Patent Description:
An ostomy pouch includes opposing sidewalls defining an internal collection area. One of the sidewalls is provided with an inlet opening to receive a stoma, and means to secure the pouch to the user. Such means include, for example, an ostomy barrier, faceplate or skin barrier ring, which may be connected to or formed integrally with the sidewall having the inlet opening. The ostomy barrier (or faceplate or barrier ring) may include adhesive on a skin-facing side to seal against the user's skin in an area surrounding the stoma. Such a system is intended to prevent or limit leakage of bodily waste discharged from the stoma through the stoma/barrier/pouch environment.

However, the seal formed between the ostomy barrier and the user may weaken, for example, with time, movement, improper installation and/or application of an external force, and thus, become susceptible to leaking. Often times, the user is unaware of, or cannot easily assess, the extent of weakening in the seal. Thus, a user is typically not aware of a weakened seal, and consequently, the risk of leakage, until a fluid discharged from the stoma leaks through to an exterior of the seal (i.e., the barrier) and becomes undesirably exposed to an external environment outside of the stoma/barrier/pouch environment.

Efforts have been made in the art to detect leakage of fluid before the fluid escapes to the exterior environment. For example, <CIT> ("US '<NUM>") discloses an ostomy device having an adhesive wafer for attaching to the skin around a stoma. The wafer includes an adhesive layer having a proximal adhesive side and a distal side, where the distal side is covered with a backing layer. The wafer also includes a central portion and a peripheral portion and further includes a proximal section located on the proximal side of the central portion and a distal section visually arranged on the distal side of the peripheral portion. The distal section changes color when the proximal section is exposed to fluid.

However, leakage indicators described in the ostomy device of US '<NUM> may require frequent inspection by the user or may be difficult to perceive.

<CIT> discloses an invention intended to prevent the excrement leaked out from externally spreading out. Adhesion unit (<NUM>) is provided so that a caption hole (<NUM>) is arranged on the circumference of the faceplate (<NUM>). An auxiliary storage bag (<NUM>) is prepared to store the excrement leaking in case of blowout. The first opening (<NUM>) through the auxiliary storage bag is coupled to the adhesion unit. The second opening (<NUM>) through the auxiliary storage bag is coupled to the faceplate. The auxiliary storage bag envelops the caption hole. The excrement as a result of blowout leaking from the caption hole is captured in the auxiliary storage bag to prevent the spreadout.

<CIT> discloses a body fitment for an ostomy appliance comprising an adhesive wafer including a body-facing side for adhesively contacting the user's body. The adhesive wafer includes a moldable region shapable by the user, and a hole therethrough for allowing the user to manually mold a stomal aperture in the moldable region. The body fitment is provided with the inner peripheral region of the adhesive bordering the hole being pre-shaped with a non-planar configuration, e.g. bent or curled away from the body-facing side of the adhesive, prior to be being molded by the user. The pre-shaped, non-planar, configuration is supported by a release device that initially protects the body-facing side of the adhesive but which is intended to be removed prior to use of the body fitment, to enable the adhesive then to be molded by a user.

<CIT> discloses an ostomy appliance having a signal generator adapted to give a user or a health care professional a warning in time to change the appliance before leakage occurs by predetermining leakage or potential leakage of stomal fluids.

<CIT> discloses an ultrasonic probe deployment device in which an ultrasound-transmitting liquid forms the portion of the ultrasonic wave path in contact with the surface being inspected (i.e., the inspection surface). A seal constrains flow of the liquid, for example preventing the liquid from surging out and flooding the inspection surface. The seal is not rigid and conforms to variations in the shape and unevenness of the inspection surface, thus forming a seal (although possibly a leaky seal) around the liquid. The probe preferably is held in place to produce optimum ultrasonic focus on the area of interest. Use of encoders can facilitate the production of C-scan area maps of the material being inspected.

<CIT> discloses that a highly viscous couplant gel or water spray to form an acoustical couple for ultrasound testing is eliminated by employing an ultrasound probe module. A porous membrane and an ultrasound probe cooperate to define a chamber which contains a liquid acoustical couplant. When pressure is applied to the liquid acoustical couplant it passes through the porous membrane. The porous membrane and chamber are disposed such that ultrasound signals going to or away from the ultrasound probe pass through the liquid acoustical couplant and porous membrane.

<CIT> discloses a soft membrane booted transducer for performing ultrasonic inspections of parts and components that have rough sound beam entry surfaces. These rough surfaces may be in the form of as-welded unprepared overlays, cladded components, as-cast parts, or other unprepared surfaces that tend to prohibit, or prevent, sound entry from normal, smooth, hard-surfaced transducer contacting shoes made from Lucite or similar materials. The booted ultrasonic transducer has a soft membrane boot (<NUM> or <NUM>') for coupling the transducer to an uneven or rough sound beam entry surface. The soft membrane is made of a flexible material capable of transmitting ultrasonic waves. When pressed into contact with the uneven or rough surface of the object being inspected, the membrane flexes to generally conform to the shape of the contacted surface. Flexing of the membrane eliminates or reduces air gaps between the transducer and the object surface, thereby increasing the ultrasonic coupling between the piezoelectric element and the object.

<CIT> discloses an ostomy device that comprises an adhesive wafer for attaching to the skin around the stoma. The wafer comprises an adhesive layer having a proximal adhesive side and a distal side, where the distal side is covered with a backing layer. The wafer comprises a central portion and a peripheral portion, and it comprises a proximal section located on the proximal side of the central portion and a distal section visually arranged on the distal side of peripheral portion, wherein the distal section changes colour when the proximal section is exposed to fluid.

<CIT> discloses an ostomy device that comprises an adhesive wafer for attaching to the skin around the stoma. The wafer comprises an adhesive layer having a proximal adhesive surface and a distal surface. The distal surface is covered with a backing layer. The wafer comprises a central portion and a peripheral portion, and it comprises at least a first and a detection zone, wherein the detection zone is configured to provide a tactile sensation on the distal surface of the wafer when exposed to moisture.

Accordingly, it is desirable to provide an ostomy appliance, such as an ostomy hydrocolloid or ostomy pouch having such an ostomy hydrocolloid, in which leakage may be detected using a sensor. It is also desirable to provide an ostomy appliance in which a notification may be provided to the user based on leakage detection by the sensor, before the leakage reaches the exterior environment.

The present disclosure provides an ostomy appliance as detailed in claim <NUM>. Advantageous features are provided in dependent claims.

In one aspect, an ostomy appliance may include an ostomy hydrocolloid having a body-facing side, a pouch-facing side and a stoma opening, at least one fluid aperture formed in the body-facing side, at least one fluidic channel embedded in the ostomy hydrocolloid having a proximal portion disposed in fluid communication with the at least one fluid aperture, and at least one window formed in the pouch facing side. The at least one window is aligned with the distal portion of the fluidic channel such that a portion of the fluidic channel is visible through the window.

The ostomy appliance may also include a color indicator disposed in the at least one fluidic channel between the proximal portion and the distal portion. The at least one fluidic channel may be made from a wicking material and may be configured to draw fluid from the at least one fluid aperture toward the distal portion. The at least one fluid aperture may include a plurality of fluid apertures disposed about the stoma opening. The fluid apertures of the plurality of fluid apertures may be disposed concentrically about the stoma opening. The at least one fluidic channel may include a plurality of fluidic channels and the at least one window may include a plurality of windows. The fluid apertures of the plurality of fluid apertures may be disposed in fluid communication with the fluidic channels of the plurality of fluidic channels, and the windows of the plurality of windows may be aligned with visible portions of the fluidic channels.

The ostomy hydrocolloid may include a skin barrier, a film and a backing layer. The ostomy hydrocolloid may also include a coupling section on the pouch-facing side.

According to one embodiment, the ostomy appliance may further include a sensor assembly configured for removable connection to the ostomy hydrocolloid. The sensor assembly may include at least one optical sensor configured to detect a color or a change in color at a visible portion of the at least one fluidic channel and output sensor information representative of the detected color or change in color.

The sensor assembly may further include a controller operably connected to the least one optical sensor. The controller may be configured to determine a leakage condition based on the sensor information. The at least one optical sensor may include a plurality of optical sensors, and the at least one window may include a plurality of windows. The optical sensors of the plurality of optical sensors may be substantially aligned with respective windows of the plurality of windows.

The sensor assembly may further include a substantially ring-shaped housing in which the plurality of optical sensors are disposed. The substantially ring-shaped housing may have a plurality of sensor windows configured for transmission of light to and from the plurality of optical sensors. The sensor assembly may further include a power supply operably connected to the controller and a releasable fastener configured to selectively fasten opposing ends of the housing to one another. The sensor assembly may further comprise a transceiver configured for wireless communication.

In one embodiment, the ostomy appliance may also include a notification device communicatively coupled to the sensor assembly via the transceiver. The notification device may be configured to output a notification based on the determined leakage condition.

In another aspect, an ostomy appliance may include a skin barrier material for attaching the ostomy appliance to a user's peristomal skin and an ultrasonic detection device configured to monitor the skin barrier material, an interface between the skin barrier material and the user's peristomal skin, and/or any material arranged between the skin barrier material and the user's peristomal skin. The ultrasonic detection device may include at least one ultrasonic transducer configured to transmit ultrasound waves through the skin barrier material and at least one receiver configured to detect the ultrasonic waves. The ultrasonic detection device may be configured to monitor at least one condition of the skin barrier material based on at least one characteristic of the ultrasonic waves traveling through the skin barrier material. In some embodiments, the at least one characteristic of ultrasonic wave may include a rate, amplitude, and/or phase of ultrasonic waves traveling through the skin barrier material. In such embodiments, the ultrasonic detection device may be configured to detect ostomy effluent leakage by detecting a change in the rate and/or the amplitude of ultrasonic waves traveling through the skin barrier material.

In an embodiment, the at least one ultrasonic transducer and the at least one receiver may be arranged at opposing peripheries of the ostomy appliance, such that the ultrasound waves generated by the at least one ultrasonic transducer are transmitted across the skin barrier material and detected by the at least one receiver. The at least one ultrasonic transducer and the at least one receiver may comprise a plurality of ultrasonic transducers and a plurality of receivers arranged spaced apart from each other and configured to monitor the skin barrier material at different locations.

In another embodiment, the ultrasonic detection device may include an ultrasonic transceiver configured to transmit and receive ultrasonic waves. The ultrasonic transceiver may be configured to transmit ultrasound waves through the skin barrier material and detect the ultrasound waves reflected and returning to the ultrasonic transceiver.

In an embodiment, the ostomy appliance may be a faceplate for a two-piece ostomy pouch system including a body-side coupling ring configured to engage with a pouch-side coupling ring provided on an ostomy pouch to attach the ostomy pouch to the faceplate. In another embodiment, the ostomy appliance may be an ostomy skin barrier for a one-piece ostomy pouch system attached to an ostomy pouch. In yet another embodiment, the ostomy appliance may be an ostomy skin barrier ring. In any of the foregoing embodiments, the skin barrier material may be a hydrocolloid. In some embodiment, the ostomy appliance may further include at least one wicking material arranged proximate the ultrasonic detection device to facilitate absorption of fluid by the skin barrier material. In an embodiment, the ultrasonic detection device may be provided as a separate stand-alone device, which may be arranged spaced apart from the ostomy appliance or in contact with the ostomy appliance and configured to monitor the ostomy appliance.

In another aspect, an ostomy appliance system may include an ultrasonic detection device and a wearable device removably connected to the ostomy appliance and operably connected to the ultrasonic detection device. The wearable device may include a housing, a power supply, and a controller operably connected to the power supply.

The controller may be configured to determine a condition of the ostomy appliance based on the at least one characteristic of the ultrasound waves detected by the ultrasonic detection device. For example, the controller may be configured to determine an ostomy effluent leakage condition based on a change in the at least one characteristic of the ultrasound waves traveling through the skin barrier material upon the skin barrier material being exposed to ostomy effluent. The wearable device may further include one or more output devices operably connected to the controller and configured to output a notification based on the determined condition. The wearable device also may include a wireless transceiver.

According to an embodiment, the ostomy appliance system may further include a personal communication device communicatively connected to the wearable device via the wireless transceiver. The personal communication device may be configured to output a notification based on a condition of the ostomy appliance. The personal communication device may be a smartphone.

<FIG> is a perspective view of an ostomy appliance <NUM> according to an embodiment. In one embodiment, the ostomy appliance <NUM> includes an ostomy hydrocolloid <NUM> configured to connect an ostomy pouch <NUM> (<FIG>) to a user. The ostomy hydrocolloid <NUM> may be, for example, any of an ostomy barrier, an ostomy faceplate or an ostomy skin barrier ring. In one embodiment, the ostomy hydrocolloid <NUM> generally includes a skin barrier <NUM> and a backing layer <NUM>. The skin barrier <NUM> may include a known, medical grade adhesive suitable for adhering to the user's skin and sealing around a stoma. The backing layer <NUM> may be formed by a soft, flexible material that is generally soft and non-irritable to the user's skin, such as a nonwoven or foam material. The backing layer <NUM> may include an adhesive on a body-facing side <NUM> of the ostomy appliance <NUM>, configured to adhere to the user in a peripheral region outside of the skin barrier <NUM>.

The ostomy appliance <NUM> includes a stoma opening <NUM> extending through the skin barrier <NUM> and the backing layer <NUM>. The stoma opening <NUM> is configured to receive the stoma and allow for flow of stoma fluid into the ostomy pouch.

At least one fluid aperture <NUM> is formed on the body-facing side <NUM> of the ostomy appliance <NUM>, for example, in the skin barrier <NUM>. In one embodiment, the at least one fluid aperture <NUM> includes a plurality of fluid apertures <NUM> discretely disposed about and spaced from the stoma opening <NUM>. It is envisioned that the plurality of fluid apertures <NUM> may be disposed concentrically about the opening <NUM>, but the present disclosure is not limited to such a configuration. For example, the fluid apertures <NUM> may be radially staggered relative to the stoma opening <NUM>.

<FIG> is another perspective view of the ostomy appliance <NUM> according to an embodiment. In one embodiment, the ostomy appliance <NUM> further includes a coupling section <NUM> at a pouch-facing side <NUM>. In one embodiment, the coupling section <NUM> may be a known ostomy appliance flange configured for coupling to an ostomy pouch in a two-piece pouch configuration. In another embodiment, the coupling section <NUM> may be a known bag-barrier interface in a one-piece pouch configuration.

The ostomy appliance <NUM> further includes at least one window <NUM> at the pouch-facing side <NUM>, extending through the backing layer <NUM>. In one embodiment, the at least one window <NUM> includes a plurality of windows <NUM> spaced from the stoma opening <NUM>. In one embodiment, the windows <NUM> are concentrically positioned about the stoma opening <NUM>. However, the present disclosure is not limited to such an example. For instance, the windows <NUM> may be radially staggered relative to the stoma opening <NUM>.

<FIG> is an exploded view of the ostomy appliance <NUM> according to an embodiment. In one embodiment, an embedded film <NUM> is disposed between the skin barrier <NUM> and the backing layer <NUM>. The embedded film <NUM> may be a laminate film and is preferably liquid impermeable. The embedded film <NUM> may be gas impermeable as well. The stoma opening <NUM> extends through the embedded film <NUM>. Further, in one embodiment, the coupling section <NUM> may optionally be secured to the backing layer <NUM>, directly or indirectly, with a flange attachment film <NUM>.

At least one fluidic channel <NUM> is embedded in ostomy appliance <NUM>. For example, in one embodiment, the at least one fluidic channel <NUM> may be disposed between the skin barrier <NUM> and the embedded film <NUM>. The fluidic channel <NUM> includes a proximal portion <NUM> disposed in fluid communication with the at least one fluid aperture <NUM> and a distal portion <NUM> spaced from the proximal portion <NUM>. In one embodiment, the distal portion <NUM> is disposed at a radial distance farther from the stoma opening <NUM> than the proximal portion <NUM>. In one embodiment, the fluidic channel <NUM> may include a plurality of proximal portions <NUM> and a common distal portion <NUM> fluidically connected to the plurality of proximal portions <NUM>. The proximal portion <NUM> and the distal portion <NUM> may be a proximal end and a distal end, respectively. In one embodiment, the at least one fluidic channel <NUM> includes a plurality of fluidic channels <NUM>.

The fluidic channel <NUM> is formed of a material capable of transferring fluid from the proximal portion <NUM> to the distal portion <NUM>. For example, the fluidic channel <NUM> may be formed of a wicking material through which a fluid may be transferred by capillary action.

<FIG> is a perspective view of the ostomy appliance <NUM> showing an enlarged cutaway section view showing the fluidic channel <NUM> positioned relative to the window <NUM>, according to an embodiment. In one embodiment, the window <NUM> is aligned with a visible portion <NUM> of the fluidic channel <NUM>. The embedded film <NUM> is transparent or translucent or includes sections of transparent or translucent material aligned with the window <NUM>. Accordingly, the visible portion <NUM> of the fluidic channel <NUM> is visible through the window <NUM> and the embedded film <NUM>. In one embodiment, the visible portion <NUM> of the fluidic channel <NUM> is the distal portion <NUM> of the fluidic channel <NUM>. In one embodiment, windows <NUM> of a plurality of windows <NUM> are aligned with respective visible portions <NUM> of a plurality of fluidic channels <NUM>.

The at least one fluidic channel <NUM> may optionally include an embedded color indicator <NUM> between the proximal portion <NUM> and the visible portion <NUM>. The color indicator <NUM> may be a biocompatible dye or other chemical configured to move through the fluidic channel <NUM> with a fluid.

Accordingly, in the embodiments above, stoma fluid may be received in the fluid aperture <NUM> and migrate into the fluidic channel <NUM>, in the event of stoma fluid leakage from the stoma opening <NUM> between the ostomy appliance <NUM> and the user's skin. The fluid may move through the fluidic channel <NUM> from the proximal portion <NUM> toward the distal portion <NUM> and may be visible through the window <NUM> upon reaching the visible portion <NUM>. In one embodiment, the color indicator <NUM> may also be visible at the visible portion <NUM> when the fluid reaches the visible portion <NUM>.

<FIG> is a perspective view of a sensor assembly <NUM> of the ostomy appliance <NUM> according to an embodiment, and <FIG> is a partial exploded view of the sensor assembly <NUM> according to an embodiment. The sensor assembly <NUM> is configured to detect a color or a change in color of the visible portion <NUM>. Accordingly, the sensor assembly <NUM> may detect that a fluid has reached the visible portion <NUM> of the fluidic channel <NUM> based on a change in color at the visible portion <NUM> caused by the fluid.

In one embodiment, the sensor assembly <NUM> includes a housing <NUM>. The housing <NUM> may be made from a flexible, durable material, such as, but not limited to, silicone, polyurethane or materials having similar properties.

Referring to <FIG>, the sensor assembly <NUM> further includes at least one sensor <NUM> operably connected to a controller <NUM>. In one embodiment, a plurality of sensors <NUM> are operably connected to the controller <NUM>. The sensor(s) <NUM> and the controller <NUM> may be interconnected by electrical circuitry, which may be flexible so to move with the housing <NUM>.

The sensor <NUM> is an optical sensor configured to detect a color or change in color. Such optical sensors include, for example, a light sensor, reflective IR sensors, RGB sensors and other sensors capable of detecting a mild (white to off-white) or stark (white to black) color or color change.

The controller <NUM> may be a microcontroller and may include a processor, memory and communication module. The processor is configured to execute program instructions stored in the memory and the communication module is configured to send or receive signals to and from the processor to carry out operations based on the program instructions.

The sensor assembly <NUM> may further include a power supply <NUM>, such as a battery, charging pads <NUM> for charging the power supply <NUM>, and a transceiver <NUM> configured for electrical communications with one or more external devices as will be discussed further below. The controller <NUM>, power supply <NUM>, charging pads <NUM> and transceiver <NUM> may be operably connected to one another, for example, on a printed circuit board (PCB) <NUM>.

In one embodiment, the transceiver <NUM> may be a wireless transceiver 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 transceiver <NUM> 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.

<FIG> is another perspective view of the sensor assembly <NUM>, according to an embodiment. In one embodiment, the housing <NUM> may include one or more sensor windows <NUM> through which light may be transmitted to or from the at least one sensor <NUM>. The housing <NUM> may also include a first charging interface <NUM> operably connected to the charging pads <NUM> (<FIG>).

<FIG> is a perspective view of the ostomy appliance <NUM>, according to an embodiment. In one embodiment, the sensor assembly <NUM> is configured to be attached to the ostomy hydrocolloid <NUM>, for example, at the pouch-facing side <NUM>. For example, the sensor assembly <NUM> may fit around the coupling section <NUM>. In one embodiment, an inner profile <NUM> of the housing <NUM> may be keyed to an outer profile <NUM> of the coupling section <NUM> for positioning of the sensor assembly <NUM> relative to the ostomy hydrocolloid <NUM> in a desired manner. In one embodiment, the coupling section <NUM> may also include a retaining tab <NUM> for holding the sensor assembly <NUM>. In normal use, the sensor assembly <NUM> may be retained between the ostomy hydrocolloid <NUM> and the ostomy pouch <NUM>.

<FIG> is an enlarged perspective view of the ostomy appliance <NUM> with the sensor assembly <NUM> in an open-ring configuration, according to an embodiment. The sensor assembly <NUM> is movable between a closed-ring configuration (<FIG>) and the open-ring configuration of <FIG> through operation of a fastener <NUM>. The fastener <NUM> may be, for example, a latch, a clasp, an adhesive, a clip or other suitable physical fastener. In the closed-loop configuration, the fastener <NUM> may be fastened to secure opposing ends <NUM>, <NUM> of the housing <NUM> together. The fastener <NUM> may be released to move the sensor assembly <NUM> to the open-ring condition, where the opposing ends <NUM>, <NUM> may be moved apart from another, for example, by flexing the housing <NUM>. In one embodiment, the fastener <NUM> may be released by way of a pushbutton <NUM> or the like formed on the housing <NUM>.

Referring now to <FIG>, <FIG> and <FIG>, the sensor assembly <NUM> is configured to be positioned relative to the ostomy hydrocolloid <NUM> such that the at least one sensor <NUM> is substantially aligned with a corresponding window <NUM> of the ostomy hydrocolloid <NUM>. Accordingly, the at least one sensor <NUM> is configured to detect a color or change in color of the visible portion <NUM> of the fluidic channel <NUM> through the window <NUM> of the ostomy hydrocolloid <NUM>. In one embodiment, a plurality of sensors <NUM> are aligned with a plurality of corresponding windows <NUM> of the ostomy hydrocolloid <NUM> such that a color or change in color at the visible portion <NUM> may be detected at a plurality of locations.

<FIG> show the ostomy appliance <NUM> with the sensor assembly <NUM> disconnected from the ostomy hydrocolloid <NUM> according to an embodiment. As shown in <FIG>, it is envisioned that the ostomy appliance <NUM> may be formed in different sizes by manufacturing the ostomy hydrocolloid <NUM> and the sensor assembly <NUM> as differently sized pairs for use with one another.

<FIG> shows additional components which may be part of, or configured for use with, the ostomy appliance <NUM>, according to an embodiment. In one embodiment, a charging device <NUM> may include a second charging interface <NUM> configured for operable connection with the first charging interface <NUM> of the sensor assembly <NUM> to charge the power supply <NUM>.

The ostomy appliance <NUM> may further include an ostomy pouch <NUM> configured for coupling with the ostomy hydrocolloid <NUM>. In one embodiment, the ostomy pouch <NUM> may be coupled to the ostomy hydrocolloid <NUM> at the coupling section <NUM> by way of a corresponding pouch coupling section <NUM>. An inlet opening <NUM> is included in the ostomy pouch <NUM> and is configured for alignment with the stoma opening <NUM>. In another embodiment, the ostomy pouch <NUM> and the ostomy hydrocolloid <NUM> are formed as a one-piece construction.

A notification device <NUM> may be communicatively connected to the to the sensor assembly <NUM>. In one embodiment, the notification device <NUM> may be may be a mobile communication device such as a smartphone or other mobile phone communicatively connected to the sensor assembly <NUM> via the transceiver <NUM> over a wireless communication interface. Alternatively, or in addition, the notification device <NUM> may be another mobile communication device, portable electronic device, or other electronic device configured for communication, directly or indirectly, with the sensor assembly <NUM>. 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 some embodiments, the notification device <NUM> may be operably connected to sensor assembly <NUM> over either a wired connection or wireless connection. In one embodiment, the notification device <NUM> includes a display screen <NUM>.

In one embodiment, the notification device <NUM> may be integrated with the sensor assembly <NUM>. For example, the notification device <NUM> may be disposed within the housing <NUM> and operably connected to the controller <NUM>.

In one embodiment, the sensor assembly <NUM> may be paired, synced, or otherwise communicatively connected to the notification device <NUM>, with a known operation, which may be initiated, for example, by operation of a power and/or sync button <NUM> (<FIG> and <FIG>) on the sensor assembly <NUM>.

In one embodiment, the at least one sensor <NUM> may provide sensor information to the controller <NUM>. The sensor information may include, for example, a detected color of the visible portion <NUM>, a detected change in color of the visible portion <NUM>, or both. In one embodiment, the sensor information may be provided as raw analog or digital data. In one embodiment, the sensor information may also include identification information of the sensor <NUM>. With a position of the sensor <NUM> known, a location of the detected color or change in color may be determined.

A leakage condition of the ostomy appliance <NUM> may be determined based on the sensor information. In one embodiment, the determined leakage condition may indicate that stoma fluid leakage is not detected, that stoma fluid leakage is detected, and in one embodiment, an extent of the detected stoma fluid leakage.

In one embodiment, a condition indicating that stoma fluid leakage is not detected may be determined when the detected color of the visible portion <NUM> corresponds to a known color associated with a "dry" (i.e., no stoma fluid present) visible portion, or conversely, if the detected color of the visible portion does not correspond to a known color associated with a "wet" (i.e., stoma fluid present) visible portion. Alternatively, or in addition, the condition indicating that stoma fluid leakage is not detected may be determined if the sensor <NUM> does not detect a change in color of visible portion <NUM>, or detects a change in color that remains within a known range of colors associated with a "dry" visible portion <NUM>.

In one embodiment, a condition indicating that stoma fluid leakage is detected may be determined if the detected color of the visible portion <NUM> corresponds to a known color associated with a "wet" visible portion <NUM>, or conversely, if the detected color of the visible portion <NUM> does not correspond to a known color associated with a "dry" visible portion <NUM>. Alternatively, or in addition, the condition indicating that stoma fluid leakage is detected may be determined if the sensor <NUM> detects a change in color of the visible portion <NUM>, or detects a change in color that falls within a known range of colors associated with a "wet" visible portion <NUM>.

In one embodiment, the extent of detected stoma fluid leakage may refer to how widespread the detected stoma fluid leakage is across the ostomy hydrocolloid <NUM>. For example, the extent of stoma fluid leakage may be determined based on the number of sensors <NUM> which have detected the stoma fluid leakage at respective visible portions <NUM>. In one embodiment, the extent of detected stoma fluid leakage may also refer to a distance from a reference point, such as the stoma opening <NUM> or outer periphery of the ostomy hydrocolloid, that the stoma fluid leakage has migrated. Such an extent may be determined, for example, by staggering the fluid apertures <NUM> radially relative to the stoma opening <NUM>. The locations of visible portions <NUM> of fluidic channels <NUM> which correspond to different fluid apertures <NUM> may be known. Accordingly, in one embodiment, an extent of stoma fluid leakage may be determined based on the known relationship between the position of a fluid aperture <NUM> relative to the stoma opening <NUM> and the visible portion <NUM> of the fluidic channel <NUM> fluidically connected to the fluid aperture <NUM>.

The condition may be determined, for example, at the sensor assembly <NUM>, the notification device <NUM>, or both. For example, the controller <NUM> of the sensor assembly <NUM> may determine the condition based on the sensor information. The sensor assembly <NUM> may transmit the determined condition to the notification device <NUM>, for example, over a wireless communication interface with the transceiver <NUM>. Alternatively, or in addition, the sensor assembly <NUM> may transmit the sensor information to the notification device <NUM> and the notification device <NUM> may be configured to determine the condition in the manner described above.

In one embodiment, the notification device <NUM> may periodically receive the determined condition from the sensor assembly <NUM>. Alternatively, or in addition, a user may operate the notification device <NUM> to request the determined condition from the sensor assembly <NUM> and, in response to receiving the request, the sensor assembly <NUM> may determine and transmit the condition to the notification device <NUM>.

In one embodiment, the notification device <NUM> is configured to output a notification based on the determined condition. The notification may be one or more of an audio notification, a visual notification or a vibratory notification to be sensed by the user. In one embodiment, the notification may include graphics, text, symbols, representative models of the ostomy hydrocolloid <NUM> and the like, which may be provided on a display <NUM> of the notification device <NUM>. In one embodiment, the notification may vary depending on the determined condition. For example, the notification may vary in type, frequency, intensity, volume, brightness, pattern, or the like. In one embodiment, the notification may include instructions to replace the ostomy hydrocolloid <NUM>.

In one embodiment, the notification device <NUM>, embodied as a smartphone, may perform functions according to a smartphone application directed to the ostomy appliance <NUM>. The smartphone application may include program instructions stored in a memory unit of the smartphone which are configured to be executed by a processor of the smartphone to control the smartphone to perform the functions. For example, the smartphone may be controlled to generate and output the notification. The smartphone may also be controlled to store additional data and enable further communications. For example, the smartphone may be configured to track leaks or degradation of the ostomy hydrocolloid <NUM>, behaviors and activities that could potentially affect wear time, including, but not limited to: pouch changes, diet, leakage occurrence, gas occurrence and physical activity.

In one embodiment, the smartphone may be configured to provide a platform to share practices and advice from other users and clinicians. In one embodiment, the smartphone may be configured to allow for communication with other information sources, for example, to access video tutorials providing additional education and instruction on managing a stoma. In one embodiment, the smartphone may be configured to allow for pictures to be taken and stored of the stoma and skin health. In one embodiment the smartphone may be configured to facilitate contact with a wound, ostomy and continence (WOC) nurse (also referred to as an enterostomal therapy (ET) nurse), for example, to troubleshoot or share stoma and skin health conditions. In one embodiment, the smartphone may be configured to allow for ordering or automatic re-ordering of an ostomy appliance <NUM> or related supplies when a determination is made that such supplies are running low. In one embodiment, the smartphone may be configured to provide usage and patient data to, for example, the ostomy appliance manufacturer, such as marketing, research and product support teams. In one embodiment, such usage and data may be provided, for example, after a user opts-in, and the data may be provided securely, anonymously, and/or in accordance with local privacy laws and regulations, to support health economics.

Those having ordinary skill in the art will appreciate that the present disclosure is not limited to a smartphone application executed to control functions of a smartphone according to the examples above. For instance, it is also envisioned that a similar software application could be executed by a tablet or other portable device, a remote server configured to be accessed by the user through a known communications interface, or at a personal computing device, such as a laptop or desktop computer, or some combination of the above.

<FIG> show examples of a user configuring the ostomy appliance <NUM> for use, according to an embodiment. For example, the user may secure ostomy pouch <NUM> (<FIG>), communicatively connect the notification device <NUM> to the sensor assembly <NUM> (<FIG>) and connect the sensor assembly <NUM> to the ostomy hydrocolloid <NUM> (<FIG>).

<FIG> show examples of a user during normal use of the ostomy appliance <NUM>, according to an embodiment. For example, the user may interact in a social setting (<FIG>), the sensor assembly <NUM> may monitor the ostomy appliance <NUM> for stoma fluid leakage (<FIG>), and the sensor assembly <NUM> may detect stoma fluid leakage 'L' along the ostomy hydrocolloid <NUM> (<FIG>).

<FIG> show examples of a user receiving a notification of a leakage condition and tending to the ostomy appliance <NUM>, according to an embodiment. For example, a notification of the leakage condition may be output on the notification device <NUM> (<FIG>), the user may move to a location to tend to the ostomy appliance <NUM> (<FIG>) and the user may remove the sensor assembly <NUM> from the ostomy hydrocolloid <NUM> (<FIG>) to replace the ostomy hydrocolloid <NUM>.

<FIG> is a schematic illustration of an ostomy appliance <NUM> configured for ultrasonic fluid detection according to an embodiment. The ostomy appliance <NUM> 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. The ostomy appliance <NUM> may include a skin barrier material <NUM> provided on a body-facing side <NUM> for adhering to user's skin. The skin barrier material <NUM> may be formed from a suitable medical grade adhesive, such as a hydrocolloid adhesive. A backing layer (not shown) may be provided on a pouch-facing side of the ostomy appliance <NUM>. The backing layer may be formed from a soft, flexible material that is generally soft and non-irritable to the user's skin, such as a nonwoven or foam material. The ostomy appliance <NUM> may include a stoma opening <NUM> configured to receive the stoma and allow for passage of stoma fluid into an ostomy pouch (not shown.

In an embodiment, the ostomy appliance <NUM> may be configured as a faceplate for a two-piece ostomy pouch system. In such an embodiment, the ostomy appliance <NUM> may include a body-side coupling ring (not shown) attached the pouch-facing side of the ostomy appliance <NUM>. The body-side coupling ring may be configured to releasably engage a pouch-side coupling ring (not shown) provided on a pouch to attach the pouch to the ostomy appliance <NUM>. In another embodiment, the ostomy appliance <NUM> may be configured as an ostomy barrier for a one-piece ostomy pouch system, wherein the pouch-facing side of the ostomy appliance <NUM> is sealed to a pouch wall proximate a stoma opening of the pouch.

The ostomy appliance <NUM> may include an ultrasonic fluid detection device. The ultrasonic fluid detection device may include at least one ultrasonic transducer and at least one receiver, which may be integrated into or arranged on or around the ostomy appliance <NUM>. For example, the ultrasonic transducer and receiver may be embedded in the skin barrier material <NUM> or arranged at a periphery of the skin barrier material <NUM>.

In the embodiment of <FIG>, the ultrasonic fluid detection device may include an ultrasonic transducer <NUM> and a receiver <NUM>. The ultrasonic transducer <NUM> and the receiver <NUM> may be arranged at opposing peripheries of the ostomy appliance <NUM>. The ultrasonic transducer <NUM> and the receiver <NUM> may be arranged to contact the skin barrier material <NUM>. The ultrasonic fluid detection device may be configured to measure and record a travel time of ultrasonic sound waves generated by the transducer <NUM> to reach the receiver <NUM> and/or amplitudes of the ultrasound waves. A rate of ultrasound waves traveling through the skin barrier material <NUM> may change when physical properties of the skin barrier material <NUM> is altered. For example, a rate of ultrasound waves traveling through the skin barrier material <NUM> may change when the skin barrier material <NUM> becomes wet by ostomy effluent. Further, an amplitude of ultrasound waves traveling through the skin barrier material <NUM> also may change because the skin barrier material <NUM> when wet may absorb or transmit the ultrasound waves differently when compared to the skin barrier material <NUM> prior to being exposed to fluid. As such, the ultrasonic fluid detection device may be configured to analyze the recorded travel times and amplitudes of the ultrasound waves to detect fluid leakage.

In some embodiments, the ultrasonic fluid detection device of the ostomy appliance <NUM> may comprise a plurality of ultrasonic transducers <NUM> and receivers <NUM> arranged spaced apart on or embedded in the ostomy appliance <NUM> in contact with the skin barrier material <NUM> to detect fluid leakage at multiple locations of the ostomy appliance <NUM>.

In one embodiment, the ostomy barrier <NUM> may include at least one wicking material <NUM> arranged proximate the body-facing side <NUM> of the skin barrier material <NUM> to facilitate absorption of fluid. In the embodiment of <FIG>, the wicking material <NUM> may be arranged between the ultrasonic transducer <NUM> and the receiver <NUM> to facilitate absorption of fluid by a portion of the skin barrier material <NUM> below the wicking material <NUM> to facilitate detection of fluid leakage.

In some embodiments, an ultrasonic transducer and a receiver may be arranged adjacent each other and configured to record reflected ultrasonic waves, similar to the known technology used for pregnancy sonograms. In such embodiments, a travel time and/or amplitude of the reflected ultrasonic waves may be recorded.

<FIG> is a schematic illustration of an ostomy appliance <NUM> configured for ultrasonic leakage detection according to another embodiment. The ostomy appliance <NUM> may be configured similar to the ostomy appliance <NUM> generally comprising a skin barrier material <NUM> and an ultrasonic fluid detection device. In this embodiment, the ultrasonic fluid detection device may include an ultrasonic transceiver <NUM> configured to transmit and receive ultrasonic waves. The ultrasonic transceiver <NUM> may be embedded in or arranged on a pouch-facing side <NUM> of the ostomy appliance <NUM>. The ultrasonic transceiver <NUM> may be configured to generate and transmit ultrasonic waves through a thickness of the skin barrier material <NUM> and record travel times and/or amplitudes of the ultrasonic waves reflected and returning to the transceiver <NUM>. In such an embodiment, the ultrasonic transceiver <NUM> may be configured to record and analyze travel times and/or amplitudes of the reflected ultrasonic waves to detect ostomy effluent leakage at a body-facing side <NUM> of the ostomy appliance <NUM>.

In some embodiments, the skin barrier material <NUM>, <NUM> may comprise at least one material configured to amplify changes in characteristics of ultrasonic waves traveling through the skin barrier material <NUM>, <NUM> in response to the skin barrier material <NUM>, <NUM> being in contact with fluid or becoming wet, for example, cellulosic paper. For example, the skin barrier material <NUM>, <NUM> may be formulated with at least one material configured to change a travel time or amplitude of ultrasound waves more drastically when wet.

In the embodiments above, the ostomy appliance <NUM>, <NUM> may be monitored for one or more conditions on the basis of the characteristics of ultrasound waves traveling through skin barrier material <NUM>, <NUM>, such as traveling time and amplitudes, detected at the receiver <NUM>, <NUM>. Such conditions may include, but are not limited to, stoma fluid leakage and seal degradation.

The ostomy appliance <NUM>, <NUM> may also include an electrically-attached controller configured to analyze the ultrasonic waves recorded by the receiver and alert a user of a potential leak via audio, vibrational, optical or tactile alerts. In some embodiments, the ostomy appliance <NUM>, <NUM> may be provided with a wearable device 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>, <NUM>, for example, by way of friction fit, interference fit, clamping, mechanical interlock, or other suitable fastening mechanism.

The controller may be a microcontroller and may include a processor, memory, and communication module. The processor may be configured to execute program instructions stored in the memory, and the communication module may be configured to send or receive signals to and from the processor to carry out operations based on the program instructions. 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 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>, <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 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.

In additions, various features described with respect to any of the embodiments above may be used together, implemented in, or replace features in any of the other embodiments described above.

Claim 1:
An ostomy appliance (<NUM>) comprising:
an ostomy hydrocolloid (<NUM>) having a body-facing side, a pouch-facing side and a stoma opening (<NUM>);
at least one fluid aperture (<NUM>) formed in the body-facing side;
wherein the ostomy appliance further comprises at least one fluidic channel (<NUM>) embedded in the ostomy hydrocolloid having a proximal portion (<NUM>) disposed in fluid communication with the at least one fluid aperture (<NUM>); and
at least one window (<NUM>) formed in the pouch facing side, the at least one window aligned with a distal portion (<NUM>) of the fluidic channel such that a portion of the fluidic channel is visible through the window (<NUM>),
characterised in that the ostomy appliance further comprises a sensor assembly (<NUM>) configured for removable connection to the ostomy hydrocolloid (<NUM>), the sensor assembly comprising at least one optical sensor (<NUM>) configured to detect a color or change in color at a visible portion (<NUM>) of the at least one fluidic channel (<NUM>) and output sensor information representative of the detected color or change in color.