Patent Description:
An ostomy pouch system typically includes a pouch formed from opposing sidewalls defining an internal 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 of a one-piece pouch system, which is attached to one of the pouch sidewalls proximate an inlet opening, a faceplate for a two-piece pouch system configured to releasably engage a pouch, and a barrier ring. The ostomy appliance may include a skin barrier material for adhering to and sealing against user's peristomal skin surrounding the stoma.

The ostomy appliance may be susceptible to ostomy effluent leakage, and the seal formed between the skin barrier material and the user may weaken. Often times, the user may be unaware of or cannot easily assess an extent of weakening in the seal. Thus, the user may not become aware of a weakened seal, and consequently, the ostomy effluent may leak through to an exterior of the ostomy appliance.

<CIT> discloses a dressing for application to an object that is, at least partly, electrically conductive. The dressing includes an adhesive for attaching the dressing to the object, and at least two electrodes. The electrodes are adapted to be arranged at a distance from the partly electrically conductive object so that a first capacitor is formed between a first electrode and the partly electrically conductive object, and a second capacitor is formed between a second electrode and the partly electrically conductive object.

Accordingly, it is desirable to provide a leakage detection system for ostomy devices.

In an embodiment, an ostomy device includes a proximal side configured for attachment to a user, a distal side opposite to the proximal side, and a leakage detection sensor having electrically conductive circuitry supported on a support layer. The leakage detection sensor is configured to detect ostomy effluent by detecting a change in resistance in the electrically conductive circuitry.

The support layer may be a skin barrier and the proximal side is a proximal side of the skin barrier. The leakage detection sensor may be configured to detect ostomy effluent by detecting a change in a resistance in the skin barrier. The leakage detection sensor may include includes at least one resistance sensor, wherein the at least one resistance sensor may be configured to detect a change in resistance.

The leakage detection sensor may be configured to determine a location of an ostomy effluent leak and may include a plurality of resistance sensors. The leakage detection sensor may include a ring-shaped body formed from a flexible printed circuit board and a plurality of resistance sensors arranged on the ring-shaped body.

The plurality of resistance sensors may be arranged in at least two rows. The resistance sensors arranged in a first row are closer to a center of the leakage detection sensor than the resistance sensors arranged in a second row. The plurality of resistance sensors may be arranged in at least two different quadrants of the ring-shaped body.

The leakage detection sensor may be configured to determine a location of an ostomy effluent leak by associating a signal indicating a change in resistance to a location of the resistance sensor generating the signal. The leakage detection sensor may be configured to track a progress of an ostomy effluent leak by associating a first signal indicating a change in resistance to a location of the resistance sensor generating the first signal and associating a second signal indicating a change in resistance to a location of the resistance sensor generating the second signal.

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

The ostomy device may further include at least one wicking component configured to facilitate transport of the ostomy effluent toward the leakage detection sensor. The at least one wicking component may be configured to reduce a signal noise by filtering out at least some solid components in the ostomy effluent. The at least one wicking component may be configured to saturate at a threshold liquid volume, wherein the at least one resistance sensor may be configured to generate a consistent signal at or above the threshold liquid volume. The leakage detection sensor may be configured to generate an alarm when the consistent signal is received. The skin barrier may include at least one cut-out configured to contain the at least one wicking component.

The leakage detection sensor may include a plurality of resistance sensors formed of eight pairs of conductive traces arranged in two rows and in four quadrants of the ring-shaped body. The ostomy device may include eight wicking components, each of the wicking components configured and arranged to cover an adjacent conductive trace pair. The skin barrier may include eight cut-outs configured to contain the eight wicking components. The ostomy device may further include a backing layer. The leakage detection sensor may be arranged between the skin barrier and the backing layer.

In an embodiment, the leakage detection sensor may be a leak detection system configured to identify an ostomy effluent leakage event by detecting a change in resistance of a user's skin. The leak detection system may include at least one pair of electrodes arranged on a body-side surface of the skin barrier. Each of the at least one pair of electrodes is configured to measure resistance of a portion of user's skin adjacent the electrode pair. The body-side surface may be at the proximal side. The at least one pair of electrodes may be formed from a plurality of resistance sensors.

The leak detection system may be configured to identify an ostomy effluent leakage event by detecting a change in resistance of a user's skin resulting from a presence of ostomy effluent at an intersection between the skin barrier and the user's skin. The leak detection system may be configured to identify a skin inflammation event by detecting a change in resistance of a user's skin. The leak detection system may be configured to determine a location of an ostomy effluent leakage by associating a signal indicating a change in resistance to a location of the electrode pair generating the signal.

The leak detection system may be configured to track a progress of an ostomy effluent leakage by associating a first signal indicating a change in resistance to a location of an electrode pair generating the first signal and associating a second signal indicating a change in resistance to a location of an electrode pair generating the second signal. The leak detection system may include at least two pairs of electrodes arranged in at least two rows. The electrode pair arranged in a first row is closer to a center of the leak detection device than the electrode pair arranged in a second row. The at least two pairs of electrodes may be arranged in at least two different quadrants of the skin barrier.

In an embodiment, the skin barrier may be formed from a hydrocolloid adhesive. In an embodiment, the ostomy device may be an ostomy appliance. In an embodiment, the ostomy appliance may be a skin barrier ring. In an embodiment, the distal side may be configured to be attached to an ostomy pouch.

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 leakage detection sensor is a sensor layer disposed between the adhesive layer and the barrier-side layer. The barrier-side layer may be configured to be adhered to an ostomy appliance, and the distal side may include a distal side of the barrier-side layer. In an embodiment, the ostomy appliance may be a barrier of an ostomy pouch system.

In an embodiment, the ostomy device may further include a stoma passage extending through the adhesive layer, the sensor layer and the barrier-side layer. In an embodiment, the ostomy device may include a second adhesive layer disposed between the sensor layer and the barrier-side layer. In an embodiment, the barrier-side layer may be a film layer formed from a polymeric film material.

In an embodiment, the barrier-side layer may be a barrier-side adhesive layer formed from an adhesive material. The ostomy device may include a proximal side release liner removably disposed over the proximal side. The ostomy device may include a distal side release liner removably disposed over the distal side. In an embodiment, the distal side release liner may have a greater width than the proximal side release liner.

The sensor layer may include a sensor section and a connector section. The electrically conductive circuitry may be arranged in a pattern extending at least partially about the stoma passage at the sensor section. For example, the electrically conductive circuitry may be arranged in a circular pattern. The connector section may be an elongated section extending from the sensor section. The connector section may be flexible. In an embodiment, the connector section may extend beyond an outer periphery of the adhesive layer and/or the barrier-side layer in a direction radially outward from the stoma passage.

In an embodiment, the sensor layer further include an electrical connector. The electrically conductive circuitry may include a plurality of electrodes and/or conductive traces. The electrically conductive circuitry may be arranged at a plurality of different, radial distances from the stoma passage. The ostomy device may be an ostomy accessory configured for attachment to an ostomy appliance.

According to another aspect, an ostomy assembly may include an ostomy device, wherein the ostomy device is an ostomy accessory, and an ostomy pouch system having an ostomy appliance and an ostomy pouch. The distal side of the ostomy accessory may be adhered to a proximal side of the ostomy accessory.

The ostomy appliance may include a barrier having an adhesive material, and the ostomy pouch may be coupled to the barrier. The distal side of the ostomy accessory may be adhered to the proximal side of the adhesive material of the barrier.

In the following description <NUM> mil is the equivalent of <NUM>.

According to embodiments herein, an ostomy leakage detection sensor may be embodied as or include, for example, a leakage detection system, a leakage detection device, a resistance sensor and/or a sensor layer. According to embodiments herein, an ostomy device may include the ostomy leakage detection sensor. The ostomy device may be embodied as, or include, for example, an ostomy appliance or an ostomy accessory.

According to an embodiment, an ostomy appliance may comprise a skin barrier material and may be configured as a faceplate assembly for a two-piece ostomy pouch system, an ostomy barrier for a one-piece ostomy pouch system, an ostomy skin barrier ring, and the like.

According to an embodiment, an ostomy accessory may be configured for attachment to an ostomy appliance, such as a barrier of the ostomy appliance.

According to an embodiment, an ostomy pouch system may include an ostomy appliance and an ostomy pouch. The ostomy accessory may be attached to the ostomy pouch system, for example, to a barrier of the ostomy pouch system.

According to an embodiment, an ostomy assembly may include, for example, an ostomy accessory, an ostomy appliance and an ostomy pouch.

According to an embodiment, the ostomy leakage detection sensor may generally include electrically conductive circuitry supported by a support layer. The electrically conductive circuitry may include, for example, electrodes, conductive traces and the like. The support layer may be a layer of material, such as a polymeric film layer, an adhesive layer, or other layer of material suitable for use in ostomy applications. The electrically conductive circuitry may be applied on the support layer, embedded in the support layer, or some combination thereof. In an embodiment, the electrically conductive circuitry may be a printed circuit formed using an electrically conductive ink.

The leakage detection sensor may be configured to detect ostomy effluent by detecting an electrical resistance and/or a change in electrical resistance in the electrically conductive circuitry. For example, in the event of ostomy effluent being introduced between spaced apart portions of the electrically conductive circuitry, for instance, during a leakage event, the electrical resistance between the spaced apart portions may decrease. Thus, the lower electrical resistance and/or decrease in electrical resistance detected by the leakage detection sensor may be indication of an ostomy effluent leakage event.

In an embodiment, the ostomy leakage detection sensor may further include, or be operably connected to, a controller. The controller may be configured to receive information, for example in the form of a signal, from the electrically conductive circuitry, 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, and the like, using known wired and/or wireless communications.

The information received from the electrically conductive circuitry may be information indicative of a measured electrical resistance or measured change in electrical resistance. In different embodiments, the controller may store threshold values of electrical resistance or changes in electrical resistance and may compare the received information to one or more of the stored threshold values to determine whether a leakage event has occurred. The controller may also store position information of the electrically conductive circuitry and may determine, for example, a location and/or an extent of a leakage event based on, for example, the position information, the received information and the stored information.

The controller may generate a notification to be provided to a user based on the determination of whether a leakage event has occurred. The notification may include indications of whether a leakage event has occurred, the position of the leakage event, and/or the extent of the leakage event. The controller may include or be operably connected to an output module or device configured to provide the notification to a user. The output module or device may be, for example, a visual display, an audio speaker, a vibrating motor, and the like, to provide visual, audio and/or haptic notifications.

In an embodiment, the controller may be removably connected to the ostomy leakage detection sensor. For example, in an embodiment, the controller may be part of a wearable device or control unit that may be connected to and disconnected from the leakage detection sensor. In an embodiment, the controller may be wirelessly connected to the leakage detection sensor. The controller may be electrically connected to the electrically conductive circuitry. The controller may include, or be operably connected to, a power source configured to apply an electrical current to the electrically conductive circuitry. In an embodiment, a power supply may be included with the wearable device or included with the leakage detection sensor on the ostomy device.

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

According to embodiments, the ostomy device may generally include a proximal, body-facing side configured to face toward the user, and a distal, pouch-facing side configured to face away from the user, for example, toward an ostomy pouch.

<FIG> is a schematic illustration of an ostomy appliance <NUM> comprising an ostomy leakage detection sensor <NUM> according to an embodiment. In an embodiment, the ostomy leakage detection sensor <NUM> may be a leakage detection system <NUM>. The ostomy appliance <NUM> may comprise a skin barrier material <NUM> and may be configured as a faceplate assembly for a two-piece ostomy pouch system, an ostomy barrier for a one-piece ostomy pouch system, an ostomy skin barrier ring, and the like. In the embodiment of <FIG>, the ostomy appliance <NUM> may be attached to an ostomy pouch <NUM>.

The leakage detection system <NUM> may comprise electrically conductive circuitry, for example, one or more pairs of electrodes <NUM>, <NUM>, <NUM>, <NUM>, configured to measure electrical resistance between the pairs of electrodes to detect ostomy effluent leakage. The electrodes <NUM>, <NUM>, <NUM>, <NUM> may be arranged on a support layer at body-side surface, a distal surface, or embedded in the ostomy appliance <NUM>. In the embodiment of <FIG>, the support layer may be the skin barrier material <NUM>, and the electrodes <NUM>, <NUM>, <NUM>, <NUM> may be embedded in the skin barrier material <NUM>. In some embodiments, the ostomy appliance <NUM> may include at least one wicking component configured to direct ostomy effluent toward the electrodes <NUM>, <NUM>, <NUM>, <NUM> to facilitate leak detection.

The electrodes <NUM>, <NUM>, <NUM>, <NUM> may be electrically connected via a printed circuit or wiring to a controller (not shown) or a wireless transmitter configured to transmit information to a controller. In an embodiment, the controller may be a microcontroller. The controller may include a processor, a memory and a communication module operably connected to one another. The processor may be a microprocessor or other processing device configured to execute program instructions. The processor may be configured to control operations 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 communications. The communication module may be configured to transmit information to, and receive information from, other electronic devices, sensors, and the like.

In an embodiment, the controller may further include, or be operably connected to, for example, and input module configured to receive input from a user or sensor, an output module configured to output information to a user, and/or a power supply to provide electrical current to the electrically conductive circuitry.

In an embodiment, the controller may 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 an embodiment, the controller may be implemented as a component of the ostomy appliance <NUM>, for example, as part leakage detection system <NUM>.

In an embodiment, the controller may be located at a single device, such as the ostomy appliance <NUM> and all operations of the controller may be carried out at the device. In another embodiment, the controller may be distributed across multiple devices, such as the ostomy appliance <NUM> and a portable electronic device. Components of the controller, such as those described above, may be located at one or more of the multiple devices, and operations of the controller, such as those described above, may be performed at one or more of the multiple devices.

In an embodiment, the leakage detection system <NUM> may be configured to determine a baseline resistance measurement R1 immediately after the ostomy appliance <NUM> is attached to a user. Alternatively, the baseline resistance measurement R1 may be determined during product development and preprogrammed in the leakage detection system <NUM>. The leakage detection system <NUM> may be configured to detect a leak from a change in resistance across the ostomy appliance <NUM>. In an embodiment, the leakage detection system <NUM> may be configured to detect a leak when ostomy effluent is absorbed by the skin barrier material <NUM> and/or by one or more wicking components in the ostomy appliance <NUM>, which may increase the conductivity across the ostomy appliance, thereby reducing resistance R2. For example, the leakage detection system <NUM> may be configured to detect a leak when ostomy effluent, which may contain aqueous salts, bridges one or more pairs the electrodes <NUM>, <NUM>, <NUM>, <NUM>.

Referring to <FIG>, an ostomy appliance <NUM> having an ostomy leakage detection sensor according to an embodiment is illustrated. In an embodiment, the ostomy leakage detection sensor may be a leakage detection device <NUM>. As best shown in <FIG>, the ostomy appliance <NUM> may generally comprise a skin barrier <NUM>, the leakage detection device <NUM>, a plurality of wicks <NUM>, and a backing layer <NUM>. In an embodiment, the ostomy appliance <NUM> may be configured as an ostomy skin barrier ring including an opening <NUM> for receiving user's stoma. The ostomy appliance <NUM> may be configured to have a relatively thin profile (<FIG>) to provide flexibility sufficient for use with an ostomy pouch.

The skin barrier <NUM> may be provided on a body side of the ostomy appliance <NUM> for attaching the ostomy appliance <NUM> to user's skin. The skin barrier <NUM> may be formed from a suitable medical grade adhesive, such as a hydrocolloid adhesive. The backing layer <NUM> may be provided on a distal side of the ostomy appliance <NUM>. The backing layer <NUM> may be formed from a soft, flexible material that is generally soft and non-irritable to the user's skin, such as an adhesive, nonwoven or foam material. In an embodiment, the backing layer <NUM> may be formed from a malleable hydrocolloid. For example, the backing layer <NUM> may be formed from the same hydrocolloid adhesive used to form the skin barrier <NUM>. In such an embodiment, release liners <NUM>, <NUM> may be provided to cover the skin barrier <NUM> and the backing layer <NUM>.

The leakage detection device <NUM> may comprise a flexible printed circuit board (PCB) including an electrically conductive circuit having a plurality of resistance sensors. In an embodiment, the leakage detection device <NUM> may comprise a top layer <NUM> (<FIG>), a bottom layer <NUM> (<FIG>), and a stiffener layer <NUM> (<FIG>). The top layer <NUM> may be arranged on the skin barrier <NUM> facing side of the leakage detection device <NUM>, while the bottom layer <NUM> may be arranged on the backing layer <NUM> facing side. The stiffener layer <NUM> may be arranged between the top layer <NUM> and the bottom layer <NUM>. The plurality of resistance sensors <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> may be provided on a PCB having a generally ring-shaped body including notches <NUM>, <NUM>, <NUM>, <NUM>, which may divide the PCB into four quadrants <NUM>, <NUM>, <NUM>, <NUM>.

The plurality of resistance sensors may be configured and arranged for consistent and accurate signal generation and for location detection of a leak. In an embodiment, the leakage detection device may comprise eight pairs of resistance sensors <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, which may be arranged on the top layer <NUM> as shown in <FIG>. The eight pairs of resistance sensors <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> may be formed of eight pairs of arc-shaped conductive traces, which may be arranged in four quadrants <NUM>, <NUM>, <NUM>, <NUM> in two rows. In such an embodiment, the first row sensors <NUM>, <NUM>, <NUM>, <NUM> may be arranged closer to an inner periphery of the leakage detection device <NUM> the second row sensors <NUM>, <NUM>, <NUM>, <NUM>. In some embodiments, the leakage detection device <NUM> may comprise two or more different types of sensors. For example, the leakage detection device <NUM> may comprise at least one set of resistance sensors and at least one self-heating thermistor.

The pairs of resistance sensors <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> may be configured and arranged for a location detection of a leak. For example, the leakage detection device <NUM> may be configured to determine a location of a leak by associating signals indicating a change in resistance to the location of the sensors that generated the signals. The leakage detection device <NUM> may also be configured to track a progress of a leak by tracking the locations of the sensors generating signals indicating a change in resistance. For example, a signal indicating a change in resistance may be first generated by the pair of sensors <NUM>, and subsequently also generated by the pair of sensors <NUM>, which may indicate a leak progressing from the first quadrant <NUM> to the second quadrant <NUM>. In another example, a signal indicating a change in resistance may be first generated by the pair of sensors <NUM>, and subsequently also generated by the pairs of sensors <NUM>, which may indicate a leak progressing toward an outer periphery of the leakage detection device <NUM>.

In some embodiments, the leakage detection device <NUM> may be configured with a threshold resistance value for a user notification. The leak detection device <NUM> may also be configured to monitor resistance values measured by the resistance sensors and use the data in algorithms to predict a potential leak or generate various information about a leak. For example, the leakage detection device <NUM> may be configured to analyze resistance date to predict a wear time of the ostomy appliance <NUM> before a leak reaches a critical threshold.

In other embodiments, the leakage detection device <NUM> may comprise less than eight pairs of resistance sensors or more than eight pairs of resistance sensors, which may be configured and arranged to detect and inform a leak to a user. In some embodiments, the leakage detection device <NUM> may include a single type of sensor or more than two types of sensors.

<FIG> is a schematic cross-sectional view of the leakage detection device <NUM> according to an embodiment. In this embodiment, the top layer <NUM> may comprise conductive traces <NUM> printed on a support layer <NUM> to form the pairs of resistance sensors <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>. In an embodiment, and as shown in <FIG>, the support layer may be a first substrate <NUM>. The stiffener layer <NUM> may comprise a flexible polymeric film <NUM> arranged between copper layers <NUM>, <NUM>. The bottom layer <NUM> may comprise a second substrate <NUM> and circuits <NUM> printed thereon.

Each of the first and second substrates <NUM>, <NUM> may be formed from a suitable flexible polymeric material, such as a polyimide film. The first and second substrates <NUM>, <NUM> may be formed from a same flexible polymeric material or different flexible polymeric materials. Each of the first and second substrates <NUM>, <NUM> may have a thickness of about <NUM> mil to about <NUM> mil, preferably, about <NUM> mil to about <NUM> mil, and more preferably about <NUM> mil. In an embodiment, each of the first and second substrates <NUM>, <NUM> may be formed from a coverlay film having a thickness of about <NUM> mil and comprising a polyimide film coated with an acrylic adhesive on one side, such as PYRALUX® <CIT> available from Dupont.

The stiffener layer <NUM> may comprise a first copper layer <NUM>, a flexible laminate <NUM>, and a second copper layer <NUM>. The flexible laminate <NUM> may have a thickness of about <NUM> mil to about <NUM> mil, preferably about <NUM> mil to <NUM> mil, and more preferably about <NUM> mil. Each of the copper layers <NUM>, <NUM> may have a thickness of about <NUM> mil to about <NUM> mil, preferably about <NUM> mil to <NUM> mil, and more preferably about <NUM> mil. The flexible laminate <NUM> may be formed from a suitable flexible circuit board material having a thickness of about <NUM> mil and comprising a polyimide substrate laminated between copper foil layers, such as FELIOS® RF775 available from Panasonic.

In an embodiment, the ostomy appliance <NUM> may comprise a plurality of wicks <NUM> configured to facilitate transport of ostomy effluent toward the resistance sensors <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>. The plurality of wicks <NUM> may be configured to transport components of ostomy effluent, for example, moisture, liquid, and some solid dissolved or dispersed in liquid, which may bridge one or more pairs of the resistance sensors <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> to cause a change in resistance. In the embodiment of <FIG>, the plurality of wicks <NUM> may comprise eight arc-shaped wicks arranged over the eight pairs of similarly shaped resistance sensors <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, wherein each of the eight wicks may be configured to cover a corresponding resistance sensor. The skin barrier <NUM> may be provided with eight arc-shaped cut-outs <NUM> configured to contain the plurality of wicks <NUM>. Such a configuration may allow ostomy effluent to contact the plurality of wicks <NUM> directly to facilitate leak detection.

In an embodiment, the plurality of wicks <NUM> may be configured to facilitate consistent and reliable signal generation by leak detection sensors. For example, the plurality of wicks <NUM> may be configured to filter larger solid components in ostomy effluent and transport moisture and liquid components to the sensors, which may reduce signal noise. In another example, the plurality of wicks <NUM> may be configured to have a predetermined liquid saturation threshold, above which the sensors may generate the same signal. The threshold saturation volume of the wicks <NUM> may be adjusted by changing a wick material or changing the geometry of the wicks <NUM>. In an embodiment, the plurality of wicks <NUM> may be configured to saturate at a predetermined threshold leak volume, above which may be a concern to a user. In such an embodiment, the leakage detection system <NUM> may be configured to alert the user at or above the threshold point, such that false or premature alarms, such as small leaks that may not pose a risk to the user or a change in resistance triggered by sweat, may be reduced. In an embodiment, the plurality of wicks <NUM> may be configured for a selective detection. For example, the plurality of wicks <NUM> may be configured to transport certain components of ostomy effluent that are not contained in other materials, such as sweat, such that selective detection of ostomy effluent leak may be enabled.

The plurality of wicks <NUM> may be formed from a suitable wicking material, such cellulose materials, paper-like materials and the like. In an embodiment, the plurality of wicks <NUM> may be formed from an open-cell foam.

In other embodiments, the ostomy appliance <NUM> may include less than eight wicks or more than eight wicks. In an embodiment, the ostomy appliance <NUM> may include a single wick configured and arranged to facilitate transport of ostomy effluent toward one or more sensors. In some embodiments, the single wick may be configured to have varying flow rates in one or more portions thereof. For example, the single wick may be compressed, thinned or otherwise altered in one or more portions to provide dead zones or reduce flow rate zones, such that the single wick may function similar to a plurality of wicks. In an embodiment, portions of the wick may be impregnated with a substance to block flow, such as wax, to create dead zones. In some embodiments, the ostomy appliance <NUM> may include one or more wicks configured and arranged to completely encircle the opening <NUM> to ensure that ostomy effluent contacts the one or more wicks as a leak propagates outwardly from the stoma.

The ostomy appliance <NUM> may also include an electrically-attached controller (not shown) configured to receive signals from the resistance sensors, analyze the received signals, and provide an alert or notification to a user of a potential leak via audio, vibrational, optical or tactile alerts, based on the received signals. The received signals may be indicative of a detected resistance or change in resistance.

In some embodiments, the ostomy appliance <NUM> may be provided with a wearable device including the controller. The wearable device may also include a power supply, such as a battery, and a wireless transceiver operably connected to the controller. The wearable device may be removably connected to the ostomy appliance <NUM>, for example, by way of friction fit, interference fit, clamping, mechanical interlock, or other suitable fastening mechanism. In an embodiment, the wearable device may be removably connected to a portion of the leakage detection device <NUM>.

In an embodiment, the electrically-attached controller may be same as the controller described above. In an embodiment, the electrically-attached controller may 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 electrically-attached controller may 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 transmit and/or receive information. In an embodiment, the processor, computer-readable storage medium and communication module may be operably connected to one another by a bus.

In an embodiment, the communication module may include a wired communication interface and/or a wireless communication interface configured to facilitate transmission and/receipt of information according to known, suitable communication protocols. In an embodiment, the communication interface may include the wireless transceiver. The wireless transceiver may be configured for wireless communications 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. Accordingly, 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.

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

The controller may further include a power supply such as a battery, configured for applying electrical current to the leakage detection system <NUM>. In another embodiment, the controller may be operably connected to a power supply and may control operations of power supply.

In one embodiment, the wearable device may include one or more output devices operably connected to the controller, such as a visual indicator, an audio indicator, or both. Alternatively, or in addition, other output devices may be envisioned as well, such as a vibrating indicator. The visual indicator may include, for example, a light emitting diode (LED) or a display, such as a liquid crystal display (LCD).

In one embodiment, the ostomy appliance <NUM> may be communicatively coupled to a personal notification device. The personal notification device may be communicatively coupled to the wearable device over a wireless communication interface via the wireless transceiver. In one embodiment, the personal notification device may be a mobile communication device, such as a smartphone or other mobile phone. Alternatively, or in addition, the personal notification device may be another mobile communication device, a portable electronic device, or other electronic device configured for communication, directly or indirectly, with the wearable device. Such devices may include, but are not limited to, tablets, laptop computers, desktop computers, smart speakers, connected wearable accessories such as fitness trackers, smart watches and the like, smart televisions, personal digital assistants and the like. In an embodiment, the personal notification device may include the controller. In an embodiment, the controller may include components at the ostomy appliance, for example, at the wearable device, and the personal notification device. In an embodiment, separate controllers of the type described herein may be located at the ostomy appliance, for example, at the wearable device, and the personal notification device and may be configured to communicate with one another.

In one embodiment, the wearable device may be paired, synced, or otherwise communicatively connected to the personal notification device with a known pairing or syncing operation, which may be initiated, for example, by operation of a switch.

<FIG> is a schematic illustration of an ostomy appliance <NUM> comprising an ostomy leakage detection sensor <NUM> according to an embodiment. In an embodiment, the ostomy leakage detection sensor <NUM> may be a leakage detection system <NUM>. The ostomy appliance <NUM> may comprise a skin barrier <NUM> and may be configured as a faceplate assembly for a two-piece ostomy pouch system, an ostomy barrier for a one-piece ostomy pouch system, an ostomy skin barrier ring, and the like. In the embodiment of <FIG>, the ostomy appliance <NUM> may be attached to an ostomy pouch <NUM>. The leak detection system <NUM> may comprise electrically conductive circuitry, for example, one or more pairs of electrodes <NUM>, <NUM>, <NUM>, <NUM>, wherein each pair of electrodes is configured to measure electrical conductance or resistance across a portion of user's skin. The electrodes <NUM>, <NUM>, <NUM>, <NUM> may be arranged on a support layer on a body-side surface of the ostomy appliance <NUM> at a distance apart from each other in pairs and in contact with user's skin. In an embodiment, the support layer may be the skin barrier <NUM>. The leak detection system <NUM> may be configured to detect and notify an ostomy effluent leakage event using the electrical conductance or resistance of user's skin measured by the electrode pairs.

In the embodiment of <FIG>, the leak detection system <NUM> may include at least two pairs of electrodes comprising a first pair <NUM>, <NUM> and a second pair <NUM>, <NUM>. In an embodiment, multiple pairs of electrodes may be arranged at various locations on the body-side surface of the ostomy appliance <NUM> to detect ostomy effluent leakage. For example, the multiple electrode pairs may be arranged to surround the stoma.

In an embodiment, each of the electrode pairs <NUM>, <NUM>, <NUM>, <NUM> may be configured to measure a resistance across a portion of user's skin adjacent the corresponding electrode pair, for example, resistance R1 measured by a first electrode pair <NUM>, <NUM> and resistance R2 measured by a second electrode pair <NUM>, <NUM> in <FIG>. The leak detection system <NUM> may be configured to identify a leakage event from a change in resistance measured by a pair of electrodes, which may be triggered by the presence of ostomy effluent at an interface between user's skin and the ostomy appliance <NUM>. In the embodiment of <FIG>, the leak detection system <NUM> may be configured to identify a leakage event from a change in resistance measured by the second electrode pair <NUM>, <NUM> triggered by the presence of ostomy effluent <NUM>. In some embodiments, the leak detection system <NUM> may be configured to identify a location of leakage by determining the location of the electrode pair that measured the leakage event triggering resistance change.

The resistance or conductivity of user's skin may be affected by various factors, such as humidity, temperature, sweat gland activity, sympathetic nervous system activity, inflammation response, hydration, etc. In an embodiment, the leak detection system <NUM> may be configured to identify a skin inflammation event from a change in resistance measured by an electrode pair at a corresponding portion of user's skin resulting from an inflammatory response of user's skin being exposed to ostomy effluent. In some embodiments, the leak detection system <NUM> may be configured to adjust and individualize identification of leak and/or inflammation events by analyzing a user's skin resistance measurement data. For example, the leak detection system <NUM> may be configured to collect and analyze user's historical data and utilize machine learning to filter out noise or adjust and individualize a response for a user. The electrodes <NUM>, <NUM>, <NUM>, <NUM> may be electrically connected to a controller (not shown) via a printed circuit or wiring or a wireless transmitter. The controller may be configured to send power to the electrodes, receive signals from the electrodes, process the signals, and transmit the processed signals to notify a user. In an embodiment, the controller may be the same as any of the controllers described in other embodiments herein. In an embodiment, the controller may include one or more of components of the controllers described herein and may perform one or more of the functions of the controllers described herein.

In an embodiment, the ostomy appliance <NUM> may be configured as an ostomy skin barrier ring including an opening (not shown) for receiving user's stoma. The skin barrier <NUM> may be provided on a body side of the ostomy appliance <NUM> for attaching the ostomy appliance <NUM> to user's skin. The skin barrier <NUM> may be formed from a suitable medical grade adhesive, such as a hydrocolloid adhesive. The ostomy appliance <NUM> may also include a backing layer provided on a distal side of the ostomy appliance <NUM>, which may be formed from a soft, flexible material that is generally soft and non-irritable to the user's skin, such as an adhesive, a polymeric film, a nonwoven, a foam, and the like. The electrode pairs <NUM>, <NUM>, <NUM>, <NUM> may be formed from plurality of resistance sensors that are configured and arranged for consistent and accurate signal generation and for location detection of a leak.

In an embodiment, the leak detection system <NUM> may include at least two pairs of electrodes arranged in at least two rows, wherein the electrode pair arranged in a first row are closer to a center of the ostomy appliance <NUM> than the electrode pair arranged in a second row. The at least two pairs of electrodes may be arranged in at least two different quadrants of the skin barrier <NUM>. In an embodiment, the leak detection system <NUM> may be configured to determine a location of a leakage by associating signals indicating a change in resistance to the location of the electrode pair that generated the signals. The leak detection system <NUM> may also be configured to track a progress of a leak by tracking the locations of the electrode pairs generating signals indicating a change in resistance.

In some embodiments, the leak detection system <NUM> may be configured with a threshold resistance value for a user notification. The leak detection system <NUM> may also be configured to monitor resistance data measured by the electrode pairs and use the data in algorithms to predict a potential leak or generate various information about a leak. For example, the leak detection system <NUM> may be configured to analyze resistance date to predict a wear time of the ostomy appliance <NUM> before a leak reaches a critical threshold.

In an embodiment, the ostomy appliance <NUM> may include an electrically-attached controller (not shown) configured to analyze signals generated by the electrode pairs and alert a user of a potential leak via audio, vibrational, optical or tactile alerts. In some embodiments, the ostomy appliance <NUM> may be provided with a wearable device (not shown) including a controller, a power supply, such as a battery, and a wireless transceiver. The wearable device may be removably connected to the ostomy appliance <NUM>, for example, by way of friction fit, interference fit, clamping, mechanical interlock, or other suitable fastening mechanism.

The controller may be any of the controllers described herein. In an embodiment, the controller may be a microcontroller. In an embodiment, the controller may include a processor, a memory and a communication module operably connected to one another. The processor may be a microprocessor or other processing device configured to execute program instructions. The processor may be configured to control operations 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 communications. The communication module may be configured to transmit information to, and receive information from, other electronic devices, sensors, and the like.

In an embodiment, the controller, for example, the communication module, may include a wireless transceiver. In an embodiment, a wireless transceiver may be configured to communicate with the controller. The wireless transceiver may be configured for wireless communications 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. Accordingly, 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 an embodiment, the wireless transceiver may be a Bluetooth enabled microchip.

In an embodiment, the wearable device may include one or more output devices or modules operably connected to the controller, such as a visual indicator, an audio indicator, or both. Alternatively, or in addition, other output devices may be envisioned as well, such as a vibrating indicator. The visual indicator may include, for example, a light emitting diode (LED) or a display, such as a liquid crystal display (LCD).

In an embodiment, the ostomy appliance <NUM> may be communicatively coupled to a personal notification device. The personal notification device may be communicatively coupled to the wearable device over a wireless communication interface via the wireless transceiver. In an embodiment, the personal notification device may be a mobile communication device, such as a smartphone or other mobile phone. Alternatively, or in addition, the personal notification device may be another mobile communication device, a portable electronic device, or other electronic device configured for communication, directly or indirectly, with the wearable device. Such devices may include, but are not limited to, tablets, laptop computers, desktop computers, smart speakers, connected wearable accessories such as fitness trackers, smart watches and the like, smart televisions, personal digital assistants and the like.

In an embodiment, the wearable device may be paired, synced, or otherwise communicatively connected to the personal notification device with a known pairing or syncing operation, which may be initiated, for example, by operation of a switch.

<FIG> is an exploded view illustrating an example of an ostomy accessory <NUM> according to an embodiment. <FIG> is a diagram schematically illustrating a side view of the ostomy accessory <NUM> according to an embodiment. Referring to <FIG> and <FIG>, the ostomy accessory <NUM> may include, for example, an ostomy leakage detection sensor and may be configured to be attached to an ostomy pouch system. The ostomy accessory <NUM> may have a proximal or body-facing side <NUM> and a distal or barrier-facing side <NUM> (<FIG>). In an embodiment, the ostomy accessory <NUM> may include a first adhesive layer <NUM>, a sensor layer <NUM> and a barrier-side layer <NUM>. A stoma passage <NUM> may extend through the ostomy accessory <NUM> and may be configured to receive a portion of a stoma and/or stomal effluent discharged from the stoma. The stoma passage <NUM> may be formed by respective openings extending through individual layers of the ostomy accessory <NUM>.

Each layer <NUM>, <NUM>, <NUM> of the ostomy accessory <NUM> has a proximal side and a distal side. In use, with the ostomy accessory <NUM> attached to a patient, the respective proximal sides generally face toward the patient and the respective distal sides generally face away from the patient.

The first adhesive layer <NUM> may be disposed at the body-facing side <NUM> of the ostomy accessory <NUM>. In an embodiment, the proximal side of the first adhesive layer <NUM> may form at least a portion of the body-facing side <NUM> of the ostomy accessory <NUM>. The proximal side of the first adhesive layer <NUM> may be configured to adhere to peristomal skin surfaces of the patient and seal against stomal fluid leakage around the stoma. In an embodiment, the first adhesive layer <NUM> may be formed from a medical-grade pressure sensitive adhesive that can adhesively secure the ostomy accessory <NUM> to a patient's peristomal skin surfaces. In an embodiment, the first adhesive layer <NUM> may include a hydrocolloid.

<FIG> is a plan view illustrating the sensor layer <NUM> according to an embodiment. In an embodiment, the sensor layer <NUM> may be the ostomy leakage detection sensor. Referring to <FIG>, the sensor layer <NUM> may include electrically conductive circuitry <NUM>, such as a plurality of electrodes, conductive traces or the like. The electrically conductive circuitry <NUM> may be disposed on a support layer, such as substrate <NUM>. In an embodiment, the sensor layer <NUM> may include a connector section <NUM> and a sensor section <NUM>. The electrically conductive circuitry <NUM> may be arranged in a predetermined pattern at the sensor section <NUM>. For example, the electrically conductive circuitry <NUM> may be arranged generally in a circular or semi-circular pattern. Other suitable patterns are envisioned as well, such as an oval or oblong pattern, or other closed or substantially closed loop pattern. The electrically conductive circuitry <NUM> at the sensor section <NUM> may be arranged at one or more radial distances from the stoma passage <NUM>. For example, the electrically conductive circuitry <NUM> may be arranged at a plurality of different, radial distances from the stoma passage <NUM>.

In an embodiment, the connector section <NUM> may generally be formed as an elongated section extending from the sensor section <NUM>. For example, the electrically conductive circuitry <NUM> may extend along the elongated section. In an embodiment, the connector section <NUM> may be flexible along at least a portion of its length such that it may be folded or wrapped. In an embodiment, the connector section <NUM> may extend beyond an outer periphery of the adhesive layer <NUM> and/or the barrier-side layer <NUM> in a direction radially outward from the stoma passage <NUM>.

The ostomy accessory <NUM> may further include an electrical connector <NUM>. The electrical connector <NUM> may be electrically connected to the electrically conductive circuitry <NUM>. The electrical connector may be disposed on the connector section <NUM>. The electrical connector <NUM> may include an externally accessible portion configured for electrical connection to an external device, such as a control unit <NUM> (<FIG>). The control unit <NUM> may be, for example, a wearable device of the type described above, and may include a controller according to any of the embodiments above. In this manner, the electrical connector <NUM> may provide an electrical connection between the control unit <NUM> and the electrically conductive circuitry <NUM>. The externally accessible portion of the electrical connector <NUM> may be any suitable electrical interface for forming an electrical connection between two electrical components, such as one or more electrically conductive contacts, pins, and the like.

The electrical connector <NUM> may also include one or more alignment members <NUM>. The one or more alignment members <NUM> are configured to engage corresponding alignment members (not shown) of the control unit <NUM> to indicate suitable positioning of the electrical connector <NUM> relative to the control unit <NUM> for providing the electrical connection. In an embodiment, the one or more alignment members <NUM> of the electrical connector <NUM> may be an opening, recess or slot. The corresponding alignment members (not shown) of the control unit <NUM> may be one or more projections (not shown) configured for receipt in the opening, recess or slot of the electrical connector <NUM>.

The control unit <NUM> (<FIG>) may be selectively and removably electrically connected to the electrical connector <NUM>. For example, the control unit <NUM> may include a corresponding electrical connector (not shown) for interfacing with the electrical connector <NUM>. The control unit <NUM> may be removably connected to the electrical connector <NUM> using a known, suitable mechanical fastener, such as a spring-load clip, mechanical interlock, clamp, interference fit, and the like, including combinations thereof. Alternatively, the control unit <NUM> may be integrated with the sensor layer <NUM>.

The control unit <NUM>, for example via the controller, may be configured to provide an electrical current to the electrically conductive circuitry <NUM> and detect a change in electrical resistance in the electrically conductive circuitry <NUM>. For example, leakage of stomal effluent from the stoma passage <NUM> outward into or along the first adhesive layer <NUM>, may cause electrical resistance between, for example, a pair of electrodes of the electrically conductive circuitry to decrease. The control unit <NUM> may detect the decrease in electrical resistance and determine that a leak is occurring based on the decreased electrical resistance. In an embodiment, the control unit <NUM>, via the controller, may be configured to determine a location of the change in electrical resistance. The control unit <NUM> may be further configured to provide a notification or alert indicating that a leak has been detected and/or a location of the leak. The notification or alert may be, for example, an audible, visible, or haptic alert, or a combination thereof. The control unit <NUM> may also be configured for wired and/or wireless communication with other electronic devices, such as a smart phone and the like.

In an embodiment, the barrier-side layer <NUM> may be a film layer formed from a polymeric film material. In an embodiment, the polymeric film material may be a material having properties which allow for stretching and very little elastic return, commonly referred to as a "dead-stretch" property. Such materials may have beneficial moldability properties as well. A non-limiting example of such a material is a thermoplastic urethane - phenoxy film. Alternatively, the barrier-side layer <NUM> may be a barrier-side adhesive layer formed from an adhesive material. The barrier-side layer <NUM> may be configured for application to a barrier of an ostomy pouch system as described further below. A distal side of the barrier-side layer <NUM> may form at least a portion of the barrier-facing side <NUM> of the ostomy accessory <NUM>.

The ostomy accessory <NUM> of the present embodiments is not limited to the examples described above and shown in <FIG> and <FIG>, however. For example, in other embodiments, the ostomy accessory <NUM> may include a second adhesive layer, as described below with reference to <FIG>, and the sensor layer <NUM> may be disposed between the first adhesive layer <NUM> and the second adhesive layer. In an embodiment, the second adhesive layer may be disposed between the sensor layer <NUM> and the barrier-side layer <NUM>. In an embodiment, the barrier-side adhesive layer and/or the second adhesive layer may be formed from a medical-grade pressure sensitive adhesive, such as a hydrocolloid.

<FIG> is a side cross-sectional view illustrating an example of an ostomy pouch system <NUM> to which the ostomy accessory <NUM> may be applied. The ostomy pouch system <NUM> may be any known ostomy pouch system having a barrier and an ostomy pouch. For the purposes of example, reference is made to a specific, known ostomy pouch system <NUM> shown in <FIG>. However, it is understood that the ostomy accessory <NUM> of the present embodiments is not limited for use with the ostomy pouch system <NUM> of the examples herein. Indeed, the ostomy accessory <NUM> of the present embodiments may be used together with any known ostomy pouch system having a barrier configured to be adhered to a patient's peristomal skin surfaces.

Referring to <FIG>, an example of a suitable ostomy pouch system <NUM> with which the ostomy accessory <NUM> may be used includes, generally, ostomy appliance such as a barrier ring or faceplate assembly <NUM> having a barrier <NUM>. The barrier <NUM> includes a skin attachment surface <NUM> conventionally configured for adhering to peristomal skin surfaces. That is, the barrier <NUM> is made of, or includes, an adhesive material exposed at the skin attachment surface <NUM> and configured to adhere to a patient's peristomal skin surfaces. The ostomy appliance, shown as faceplate assembly <NUM> in a non-limiting example, may optionally include a barrier release liner <NUM> removably disposed over the skin attachment surface <NUM>. The faceplate assembly <NUM> may also optionally include an adhesive layer <NUM> on a distal side of the barrier <NUM> and a faceplate <NUM> at a distal side (i.e., a pouch-facing side) of the faceplate assembly <NUM>.

The ostomy pouch system <NUM> may be a one-piece ostomy pouch system or a two-piece ostomy pouch system. A two-piece ostomy pouch system <NUM>, of the type shown in <FIG>, may further include a first coupling ring <NUM> at a distal side of the face plate <NUM>.

The ostomy pouch system <NUM> may further include an ostomy pouch <NUM>. The ostomy pouch <NUM> may have an interior volume <NUM> configured to receive and store stomal effluent. In a two-piece ostomy pouch system, the ostomy pouch <NUM> may also include a second coupling ring <NUM> configured for mating engagement with the first coupling ring <NUM>.

A stoma opening <NUM> may extend through the faceplate assembly <NUM> and a body-facing side of the ostomy pouch <NUM>. The stoma opening <NUM> is configured to dispose the interior volume <NUM> of the ostomy pouch <NUM> in fluid communication with the stoma, such that stomal effluent may be received in the interior volume <NUM> through the stoma opening <NUM>.

<FIG> is a side cross-sectional view illustrating an example of the ostomy accessory <NUM> positioned for application to the ostomy pouch system <NUM>, according to an embodiment. In an embodiment, the ostomy accessory <NUM> may first be applied to the ostomy pouch system <NUM>, and then applied to the patient. As shown in <FIG>, the ostomy accessory may be positioned with the body-facing side <NUM> facing away from the ostomy pouch system <NUM> and the barrier-facing side <NUM> facing toward the ostomy pouch system <NUM>.

The barrier release liner <NUM> of the ostomy pouch system <NUM> may be removed to expose the adhesive material of the barrier <NUM>. The ostomy accessory <NUM> may be moved toward the barrier <NUM> as indicated by the arrow in <FIG>. The barrier-facing side <NUM>, for example, the distal side of the barrier-side layer <NUM>, may then be adhered to the barrier <NUM>. The stoma passage <NUM> of the ostomy accessory <NUM> and the stoma opening <NUM> of the ostomy pouch system <NUM> may be generally aligned to form a sealed passage for stomal effluent to flow from the stoma into the ostomy pouch <NUM>.

An ostomy assembly according to embodiments herein may include the ostomy accessory <NUM> and the ostomy pouch system <NUM>, including the barrier <NUM> and the ostomy pouch <NUM>, wherein the barrier-facing side <NUM> of the ostomy accessory <NUM> is adhered to the adhesive material of the barrier <NUM>.

The ostomy accessory <NUM> may also be configured to attach the ostomy pouch system <NUM> to the patient. For example, the ostomy accessory <NUM> may be applied to the barrier <NUM> of the ostomy pouch system <NUM> in the manner described above. The body-facing side <NUM> of the ostomy accessory <NUM>, including the proximal side of the adhesive layer <NUM>, may be adhered to the patient's peristomal skin surfaces to seal around the stoma and attach the ostomy accessory <NUM> and the ostomy pouch system <NUM> to the patient.

<FIG> is a diagram schematically illustrating another side view of the ostomy accessory <NUM> according to an embodiment. With reference to <FIG> and <FIG>, the ostomy accessory <NUM> may include a body-facing side release liner <NUM>. The body-facing release liner <NUM> may extend over the body-facing side <NUM> of the ostomy accessory <NUM>. In an embodiment, the body-facing release liner <NUM> extends over the proximal side of the adhesive layer <NUM>. The ostomy accessory <NUM> may further include a barrier-facing side release liner <NUM>. The barrier-facing side release liner <NUM> may extend over the barrier-facing side <NUM> of the ostomy accessory <NUM>. One, or both, of the release liners <NUM>, <NUM> may be included with the ostomy accessory <NUM>, for example, for shipping and storage. In use, an end user may remove each release liner <NUM>, <NUM> to expose the body-facing side <NUM> and the barrier-facing side <NUM> of the ostomy accessory <NUM>. In some embodiments, the barrier-facing side release liner <NUM> may be omitted. For example, the barrier-facing side release liner <NUM> may be omitted when the barrier-side layer <NUM> is a polymeric film material. That is, in some embodiments, the barrier-facing side release liner <NUM> may be omitted when the barrier-side layer <NUM> is not an adhesive layer. Accordingly, the barrier-side layer <NUM>, when formed as a polymeric film, may be molded to size and may be adhered directly to the ostomy pouch system <NUM>.

<FIG> is an exploded view illustrating an example of the ostomy accessory <NUM> according to an embodiment in which the barrier-side layer <NUM> is a second adhesive layer. That is, in an embodiment, the ostomy accessory may include a second adhesive layer positioned for use as a barrier-side adhesive layer <NUM>. Referring to <FIG>, the ostomy accessory <NUM> may include the body-facing side release liner <NUM>, the first adhesive layer <NUM>, the sensor layer <NUM>, the barrier-side layer <NUM> formed as a second adhesive layer, i.e., a barrier-side adhesive layer, and the barrier-facing side release liner <NUM>.

In some embodiments, the ostomy accessory <NUM> may further include a barrier-side cover <NUM> for the sensor layer <NUM> and a body-side cover <NUM> for the sensor layer <NUM>. In an embodiment, the barrier-side cover <NUM> may be disposed over a barrier-facing side of the connector section <NUM> and the body-side cover <NUM> may be disposed over a body-facing side of the connector section <NUM>. The barrier-side cover <NUM> and/or the body-side cover <NUM> may be formed of a non-woven material in an embodiment. In an embodiment, the ostomy accessory <NUM> may also include a non-woven adhesive paper release liner <NUM>.

The ostomy accessory <NUM> may be configured for application to the ostomy pouch system <NUM> by the end user, such as the patient, caretaker or other medical professional. In an embodiment, the ostomy accessory <NUM> may include one or more features to promote a preferred orientation and/or order of steps to apply the ostomy accessory <NUM> to the ostomy pouch system <NUM>. For example, it may be preferred that the barrier-facing side <NUM> of the ostomy accessory <NUM> is oriented toward the ostomy pouch system <NUM> and is applied to the ostomy pouch system <NUM> before being applied to the patient.

For example, in an embodiment, the ostomy accessory <NUM> may include printed indicia or other marking to identify the body-facing side <NUM> and/or the barrier-facing side <NUM>. In an embodiment, the body-facing side release liner <NUM> may include printed indicia such as "body-facing side" or other similar indicia to indicate the side of the ostomy accessory <NUM> configured to adhere to the patient's peristomal skin. Alternatively, or in addition, the body-facing side <NUM>, and/or a distal side of the barrier-facing side release liner <NUM> may include printed indicia or other marking such as "barrier-facing side" or other similar indicia to indicate the side of the ostomy accessory <NUM> configured to be applied to the barrier <NUM>. Other printed indicia, such as graphics, colors and the like may be suitable as well. Alternatively, or in addition, the printed indicia or other marking may be included on the sensor layer <NUM>, for example, on the substrate <NUM>.

Alternatively, or in addition, the body-facing side release liner <NUM> and the barrier-facing side release liner <NUM> may be asymmetrically formed. For example, the barrier-facing side release liner <NUM> may be larger than the body-facing side release liner <NUM>. For instance, the barrier-facing side release liner <NUM> may have a larger width or diameter than the body-facing side release liner <NUM>. In an embodiment, an outer periphery of the body-facing side release liner <NUM> may be entirely within an outer periphery of the barrier-facing side release liner <NUM>. Accordingly, an end user may more easily manipulate a portion of the barrier-facing side release liner <NUM> for removal before removing the body-facing side release liner <NUM>. In this manner, application of the barrier-facing side <NUM> of the ostomy accessory <NUM> to the barrier <NUM> may be promoted before application of the body-facing side <NUM> of ostomy accessory <NUM> to the peristomal skin surfaces of the patient.

Alternatively, or in addition, the ostomy accessory <NUM> may be packaged in a way which promotes the preferred orientation and/or order of steps to apply the ostomy accessory <NUM> to the barrier <NUM>. For example, the ostomy accessory <NUM> may be packaged with the barrier-facing side <NUM> exposed upon opening the package. The package may be, for example, a box or a clamshell, such as a thermo-formed clamshell. In an embodiment, the package may be partially comprised of a release liner. While in the package, the barrier-facing side <NUM> of the ostomy accessory <NUM> may be lined by the release liner of the package. Opening the package may remove the release liner of the package to expose the barrier-facing side <NUM> of the ostomy accessory <NUM>.

In an embodiment, the ostomy accessory <NUM> may be packaged in a four-side film pouch. The body-facing side <NUM> and the barrier-facing side <NUM> may both be lined by the film. When opening the ostomy accessory <NUM>, the film may be removed from the barrier-facing side <NUM> first, allowing the ostomy accessory <NUM> to be applied to the barrier <NUM>. The film may be completely removed to expose the body-facing side <NUM> to the apply the ostomy accessory <NUM> to the patient.

As described above, the control unit <NUM> may be attached to the ostomy accessory <NUM>. In an embodiment, if the control unit <NUM> is attached in an incorrect orientation, an electrical connection to the ostomy accessory <NUM> may be precluded. Accordingly, in an embodiment, the control unit <NUM> may be configured to check for a circuit connection to the sensor layer <NUM> of the ostomy accessory <NUM>. If the control unit <NUM> determines that a circuit connection is not made, the control unit <NUM> may provide a notification to the user.

Accordingly, in the embodiments above, an ostomy accessory <NUM> may be provided separately from an ostomy pouch system <NUM>, and in particular, separate from a barrier <NUM> or faceplate assembly <NUM> of an ostomy pouch system <NUM>. In this manner, the ostomy accessory <NUM> of the present embodiments may be applied to a wide range of existing ostomy pouch systems and is not necessarily limited to a particular brand, model or configuration of an ostomy pouch system. Thus, an end user may selectively use the ostomy accessory <NUM> with existing ostomy pouch systems. As such, the end user may be presented a wide range of flexibility and options when selecting ostomy pouch systems.

The ostomy accessory <NUM> of the present embodiments is configured to detect leakage of stomal effluent into the seal formed between the adhesive layer <NUM> and the peristomal skin surfaces. The ostomy accessory <NUM> is further configured to provide an alert or notification when such a leak is detected. In an embodiment, a location of the leak may be determined as well. In this manner, the patient may be notified of a stomal effluent leak and thus, may replace the ostomy accessory <NUM> and optionally, the ostomy pouch system <NUM>. Accordingly, prolonged exposure of peristomal skin to the leaking stomal effluent may be avoided. In addition, by detecting and notifying of stomal fluid leakage, the ostomy accessory <NUM> may be replaced before the stomal effluent leak propagates to an outer periphery of the ostomy accessory <NUM> or barrier <NUM>.

Further, the ostomy accessory <NUM> of the present embodiments may include features to promote correct orientation and/or preferred application process of the ostomy accessory <NUM> to the barrier <NUM>.

It is understood that various features or components described with respect to any of the embodiments above may be combined with, used together with, or replace features or components described with respect to any of the other embodiments.

Claim 1:
An ostomy device (<NUM>, <NUM>, <NUM>, <NUM>) comprising:
a proximal side (<NUM>) configured for attachment to a user;
a distal side (<NUM>) opposite to the proximal side; and
a leakage detection sensor (<NUM>, <NUM>) comprising electrically conductive circuitry supported on a support layer,
wherein the leakage detection sensor (<NUM>, <NUM>) is configured to detect ostomy effluent based on the electrically conductive circuitry detecting a change in resistance,
characterized in that the leakage detection sensor (<NUM>, <NUM>) comprises a plurality of resistance sensors (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>) arranged in at least two different quadrants (<NUM>, <NUM>, <NUM>, <NUM>) of a ring-shaped body and is configured to track a progress of an ostomy effluent leak,
wherein the ostomy device is an ostomy accessory (<NUM>) configured for attachment to an ostomy appliance,
wherein the ostomy appliance includes a barrier (<NUM>) having an adhesive material, and an ostomy pouch is coupled to the barrier.