Leak Detection System for Stoma Appliance

Abstract

An ostomy device includes a proximal side configured to be attached to a user, a distal side opposite the proximal side, and a leak detection sensor having a conductive circuit supported on a support layer. The leak detection sensor is configured to detect stoma discharge by detecting a change in resistance in the conductive circuit. The ostomy device can be an ostomy appliance or an ostomy accessory.

Description

Technical Field

[0001] The following description relates generally to leak detection systems for medical devices, and more particularly to leak detection systems for ostomy devices. Background Art

[0002] An ostomy pouch system generally includes a pouch formed of opposing sidewalls defining an interior collection area, an inlet opening for receiving a stoma, and an ostomy appliance for attaching the pouch to a user. The ostomy appliance may include, for example, an ostomy barrier for a one-piece pouch system that is attached to one of the pouch sidewalls proximal to the inlet opening; a faceplate for a two-piece pouch system that is configured to releasably engage the pouch; and a barrier ring. The ostomy appliance may include a skin barrier material for adhering to and sealing the user's peristoma skin around the stoma.

[0003] Ostomy appliances may be susceptible to leakage of stoma fluid, and the seal formed between the skin barrier material and the user may be weakened. Often, the user may not be aware of or be unable to easily assess the extent of the weakening of the seal. Consequently, the user may not be aware of the weakening of the seal, and as a result, stoma fluid may leak outside the ostomy appliance.

[0004] Therefore, it would be desirable to provide a leak detection system for an ostomy device. Summary of the Invention

[0005] In one embodiment, an ostomy device includes a proximal side configured to be attached to a user, a distal side opposite the proximal side, and a leak detection sensor having a conductive circuit supported on a support layer. The leak detection sensor is configured to detect stoma discharge by detecting a change in resistance in the conductive circuit.

[0006] The support layer may be a skin barrier and the proximal side may be a proximal side of the skin barrier. The leak detection sensor may be configured to detect stoma discharge by detecting a change in electrical resistance in the skin barrier. The leak detection sensor may include at least one resistance sensor, wherein the at least one resistance sensor may be configured to detect a change in electrical resistance.

[0007] The leak detection sensor may be configured to determine a location of stoma effluent leakage and may include a plurality of resistance sensors.The leak detection sensor may include an annular body formed of a flexible printed circuit board and a plurality of resistance sensors arranged on the annular body.

[0008] The plurality of resistance sensors may be arranged in at least two rows. The resistance sensors arranged in the first row are closer to the center of the leak detection sensor than the resistance sensors arranged in the second row. The plurality of resistance sensors may be arranged in at least two different quadrants of the annular body.

[0009] The leak detection sensor may be configured to determine the location of stoma exudate leakage by correlating a signal indicative of a change in resistance with the location of the resistance sensor generating the signal. The leak detection sensor may be configured to track the progression of stoma exudate leakage by correlating a first signal indicative of a change in resistance with the location of the resistance sensor generating the first signal, and correlating a second signal indicative of a change in resistance with the location of the resistance sensor generating the second signal.

[0010] In one embodiment, the support layer may be a substrate and the leakage detection sensor may be disposed between the skin barrier and the backing layer, the leakage detection sensor may include at least one resistance sensor, and the proximal side may be a proximal side of the skin barrier.

[0011] The ostomy device may further comprise at least one wicking member configured to facilitate transport of stoma effluent toward the leak detection sensor. The at least one wicking member may be configured to reduce signal noise by filtering out at least some solid components in the stoma effluent. The at least one wicking member may be configured to saturate at a threshold liquid volume, wherein the at least one resistance sensor may be configured to generate a continuous signal at or above the threshold liquid volume. The leak detection sensor may be configured to generate an alarm upon receiving the continuous signal. The skin barrier may comprise at least one incision configured to contain the at least one wicking member.

[0012] The leak detection sensor may include a plurality of resistive sensors formed from eight pairs of conductive traces arranged in two rows and disposed in four quadrants of the annular body. The ostomy device may include eight wicking members, each configured and arranged to cover an adjacent pair of conductive traces. The skin barrier may include eight incisions configured to contain the eight wicking members. The ostomy device may further include a backing layer. The leak detection sensor may be disposed between the skin barrier and the backing layer.

[0013] In one embodiment, the leakage detection sensor may be a leakage detection system configured to identify stoma discharge leakage events by detecting changes in the electrical resistance of a user's skin. The leakage detection system may include at least one pair of electrodes disposed on a body-facing surface of a skin barrier. Each electrode in the at least one pair of electrodes is configured to measure the electrical resistance of a portion of the user's skin adjacent to the electrode pair. The body-facing surface may be on the proximal side. The at least one pair of electrodes may be formed from a plurality of electrical resistance sensors.

[0014] The leak detection system can be configured to identify stoma discharge leakage events by detecting a change in the user's skin electrical resistance, where the change in the user's skin electrical resistance is caused by the presence of stoma discharge at the intersection of the skin barrier and the user's skin. The leak detection system can be configured to identify skin inflammation events by detecting a change in the user's skin electrical resistance. The leak detection system can be configured to determine the location of the stoma discharge leakage by correlating a signal indicative of the resistance change with the location of the electrode pair generating the signal.

[0015] The leak detection system can be configured to track the progression of stoma effluent leakage by correlating a first signal indicating a change in resistance with the position of an electrode pair generating the first signal, and correlating a second signal indicating a change in resistance with the position of an electrode pair generating the second signal. The leak detection system can include at least two pairs of electrodes arranged in at least two rows. The electrodes arranged in the first row are closer to the center of the leak detection device than the electrode pairs arranged in the second row. The at least two pairs of electrodes can be arranged in at least two different quadrants of the skin barrier.

[0016] In one embodiment, the skin barrier may be formed from a hydrocolloid adhesive. In one embodiment, the ostomy device may be an ostomy appliance. In one embodiment, the ostomy appliance may be a skin barrier ring. In one embodiment, the distal side may be configured to attach to an ostomy bag.

[0017] The ostomy device may further include an adhesive layer and a barrier-side layer, and the proximal side may include a proximal side of the adhesive layer. The support layer is a substrate, and the leak detection sensor is a sensor layer disposed between the adhesive layer and the barrier-side layer. The barrier-side layer may be configured to adhere to the ostomy appliance, and the distal side may include a distal side of the barrier-side layer. In one embodiment, the ostomy appliance may be a barrier of an ostomy bag system.

[0018] In one embodiment, the ostomy device may further include a stoma channel extending through the adhesive layer, the sensor layer, and the barrier-side layer. In one embodiment, the ostomy device may include a second adhesive layer disposed between the sensor layer and the barrier-side layer. In one embodiment, the barrier-side layer may be a film layer formed of a polymeric film material.

[0019] In one embodiment, the barrier-side layer can be a barrier-side adhesive layer formed of an adhesive material. The ostomy device can include a proximal release liner removably disposed over the proximal side. The ostomy device can include a distal release liner removably disposed over the distal side. In one embodiment, the distal release liner can have a greater width than the proximal release liner.

[0020] The sensor layer may include a sensor portion and a connector portion. The conductive circuit may be arranged in a pattern that extends at least partially around the stoma channel at the sensor portion. For example, the conductive circuit may be arranged in a circular pattern. The connector portion may be an elongated portion extending from the sensor portion. The connector portion may be flexible. In one embodiment, the connector portion may extend radially outward from the stoma channel beyond the periphery of the adhesive layer and / or the barrier side layer.

[0021] In one embodiment, the sensor layer further comprises an electrical connector. The conductive circuit may comprise a plurality of electrodes and / or conductive traces. The conductive circuit may be arranged at a plurality of different radial distances from the stoma channel. The ostomy device may be an ostomy attachment configured to be attached to an ostomy appliance.

[0022] According to another aspect, an ostomy assembly may include an ostomy device, wherein the ostomy device is an ostomy attachment, and an ostomy bag system having an ostomy appliance and an ostomy bag.The distal side of the ostomy attachment may be adhered to the proximal side of the ostomy attachment.

[0023] The ostomy appliance may comprise a barrier having an adhesive material, and the ostomy bag may be connected to the barrier.The distal side of the ostomy attachment may be adhered to the proximal side of the adhesive material of the barrier.

[0024] According to another aspect, a leak detection system for a medical device may include at least one sensor configured to detect a leak and at least one wicking component. The at least one wicking component may be configured to facilitate transport of leaking material to the sensor and facilitate generation of a continuous and reliable signal by the at least one sensor. The at least one wicking component may be configured to saturate at a threshold liquid volume. The at least one sensor may be configured to generate a continuous signal at or above the threshold liquid volume.

[0025] The at least one wicking member can be configured to filter out at least some solids from the leaking material. The at least one wicking member can be configured to transfer a specific component of the leaking material to the at least one sensor for selective leak detection. The at least one wicking member can include at least two regions. Each region can be configured to transport the leaking material at a different flow rate.

[0026] Other objects, features and advantages of the present disclosure will become apparent from the following description with reference to the accompanying drawings, in which like reference numerals designate like parts, elements, assemblies, steps and processes. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] Figure 1 is a schematic diagram of an ostomy appliance including a leak detection system according to an embodiment;

[0028] Figure 2 is a schematic top view of an ostomy appliance including a leakage detection device according to an embodiment;

[0029] Figure 3 yes Figure 2 A schematic side view of an ostomy appliance;

[0030] Figure 4 yes Figure 2 Exploded view of an ostomy appliance;

[0031] Figure 5A yes Figure 2 A schematic diagram of a top layer of a leak detection device for an ostomy appliance;

[0032] Figure 5B yes Figure 2 A schematic diagram of a bottom layer of a leakage detection device for an ostomy appliance;

[0033] Figure 5C yes Figure 2 A schematic diagram of a reinforcement layer of a leakage detection device for an ostomy appliance;

[0034] Figure 6 yes Figure 2 A schematic cross-sectional view of a leakage detection device for an ostomy appliance;

[0035] Figure 7 is a schematic diagram of an ostomy appliance including a leak detection system according to an embodiment;

[0036] Figure 8 is an exploded view illustrating an example of an ostomy attachment according to an embodiment;

[0037] Figure 9 is a diagram schematically showing a side view of an ostomy attachment according to an embodiment;

[0038] Figure 10 is a plan view showing a sensor layer of an ostomy attachment according to an embodiment;

[0039] Figure 11 is a side cross-sectional view illustrating an example of a known ostomy bag system;

[0040] Figure 12 is a side cross-sectional view illustrating an example of an ostomy accessory positioned for application to an ostomy bag system according to an embodiment;

[0041] Figure 13 is a diagram schematically showing another side view of an ostomy attachment according to an embodiment; and

[0042] Figure 14 is another exploded view of an ostomy accessory according to an embodiment. DETAILED DESCRIPTION

[0043] While the present disclosure is susceptible to various forms of embodiment, one or more embodiments are shown in the drawings and will be described below, but it should be understood that the disclosure is to be considered illustrative only and is not intended to limit the disclosure to the various embodiments described or illustrated.

[0044] According to embodiments herein, an ostomy leak detection sensor may be embodied as or include, for example, a leak detection system, a leak detection device, a resistance sensor, and / or a sensor layer. According to embodiments herein, an ostomy device may include an ostomy leak detection sensor. An ostomy device may be embodied as or include, for example, an ostomy appliance or an ostomy accessory.

[0045] According to one embodiment, the ostomy appliance may include a skin barrier material and may be configured as a faceplate assembly for a two-piece ostomy bag system, an ostomy barrier for a one-piece ostomy bag system, an ostomy skin barrier ring, or the like.

[0046] According to one embodiment, the ostomy attachment may be configured to be attached to an ostomy appliance, such as a barrier of an ostomy appliance.

[0047] According to one embodiment, the ostomy bag system may comprise an ostomy appliance and an ostomy bag.An ostomy accessory may be attached to the ostomy bag system, for example, to a barrier of the ostomy bag system.

[0048] According to one embodiment, the ostomy components may include, for example, ostomy accessories, ostomy appliances, and ostomy bags.

[0049] According to one embodiment, the ostomy leak detection sensor may generally include a conductive circuit supported by a support layer. The conductive circuit may include, for example, electrodes, conductive traces, etc. The support layer may be a layer of material, such as a polymer film layer, an adhesive layer, or other material layer suitable for ostomy applications. The conductive circuit may be applied to the support layer, embedded in the support layer, or some combination thereof. In one embodiment, the conductive circuit may be a printed circuit formed using conductive ink.

[0050] The leak detection sensor can be configured to detect stoma effluent by detecting resistance and / or a change in resistance in the conductive circuit. For example, during a leakage event, when stoma effluent is introduced between the spaced-apart portions of the conductive circuit, the resistance between the spaced-apart portions may decrease. Thus, a lower resistance and / or a decrease in resistance detected by the leak detection sensor can indicate a stoma effluent leakage event.

[0051] In one embodiment, the ostomy leak detection sensor may further include or be operably connected to a controller. The controller may be configured to receive information, such as signals, from the conductive circuit, process the received information, determine whether a leakage event has occurred, and / or provide a notification. The controller may also communicate with other devices, such as portable electronic devices, servers, wearable devices, etc., using known wired and / or wireless communications.

[0052] The information received from the conductive circuit may be information indicating a measured resistance or a measured change in resistance. In various embodiments, the controller may store threshold values for resistance or changes in resistance and may compare the received information to one or more stored threshold values to determine whether a leakage event has occurred. The controller may also store positional information of the conductive circuit and may determine, for example, the location and / or extent of a leakage event based on the positional information, the received information, and the stored information.

[0053] The controller can generate a notification to be provided to the user based on whether a leakage event has occurred. The notification can include an indication of whether a leakage event has occurred, the location of the leakage event, and / or the extent of the leakage event. The controller can include or be operably connected to an output module or device configured to provide the notification to the user. The output module or device can be, for example, a visual display, an audio speaker, a vibration motor, etc., to provide visual, audio, and / or tactile notifications.

[0054] In one embodiment, the controller can be removably connected to the ostomy leak detection sensor. For example, in one embodiment, the controller can be part of a wearable device or a control unit that can be connected to and disconnected from the leak detection sensor. In one embodiment, the controller can be wirelessly connected to the leak detection sensor. The controller can be electrically connected to the conductive circuit. The controller can include or be operably connected to a power source configured to apply current to the conductive circuit. In one embodiment, the power source can be included in the wearable device or included in the leak detection sensor on the ostomy device.

[0055] In one embodiment, the controller may be a single controller or may include multiple controllers. The controller may be located at different devices, such as an ostomy device, a wearable device, a portable electronic device, etc., and may perform some or all of the operations described herein at one or more devices.

[0056] According to an embodiment, the ostomy device may generally include a proximal, body-facing side and a distal, pouch-facing side, wherein the body-facing side is configured to face the user and the pouch-facing side is configured to face away from the user, e.g., toward the ostomy pouch.

[0057] Figure 1 is a schematic diagram of an ostomy appliance 10 including an ostomy leak detection sensor 11 according to an embodiment. In one embodiment, the ostomy leak detection sensor 11 can be a leak detection system 11. The ostomy appliance 10 can include a skin barrier material 12 and can be configured as a panel assembly for a two-piece ostomy bag system, an ostomy barrier for a one-piece ostomy bag system, an ostomy skin barrier ring, etc. Figure 1 In an embodiment of the present invention, the ostomy appliance 10 can be attached to an ostomy bag 14.

[0058] The leakage detection system 11 may include a conductive circuit, such as one or more pairs of electrodes 16, 18, 20, 22, configured to measure resistance between the electrode pairs to detect stoma effluent leakage. The electrodes 16, 18, 20, 22 may be disposed on a supporting layer at the body-facing surface, the distal surface, or embedded in the ostomy appliance 10. Figure 1 In some embodiments, the support layer can be the skin barrier material 12, and the electrodes 16, 18, 20, 22 can be embedded in the skin barrier material 12. In some embodiments, the ostomy appliance 10 can include at least one wicking component configured to direct stoma effluent toward the electrodes 16, 18, 20, 22 to facilitate leak detection.

[0059] Electrodes 16, 18, 20, 22 can be electrically connected to a controller (not shown) via a printed circuit or wiring or electrically connected to a wireless transmitter that transmits information to the controller. In one embodiment, the controller can be a microcontroller. The controller can include a processor, a memory, and a communication module that are operably connected to each other. The processor can be a microprocessor or other processing device configured to execute program instructions. The processor can be configured to control the operation of the controller based on the program instructions. The memory can be a computer-readable medium, such as a non-transitory computer-readable medium. The program instructions can be stored in the memory. The communication module can be configured for wired and / or wireless communication. The communication module can be configured to send information to other electronic devices, sensors, etc. and receive information from other electronic devices, sensors, etc.

[0060] In one embodiment, the controller may further include, or be operably connected to, for example, an input module, an output module and / or a power supply, wherein the input module is configured to receive input from a user or a sensor, the output module is configured to output information to the user, and the power supply is used to provide current to the conductive circuit.

[0061] In one embodiment, the controller can be configured to, for example, apply current to the electrodes, receive signals from the electrodes, process the signals, transmit the signals or processed signals to another electronic device, receive information from another electronic device or a user interface, and / or provide a notification or alert to a user based on the processed signals. In one embodiment, the controller can be implemented as a component of the ostomy appliance 10, for example, as part of the leak detection system 11.

[0062] In one embodiment, the controller can be located in a single device, such as the ostomy appliance 10, and all operations of the controller can be performed at the device. In another embodiment, the controller can be distributed across multiple devices, such as the ostomy appliance 10 and a portable electronic device. Components of the controller, such as those described above, can be located in one or more of the multiple devices, and operations of the controller, such as those described above, can be performed at one or more of the multiple devices.

[0063] In one embodiment, the leak detection system 11 can be configured to determine a baseline resistance measurement R1 immediately after the ostomy appliance 10 is attached to the user. Alternatively, the baseline resistance measurement R1 can be determined during product development and pre-programmed in the leak detection system 11. The leak detection system 11 can be configured to detect leakage from a change in resistance across the ostomy appliance 10. In one embodiment, the leak detection system 11 can be configured to detect leakage when ostomy exudate is absorbed by the skin barrier material 12 and / or one or more wicking components in the ostomy appliance 10, which can increase the conductivity across the ostomy appliance, thereby reducing the resistance R2. For example, the leak detection system 11 can be configured to detect leakage when ostomy exudate (which may contain aqueous salts) bridges one or more pairs of electrodes 16, 18, 20, 22.

[0064] Reference Figure 2-4 , shows an ostomy appliance 100 with an ostomy leak detection sensor according to an embodiment. In one embodiment, the ostomy leak detection sensor may be a leak detection device 114. Figure 4 , the ostomy appliance 100 may generally include a skin barrier 112, a leak detection device 114, a plurality of cores 116, and a backing layer 118. In one embodiment, the ostomy appliance 100 may be configured as an ostomy skin barrier ring including an opening 102 for receiving a user's stoma. The ostomy appliance 100 may be configured to have a relatively thin profile ( Figure 3 ) to provide sufficient flexibility for use with ostomy bags.

[0065] A skin barrier 112 can be disposed on the body side of the ostomy appliance 100 for attaching the ostomy appliance 100 to the user's skin. The skin barrier 112 can be formed from a suitable medical grade adhesive, such as a hydrocolloid adhesive. A backing layer 118 can be disposed on the distal side of the ostomy appliance 100. The backing layer 118 can be formed from a soft, flexible material that is generally soft and non-irritating to the user's skin, such as an adhesive, a nonwoven, or a foam material. In one embodiment, the backing layer 118 can be formed from a stretchable hydrocolloid. For example, the backing layer 118 can be formed from the same hydrocolloid adhesive used to form the skin barrier 112. In such an embodiment, a release liner 120, 122 can be provided to cover the skin barrier 112 and the backing layer 118.

[0066] The leakage detection device 114 may include a flexible printed circuit board (PCB) including a conductive circuit having a plurality of resistance sensors. In one embodiment, the leakage detection device 114 may include a top layer 130 ( Figure 5A )、bottom floor 132( Figure 5B ) and reinforcement layer 134 ( Figure 5C ). The top layer 130 can be arranged on a side of the skin barrier 112 facing the leakage detection device 114, while the bottom layer 132 can be arranged on a side facing the backing layer 118. The reinforcement layer 134 can be arranged between the top layer 132 and the bottom layer 132. A plurality of resistive sensors 140, 142, 144, 146, 148, 150, 152, 154 can be provided on a PCB having a generally annular body, wherein the generally annular body includes notches 170, 172, 174, 176 that can divide the PCB into four quadrants 160, 162, 164, 166.

[0067] The plurality of resistance sensors may be configured and arranged for continuous and accurate signal generation and for leak location detection. In one embodiment, the leak detection apparatus may include eight pairs of resistance sensors 140, 142, 144, 146, 148, 150, 152, 154, which may be arranged as follows: Figure 5AThe eight pairs of resistive sensors 140, 142, 144, 146, 148, 150, 152, 154 can be formed from eight pairs of arc-shaped conductive traces, which can be arranged in two rows within four quadrants 160, 162, 164, 166. In such an embodiment, the first row of sensors 142, 146, 150, 154 can be positioned closer to the inner perimeter of the leak detection device 114 and the second row of sensors 140, 144, 148, 152. In some embodiments, the leak detection device 114 can include two or more different types of sensors. For example, the leak detection device 114 can include at least one set of resistive sensors and at least one self-heating thermistor.

[0068] The resistance sensor pairs 140, 142, 144, 146, 148, 150, 152, 154 can be configured and arranged for leak location detection. For example, the leak detection device 114 can be configured to determine the location of the leak by correlating a signal indicating a change in resistance with the location of the sensor generating the signal. The leak detection device 114 can also be configured to track the progression of the leak by tracking the location of the sensor generating the signal indicating the change in resistance. For example, a signal indicating a change in resistance can be generated first by sensor pair 142 and then by sensor pair 146, which can indicate a leak progressing from the first quadrant 160 to the second quadrant 162. As another example, a signal indicating a change in resistance can be generated first by sensor pair 142 and then by sensor pair 140, which can indicate a leak progressing toward the periphery of the leak detection device 114.

[0069] In some embodiments, the leak detection device 114 can be configured with a threshold resistance value for user notification. The leak detection device 114 can also be configured to monitor the resistance value measured by the resistance sensor and use the data in an algorithm to predict potential leaks or generate various information about leaks. For example, the leak detection device 114 can be configured to analyze the resistance data to predict the wear time of the ostomy appliance 100 before leakage reaches a critical threshold.

[0070] In other embodiments, the leak detection device 114 may include fewer than eight pairs of resistive sensors or more than eight pairs of resistive sensors that may be configured and arranged to detect a leak and notify a user of the leak. In some embodiments, the leak detection device 114 may include a single type of sensor or more than two types of sensors.

[0071] Figure 6is a schematic cross-sectional view of a leak detection device 114 according to an embodiment. In this embodiment, the top layer 130 may include conductive traces 180 printed on a support layer 182 to form resistive sensor pairs 140, 142, 144, 146, 148, 150, 152, 154. In one embodiment, as Figure 6 As shown, the support layer may be a first substrate 182. The reinforcement layer 134 may include a flexible polymer film 186 disposed between the copper layers 184, 188. The bottom layer 132 may include a second substrate 190 and a circuit 192 printed on the second substrate 190.

[0072] Each of the first and second substrates 182, 190 can be formed from a suitable flexible polymeric material, such as a polyimide film. The first and second substrates 182, 190 can be formed from the same flexible polymeric material or different flexible polymeric materials. The thickness of each of the first and second substrates 182, 190 can be from about 0.5 mil to about 3 mils, preferably from about 1 mil to about 2 mils, and more preferably about 1.5 mils. In one embodiment, each of the first and second substrates 182, 190 can be formed from a cover film having a thickness of about 1.2 mils and comprising a polyimide film coated on one side with an acrylic adhesive, such as available from DuPont. RF7013.

[0073] The reinforcement layer 134 may include a first copper layer 184, a flexible laminate 186, and a second copper layer 188. The thickness of the flexible laminate 186 may be approximately 0.25 mil to approximately 3 mils, preferably approximately 0.5 mil to 2 mils, and more preferably approximately 1 mil. The thickness of each of the copper layers 184, 188 may be approximately 0.5 mil to approximately 3 mils, preferably approximately 1 mil to 2 mils, and more preferably approximately 1.3 mils. The flexible laminate 186 may be formed from a suitable flexible circuit board material having a thickness of approximately 1 mil and comprising a polyimide substrate laminated between layers of copper foil, such as those available from Panasonic Corporation. RF775.

[0074] In one embodiment, the ostomy appliance 100 may include a plurality of wicks 116 configured to facilitate transport of stoma effluent toward the resistance sensors 140, 142, 144, 146, 148, 150, 152, 154. The plurality of wicks 116 may be configured to transport components of the stoma effluent, such as moisture, liquid, and some solids dissolved or dispersed in the liquid, which may bridge one or more pairs of resistance sensors 140, 142, 144, 146, 148, 150, 152, 154, thereby causing a change in resistance. Figure 4In an embodiment, the plurality of cores 116 may include eight arcuate cores arranged on eight pairs of similarly shaped resistance sensors 140, 142, 144, 146, 148, 150, 152, 154, wherein each of the eight cores may be configured to cover a corresponding resistance sensor. The skin barrier 112 may be provided with eight arcuate cutouts 113 configured to contain the plurality of cores 116. Such a configuration may allow stoma effluent to directly contact the plurality of cores 116 to facilitate leakage detection.

[0075] In one embodiment, the multiple wicks 116 can be configured to facilitate the generation of a continuous and reliable signal from the leak detection sensor. For example, the multiple wicks 116 can be configured to filter larger solid components in the stoma effluent and transport water and liquid components to the sensor, which can reduce signal noise. In another example, the multiple wicks 116 can be configured to have a predetermined liquid saturation threshold, above which the sensor generates a consistent signal. The threshold saturation volume of the wicks 116 can be adjusted by varying the wick material or modifying the geometry of the wicks 116. In one embodiment, the multiple wicks 116 can be configured to saturate at a predetermined threshold leakage volume, above which the user may become concerned. In such an embodiment, the leak detection system 114 can be configured to alert the user at or above the threshold, thereby reducing false or premature alarms, such as small leaks or resistance changes caused by sweat that may not pose a risk to the user. In one embodiment, the multiple wicks 116 can be configured for selective detection. For example, the plurality of cores 116 may be configured to transmit certain components of stoma effluent that are not contained in other materials, such as sweat, such that selective detection of stoma effluent leakage may be enabled.

[0076] The plurality of cores 116 may be formed from a suitable core material, such as a cellulosic material, a paper-like material, etc. In one embodiment, the plurality of cores 116 may be formed from an open-cell foam.

[0077] In other embodiments, the ostomy appliance 100 may include fewer than eight cores or more than eight cores. In one embodiment, the ostomy appliance 100 may include a single core configured and arranged to facilitate the transmission of stoma effluent toward one or more sensors. In some embodiments, the single core may be configured to have a varying flow rate in one or more portions thereof. For example, the single core may be compressed, thinned, or otherwise altered in one or more portions to provide a dead zone or reduced flow rate zone so that the function of the single core is similar to that of multiple cores. In one embodiment, portions of the core may be impregnated with a substance that prevents flow, such as wax, to create a dead zone. In some embodiments, the ostomy appliance 100 may include one or more cores configured and arranged to completely surround the opening 102 to ensure that the stoma effluent contacts the one or more cores when leakage propagates outward from the stoma.

[0078] The ostomy appliance 100 may further include an electrically attached controller (not shown) configured to receive a signal from the resistance sensor, analyze the received signal, and provide a user with an alert or notification of a possible leak via an audio, vibration, optical, or tactile alert based on the received signal. The received signal may indicate the detected resistance or a change in resistance.

[0079] In some embodiments, the ostomy appliance 100 can be equipped with a wearable device that includes a controller. The wearable device can also include a power source, such as a battery, and a wireless transceiver operably connected to the controller. The wearable device can be removably connected to the ostomy appliance 100, for example, by a friction fit, an interference fit, a clamp, a mechanical interlock, or other suitable fastening mechanism. In one embodiment, the wearable device can be removably connected to a portion of the leak detection device 114.

[0080] In one embodiment, the electrical attachment controller can be the same as the controller described above. In one embodiment, the electrical attachment controller can include some or all of the components of the controller described above and perform some or all of the operations of the controller described above. For example, the electrical attachment controller can include a processor, a computer-readable storage medium configured to store program instructions to be executed by the processor, and a communication module configured to send and / or receive information. In one embodiment, the processor, the computer-readable storage medium, and the communication module can be operably connected to each other via a bus.

[0081] In one embodiment, the communication module may include a wired communication interface and / or a wireless communication interface configured to facilitate the transmission and / or reception of information according to a known, suitable communication protocol. In one embodiment, the communication interface may include a wireless transceiver. The wireless transceiver may be configured to communicate wirelessly according to known wireless communication standards and protocols, and may communicate over known communication networks such as personal area networks, wireless local area networks, metropolitan area networks, and wide area networks. Thus, the wireless transceiver may be configured for various wireless communications, including but not limited to Bluetooth, Bluetooth low energy, near field communication, WiFi, WiMax, cellular LTE, or other cellular radio communications. In one embodiment, the wireless transceiver may be a Bluetooth-enabled microchip.

[0082] In one embodiment, the user interface may include or be operatively connected to, for example, one or more of a display device, an audio device, a tactile device, and / or a user input device. In one embodiment, the user interface may be part of an input module for receiving information from a user or a sensor or an output module for outputting information to a user.

[0083] The controller may also include a power source, such as a battery, configured to apply electrical current to the leak detection system 11. In another embodiment, the controller may be operably connected to the power source and may control the operation of the power source.

[0084] In one embodiment, the wearable device may include one or more output devices operably connected to the controller, such as a visual indicator and / or an audio indicator. Alternatively, or in addition, other output devices are also contemplated, such as a vibration indicator. The visual indicator may include, for example, a light emitting diode (LED) or a display such as a liquid crystal display (LCD).

[0085] In one embodiment, the ostomy appliance 100 can be communicatively coupled to a personal notification device. The personal notification device can be communicatively coupled to the wearable device via a wireless transceiver through a wireless communication interface. In one embodiment, the personal notification device can be a mobile communication device, such as a smartphone or other mobile phone. Alternatively or additionally, the personal notification device can be another mobile communication device, a portable electronic device, or other electronic device configured to communicate directly or indirectly with the wearable device. Such devices can include, but are not limited to, tablets, laptops, desktop computers, smart speakers, connected wearable accessories such as fitness trackers, smart watches, etc., smart televisions, personal digital assistants, etc. In one embodiment, the personal notification device can include a controller. In one embodiment, the controller can include components on the ostomy appliance at the wearable device and at the personal notification device. In one embodiment, separate controllers of the type described herein can be located at the ostomy appliance, such as at the wearable device and the personal notification device, and can be configured to communicate with each other.

[0086] In one embodiment, the wearable device may be paired, synchronized, or communicatively connected to the personal notification device through a known pairing or synchronization operation, which may be initiated, for example, by operation of a switch.

[0087] Figure 7 is a schematic diagram of an ostomy appliance 210 including an ostomy leak detection sensor 211 according to an embodiment. In one embodiment, the ostomy leak detection sensor 211 can be a leak detection system 211. The ostomy appliance 210 can include a skin barrier 212 and can be configured as a faceplate assembly for a two-piece ostomy bag system, an ostomy barrier for a one-piece ostomy bag system, an ostomy skin barrier ring, etc. Figure 7 In an embodiment, the ostomy appliance 210 can be attached to an ostomy bag 214. The leakage detection system 211 can include a conductive circuit, such as one or more pairs of electrodes 216, 218, 220, 222, wherein each pair of electrodes is configured to measure conductivity or resistance across a portion of the user's skin. The electrodes 216, 218, 220, 222 can be arranged on a support layer on the body-facing surface of the ostomy appliance 210, spaced apart from each other in pairs and in contact with the user's skin. In an embodiment, the support layer can be a skin barrier 212. The leakage detection system 211 can be configured to detect and notify of a stoma effluent leakage event using the conductance or resistance of the user's skin measured by the electrode pairs.

[0088] exist Figure 7In an embodiment, the leakage detection system 211 may include at least two pairs of electrodes, including a first pair 216, 218 and a second pair 220, 222. In an embodiment, multiple pairs of electrodes may be arranged at different locations on the body-side surface of the ostomy appliance 210 to detect stoma effluent leakage. For example, multiple electrode pairs may be arranged around the stoma.

[0089] In one embodiment, each of the electrode pairs 216, 218, 220, 222 can be configured to measure the resistance of a portion of the user's skin adjacent to the corresponding electrode pair, e.g., Figure 7 The resistance R1 measured by the first electrode pair 216, 218 and the resistance R2 measured by the second electrode pair 220, 222 in the ostomy device 210. The leakage detection system 211 may be configured to identify a leakage event based on a change in resistance measured by a pair of electrodes, which may be caused by stoma discharge at the interface between the user's skin and the ostomy appliance 210. Figure 7 In some embodiments, the leak detection system 211 can be configured to identify a leak event based on a change in resistance measured by the second electrode pair 220, 222 triggered by the presence of stoma effluent 224. In some embodiments, the leak detection system 211 can be configured to identify the location of the leak by determining the location of the electrode pair that measured the leak event that triggered the change in resistance.

[0090] The resistance or conductivity of a user's skin may be affected by various factors, such as humidity, temperature, sweat gland activity, sympathetic nervous system activity, inflammatory response, hydration, etc. In one embodiment, the leakage detection system 211 can be configured to identify skin inflammatory events based on changes in resistance measured by the electrode pairs at corresponding portions of the user's skin, which resistance changes are caused by an inflammatory response of the user's skin exposed to stoma effluent. In some embodiments, the leakage detection system 211 can be configured to adjust and personalize the identification of leakage and / or inflammatory events by analyzing the user's skin resistance measurement data. For example, the leakage detection system 211 can be configured to collect and analyze the user's historical data and use machine learning to filter out noise or adjust and personalize the user's response. The electrodes 216, 218, 220, 222 can be electrically connected to a controller (not shown) via printed circuits or wiring or a wireless transmitter. The controller can be configured to send power to the electrodes, receive signals from the electrodes, process the signals, and send the processed signals to notify the user. In one embodiment, the controller can be the same as any controller described in other embodiments herein. In one embodiment, the controller can include one or more components of the controller described herein and can perform one or more functions of the controller described herein.

[0091] In one embodiment, the ostomy appliance 210 can be configured as an ostomy skin barrier ring comprising an opening (not shown) for receiving a user's stoma. A skin barrier 212 can be provided on the body side of the ostomy appliance 210 for attaching the ostomy appliance 210 to the user's skin. The skin barrier 212 can be formed by a suitable medical grade adhesive, such as a hydrocolloid adhesive. The ostomy appliance 210 can also include a backing layer provided on the distal side of the ostomy appliance 210, which can be formed by a soft, flexible material that is generally soft and non-irritating to the user's skin, such as an adhesive, a polymer film, a non-woven fabric, a foam, etc. The electrode pairs 216, 218, 220, 222 can be formed by a plurality of resistive sensors that are configured and arranged for continuous and accurate signal generation and for location detection of leaks.

[0092] In one embodiment, the leak detection system 211 may include at least two pairs of electrodes arranged in at least two rows, wherein the electrodes arranged in the first row are closer to the center of the ostomy appliance 210 than the electrode pairs arranged in the second row. The at least two pairs of electrodes may be arranged in at least two different quadrants of the skin barrier 212. In one embodiment, the leak detection system 211 may be configured to determine the location of the leak by correlating a signal indicating a change in resistance with the location of the electrode pair that generated the signal. The leak detection system 211 may also be configured to track the progression of the leak by tracking the location of the electrode pair that generated the signal indicating a change in resistance.

[0093] In some embodiments, the leak detection system 211 can be configured with a threshold resistance value for user notification. The leak detection system 211 can also be configured to monitor the resistance data measured by the electrode pairs and use the data in an algorithm to predict potential leaks or generate various information about leaks. For example, the leak detection system 211 can be configured to analyze the resistance data to predict the wear time of the ostomy appliance 210 before leakage reaches a critical threshold.

[0094] In one embodiment, the ostomy appliance 210 may include an electrical attachment controller (not shown) configured to analyze the signals generated by the electrode pair and alert the user of potential leakage via an audio, vibration, optical, or tactile alarm. In some embodiments, the ostomy appliance 210 may be equipped with a wearable device (not shown) including a controller, a power source (e.g., a battery), and a wireless transceiver. The wearable device may be removably connected to the ostomy appliance 210, for example, by a friction fit, an interference fit, a clamp, a mechanical interlock, or other suitable fastening mechanism.

[0095] The controller may be any controller described herein. In one embodiment, the controller may be a microcontroller. In one embodiment, the controller may include a processor, a memory, and a communication module operably connected to each other. The processor may be a microprocessor or other processing device configured to execute program instructions. The processor may be configured to control the operation of the controller based on the program instructions. The memory may be a computer-readable medium, such as a non-transitory computer-readable medium. The program instructions may be stored in the memory. The communication module may be configured for wired and / or wireless communication. The communication module may be configured to send information to other electronic devices, sensors, etc. and receive information from other electronic devices, sensors, etc.

[0096] In one embodiment, the controller, such as the communication module, may include a wireless transceiver. In one embodiment, the wireless transceiver may be configured to communicate with the controller. The wireless transceiver may be configured to communicate wirelessly according to known wireless communication standards and protocols, and may communicate over known communication networks such as personal area networks, wireless local area networks, metropolitan area networks, and wide area networks. Thus, the wireless transceiver may be configured for various wireless communications, including but not limited to Bluetooth, Bluetooth Low Energy, near field communication, WiFi, WiMax, cellular LTE, or other cellular radio communications. In one embodiment, the wireless transceiver may be a Bluetooth-enabled microchip.

[0097] In one embodiment, the wearable device may include one or more output devices or modules operably connected to the controller, such as a visual indicator and / or an audio indicator. Alternatively, or in addition, other output devices are also contemplated, such as a vibration indicator. The visual indicator may include, for example, a light emitting diode (LED) or a display such as a liquid crystal display (LCD).

[0098] In one embodiment, the ostomy appliance 210 can be communicatively coupled to a personal notification device. The personal notification device can be communicatively coupled to the wearable device via a wireless transceiver through a wireless communication interface. In one embodiment, the personal notification device can be a mobile communication device, such as a smartphone or other mobile phone. Alternatively or additionally, the personal notification device can be another mobile communication device, a portable electronic device, or other electronic device configured to communicate directly or indirectly with the wearable device. Such devices can include, but are not limited to, tablets, laptops, desktop computers, smart speakers, connected wearable accessories such as fitness trackers, smart watches, etc., smart televisions, personal digital assistants, etc.

[0099] In one embodiment, the wearable device may be paired, synchronized, or communicatively connected to the personal notification device through a known pairing or synchronization operation, which may be initiated, for example, by operation of a switch.

[0100] Figure 8 is an exploded view illustrating an example of an ostomy attachment 310 according to an embodiment. Figure 9 is a diagram schematically showing a side view of an ostomy attachment 310 according to an embodiment. Figure 8 and Figure 9 The ostomy attachment 310 may include, for example, an ostomy leak detection sensor and may be configured to be attached to an ostomy bag system. The ostomy attachment 310 may have a proximal or body-facing side 312 and a distal or barrier-facing side 314 ( Figure 9 In one embodiment, the ostomy attachment 310 can include a first adhesive layer 316, a sensor layer 318, and a barrier side layer 320. A stoma passage 322 can extend through the ostomy attachment 310 and can be configured to receive a portion of a stoma and / or stoma effluent discharged from the stoma. The stoma passage 322 can be formed by corresponding openings extending through the various layers of the ostomy attachment 310.

[0101] Each layer 316, 318, 320 of the ostomy attachment 310 has a proximal side and a distal side. In use, with the ostomy attachment 310 attached to a patient, the respective proximal side generally faces the patient and the respective distal side generally faces away from the patient.

[0102] The first adhesive layer 316 can be disposed on the body-facing side 312 of the ostomy attachment 310. In one embodiment, the proximal side of the first adhesive layer 316 can form the proximal side of at least a portion of the body-facing side 312 of the ostomy attachment 310. The proximal side of the first adhesive layer 316 can be configured to adhere to the patient's peristomal skin surface and seal to prevent leakage of ostomy fluid around the stoma. In one embodiment, the first adhesive layer 316 can be formed from a medical-grade pressure-sensitive adhesive that can adhesively secure the ostomy attachment 310 to the patient's peristomal skin surface. In one embodiment, the first adhesive layer 316 can include a hydrocolloid.

[0103] Figure 10 is a plan view showing a sensor layer 318 according to an embodiment. In one embodiment, the sensor layer 318 may be an ostomy leak detection sensor. Figure 8-10, the sensor layer 318 can include a conductive circuit 324, such as a plurality of electrodes, conductive traces, and the like. The conductive circuit 324 can be disposed on a support layer, such as a substrate 326. In one embodiment, the sensor layer 318 can include a connector portion 328 and a sensor portion 330. The conductive circuit 324 can be arranged at the sensor portion 330 in a predetermined pattern. For example, the conductive circuit 324 can be generally arranged in a circular or semicircular pattern. Other suitable patterns are also contemplated, such as an oval or rectangular pattern, or other closed or substantially closed ring patterns. The conductive circuit 324 at the sensor portion 330 can be arranged at one or more radial distances from the stoma channel 322. For example, the conductive circuit 324 can be arranged at a plurality of different radial distances from the stoma channel 322.

[0104] In one embodiment, the connector portion 328 can be generally formed as an elongated portion extending from the sensor portion 330. For example, the conductive circuit 324 can extend along the elongated portion. In one embodiment, the connector portion 328 can be flexible along at least a portion of its length so that the connector portion 328 can be folded or wrapped. In one embodiment, the connector portion 328 can extend beyond the periphery of the adhesive layer 318 and / or the barrier side layer 320 in a direction radially outward from the stoma channel 322.

[0105] The ostomy attachment 310 may also include an electrical connector 332. The electrical connector 332 may be electrically connected to the conductive circuit 324. The electrical connector may be disposed on the connector portion 328. The electrical connector 332 may include an externally accessible portion configured to electrically connect to an external device, such as a control unit 334 ( Figure 9 ). The control unit 334 can be, for example, a wearable device of the type described above and can include a controller according to any of the embodiments described above. In this manner, the electrical connector 332 can provide an electrical connection between the control unit 334 and the conductive circuit 324. The externally accessible portion of the electrical connector 332 can be any suitable electrical interface for forming an electrical connection between two electrical components, such as one or more conductive contacts, pins, etc.

[0106] The electrical connector 332 may also include one or more alignment members 333. The one or more alignment members 333 are configured to engage corresponding alignment members (not shown) of the control unit 334 to indicate proper positioning of the electrical connector 332 relative to the control unit 334 to provide an electrical connection. In one embodiment, the one or more alignment members 333 of the electrical connector 332 may be openings, recesses, or slots. The corresponding alignment members (not shown) of the control unit 334 may be one or more protrusions (not shown) configured to be received in the openings, recesses, or slots of the electrical connector 332.

[0107] Control unit 334 ( Figure 9 ) can be selectively and removably electrically connected to the electrical connector 332. For example, the control unit 334 can include a corresponding electrical connector (not shown) for interfacing with the electrical connector 332. The control unit 334 can be removably connected to the electrical connector 332 using known, suitable mechanical fasteners, such as spring-loaded clips, mechanical interlocks, clamps, interference fits, etc., including combinations thereof. Alternatively, the control unit 334 can be integrated with the sensor layer 318.

[0108] The control unit 334, for example, via a controller, can be configured to provide current to the conductive circuit 324 and detect a change in resistance in the conductive circuit 324. For example, stoma effluent from outside the stoma channel 322 leaks into or along the first adhesive layer 316, which may cause, for example, a decrease in resistance between a pair of electrodes of the conductive circuit. The control unit 334 can detect the decrease in resistance and determine that a leak is occurring based on the decreased resistance. In one embodiment, the control unit 334 can be configured to determine the location of the change in resistance via the controller. The control unit 334 can also be configured to provide a notification or alarm indicating that a leak has been detected and / or the location of the leak. The notification or alarm can be, for example, an audible, visible, or tactile alarm, or a combination thereof. The control unit 334 can also be configured to communicate wired and / or wirelessly with other electronic devices, such as smart phones.

[0109] In one embodiment, the barrier-side layer 320 can be a film layer formed from a polymeric film material. In one embodiment, the polymeric film material can be a material having properties that allow stretching and very little elastic recovery, often referred to as "dead stretch" properties. Such a material can also have beneficial moldability. A non-limiting example of such a material is a thermoplastic polyurethane-phenoxy film. Alternatively, the barrier-side layer 320 can be a barrier-side adhesive layer formed from an adhesive material. The barrier-side layer 320 can be configured to be applied to a barrier of an ostomy bag system, as further described below. The distal side of the barrier-side layer 320 can form at least a portion of the barrier-facing side 314 of the ostomy attachment 310.

[0110] The ostomy attachment 310 of this embodiment is not limited to the ones described above and Figure 8 and Figure 9 However, in other embodiments, the ostomy attachment 310 may include a combination of Figure 14The second adhesive layer, sensor layer 318, can be disposed between the first adhesive layer 316 and the second adhesive layer. In one embodiment, the second adhesive layer can be disposed between the sensor layer 318 and the barrier-side layer 320. In one embodiment, the barrier-side adhesive layer and / or the second adhesive layer can be formed of a medical-grade pressure-sensitive adhesive, such as a hydrocolloid.

[0111] Figure 11 is a side cross-sectional view showing an example of an ostomy bag system 400 to which the ostomy attachment 310 may be applied. The ostomy bag system 400 may be any known ostomy bag system having a barrier and an ostomy bag. For purposes of example, reference is made to Figure 11 . However, it should be understood that the ostomy attachment 310 of the present embodiment is not limited to use with the ostomy bag system 400 illustrated herein. In fact, the ostomy attachment 310 of the present embodiment can be used with any known ostomy bag system having a barrier configured to adhere to the peristomal skin surface of a patient.

[0112] Reference here Figure 11 An example of a suitable ostomy bag system 400 that can be used with the ostomy attachment 310 generally includes an ostomy appliance, such as a barrier ring or faceplate assembly 410 having a barrier 412. The barrier 412 generally includes a skin attachment surface 414 that is configured to adhere to the peristomal skin surface. That is, the barrier 412 is made of or includes an adhesive material that is exposed below the skin attachment surface 414 and is configured to adhere to the patient's peristomal skin surface. The ostomy appliance shown as the faceplate assembly 410 in the non-limiting example can optionally include a barrier release liner 416 that is removably disposed on the skin attachment surface 414. The faceplate assembly 410 can also optionally include an adhesive layer 418 on the distal side of the barrier 412 and a faceplate 420 on the distal side (i.e., the side facing the bag) of the faceplate assembly 410.

[0113] The ostomy pouch system 400 may be a one-piece ostomy pouch system or a two-piece ostomy pouch system. Figure 11 A two-piece ostomy pouch system 400 of the type shown in may also include a first coupling ring 422 at a distal side of the panel 420 .

[0114] The ostomy bag system 400 may further include an ostomy bag 430. The ostomy bag 430 may have an interior volume 432 configured to receive and store ostomy effluent. In a two-piece ostomy bag system, the ostomy bag 430 may further include a second coupling ring 434 configured to cooperatively engage with the first coupling ring 422.

[0115] The stoma opening 440 may extend through the body-facing side of the faceplate assembly 410 and the ostomy bag 430. The stoma opening 440 is configured to place the interior volume 432 of the ostomy bag 430 in fluid communication with the stoma such that stoma effluent may be received in the interior volume 432 through the stoma opening 440.

[0116] Figure 12 is a side cross-sectional view showing an example of an ostomy accessory 310 positioned for application to an ostomy bag system 400, according to one embodiment. In one embodiment, the ostomy accessory 310 can be applied to the ostomy bag system 400 first and then to the patient. Figure 12 As shown, the ostomy accessory may be positioned with the body-facing side 312 away from the ostomy bag system 400 and with the barrier-facing side 314 facing the ostomy bag system 400 .

[0117] The barrier release liner 416 of the ostomy bag system 400 can be removed to expose the adhesive material of the barrier 412. The ostomy attachment 310 can be as Figure 12 4. The barrier-facing side 314, e.g., the distal side of the barrier side layer 320, can then be adhered to the barrier 412. The stoma channel 322 of the ostomy attachment 310 and the stoma opening 440 of the ostomy bag system 400 can be generally aligned to form a sealed passage for stoma effluent to flow from the stoma into the ostomy bag 430.

[0118] An ostomy assembly according to embodiments herein may include an ostomy accessory 310 and an ostomy pouch system 400 including a barrier 412 and an ostomy pouch 430 , wherein a barrier-facing side 314 of the ostomy accessory 310 is adhered to an adhesive material of the barrier 412 .

[0119] The ostomy attachment 310 can also be configured to attach the ostomy bag system 400 to the patient. For example, the ostomy attachment 310 can be applied to the barrier 412 of the ostomy bag system 400 in the manner described above. The body-facing side 312 of the ostomy attachment 310, including the proximal side of the adhesive layer 316, can be adhered to the patient's peristomal skin surface to seal around the stoma and attach the ostomy attachment 310 and the ostomy bag system 400 to the patient.

[0120] Figure 13 is a diagram schematically showing another side view of the ostomy attachment 310 according to an embodiment. Figure 8 and 13The ostomy attachment 310 may include a body-facing release liner 336. The body-facing release liner 336 may extend over the body-facing side 312 of the ostomy attachment 310. In one embodiment, the body-facing release liner 336 extends over the proximal side of the adhesive layer 316. The ostomy attachment 310 may also include a barrier-facing release liner 338. The barrier-facing release liner 338 may extend over the barrier-facing side 314 of the ostomy attachment 310. One or both of the release liners 36, 38 may be included in the ostomy attachment 310, for example, for shipping and storage. In use, the end user may remove each release liner 336, 338 to expose the body-facing side 312 and the barrier-facing side 314 of the ostomy attachment 310. In some embodiments, the barrier-facing release liner 338 may be omitted. For example, the barrier-facing release liner 38 may be omitted when the barrier-side layer 320 is a polymer film material. That is, in some embodiments, when the barrier side layer 320 is not an adhesive layer, the barrier side facing release liner 38 can be omitted. Thus, the barrier side layer 320, when formed as a polymer film, can be molded to size and can be directly adhered to the ostomy bag system 400.

[0121] Figure 14 is an exploded view illustrating an example of an ostomy attachment 310 according to an embodiment, wherein the barrier side layer 320 is a second adhesive layer. That is, in one embodiment, the ostomy attachment may include a second adhesive layer positioned to function as the barrier side adhesive layer 320. Figure 14 , the ostomy attachment 310 may include a body-facing release liner 336 , a first adhesive layer 316 , a sensor layer 318 , a barrier-side layer 320 formed as a second adhesive layer, ie, a barrier-side adhesive layer, and a barrier-facing release liner 338 .

[0122] In some embodiments, the ostomy attachment 310 can further include a barrier-side cover 340 for the sensor layer 318 and a body-side cover 342 for the sensor layer 318. In one embodiment, the barrier-side cover 340 can be disposed on the barrier-facing side of the connector portion 328, and the body-side cover 342 can be disposed on the body-facing side of the connector portion 328. The barrier-side cover 340 and / or the body-side cover 342 can, in one embodiment, be formed of a nonwoven material. In one embodiment, the ostomy attachment 310 can further include a nonwoven adhesive paper release liner 344.

[0123] The ostomy accessory 310 may be configured to be applied to the ostomy bag system 400 by an end user, such as a patient, a caregiver, or other medical professional. In one embodiment, the ostomy accessory 310 may include one or more features to facilitate a preferred orientation and / or sequence of steps for applying the ostomy accessory 310 to the ostomy bag system 400. For example, it may be preferred that the barrier-facing side 314 of the ostomy accessory 310 be oriented toward the ostomy bag system 400 and applied to the ostomy bag system 400 prior to application to the patient.

[0124] For example, in one embodiment, the ostomy attachment 310 can include printed indicia or other indicia to identify the body-facing side 312 and / or the barrier-facing side 314. In one embodiment, the body-facing side release liner 336 can include printed indicia, such as "Body Facing Side" or other similar indicia to indicate the side of the ostomy attachment 310 that is configured to be adhered to the patient's peristomal skin. Alternatively or additionally, the distal side of the body-facing side 314 and / or the barrier-facing side release liner 338 can include printed indicia or other indicia, such as "Barrier Facing Side" or other similar indicia to indicate the side of the ostomy attachment 310 that is configured to be applied to the barrier 412. Other printed indicia, such as graphics, colors, etc., can also be suitable. Alternatively or additionally, printed indicia or other indicia can be included on the sensor layer 318, for example, on the substrate 326.

[0125] Alternatively or additionally, the body-facing release liner 336 and the barrier-facing release liner 338 can be asymmetrically formed. For example, the barrier-facing release liner 338 can be larger than the body-facing release liner 336. For example, the barrier-facing release liner 338 can have a greater width or diameter 336 than the body-facing release liner. In one embodiment, the periphery of the body-facing release liner 336 can be completely within the periphery of the barrier-facing release liner 338. Thus, the end user can easily manipulate the barrier-facing release liner 338 for removal before removing the body-facing release liner 336. In this manner, the barrier-facing side 314 of the ostomy accessory 310 can be easily applied to the barrier 412 before applying the body-facing side 312 of the ostomy accessory 310 to the patient's peristomal skin.

[0126] Alternatively or additionally, the ostomy accessory 310 can be packaged to facilitate a preferred orientation and / or sequence of steps for applying the ostomy accessory 310 to the barrier 412. For example, the ostomy accessory 310 can be packaged so that the barrier-facing side 314 is exposed upon opening the package. The package can be, for example, a box or a clamshell, such as a thermoformed clamshell. In one embodiment, the package can be partially comprised of a release liner. While in the package, the barrier-facing side 314 of the ostomy accessory 310 can be lined with the package's release liner. Opening the package removes the package's release liner to expose the barrier-facing side 314 of the ostomy accessory 310.

[0127] In one embodiment, the ostomy accessory 310 can be packaged in a four-sided film bag. Both the body-facing side 312 and the barrier-facing side 314 can be lined with a film. When opening the ostomy accessory 310, the film can be removed from the barrier-facing side 314 first, allowing the ostomy accessory 310 to be applied to the barrier 412. The film can be completely removed to expose the body-facing side 312, allowing the ostomy accessory 310 to be applied to the patient.

[0128] As described above, the control unit 334 can be attached to the ostomy attachment 310. In one embodiment, if the control unit 334 is attached in an incorrect orientation, an electrical connection to the ostomy attachment 310 can be lost. Thus, in one embodiment, the control unit 334 can be configured to check for a circuit connection to the sensor layer 316 of the ostomy attachment 310. If the control unit 334 determines that a circuit connection is not made, the control unit 334 can provide a notification to the user.

[0129] Thus, in the above embodiment, the ostomy accessory 310 can be provided separately from the ostomy pouch system 400, and in particular, separately from the barrier 412 or the faceplate assembly 410 of the ostomy pouch system 400. In this way, the ostomy accessory 310 of this embodiment can be used with a wide range of existing ostomy pouch systems and is not necessarily limited to a specific brand, model, or configuration of ostomy pouch systems. Thus, the end user can selectively use the ostomy accessory 310 with an existing ostomy pouch system. Consequently, the end user has a wide range of flexibility and options when selecting an ostomy pouch system.

[0130] The ostomy accessory 310 of this embodiment is configured to detect leakage of stoma fluid into the seal formed between the adhesive layer 316 and the peristomal skin surface. The ostomy accessory 310 is also configured to provide an alarm or notification upon detection of such leakage. In one embodiment, the location of the leak can also be determined. In this way, the patient can be notified of a stoma fluid leak, and the ostomy accessory 310 and the optional ostomy bag system 400 can be replaced accordingly. Thus, prolonged exposure of the peristomal skin to leaking stoma fluid can be avoided. Furthermore, by detecting and notifying of stoma fluid leakage, the ostomy accessory 310 can be replaced before stoma fluid leaks onto the periphery of the ostomy accessory 310 or the barrier 412.

[0131] Furthermore, the ostomy attachment 310 of this embodiment may include features that facilitate proper orientation and / or a preferred application process of the ostomy attachment 310 to the barrier 412 .

[0132] It should be understood that various features or components described with respect to the above embodiments may be combined with, used with, or substituted for features or components described with respect to any other embodiments.

[0133] All patents mentioned herein, whether or not specifically identified in this disclosure, are hereby incorporated by reference in their entirety.

[0134] In this disclosure, the words "a" or "an" should be understood to include both the singular and the plural. Conversely, any reference to a plural item should include the singular, where appropriate. In addition, the various features described for any of the above embodiments may be used together, may be implemented in other embodiments described above, or may replace features in other embodiments described above.

[0135] It will be apparent from the foregoing that various modifications and variations may be made without departing from the true spirit and scope of the novel concepts of the present invention. It should be understood that no limitation to the specific embodiments described is intended or should be inferred. The present disclosure is intended to be covered by the appended claims, as such modifications are within the scope of the claims.

Claims

1. An ostomy device comprising: an adhesive layer; a barrier side layer; a proximal side configured to be attached to a user, the proximal side comprising a proximal side of the adhesive layer; a distal side, opposite to the proximal side, the distal side comprising a distal side of the barrier-side layer; and A leak detection sensor comprising a conductive circuit supported on a support layer, wherein the leakage detection sensor is configured to detect stoma effluent by detecting a change in resistance in the conductive circuit, and the leakage detection sensor is a sensor layer disposed between the adhesive layer and the barrier side layer, Wherein the ostomy device is an ostomy attachment configured to be attached to a barrier ring or a panel assembly, wherein the barrier ring or panel assembly includes a barrier, and the barrier side layer is configured to adhere to the barrier ring or panel assembly.

2. The ostomy device according to claim 1, wherein The leak detection sensor is configured to detect stoma effluent by detecting a change in electrical resistance in the adhesive layer.

3. The ostomy device according to claim 2, wherein The leak detection sensor includes at least one resistance sensor, wherein the at least one resistance sensor is configured to detect a change in resistance.

4. The ostomy device according to claim 2, wherein The leak detection sensor is configured to determine a location of stoma effluent leakage and includes a plurality of electrical resistance sensors.

5. The ostomy device according to claim 2, wherein The leakage detection sensor includes an annular body formed of a flexible printed circuit board and a plurality of resistance sensors arranged on the annular body.

6. The ostomy device according to claim 5, characterized in that The plurality of resistance sensors are arranged in at least two rows, wherein the resistance sensors arranged in the first row are closer to the center of the leakage detection sensor than the resistance sensors arranged in the second row.

7. The ostomy device according to claim 6, characterized in that The plurality of resistance sensors are arranged in at least two different quadrants of the annular body.

8. The ostomy device according to claim 4, wherein The leak detection sensor is configured to determine a location of the stoma effluent leak by correlating a signal indicative of a change in electrical resistance with a location of the electrical resistance sensor generating the signal.

9. The ostomy device according to claim 4, wherein The leak detection sensor is configured to track progression of stoma effluent leakage by correlating a first signal indicative of a change in resistance with a location of the resistance sensor generating the first signal, and correlating a second signal indicative of a change in resistance with the location of the resistance sensor generating the second signal.

10. The ostomy device of claim 1, wherein Also included is at least one wicking member configured to facilitate transport of the stoma effluent toward the leak detection sensor.

11. The ostomy device according to claim 10, wherein The at least one wicking component is configured to reduce signal noise by filtering out at least some solid components in the stoma effluent.

12. The ostomy device according to claim 11, wherein The at least one wicking component is configured to saturate at a threshold liquid volume, wherein the at least one resistance sensor is configured to generate a continuous signal at or above the threshold liquid volume, wherein the leak detection sensor is configured to generate an alarm upon receiving the continuous signal.

13. An ostomy device according to any one of claims 10 to 12, characterised in that The adhesive layer includes at least one cutout configured to accommodate the at least one wicking component.

14. An ostomy device according to any one of claims 10 to 12, characterised in that The leak detection sensor may include a plurality of resistive sensors formed from eight pairs of conductive traces arranged in two rows and in four quadrants of an annular body, wherein the ostomy device includes eight wicking members, each wicking member configured and arranged to cover an adjacent pair of conductive traces, wherein the adhesive layer includes eight cutouts configured to contain the eight wicking members.

15. The ostomy device of claim 1, wherein The adhesive layer is formed of a hydrocolloid adhesive.

16. The ostomy device of claim 1, wherein The barrier ring or panel assembly is part of an ostomy bag system.

17. The ostomy device according to claim 16, wherein Also included is a stoma channel extending through the adhesive layer, the sensor layer, and the barrier-side layer.

18. The ostomy device of claim 16, wherein A second adhesive layer is also included, and the second adhesive layer is disposed between the sensor layer and the barrier side layer.

19. The ostomy device of claim 16, wherein The barrier side layer is a film layer formed of a polymer film material.

20. The ostomy device of claim 16, wherein The barrier-side layer is a barrier-side adhesive layer formed of an adhesive material.

21. The ostomy device of claim 16, wherein Also included is a proximal release liner removably disposed over the proximal side.

22. The ostomy device according to claim 21, wherein Also included is a distal release liner removably disposed over the distal side.

23. The ostomy device of claim 22, wherein The distal release liner has a greater width than the proximal release liner.

24. The ostomy device of claim 17, wherein The sensor layer includes a sensor portion and a connector portion.

25. The ostomy device of claim 24, wherein The conductive circuits are arranged in a pattern extending at least partially around the stoma channel at the sensor portion.

26. The ostomy device of claim 25, wherein The conductive circuits are arranged in a circular pattern.

27. The ostomy device of claim 24, wherein The connector portion is an elongated portion extending from the sensor portion.

28. The ostomy device of claim 24, wherein The connector portion is flexible.

29. The ostomy device of claim 24, wherein The connector portion extends beyond the periphery of the adhesive layer and / or the barrier side layer in a direction radially outwards from the stoma channel.

30. The ostomy device of claim 16, wherein The sensor layer also includes an electrical connector.

31. The ostomy device of claim 16, wherein The conductive circuit includes a plurality of electrodes and / or conductive traces.

32. The ostomy device of claim 17, wherein The electrically conductive circuit is arranged at a plurality of different radial distances from the stoma channel.

33. An ostomy assembly comprising: The ostomy device of claim 1; and An ostomy bag system, comprising an ostomy appliance and an ostomy bag, Wherein, the ostomy appliance comprises a barrier ring or panel assembly and the distal side of the barrier side layer is adhered to the proximal side of the ostomy appliance.

34. The ostomy assembly of claim 33, wherein The barrier ring or panel assembly includes a barrier having an adhesive material, and the ostomy bag is connected to the barrier ring or the panel assembly.

35. The ostomy assembly according to any one of claims 33-34, characterized in that The distal side of the barrier side layer is adhered to the proximal side of the adhesive material of the barrier ring or the panel assembly.

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