing a reinforcing layer with an appropriate value in terms of tensile strength, stress on the electrodes is reduced, and thus such breakage / overstretching is suppressed.

[0058] In one embodiment, a reinforcing layer is disposed on the proximal surface of the top membrane to cover, for example, at least a portion of the electrode assembly and thus one or more of its electrodes. In another embodiment, a reinforcing layer is disposed on the distal surface of the first adhesive layer. In yet another embodiment, a reinforcing layer is disposed on the top membrane and thus on the distal surface of the base plate.

[0059] In one embodiment, a reinforcing layer is disposed between a proximal surface of the top membrane and a distal surface of the first adhesive layer. For example, the reinforcing layer may be applied to the proximal surface of the top membrane after the electrodes of the electrode assembly have been disposed thereon. Thus, the reinforcing layer may cover at least a portion of the electrode assembly such that, in a region of the substrate, the reinforcing layer is sandwiched between the electrode assembly and the distal surface of the first adhesive layer, and in other regions of the substrate, the reinforcing layer is sandwiched between the proximal surface of the top membrane and the distal surface of the first adhesive layer.

[0060] In an embodiment, a reinforcing layer is arranged in a predefined pattern on the proximal surface of the top membrane and / or the electrode assembly. Therefore, in an embodiment, the reinforcing layer covers at least a portion of the electrode assembly. In an embodiment, at least a portion of the electrode assembly is sandwiched between the proximal surface of the top membrane and the reinforcing layer. Therefore, the elasticity of the covered portion of the electrode assembly is reduced to that of the reinforcing layer. In other words, by covering at least a portion of the one or more electrodes of the electrode assembly, the reinforcing layer is able to withstand external loads (e.g., user manipulation), thereby protecting the electrodes. In an embodiment, the reinforcing layer exposes a portion of the electrode assembly such that said portion of the electrode assembly is in direct contact with the first adhesive layer, thereby allowing electrical connection with the first adhesive layer and enabling resistance measurement of the first adhesive layer. Therefore, in an embodiment, the reinforcing layer exposes at least a portion of the electrode assembly to the first adhesive layer.

[0061] In this embodiment, the reinforcing layer is electrically insulating. Therefore, the reinforcing layer can insulate a portion of the electrode assembly from the first adhesive layer to define a series of sensing portions along the one or more electrodes of the electrode assembly, where resistance measurements can be performed, while other areas of the electrode assembly can be masked / insulated from the first adhesive layer to avoid measuring the resistance of the first adhesive layer in these masked areas.

[0062] In this embodiment, the reinforcing layer is a varnish. For example, the varnish can be deposited in a predefined pattern on the proximal surfaces of the top film and the electrode assembly disposed thereon, and then cured / hardened to achieve the properties of the reinforcing layer as disclosed herein. Subsequently, the combination of the top film, the electrode assembly, and the reinforcing layer can be disposed adjacent to the distal surface of the first adhesive layer. This provides a manner for disposing of a reinforcing layer on the top film. In this embodiment, the varnish is an acrylic varnish, such as a UV-curable acrylic varnish. In alternative embodiments, other types of varnishes, such as chemically curable varnishes and / or thermocurable varnishes, can be used.

[0063] In a second aspect of the invention, a method for manufacturing a base plate for an ostomy apparatus is disclosed. The base plate has a proximal surface and a distal surface. The method includes the steps of: printing an electrode assembly, comprising one or more electrodes, on the proximal surface of a top membrane having the proximal and distal surfaces; providing a first adhesive layer having the proximal and distal surfaces; and arranging the proximal surface of the top membrane adjacent to the distal surface of the first adhesive layer, such that the distal surface of the top membrane forms / is the distal surface of the base plate.

[0064] Therefore, the method according to the second aspect of the invention provides a method for manufacturing a base plate as discussed with respect to the first aspect of the invention. The embodiments and alternatives discussed with respect to the first aspect of the invention are considered applicable. In the example, the method is a method for manufacturing a sensor patch (such as the sensor patch discussed in the examples of the first aspect of the invention).

[0065] This method provides a simple and cost-effective way to manufacture a substrate with sensing devices by providing an electrode assembly. In particular, this method is considered cost-effective because the top film is the only film included in the substrate; the top film serves both as a protective film for the distal surface of the first adhesive layer and as a support for the electrode assembly.

[0066] In an embodiment, the step of printing electrode assemblies on the proximal surface of the top membrane can be replaced by the step of arranging electrode assemblies on the proximal surface of the top membrane.

[0067] In one embodiment, the step of arranging the proximal surface of the top membrane adjacent to the distal surface of the first adhesive layer includes: arranging the proximal surface of the top membrane on the distal surface of the first adhesive layer. It should be understood that the electrode assembly on the proximal surface of the top membrane is sandwiched between the first adhesive layer and the top membrane. This provides that the top membrane is the only membrane covering the entire distal surface of the substrate, i.e., because the top membrane itself is also the distal surface of the substrate.

[0068] In an embodiment, the printed electrode assembly includes printing one or more conductive traces on the proximal surface of the top film. A conductive trace is a conductive path formed by the printing process using conductive ink. Thus, the conductive traces form the one or more electrodes of the electrode assembly. Printing is considered a cost-effective and waste-efficient way to provide electrodes on a flexible substrate (such as the top film according to the first and second aspects of the invention). The conductive ink may include graphite / carbon, silver, or other conductive materials suitable for the printing process.

[0069] In an embodiment, the method includes an intermediate step of distributing a reinforcing layer according to a predefined pattern on the surface of the top membrane, the reinforcing layer suppressing excessive stretching of the one or more electrodes of the electrode assembly. For example, the reinforcing layer is distributed according to a predefined pattern on the proximal surface of the top membrane / electrode assembly. For example, the reinforcing layer may be distributed to cover at least a portion of the electrode assembly. In an embodiment, the reinforcing layer is bonded to the top membrane and / or the electrode assembly such that the reinforcing layer can withstand loads applied to the substrate.

[0070] In one embodiment, the placement of the reinforcing layer includes depositing a varnish according to a predefined pattern. In another embodiment, the varnish is subsequently cured, for example, by ultraviolet light, a chemical process, or heat. In yet another embodiment, the varnish is a UV-curable acrylic varnish. This provides a means for an efficient method of placing a reinforcing layer on a top film. Furthermore, the deposition of the reinforcing layer provides a universal method that allows for the rapid adaptation or modification of the predefined pattern, for example, between batches of substrates or according to desired needs in different products incorporating the reinforcing layer.

[0071] In the embodiments, the choice of deposition method and paint provides for the immediate bonding of the reinforcing layer to the top film, for example, via a curing process. Attached Figure Description

[0073] Figure 1 An exploded view of a base plate 10 according to an embodiment of the present invention is shown. The base plate 10 includes a first adhesive layer 110, a reinforcing layer 140, an electrode assembly 120, and a top film 100. In an alternative embodiment of the invention, the reinforcing layer 140 is omitted, thereby the base plate 10 includes the first adhesive layer 110, the electrode assembly 120, and the top film 100.

[0074] The first adhesive layer 110 includes a proximal surface 111, a distal surface 112, and an ostomy opening 113. The proximal surface 111 of the first adhesive layer 110 is adapted to adhere to the user's skin surface, for example, after the protective release liner (not shown) has been removed. Thus, the proximal surface 111 of the first adhesive layer 110 can also serve as the proximal surface 11 of the assembled baseplate 10. The top membrane 100 includes a proximal surface 101, a distal surface 102, and an ostomy opening 103. The distal surface 102 of the top membrane 100 also serves as the distal surface 12 of the assembled baseplate 10. The electrode assembly 120 includes a plurality of electrodes 120' and a monitor interface 123 to allow electrical connection between the electrodes 120' and a monitor device that can be coupled to the monitor interface. A reinforcing layer 140 is disposed on the proximal / proximal surface 101 of the top membrane 100 such that the reinforcing layer 140 covers at least a portion of the electrode assembly 120, whereby said portion of the electrode assembly is sandwiched between the reinforcing layer 140 and the top membrane 100. Therefore, the reinforcing layer 140 can suppress excessive stretching of the electrode 120', as previously described. Further, the illustrated reinforcing layer 140 includes a plurality of openings 141 to expose the sensing portion of the electrode 120', particularly exposing said sensing portion to the distal surface 112 of the first adhesive layer 110. In embodiments where the reinforcing layer 140 is electrically insulating, these plurality of openings 141 allow manipulation of how and where electrical measurements are performed on the first adhesive layer 110 via the electrode 120' and a monitoring device coupled to the electrode assembly 120.

[0075] Figure 2 A cross-sectional view of a portion of a base plate 10 according to an embodiment of the present invention is shown. The base plate 10 shown includes a first adhesive layer 110, an electrode assembly 120, and a top film 100. The electrode assembly 120 is shown as two separate electrodes 121, 122, but the electrode assembly may include fewer or more electrodes. The elements shown are not necessarily drawn to scale. In particular, the cracks formed in the first adhesive layer 110 by the electrodes 121, 122 are highly exaggerated and do not necessarily reflect the reality that the thickness of the electrodes 121, 122 is such that neither the top film 100 nor the first adhesive layer 110 undergoes any deformation.

[0076] The substrate 10 has a proximal surface 11 and a distal surface 12. The first adhesive layer 110 has a proximal surface 113 including the proximal surface 111 and a distal surface 114 including the distal surface 112. The top film 100 has a proximal surface 111 and a distal surface 112. Electrodes 121, 122 of the electrode assembly 120 are arranged (e.g., printed) on the proximal surface 101 of the top film 100.

[0077] The first adhesive layer 110 comprises a skin-friendly adhesive, such that the proximal surface 111 of the first adhesive layer 110 can adhere to the user's skin surface. According to an embodiment, the thickness of the first adhesive layer 110 is in the range of 0.1 mm to 1.5 mm, for example, in the range of 0.2 mm to 1.2 mm, such as 0.8 mm or 1.0 mm.

[0078] According to the illustrated embodiment, the electrode assembly 120 includes two electrodes 121 and 122. These electrodes 121 and 122 can be conductive traces formed by printing conductive ink, such as silver or carbon, onto the proximal surface 101 of the top film 100. Therefore, in this embodiment, the electrode assembly 120 is disposed on the proximal surface 101 of the top film 100 via a printing process. Thus, the top film 100 and the electrode assembly 120 can be manufactured separately. Therefore, the substrate 10 can be manufactured by combining the top film 100 and the electrode assembly 120 on the distal side 114 of the first adhesive layer 110.

[0079] The top film 110 is a flexible and elastic film, such as a flexible and elastic polymer film. According to an embodiment, the top film 110 is a (thermoplastic) polyurethane film.

[0080] According to the present invention, the distal surface 102 of the top film 100 is the distal surface 12 of the base plate 10. Therefore, the top film 100 is the farthest portion of the base plate 10 and simultaneously serves as a support for electrode assemblies disposed (e.g., printed) on the proximal surface 101 of the top film 100. Thus, the distal surface 102 of the top film 100 is the distal surface 12 of the base plate 10, while the proximal surface 101 of the top film 100 serves as a support for the electrode assembly 120.

[0081] exist Figure 2 In the illustrated embodiment, electrode assembly 120 is in direct contact with the distal surface 112 of the first adhesive layer 110. Therefore, when a voltage is applied, for example, via a monitoring device coupled to electrode assembly 120, current can be conducted through the first adhesive layer 110 from the first electrode 121 to the second electrode 122. Electrical quantities such as resistance, conductance, capacitance, and inductance of the first adhesive layer 110 can thus be derived. These electrical quantities can indicate certain information about the adhesive performance or "health" of the first adhesive layer 120. Electrode assembly 120 is protected from environmental influences by being laminated between the (protective) top film 100 and the first adhesive layer 110. Voltage can be applied to electrodes 121, 122 via a monitoring device comprising a battery and a processor and mechanically and / or electrically attached to the electrode assembly, for example, via a monitoring interface (not shown) disposed in the base plate.

[0082] Figure 1 and Figure 2The substrate shown provides a substrate with one and only one membrane (i.e., top membrane 100).

[0083] Figure 3 An exploded cross-sectional view of the base plate 10 according to an embodiment of the present invention is shown. Figure 3 The embodiments illustrate Figure 2 Features of the top membrane 100, and a reinforcing layer 140 disposed between the proximal surface 101 of the top membrane 100 and the distal surface 112 of the first adhesive layer 110. In the assembled embodiment, the reinforcing layer 140 is bonded to the proximal surface 101 of the top membrane 100, thereby enabling the reinforcing layer 140 to withstand loads applied to the top membrane 100 and / or the base plate itself. In particular, the reinforcing layer 140 is capable of withstanding loads in the direction indicated by arrow L (therefore, this direction is parallel to the extent of the base plate, also represented as the appliance plane). The reinforcing layer 140 suppresses excessive stretching of the electrodes 121, 122 by withstanding loads. The Young's modulus of the reinforcing layer 140 is greater than that of the top membrane 100, and / or the electrode assembly 120, and / or the first adhesive layer 110, thereby limiting the overall elasticity of the base plate 10 to (significantly) reduce the degree of excessive stretching of the electrodes 121, 122.

[0084] The reinforcing layer 140 is arranged in a predefined pattern designed according to the intended purpose of a given portion of the base plate 10. Figure 3 In the illustrated embodiment, a reinforcing layer 140 is disposed in an edge portion W of a portion of the illustrated base plate 10. The edge portion W may be an edge portion of the base plate, thereby reinforcing the edge of the base plate. Further, the predefined pattern of the illustrated reinforcing layer 140 completely covers the first electrode 121, such that the electrode is masked from the first adhesive layer 110 (i.e., at least in a given cross-sectional view). This masking facilitates manipulation of how and / or where the electrical quantities of the first adhesive layer 110 are measured, provided the reinforcing layer 140 is electrically insulating. Further, the predefined pattern of the illustrated reinforcing layer 140 exposes a second electrode 122 to the first adhesive layer 110, such that the electrode 122 is in electrical contact with the first adhesive layer 110. The reinforcing layer 140 covers a portion of the second electrode 122 to reinforce the electrode and thus suppress overstretching, but does not completely mask the electrode from the first adhesive layer 110. Within the scope of this invention, a variety of different predefined patterns for the reinforcing layer 140 are anticipated, and the illustrated embodiments including a certain predefined pattern of the reinforcing layer 140 are intended to highlight only the characteristics of the reinforcing layer 140.

[0085] Figure 4An exemplary ostomy system is illustrated. The ostomy system 1 includes an ostomy appliance 2 having a base plate 10 according to the invention. The base plate 10 is adapted to support an ostomy bag (not shown). Further, the ostomy system 1 includes a monitor device 6 and an accessory device 8 (mobile phone). The monitor device 6 is connectable to the base plate 10 via a corresponding first connector. The monitor device 6 is configured for wireless communication with the accessory device 8. Optionally, the accessory device 8 is configured to communicate, for example, with a server device 4 of the ostomy system 1 via a network 9. The server device 4 may be operated and / or controlled by the ostomy appliance manufacturer and / or service center. Ostomy data or parametric data based on ostomy data is obtained from electrodes / sensors of the ostomy appliance 2 having the monitor device 6. The monitor device 6 processes the ostomy data and / or parametric data based on ostomy data. Based on the processed ostomy data, the monitor device 6 can determine what monitor data is being sent to the accessory device 8. In the illustrated stoma system, the accessory device 8 is a mobile phone, but it can be implemented as another handheld device, such as a tablet or a wearable device, such as a watch or other wrist-worn electronic device. Accordingly, the monitor device 6 is configured to determine monitor data and transmit it to the accessory device 8. The base plate 10 includes a connecting member 5 in the form of a connecting ring 5' for attaching a stoma bag (not shown) to the base plate (a two-piece stoma appliance). The base plate 10 has a stoma opening 13 with a center point 13'. The size and / or shape of the stoma opening 13 is typically adjusted by the user or nurse to fit the user's stoma before the stoma appliance is applied.

[0086] The stoma system 1 optionally includes a docking station 20 forming an alternative / additional accessory to the stoma system 1. The docking station 20 includes a monitor expansion interface comprising a first connector 22 configured to electrically and / or mechanically connect a monitor device 6 to the docking station 20. The monitor expansion interface can be configured to wirelessly connect a monitor device to the docking station. The docking station 20 includes a user interface 24 for receiving user input and / or providing feedback to the user regarding the operational status of the docking station 20. The user interface 24 may include a touchscreen. The user interface 24 may include one or more physical buttons and / or one or more visual indicators, such as light-emitting diodes.

[0087] Figure 5This is a schematic block diagram of an exemplary monitoring device 6. The monitoring device 6 includes a monitoring device housing 300, a processor 301, and one or more interfaces, including a first interface 302 (instrument interface) and a second interface 304 (accessory interface). The monitoring device 6 includes a memory 306 for storing ostomy data and / or parameter data based on the ostomy data. The memory 306 is connected to the processor 301 and / or the first interface 302.

[0088] The first interface 302 is configured to electrically and / or mechanically connect the monitor device 6 to an ostomy instrument, such as... Figure 4 The instrument interface of the stoma device 2. The first interface 302 includes multiple terminals for connecting to the stoma device 2 (base plate 10, for example...). Figure 1 The corresponding terminals of the monitor interface 123) form an electrical connection. The first interface 302 includes a ground terminal 308, a first terminal 310, a second terminal 312, and a third terminal 314. The first interface 302 optionally includes a fourth terminal 316 and a fifth terminal 318. The first interface 302 of the monitor device 6 includes a coupling portion 320 for forming a mechanical connection, such as a releasable connection, between the monitor device and the base plate. The coupling portion 320 of the first interface 302 and the terminals 308, 310, 312, 314, 316, and 318 form at least a portion of the first connector of the monitor device 6.

[0089] The monitor device 6 includes a power supply unit 321 for supplying power to the monitor device and its active components. Specifically, the power supply unit 321 is connected to the processor 301, the first interface 302, the second interface 304, and the memory 306. The power supply unit includes a battery and a charging circuit system. The charging circuit system is connected to the battery and terminals of the first interface 302 to charge the battery via terminals of the first interface, such as terminals of the first connector.

[0090] The second interface 304 of the monitor device is configured as an accessory interface for connecting the monitor device 6 to one or more accessory devices, such as... Figure 4 The second interface 304 includes an antenna 322 and a wireless transceiver 324 configured for wireless communication with the accessory(s). Optionally, the second interface 304 includes a speaker 326 and / or a haptic feedback element 328 for providing the user with appropriate audio signals and / or haptic feedback.

[0091] The monitoring device 6 optionally includes a sensor unit 340 connected to the processor 301. For example, the sensor unit 340 includes a temperature sensor for feeding temperature data to the processor, and / or a G-sensor or accelerometer for feeding acceleration data to the processor 301. Additionally and / or alternatively, the sensor unit 340 includes a humidity sensor and / or an acoustic sensor. The sensor unit 340 may include alternative and / or additional sensors suitable for the ostomy system as described and / or associated with it.

[0092] Processor 301 is configured to apply a processing scheme, and first interface 302 is configured to collect stoma data from a baseplate and / or sensor patch connected to the first interface. The stoma data includes first stoma data from a first electrode pair of the baseplate and / or sensor patch, second stoma data from a second electrode pair of the baseplate and / or sensor patch, and third stoma data from a third electrode pair of the baseplate and / or sensor patch. The stoma data may be stored in memory 306 and / or processed in processor 301 to obtain parameter data. Parameter data may be stored in memory 306. Processor 301 is configured to apply a processing scheme, wherein the application processing scheme includes obtaining first parameter data based on the first stoma data; obtaining second parameter data based on the second stoma data; and obtaining third parameter data based on the third stoma data. In other words, processor 301 is configured to obtain first, second, and third parameter data based on the corresponding first, second, and third stoma data. The application processing scheme includes: determining the operational status of the base plate and / or sensor assembly of the stoma device based on one or more, such as all, of a first parameter data, a second parameter data, and a third parameter data, wherein the operational status indicates the degree of radial corrosion of the base plate and / or sensor assembly and / or the serious leakage risk of the stoma device. The monitoring device 6 is configured to transmit a first monitoring signal via a second interface based on determining the operational status as a first operational status, the first monitoring signal containing monitoring data indicating the first operational status of the base plate and / or sensor assembly; and to transmit a second monitoring signal via the second interface based on determining the operational status as a second operational status, the second monitoring signal containing monitoring data indicating the second operational status of the base plate and / or sensor assembly.

[0093] Although the base plate has been described with reference to the accompanying drawings, it should be understood that similar descriptions and drawings can be applied to sensor patches for attachment to adhesive surfaces of the base plate (such as a general-purpose base plate). Therefore, a sensor patch may include a first adhesive layer, a reinforcing layer, an electrode assembly, and a top film as disclosed in the embodiments herein.

[0094] Although specific features have been shown and described, it should be understood that they are not intended to limit the claimed invention, and various changes and modifications will be apparent to those skilled in the art without departing from the spirit and scope of the claimed invention. Accordingly, the specification and drawings should be considered illustrative rather than restrictive. The claimed invention is intended to cover all alternatives, modifications, and equivalents.

[0095] Examples of this disclosure are set forth in the following terms:

[0096] 1. A sensor patch for attachment to a base plate of a stoma device, the sensor patch having a proximal surface and a distal surface and comprising:

[0097] - A first adhesive layer, the first adhesive layer having a proximal surface including a proximal surface and a distal surface including a distal surface,

[0098] - An electrode assembly, the electrode assembly comprising one or more electrodes; and

[0099] - A top film having a proximal surface and a distal surface, the top film being disposed distal to the first adhesive layer.

[0100] The electrode assembly is disposed on the proximal surface of the top membrane, and the distal surface of the top membrane is the distal surface of the sensor patch.

[0101] 2. The sensor patch according to Clause 1, wherein the one or more electrodes of the electrode assembly are conductive traces.

[0102] 3. The sensor patch according to any one of clauses 1 and 2, wherein at least a portion of the electrode assembly is in contact with the distal surface of the first adhesive layer.

[0103] 4. The sensor patch according to any one of clauses 1 to 3, wherein the proximal surface of the top film is in contact with the distal surface of the first adhesive layer.

[0104] 5. The sensor patch according to any one of clauses 1 to 4, wherein the top film is made of a polymer material.

[0105] 6. The sensor patch according to any one of Clauses 5, wherein the top film is the only polymer film of the sensor patch.

[0106] 7. The sensor patch according to any one of clauses 1 to 6, wherein the sensor patch further comprises a flexible reinforcing layer disposed on the distal side of the first adhesive layer.

[0107] 8. The sensor patch according to Clause 7, wherein the reinforcing layer is bonded to the top membrane.

[0108] 9. The sensor patch according to any one of clauses 7 and 8, wherein the reinforcing layer is disposed between the proximal surface of the top membrane and the distal surface of the first adhesive layer.

[0109] 10. The sensor patch according to any one of clauses 7 to 9, wherein the reinforcing layer covers at least a portion of the electrode assembly.

[0110] 11. The sensor patch according to any one of clauses 7 to 10, wherein the Young's modulus of the reinforcing layer is greater than the Young's modulus of the top film.

[0111] 12. The sensor patch according to any one of clauses 7 to 11, wherein the thickness of the reinforcing layer is greater than the thickness of the top film.

[0112] 13. The sensor patch according to any one of Clauses 7 to 12, wherein the reinforcing layer inhibits excessive stretching of the one or more electrodes of the electrode assembly.

[0113] 14. The sensor patch according to any one of clauses 7 to 13, wherein the reinforcing layer is electrically insulating.

[0114] 15. The sensor patch according to any one of clauses 7 to 14, wherein the reinforcing layer is paint.

[0115] 16. The sensor patch according to Clause 15, wherein the paint is an acrylic paint.

[0116] 17. A method for manufacturing a sensor patch for attachment to a base plate of an ostomy device, the sensor patch having a proximal surface and a distal surface, the method comprising the steps of:

[0117] - An electrode assembly comprising one or more electrodes is printed on the proximal surface of a top film having a proximal surface and a distal surface;

[0118] - Provides a first adhesive layer having a proximal surface and a distal surface; and

[0119] - The proximal surface of the top film is arranged adjacent to the distal surface of the first adhesive layer, such that the distal surface of the top film forms the distal surface of the sensor patch.

[0120] 18. The method according to Clause 17, wherein arranging the proximal surface of the top membrane adjacent to the distal surface of the first adhesive layer comprises: arranging the proximal surface of the top membrane on the distal surface of the first adhesive layer, wherein the electrode assembly is sandwiched between the first adhesive layer and the top membrane.

[0121] 19. The method according to any one of Clauses 17 and 18, wherein the printed electrode assembly comprises: printing one or more conductive traces on the proximal surface of the top film.

[0122] 20. The method according to any one of clauses 17 to 19, wherein the method comprises the intermediate step of arranging a reinforcing layer according to a predefined pattern on the surface of the top film, the reinforcing layer inhibiting overstretching of the one or more electrodes of the electrode assembly.

[0123] 21. The method according to Clause 20, wherein arranging the reinforcing layer comprises: depositing paint according to a predefined pattern.

Claims

1. A base plate for a stoma device, the base plate having a proximal surface and a distal surface and comprising: - A first adhesive layer having a proximal surface including a proximal surface and a distal surface including a distal surface, wherein the proximal surface of the first adhesive layer forms the proximal surface of the substrate. - Electrode assembly, the electrode assembly comprising one or more electrodes; as well as - A top film having a proximal surface and a distal surface, the top film being disposed distal to the first adhesive layer. The electrode assembly is disposed on the proximal surface of the top membrane, and the distal surface of the top membrane is the distal surface of the base plate. Furthermore, the proximal surface of the top film is in contact with the distal surface of the first adhesive layer.

2. The base plate according to claim 1, wherein, The one or more electrodes of the electrode assembly are conductive traces.

3. The base plate according to claim 1 or 2, wherein, At least a portion of the electrode assembly is in contact with the distal surface of the first adhesive layer.

4. The base plate according to claim 1 or 2, wherein, The top membrane is made of polymer material.

5. The base plate according to claim 4, wherein, The top film is the only polymer film of the bottom plate.

6. The base plate according to claim 1, wherein, The base plate further includes a flexible reinforcing layer disposed on the distal side of the first adhesive layer.

7. The base plate according to claim 6, wherein, The reinforcing layer is bonded to the top membrane.

8. The base plate according to any one of claims 6 and 7, wherein, The reinforcing layer is disposed between the proximal surface of the top membrane and the distal surface of the first adhesive layer.

9. The base plate according to any one of claims 6 to 7, wherein, The reinforcing layer covers at least a portion of the electrode assembly.

10. The base plate according to any one of claims 6 to 7, wherein, The Young's modulus of the reinforcing layer is greater than that of the top membrane.

11. The base plate according to any one of claims 6 to 7, wherein, The thickness of the reinforcing layer is greater than the thickness of the top film.

12. The base plate according to any one of claims 6 to 7, wherein, The reinforcing layer inhibits excessive stretching of one or more electrodes of the electrode assembly.

13. The base plate according to any one of claims 6 to 7, wherein, The reinforcing layer is electrically insulating.

14. The base plate according to any one of claims 6 to 7, wherein, The reinforcing layer is paint.

15. The base plate according to claim 14, wherein, The paint is an acrylic paint.

16. A method of manufacturing a base plate for an ostomy apparatus, the base plate having a proximal surface and a distal surface, the method comprising the steps of: - An electrode assembly comprising one or more electrodes is printed on the proximal surface of a top film having a proximal surface and a distal surface; - A first adhesive layer having a proximal surface and a distal surface is provided, wherein the proximal surface of the first adhesive layer forms the proximal surface of the base plate; as well as - The proximal surface of the top film is arranged adjacent to the distal surface of the first adhesive layer, such that the distal surface of the top film forms the distal surface of the base plate and the proximal surface of the top film contacts the distal surface of the first adhesive layer.

17. The method according to claim 16, wherein, Arranging the proximal surface of the top membrane adjacent to the distal surface of the first adhesive layer includes: arranging the proximal surface of the top membrane on the distal surface of the first adhesive layer, wherein the electrode assembly is sandwiched between the first adhesive layer and the top membrane.

18. The method according to any one of claims 16 and 17, wherein, The printed electrode assembly includes printing one or more conductive traces on the proximal surface of the top film.

19. The method according to any one of claims 16 to 17, wherein, The method includes the following intermediate step: arranging a reinforcing layer according to a predefined pattern on the surface of the top film, the reinforcing layer inhibiting overstretching of one or more electrodes of the electrode assembly.

20. The method according to claim 19, wherein, The reinforcement layer is arranged by depositing paint according to a predefined pattern.

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