Ostomy bag accessories

Description

[0001] The invention relates to an ostomy bag accessory according to claim 1 and to a method for using an ostomy bag accessory according to claim 12.

[0002] It is known from the prior art to equip ostomy bag devices with integrated sensors designed to detect leaks in the ostomy bag device. However, the integration of the sensors prevents easy retrofitting of ostomy bag devices in which the sensors were not already integrated during the manufacturing process. Furthermore, there is no way to remove and reattach the sensors from the ostomy bag device, making it impossible to easily replace them, for example, if the sensors become damaged.

[0003] WO 2022 / 015649 A1 discloses an example of such ostomy bag devices with integrated leakage sensors. The sensors are arranged spirally around the stoma and fixed between a substrate and a hydrocolloid plate.

[0004] The object of the invention is preferably to provide the sensors in a manner that allows increased flexibility and adaptability in design and / or application. This object is achieved according to the invention by the features of claims 1 and 12, while advantageous embodiments and further developments of the invention can be found in the subclaims. An ostomy bag accessory for use with at least one ostomy bag device is proposed, comprising at least one sensor element for detecting a leakage of the ostomy bag device in at least one application state, and comprising at least one adhesive element for releasably connecting it to the ostomy bag device in the application state.

[0005] Such a design makes it possible to provide a construction that offers increased comfort and improved flexibility. It is advantageous that the user can choose when and how often to attach the ostomy bag accessory to the ostomy bag device. Particularly advantageous is that ostomy bag devices already attached to the user can be retrofitted with the ostomy bag accessory without the need for special tools or trained personnel. For example, the ostomy bag accessory could be connected to the ostomy bag device before exercising and removed again after the activity. Furthermore, the ostomy bag device and the ostomy bag accessory can be offered separately, thus avoiding unnecessary, ongoing surcharges for users who only rarely need the ostomy bag accessory.

[0006] Preferably, the ostomy bag accessory can be connected to and removed from the ostomy bag device as often as desired. Advantageously, the ostomy bag accessory can be connected to various identical ostomy bag devices, and particularly advantageously to various different ostomy bag devices. Preferably, the ostomy bag accessory can be adapted to ostomy bag devices of different sizes. Particularly preferably, the ostomy bag accessory is stretchable and / or foldable for use with different ostomy bag devices. Furthermore, the ostomy bag accessory can preferably be designed in various sizes and / or shapes, each of which is intended for use with a specific type of ostomy bag device.

[0007] The ostomy bag device preferably comprises at least one opening surrounded by a hydrocolloid plate, which in the applied state is adhered to the skin of a user and surrounds a stoma of the user, as well as an ostomy bag, which is connected to the hydrocolloid plate and is intended to collect substances escaping from the stoma. The ostomy bag device is preferably intended for long-term use, but can be removed and reattached or replaced with a new ostomy bag device, for example in the event of damage. In the event of a leak, which can be caused, for example, by a stoma blockage, substances usually escape between the hydrocolloid plate and the user's skin, which can lead to skin irritation, inflammation and embarrassment for the user and cause unpleasant odors.The opening in most commercially available ostomy bag devices is circular.

[0008] The sensor element preferably has at least one conductor track and particularly preferably at least two conductor tracks for detecting the leak. It would be possible for the at least one conductor track to be made of copper and / or aluminum. Preferably, the sensor element determines the leak by constantly measuring local humidity. The sensor element could determine the local humidity by means of a capacitive measurement and / or a measurement of the electrical conductivity in a region close to the conductor track. Preferably, the sensor element measures the local humidity in a sensor surface, which is designed as a surface of the substrate arranged between two conductor tracks. The shape of the at least one conductor track of the sensor element can be arbitrarily designed; for example, the conductor track could be open or closed.Furthermore, the conductor track could be seamless or at least have a reversal point where two parallel sections of the conductor track meet. Furthermore, the conductor track could have at least one projection and / or at least one meandering section to improve leak detection. Advantageously, adjacent sensors are designed to encompass each other, at least in sections.

[0009] The application state is understood to be a state in which the ostomy bag device is adhered to the user's skin and the ostomy bag accessory is connected to the ostomy bag device. Preferably, the application state is a state in which both the ostomy bag device and the ostomy bag accessory provide all of their functions.

[0010] The adhesive element preferably has at least one adhesive region, which preferably contains an adhesive, very preferably an adhesive from the group of thermoplastics or elastomers. The adhesive region is preferably designed such that it can be used flexibly and is compatible with different types of ostomy bag devices. Depending on the size and / or shape of the ostomy bag device, different partial areas of the adhesive region can preferably be used for connection to the ostomy bag device. The adhesive region preferably forms the entire adhesive element. Alternatively, the adhesive element has at least one further, non-adhesive region. The adhesive element preferably has a width in a range from 1 to 50 cm, more preferably in the range from 2 to 20 cm, particularly preferably in the range from 5 to 10 cm.The adhesive element preferably has a length in a range of 2 to 100 cm, more preferably in the range of 5 to 70 cm, particularly preferably in the range of 10 to 50 cm.

[0011] The adhesive element preferably has a breathability of at least 300 g / m² / 24h. This allows skin to breathe and prevents skin damage even during prolonged use of the ostomy bag accessory. The adhesive area preferably comprises or consists of an adhesive selected from the group consisting of a silicone adhesive, an acrylate adhesive, a polyurethane adhesive, a rubber adhesive, and mixtures of at least two of these and / or other adhesives known from the field of medical plasters and wound dressings.

[0012] The connection of the ostomy bag accessory to the ostomy bag device is understood to mean the adhesive element being bonded to the hydrocolloid plate. Preferably, the connection using the adhesive element fixes the ostomy bag accessory and the ostomy bag device relative to each other.

[0013] The ostomy bag accessory comprises at least one substrate carrying the sensor element and at least one absorber, wherein the sensor element is arranged between the substrate and the absorber when viewed perpendicular to a main extension plane of the substrate. It would be conceivable for the substrate to be designed as a circuit board. The fact that the substrate carries the sensor element should be understood to mean that the sensor element is permanently connected to the substrate. For example, the sensor element could be welded, soldered, glued to the substrate and / or riveted to the substrate. The absorber is preferably provided to absorb liquids escaping in the event of a leak. Advantageously, the sensor element detects the liquid absorbed by the absorber in order to determine whether a leak is present.When viewed vertically, the sensor element could be arranged entirely between the substrate and the absorber. The sensor element preferably has at least one interface region that protrudes between the substrate and the absorber and is particularly preferably connectable, preferably detachably, to a reading device. The reading device is preferably provided for evaluating the measurement data of the sensor element. Advantageously, a humidity threshold is stored in the reading device; if exceeded, the reading device particularly advantageously triggers an alarm to the user. The alarm could, for example, be embodied as a visual alarm, an acoustic alarm, and / or a vibration alarm. It would be possible for the reading device to issue the alarm itself.Alternatively or additionally, the reader could have a communication unit designed to send a signal to an external device, such as a user's smartphone or a telemedical device, when the humidity threshold is exceeded, whereupon the external device issues the alarm. The communication unit preferably has at least one wireless transmitter, which could be configured, for example, as a radio transmitter, Bluetooth transmitter, and / or infrared transmitter. A "main extension plane" of a body is understood to be a plane that intersects the largest part of the body of all possible planes. Preferably, the substrate and the absorber are layered in a resting state, in which the substrate and the absorber lie on a flat surface and are neither bent nor folded.A "layered" body is understood to be a body whose length and width are at least ten times, advantageously at least fifteen times, and particularly advantageously at least twenty times its thickness. Preferably, the main extension plane of the substrate runs parallel to a length and width of the substrate in the resting state and is preferably aligned parallel to a main extension plane of the absorber. This ensures that any liquid escaping in the event of a leak reaches the vicinity of the sensor element and is detected there. Advantageously, the absorber can simultaneously serve to retain and / or filter the escaping liquid until the leak has been remedied or the user has been able to withdraw from the public space.

[0014] In a preferred embodiment of the ostomy bag accessory, the sensor element is designed as a printed sensor and the substrate has at least one, preferably two, particularly preferably all of the following properties: 1) an elongation at break ≥ 300% and ≤ 800%, preferably ≥ 350% and ≤ 750%, particularly preferably ≥ 400% and ≤ 700%, 2) a stress at break ≥ 30 MPa and ≤ 100 MPa, preferably ≥ 35 MPa and ≤ 95 MPa, particularly preferably ≥ 40 MPa and ≤ 90 MPa; 3) comprising a polymer selected from the group consisting of a polyester, a polycarbonate, a co-polycarbonate, a polyurethane, a thermoplastic polyurethane, an acrylonitrile-butadiene-styrene copolymer, a polyethylene terephthalate, a polyamine, a polyamide, a polystyrene and a polysiloxane or blends or mixtures of at least two thereof.

[0015] The sensor element preferably consists of an inorganic or organic ink, which is preferably formed as a solution, dispersion, or suspension of conductive microparticles and / or nanoparticles prior to a printing process. The microparticles and / or nanoparticles can comprise, for example, polyaniline, silver, gold, and / or carbon, or mixtures of at least two thereof. For example, the sensor element can be printed onto the substrate using a 2D printing process, such as screen printing or inkjet printing. It would also be conceivable for the sensor element to be printed onto the substrate using a 3D printing process, such as stereolithography, 3D screen printing, or polyjet modeling, and could preferably have a predefined three-dimensional shape. The stated values for elongation and stress at break are based on the standard DIN EN ISO 527-1:2016-06.It would be conceivable for the substrate to consist entirely of one of the polymers mentioned; alternatively, the substrate could consist of a mixture of at least two of the polymers. Preferably, the substrate contains or consists of a mixture of thermoplastic polyurethane and an acrylonitrile-butadiene-styrene copolymer, wherein a weight fraction of the acrylonitrile-butadiene-styrene copolymer is preferably 5-40 wt. %, based on the total weight of the substrate. Alternatively, the substrate contains or consists of a mixture of a thermoplastic polyurethane and a polystyrene, wherein a weight fraction of the polystyrene is preferably 5-40 wt. %, based on the total weight of the substrate. Advantageously, the substrate is adaptable in its extent, at least in a partial region which is free of the sensor element. The extent of the substrate is preferably adaptable by at least one cutting process and / or at least one punching process.This allows for a flexible and easily scalable design of the ostomy bag accessory. Advantageously, adaptation of the ostomy bag accessory, for example, to a new design of the ostomy bag device with which the ostomy bag accessory is to be used, can be provided in a simple and cost-effective manner. Particularly advantageously, the flexible design of the substrate allows the ostomy bag accessory to adapt to the shape of the user's skin area in which it is used, ensuring reliable leak detection regardless of the application site and the user.

[0016] In a preferred embodiment of the ostomy bag accessory, the absorber has at least one, preferably both of the following properties: 1) a maximum absorbable liquid volume of ≥ 40 ml, preferably ≥ 50 ml, 2) a pore size of ≤ 120 µm, preferably ≤ at most 100 µm.

[0017] The absorber is preferably designed as a superabsorbent and comprises, for example, a hydrogel. Particularly preferably, the absorber comprises at least one nonwoven fabric and / or foam. Furthermore, the absorber preferably comprises at least one cellulose material. The absorber can preferably comprise at least one additional functional material. The functional material preferably provides odor insulation and comprises activated carbon and / or titanium dioxide. This ensures detection of the leak and prevents the escape of liquids and / or odors, even in the case of larger leaks.

[0018] The absorber preferably protrudes beyond the substrate when viewed vertically. The absorber preferably has an additional partial region which is arranged behind the sensor element with respect to the ostomy bag device in order to be able to absorb additional fluid even after the leak has been detected. The additional partial region is preferably intended for connection to the adhesive element. Alternatively or additionally, the substrate can have recesses which, when viewed vertically, are arranged adjacent to the at least one conductor track of the sensor element and are intended for connection to the adhesive element. This makes it easy to fix the absorber and the substrate relative to one another.

[0019] Particularly preferably, the substrate and the absorber are at least substantially congruent with one another when viewed vertically. The term "at least substantially congruent with one another" means that the surfaces of the absorber and the substrate overlap at least 90%, preferably at least 95%, and particularly preferably completely, when viewed vertically, based on the total surface area of the substrate. Preferably, the absorber, the substrate, and the sensor element are arranged relative to one another in a sandwich construction, with the adhesive element, the substrate, the sensor element, and the absorber particularly preferably following one another in a cross-sectional view of the ostomy bag accessory viewed from top to bottom.This avoids protruding sections of the substrate or absorber, which could cause discomfort to the user, for example by getting caught on objects.

[0020] When viewed vertically, the substrate forms a ring section and, when in use, wraps at least partially around the ostomy bag device. A ring section is understood to be a continuous surface defined by an inner line, an outer line, and two end lines. The inner line and outer line are preferably identical in shape, arranged concentrically to one another, and connected at their end points by the end lines. The end lines are preferably straight. Preferably, if the inner line and outer line extend over 360° of their center angle, the ring section forms a complete ring. The inner line and outer line could be parts of polygons, and the ring section could be part of a polygonal ring; preferably, the inner line and outer line are parts of ovals, preferably circles, and the ring section is part of an oval ring, preferably a circular ring.The inner diameter of the ring section is preferably dependent on the size of the ostomy bag device to be used and is preferably adapted to this. The inner diameter of the ring section is preferably ≤ 3 cm, more preferably ≤ 2 cm, and particularly preferably ≤ 1 cm smaller than the diameter of the hydrocolloid plate. The inner diameter of the ring section is preferably ≥ 1 cm, more preferably ≥ 1.5 cm, and particularly preferably ≥ 2 cm. The inner diameter is preferably ≤ 10 cm. The outer diameter of the ring section is preferably ≥ 1 cm larger than the inner diameter of the ring section.The fact that the substrate at least partially wraps around the ostomy bag device in the application state should be understood to mean that the substrate extends at least over part of the circumference of the ostomy bag device in the application state and / or that at least part of the substrate, preferably a partial region of the substrate comprising the sensor element, wraps around the ostomy bag device in the application state. Particularly preferably, the sensor element is arranged in the vicinity of an outer edge of the hydrocolloid plate in the application state. The conductor tracks of the sensor element preferably each have at least one conductor track ring section whose diameter lies between the inner diameter and outer diameter of the ring section. This makes it easy to detect a leak regardless of where the leak occurs.Preferably, the ostomy bag accessory can be easily attached and removed. This can preferably be achieved by the adhesive of the adhesive element having an adhesive force in a range of 1 N / 20 mm to 30 N / 20 mm against steel according to DIN EN 1464:2012-06 (90° roller peel test) on a tensile testing machine according to DIN EN ISO 527-1:2016-06.

[0021] When viewed vertically, the ring section preferably extends over 360° of its central angle, forming a complete ring. In this case, the sensor element extends only over part of the ring section, and the remaining part of the ring section is formed as a thin bridge, which is intended to hold the ring section in shape. The thin bridge of the ring section is preferably designed to be stretchable. This facilitates wrapping the ostomy bag accessory around the ostomy bag device.

[0022] Particularly preferably, the ring section extends, when viewed vertically, over a maximum of 330°, advantageously a maximum of 300°, particularly advantageously a maximum of 270°, and preferably a maximum of 240° of its central angle. This allows for easy attachment of the ostomy bag accessory, which, thanks to the recess in the ring section, can also be attached to the ostomy bag device around objects. The ring section is preferably designed as an open ring section. This allows the ostomy bag accessory to be "hooked in" by guiding the ostomy bag device through the open section of the ostomy bag accessory, thus enabling the ostomy bag accessory to be connected to the ostomy bag device in a few simple steps and in the shortest possible time.

[0023] The ostomy bag accessory preferably has a width in a range of 5 to 50 cm, more preferably in the range of 6 to 40 cm, and particularly preferably in the range of 7 to 30 cm. The ostomy bag accessory preferably has a length in a range of 5 to 100 cm, more preferably in the range of 6 to 70 cm, and particularly preferably in the range of 10 to 50 cm. The ostomy bag accessory can have any shape that a person skilled in the art would use for this purpose. The ostomy bag accessory preferably has an oval or circular shape.

[0024] The substrate preferably has a width in a range of 1 to 50 cm, more preferably in the range of 2 to 20 cm, particularly preferably in the range of 5 to 10 cm. The substrate preferably has a length in a range of 2 to 100 cm, more preferably in the range of 5 to 70 cm, particularly preferably in the range of 10 to 50 cm. The substrate can have any shape that a person skilled in the art would use for this purpose. The substrate preferably has an oval or circular shape.

[0025] The absorber preferably has a width in a range of 1 to 50 cm, more preferably in the range of 2 to 20 cm, and particularly preferably in the range of 5 to 10 cm. The absorber preferably has a length in a range of 2 to 100 cm, more preferably in the range of 5 to 70 cm, and particularly preferably in the range of 10 to 50 cm. The absorber can have any shape that a person skilled in the art would use for this purpose. The absorber preferably has an oval or circular shape.

[0026] Preferably, the substrate and the absorber are initially simply placed on top of one another and, in the application state, secured by the adhesive element. Particularly preferably, the ostomy bag accessory comprises a securing unit that secures the substrate to the absorber and is permeable to liquids at least in a partial region between the sensor element and the absorber. The liquid-permeable partial region preferably extends ≥ 80%, preferably ≥ 90%, of the longest extent of the sensor element. In this context, the term "securing unit" encompasses both a group of securing elements for securing the substrate to the absorber and the spaces between the securing elements. The securing elements can be identical to one another or different from one another.The fixing elements can be arranged irregularly relative to one another; preferably, the fixing elements are arranged regularly relative to one another. For example, when viewed vertically, the fixing elements are arranged running alongside the sensor element. The fixing elements preferably have at least one weld seam, weld spot, clamp, and / or rivet, each of which is arranged at a distance from the sensor element. In this case, the liquid-permeable partial region is designed as an intermediate space between the fixing elements. More preferably, the fixing unit is designed as a continuous adhesive film and / or an adhesive tape, which is permeable to liquids in all partial regions. This prevents the substrate from slipping relative to the absorber, even before the ostomy bag accessory is connected to the ostomy bag device.Preferably, a restriction of the function of the sensor element by the fixing unit can be avoided.

[0027] Particularly preferably, the fixation unit is designed as a partial adhesive film, wherein the liquid-permeable partial region is designed as an adhesive-free region of the fixation unit. The fixation unit can preferably consist of a plurality of adhesive dots and / or adhesive strips. More preferably, the individual adhesive regions of the fixation unit have any other shapes. Preferably, the fixation unit comprises a pressure-sensitive adhesive, alternatively or additionally a structural adhesive. This allows an even more secure construction of the ostomy bag accessory to be achieved, and slippage of the substrate relative to the absorber can be prevented in a particularly simple and efficient manner.Particularly preferably, the fixing unit is applied to the substrate or the absorber by means of a liner, which is then removed to enable the other joining partner to be placed on the partial adhesive film.

[0028] The adhesive element is preferably designed as a double-sided adhesive tape, and the ostomy bag accessory has an additional cover that covers the adhesive element when in use. The adhesive tape is particularly preferably designed as a self-adhesive cover that is arranged on a side of the substrate facing away from the sensor element, at least when in use. The adhesive element preferably has an adhesive film on a side facing the substrate when in use and a carrier on a side facing away from the substrate when in use. The carrier preferably comprises at least one of cellulose, plastic, and / or foam. The carrier is preferably hydrophobic or has a hydrophobic coating. This makes it possible to avoid false detection of a leak due to liquids penetrating the carrier.When viewed vertically in the application area, the adhesive element preferably extends at least over the entire ostomy bag accessory and an edge region of the ostomy bag device. It is preferred that the adhesive element is arranged on the side of the substrate facing away from the sensor element even when not in use. In this case, the ostomy bag accessory preferably has a release liner that covers part of the adhesive area intended to be placed on the patient's skin before the ostomy bag accessory is applied. Alternatively, the adhesive element is only arranged on the side of the substrate facing away from the sensor element during the application of the ostomy bag accessory. This allows the ostomy bag accessory to be connected to the ostomy bag device by simply placing and smoothing the ostomy bag accessory.

[0029] When viewed vertically in the application state, the adhesive element preferably protrudes beyond the substrate on both sides by at least 30%, based on the width of the substrate. It would be possible for the adhesive element to protrude to varying degrees along the length of the substrate. When viewed vertically, the adhesive element is preferably designed as a ring section and particularly preferably identical in shape to the substrate. This allows a robust connection of the ostomy bag accessory to the ostomy bag device to be achieved. Advantageously, the adhesive element can adhere simultaneously to the hydrocolloid plate of the ostomy bag device, the substrate of the ostomy bag accessory, and the user's skin.

[0030] The ostomy bag accessory preferably has exactly one sensor element. More preferably, the ostomy bag accessory has a plurality of sensor elements arranged concentrically with one another. The ostomy bag accessory preferably has two or three sensor elements. More preferably, adjacent sensor elements share one of the conductor tracks. The sensor elements are preferably arranged at regular radial intervals from one another on the substrate. In addition to the information that a leak is occurring, this makes it possible to make a statement about the severity of the leak by determining which of the sensor elements receives how much moisture. Advantageously, redundancy can be created, which allows detection of a leak even if one of the sensor elements is defective.

[0031] A further subject of the invention relates to a system comprising at least one ostomy bag device and at least one ostomy bag accessory. This makes it possible to provide a system with improved structural properties.

[0032] Another subject matter of the invention relates to a method for applying an ostomy bag accessory with an ostomy bag device, preferably a previously described ostomy bag accessory according to the invention. The ostomy bag accessory is positioned around an edge of a hydrocolloid plate of the ostomy bag device and secured by applying an adhesive element of the ostomy bag accessory to the hydrocolloid plate and to the skin surrounding the ostomy bag device. This enables attachment and removal of the ostomy bag accessory in a simple and intuitive manner.

[0033] All information for the previously described ostomy bag accessory and the ostomy bag device according to the invention, such as dimensions, properties, compositions and shapes mentioned therein, also apply equally to the method for using the ostomy bag accessory.

[0034] In a preferred embodiment of the method, an absorber and a substrate of the ostomy bag accessory are detached from one another in an unattached state of the ostomy bag accessory, and the substrate is only fixed to the adhesive element during application of the adhesive element. This allows individual components of the ostomy bag accessory to be easily replaced, for example in the event of a defect. To prevent incorrect application of the ostomy bag accessory, it is proposed that the absorber and the substrate be connected to one another in the unattached state, and that the substrate be connected to the adhesive element before the adhesive element is applied to the hydrocolloid plate. This allows the user to attach the ostomy bag accessory in just a few steps immediately after purchase.

[0035] The ostomy bag accessory and the method are not intended to be limited to the application and embodiment described above. Preferably, the ostomy bag accessory and the method may comprise a number of individual elements, components, units, or method steps that differs from the number stated herein to fulfill a function described herein.

[0036] A method for producing the ostomy bag accessory preferably comprises at least the following steps: 1) Providing the substrate, 2) Printing the sensor element onto the substrate, 3) Applying and securing the substrate to the absorber. Preferably, the method for producing the ostomy bag accessory can comprise an additional step in which the substrate and the absorber are secured by applying the adhesive element to the substrate. This allows the production of an ostomy bag accessory with increased comfort and improved flexibility.

[0037] Further advantages will become apparent from the following description of the drawings. The drawings illustrate an exemplary embodiment of the invention. The drawings, the description, and the claims contain numerous features in combination. Those skilled in the art will also expediently consider the features individually and combine them into useful further combinations.

[0038] They show: Fig. 1 is a schematic representation of a system with an ostomy bag device and an ostomy bag accessory according to the invention in a cross-sectional view, Fig. 2 is a schematic representation of the system in a plan view, Fig. 3 is a schematic representation of a part of the system in a closer plan view and Fig. 4 is a schematic flow diagram of a method for using the ostomy bag accessory.

[0039] For reasons of clarity, only one reference symbol is assigned to several identical objects in the figures.

[0040] The Figure 1 and 2 show a system 28. The system 28 is in a state of use. The system 28 comprises an ostomy bag device 12. The ostomy bag device 12 is arranged via an opening 36 on a stoma 30 of a user (not shown). The ostomy bag device 12 comprises a hydrocolloid plate 24. The hydrocolloid plate 24 is adhered to a skin 26 of the user and encloses the stoma 30. The ostomy bag device 12 comprises an ostomy bag 32 (which for reasons of clarity is only shown in Figure 1 The stoma bag 32 is provided for receiving substances escaping from the stoma 30 and is connected to the hydrocolloid plate 24.

[0041] The system 28 comprises an ostomy bag accessory 10. The ostomy bag accessory 10 comprises a substrate 18. The substrate 18 is formed as a flexible film. The substrate 18 has an elongation at break of 500%. The substrate 18 has a breaking stress of 50 MPa. The substrate 18 is made of polycarbonate. The ostomy bag accessory 10 comprises a sensor element 14. The sensor element 14 is formed as a printed sensor. The sensor element 14 consists of an inorganic ink containing silver particles. The sensor element 14 serves to detect a leak in the ostomy bag device 12. The sensor element 14 is formed as a moisture sensor. The sensor element 14 is printed onto the substrate 18. The sensor element 14 has two conductive tracks. The conductive tracks are formed as open conductive tracks which are non-reversible and free of protrusions.Alternatively, the conductor tracks could be closed, have reversal points and / or have protrusions.

[0042] The ostomy bag accessory 10 has three conductor tracks 15. The conductor tracks 15 are identical to one another. Alternatively, the conductor tracks 15 could also be different from one another. The ostomy bag accessory 10 has an additional sensor element. The additional sensor element shares one of the conductor tracks 15 with the sensor element 14. The sensor element 14 and the additional sensor element are arranged concentrically with one another. The sensor element 14 and the additional sensor element are spaced evenly radially from one another.

[0043] The ostomy bag accessory 10 includes an absorber 20. The absorber 20 is made of a nonwoven fabric. Alternatively or additionally, the absorber 20 can also include a foam and / or cellulose. The absorber 20 has a maximum absorbable liquid volume of 50 ml. The absorber 20 has a maximum pore size of 100 µm. The absorber 20 is placed on the user's skin 26. The substrate 18 is placed on the absorber 20. The sensor element 14 is arranged between the substrate 18 and the absorber 20. The substrate 18 and the absorber 20 are congruent with one another. The substrate 18, the sensor element 14, and the absorber 20 are arranged relative to one another in a sandwich construction.

[0044] The ostomy bag accessory 10 has an adhesive element 16. The adhesive element 16 serves to detachably connect the ostomy bag accessory 10 to the ostomy bag device 12. The adhesive element 16 is designed as a self-adhesive cover. The adhesive element 16 has a cover side and an adhesive side. The adhesive element 16 has an adhesive area provided with a polyurethane adhesive, which extends over the entire adhesive side. The adhesive element 16 is arranged on a side of the substrate 18 facing away from the sensor element 14. The adhesive element 16 is placed on the substrate 18 (in Figure 1 (For clarity, a gap was left between the adhesive element 16 and the substrate 18.) The adhesive element 16 protrudes on both sides of the substrate 18 by approximately 30% of the width of the substrate 18. The adhesive element 16 is placed on an edge of the hydrocolloid plate 24. The adhesive element 16 is placed on the skin 26 of the user.

[0045] The substrate 18 forms a ring section (see Figure 2 ). The substrate 18 partially wraps around the ostomy bag device 12. The ring section extends over approximately 320° when viewed vertically.

[0046] The stoma bag accessory 10 has a fixing unit 22, which is Figure 3 is shown. The fixing unit 22 fixes the substrate 18 to the absorber 20. The fixing unit 22 is permeable to liquids in a partial area between the sensor element 14 and the absorber 20. The fixing unit 22 is designed as a partial adhesive film. The fixing unit 22 comprises a group of fixing elements 34 and spaces between the fixing elements 34. The fixing elements 34 are designed as adhesive dots; alternatively, the fixing elements 34 could also be designed as adhesive strips. The partial area is designed as an adhesive-free region of the fixing unit 22.

[0047] Figure 4 shows a schematic flow diagram of a method for applying the ostomy bag accessory 10 with the ostomy bag device 12. In a preparation step 100, the substrate 18 is fixed to the adhesive element 16 by pressing it against the adhesive area of the adhesive element 16. The preparation step 100 can be performed either by the user himself or during the manufacture of the ostomy bag accessory.

[0048] In a placement step 110, the ostomy bag accessory 10 is positioned around the edge of the hydrocolloid plate 24 and secured by applying the adhesive element 16 to the hydrocolloid plate 24 and the skin 26. The placement step 110 follows the preparation step 100. Alternatively, the placement step 110 could not be followed by any other step; in this case, the placement step 110 would additionally include applying the substrate 18 and the absorber 20 to the skin 26 prior to applying the adhesive element 22. Reference symbol

[0049] 10Stoma bag accessories 12Stoma bag device 14Sensor element 15Conductor track 16Adhesive element 18Substrate 20Absorber 22Fixation unit 24Hydrocolloid plate 26Skin 28System 30Stoma 32Stoma bag 34Fixation element 36Opening 100Preparation step 110Laying step

Claims

1. Ostomy pouch accessory (10) for usage with at least one ostomy pouch device (12), comprising at least one sensor element (14) for detection of a leakage of the ostomy pouch device (12) in at least one applied state, further comprising at least one substrate (18) carrying the sensor element (14), and further comprising at least one absorber (20), wherein the sensor element (14), in a perpendicular view onto a main extension plane of the substrate (18), is arranged between the substrate (18) and the absorber (20), characterized by at least one adhesive element (16) configured for a detachable adhering of the ostomy pouch accessory (10) to a hydrocolloid plate (24) of the ostomy pouch device (14) in the applied state, wherein the substrate (18) forms a ring section in the perpendicular view and surrounds the ostomy pouch device (12) at least partially in the applied state.

2. Ostomy pouch accessory (10) according to claim 1, characterized in that the sensor element (14) is a printed sensor and the substrate (18) exhibits at least one, preferably two, especially preferably all of the following properties: 1) an elongation at break ≥ 300 % and ≤ 800 % 2) a breaking stress ≥ 30 MPa and ≤ 100 MPa 3) comprising a polymer selected from the group consisting of a polyester, a polycarbonate, a co-polycarbonate, a polyurethane, a thermoplastic polyurethane, an acrylonitrile-butadiene-styrene-copolymer, a polyethylene terephthalate, a polyamine, a polyamide, a polystyrene and a polysiloxane or blend or mixture of at least two thereof.

3. Ostomy pouch accessory (10) according to claim 1 or 2, characterized in that the absorber (20) exhibits at least one, preferably all of the following properties: 1) a maximum liquid absorption of ≥ 40 ml 2) a pore size of ≤ 120 µm.

4. Ostomy pouch accessory (10) according to any of the preceding claims, characterized in that the substrate (18) and the absorber (20) are at least substantially congruent in the perpendicular view.

5. Ostomy pouch accessory (10) according to any of the preceding claims, characterized in that the ring section extends over at most 330° of its central angle in the perpendicular view.

6. Ostomy pouch accessory (10) according to any of the preceding claims, characterized by a fixation unit (22) attaching the substrate (18) to the absorber (20), the fixation unit (22) being permeable for fluids in at least a partial area between the sensor element (14) and the absorber (20).

7. Ostomy pouch accessory (10) according to claim 6, characterized in that the fixation unit (22) is a partially adhesive film, the partial area being a section of the fixation unit (22) which is free of adhesive.

8. Ostomy pouch accessory (10) according to any of the preceding claims, characterized in that the adhesive element (16) is a self-adhesive cover which, at least in the applied state, is arranged on a side of the substrate (18) opposite the sensor element (14).

9. Ostomy pouch accessory (10) according to any of the preceding claims, characterized in that the adhesive element (16) protrudes past the substrate (18) on both sides of the substrate (18) by at least 30 % of a width of the substrate (18) in the perpendicular view.

10. Ostomy pouch accessory (10) according to any of the preceding claims, characterized by a multitude of sensor elements (14) arranged concentrically.

11. System with at least one ostomy pouch device (12) and at least one ostomy pouch accessory (10) according to any of the preceding claims.

12. Method of using an ostomy pouch accessory (10) according to one of the claims 1 to 10 with an ostomy pouch device (12), characterized in that the ostomy pouch accessory (10) is arranged around a rim of a hydrocolloid plate (24) of the ostomy pouch device (12) and attached by placing an adhesive element (16) of the ostomy pouch accessory (10) onto the hydrocolloid plate (24) and a skin (26) surrounding the ostomy pouch device (12).

13. Method according to claim 12, characterized in that an absorber (20) and a substrate (18) of the ostomy pouch accessory (10) are attached to each other in an un-applied state of the ostomy pouch accessory (10) and in that the substrate (18) and the adhesive element (16) are attached to each other before the adhesive element (16) is placed onto the hydrocolloid plate (24).