Detachable sensing module for ostomy implants

Abstract

The present disclosure relates to a sensing module for an ostomy implant, configured to measure physiological conditions, device state, and user activity. The sensing module comprises one or more sensors, a power source, and a communication interface for transmitting or storing collected data. It may be secured to an ostomy implant directly or via an ostomy device, and in some embodiments, it may be detachably secured for removal or servicing. The sensors may measure fluid volume, pH, temperature, pressure variations, leakage, and device usage patterns. The collected data may be processed locally or transmitted for analysis, supporting ostomy management, early complication detection, and healthcare integration.

Description

[0001] Detachable Sensing Module for Ostomy Implants

[0002] The present invention relates to sensor-based medical devices for ostomy management, and more particularly to a detachable sensing module configured to monitor parameters associated with ostomy implants, such as device state, physiological conditions, and user activity.

[0003] Background

[0004] Ostomy implants are a necessary medical intervention for individuals requiring the diversion of bodily waste due to various health conditions, including colostomy, ileostomy, and urostomy procedures. These implants generally involve a surgically created opening, or stoma, through which waste exits the body, often requiring an external device for collection and management. One type of ostomy system includes transcutaneous ostomy implants, which provide a permanent interface between the internal waste diversion pathway and an external collection system. These implants, along with traditional peristomal adhesive-based ostomy devices, play a critical role in enabling patients to manage their conditions effectively.

[0005] While widely adopted, ostomy devices are primarily designed for passive waste containment and may present various challenges in daily management and long-term care. Existing systems do not typically include monitoring functionalities, making it difficult to assess health parameters, pressure fluctuations, fluid accumulation, gas buildup, or the presence of leakage in real time. As a result, users must rely on manual checks and subjective assessments, which may delay the identification of potential complications and limit the ability to optimize care based on actual conditions.

[0006] Additionally, ostomy-related devices may pose challenges in terms of maintenance, long-term reliability, and adaptation to individual needs. In cases where components degrade, require adjustments, or no longer function optimally, users often experience difficulties in ensuring continued performance without replacing significant portions of their system. Furthermore, variability in patient-specific requirements means that some users may need greater flexibility in how their ostomy system is configured, yet existing designs often lack customization options to accommodate such needs.

[0007] It is therefore a technical challenge in the field to improve the monitoring capabilities, usability, and adaptability of ostomy-related devices while maintaining practicality, reliability, and ease of use for patients with different types of ostomies.Summary

[0008] In view of limitations of existing ostomy-related devices, including limited adaptability, practical maintenance challenges, and limited availability of integrated monitoring, there exists a need for an ostomy monitoring solution that supports modularity, compatibility with different device configurations, and access to ostomy data for users and / or caregivers.

[0009] Accordingly, in a first aspect, the present disclosure relates to a sensing module for an ostomy system, the sensing module comprising: a power source; and a communication interface configured to transmit ostomy data to an external device; wherein the sensing module is configured to be detachably secured to an ostomy implant, either directly or via an ostomy device attachable to the ostomy implant.

[0010] In some embodiments, the sensing module comprises one or more sensors configured to generate ostomy data. In other embodiments, additionally or alternatively, the sensing module is configured to operatively communicate with one or more sensors provided in the ostomy implant and / or in the ostomy device, for example with one or more sensor elements arranged to be exposed to, or in fluid communication with, an internal lumen of the ostomy implant during use. In such embodiments, the sensing module may obtain sensor signals via electrical coupling, inductive coupling, capacitive coupling, and / or wireless coupling and may store and / or transmit ostomy data derived from the sensor signals.

[0011] The detachable configuration may support independent servicing, recalibration, replacement, and / or upgrading of the sensing module while allowing continued use of the ostomy implant. In some embodiments, the sensing module is configured to generate ostomy data indicative of one or more of physiological conditions, device state, and / or user activity, including for example data indicative of an open or closed state of a lid, attachment and / or seal integrity, pressure variation, gas accumulation, leakage-indicative conditions, and / or usage events. The sensing module may transmit ostomy data periodically, in response to an external prompt, and / or in response to detected events, and may additionally or alternatively store ostomy data locally for later retrieval.In some embodiments, the sensing module may be detachably secured using one or more mechanical, magnetic, adhesive, and / or elastic interfaces, thereby allowing attachment during use and detachment when desired.

[0012] Description of the drawings

[0013] In the following, embodiments and examples are described in greater detail with reference to the accompanying drawings:

[0014] Fig. 1 shows a schematic illustration of a networked ostomy monitoring environment comprising a sensing module according to an embodiment of the present disclosure. Fig. 2 shows a schematic block diagram of a sensing module and associated components according to an embodiment of the present disclosure.

[0015] Fig. 3 shows an ostomy device comprising a lid assembly with a base portion and a movable closure portion according to an embodiment of the present disclosure.

[0016] Fig. 4 shows an ostomy implant defining an internal lumen and comprising one or more sensor elements arranged on an internal surface and / or in fluid communication with the lumen according to an embodiment of the present disclosure.

[0017] Detailed description

[0018] In a first aspect, the present disclosure relates to a sensing module. The sensing module may be intended for use with an ostomy system comprising an ostomy implant and may be configured to support monitoring and management of ostomy care, including generating, storing, and / or transmitting ostomy data. The sensing module may provide a modular solution configured to support adaptability, usability, and functionality of ostomy devices. As used herein, an ostomy device may include a lid, pouch, adapter, and / or other component configured to couple to the ostomy implant. In some embodiments, the sensing module comprises one or more sensors arranged to sense one or more parameters relevant to operation of the ostomy implant and / or an associated ostomy device and to output one or more sensor signals representative of such parameters. In other embodiments, additionally or alternatively, the sensing module is configured to operatively communicate with one or more sensors that are not comprised in the sensing module, for example one or more sensors provided in the ostomy implant and / or in an ostomy device attached thereto, such as a lid or pouch. Insuch embodiments, the sensing module may be configured to obtain sensor signals via electrical coupling, inductive coupling, capacitive coupling, and / or wireless coupling. The sensing module may be detachably secured to the ostomy implant and / or the ostomy device, and / or integrated into or form at least a portion of the ostomy device in some embodiments.

[0019] The one or more sensors may generate one or more sensor signals, where a sensor signal may comprise an electrical, optical, mechanical, or other signal output by a sensor in response to a sensed condition. The sensing module may obtain, sample, and / or store the sensor signal as sensor data, which may include analog values and / or digitized values (e.g., time-series samples) corresponding to the sensor signal. The one or more sensors and / or sensor signals may be used to generate ostomy data, which may include sensor data and / or other data derived therefrom, and which may include data indicative of physiological conditions (e.g., pressure, temperature, waste consistency, electrical conductivity, and / or pH), device state (e.g., attachment security, seal integrity, open / closed state, pressure variation, and / or leakage-indicative measurements), and / or user activity (e.g., movement and / or interactions with the ostomy device). The ostomy data may be used to provide information indicative of operating conditions of the ostomy implant and / or an associated ostomy device and may be used to generate outputs such as event logs and / or notifications. For example, pressure-related data may be indicative of waste accumulation, gas accumulation, and / or flow restriction, and temperature-related data may be indicative of temperature variation at or near an implant site and / or in a waste flow path. Processing of sensor data and / or ostomy data may be performed by the sensing module and / or by an external device after transmission or retrieval of the data.

[0020] "Physiological conditions", as used herein, refer to measurable properties associated with the internal environment of the ostomy implant, bodily waste, and related biological factors, including but not limited to pressure, temperature, viscosity, fluid volume, electrical conductivity, gas presence, acoustic impedance, pH, and turbidity, and / or an indication of leakage. These conditions may reflect both waste characteristics and physiological changes within the ostomy system, for example internal pressure variations that may be indicative of peristaltic activity, gas accumulation, restricted flow, or abnormal waste consistency. Additionally, physiological conditions may encompass biochemical or metabolic indicators relevant to hydration status, digestive health, inflammation, and / or infection."Device state", as used herein, refers to data collected regarding the operational condition, identity, and / or configuration of an ostomy device within the ostomy system. This includes, but is not limited to, seal integrity, attachment security, device position, internal pressure variations, signs of wear or malfunction, authentication of the ostomy implant and / or sensing module, and / or whether the ostomy device is in an open or closed state. Device-state data may be directly measured by one or more sensors and / or derived from sensor signals, and in some cases may be indicative of, or correlated with, one or more physiological conditions.

[0021] "User activity", as used herein, refers to data collected regarding a user’s state and activity in relation to the ostomy device, including but not limited to device usage patterns, opening and closing cycles, and / or the user’s physical movement, rest periods, positional state, or changes in posture. User-activity data may be used to assess how and when the ostomy device is accessed, identify usage patterns, and / or identify correlations between user state and activity, ostomy function, and health conditions. In some embodiments, the sensing module may monitor positional changes, activity levels, and / or prolonged inactivity to provide information regarding mobility and / or device usage.

[0022] “Detachable" or "Detachably Secured", as used herein, refers to a configuration in which the sensing module is configured to be affixed to, and intentionally removed from, an ostomy device and / or an ostomy implant without requiring destructive force or permanent modification. A detachably secured component is configured to remain affixed under expected operating conditions, such as normal use, patient movement, and routine handling, while permitting intentional removal, reattachment, or replacement by a user or caregiver using a non-destructive detachment mechanism. Such detachment mechanisms may include, for example, mechanical fasteners (e.g., clips, snap-fit connectors, or latches), magnetic couplings (e.g., retention magnets or polarized locking magnets), and / or interfacing structures that facilitate secure engagement and disengagement, such as adapters or mounting features. Other reversible attachment systems may also be used, provided they allow repeated detachment and reattachment without substantially compromising the integrity or functionality of the sensing module or the ostomy device. A detachably secured component may be configured to allow intentional removal and reattachment, in contrast to certain permanently affixed or integrated components.As used herein, a sensing element (also referred to as sensors in some embodiments) refers to any component, structure, or functional portion configured to detect, measure, or respond to a physical, chemical, electrical, mechanical, thermal, magnetic, or optical condition and to generate a signal indicative of such condition. A sensing element may generate an electrical signal directly or may modify a property (e.g. resistance, capacitance, inductance, optical transmission, resonance, or magnetic field) that can be detected or read out by associated circuitry.

[0023] A sensing element may be configured to detect, for example, a device state, a user interaction, and / or a physiological or functional condition associated with an ostomy implant, including but not limited to position, movement, opening or closing of a lid or closing part, attachment or sealing state, pressure, temperature, gas presence, fluid presence, electrical conductivity, pH, viscosity, or leakage-indicative conditions.

[0024] A sensing element may be arranged in or on a sensing module, in or on a lid or closing part, and / or in or on an ostomy implant, and may be positioned to be exposed to, or in fluid communication with, an internal lumen of the ostomy implant during use. As used herein, the term “internal lumen” refers to an internal passage and / or volume of the ostomy implant configured to convey waste and / or gas.

[0025] In some embodiments, a sensing element does not comprise active electronics and may be implemented as a passive structure, such as an electrode, conductive region, resistive or capacitive element, magnetic element, mechanical feature, membrane, or optical feature, configured to be read out by a sensing module.

[0026] The sensing module may include a power source. The power source can be configured to supply energy to the sensors and other components of the module. In some embodiments, the power source may comprise a rechargeable battery, a supercapacitor, or an energy harvesting system. These configurations can enhance the usability of the module by providing reliable energy while minimizing the need for frequent maintenance or replacement.

[0027] The sensing module may further include a communication interface. This interface can enable the transmission of the collected ostomy data to an external device, such as a smartphone, a dedicated monitor, or a healthcare management system. The communication interface may employ wireless protocols, such as Bluetooth LowEnergy (BLE), Near-Field Communication (NFC), or other similar standards, to facilitate data transmission while maintaining energy efficiency.

[0028] The sensing module may be configured to be detachably secured to an open end of the ostomy implant. This detachability can allow the sensing module to be connected directly to the implant or indirectly via an intermediate ostomy device, such as a lid or pouch. The detachable configuration may facilitate maintenance, cleaning, and replacement of the module, while also enabling compatibility with various ostomy devices and configurations. This adaptability can enhance the practicality of the sensing module and support diverse user needs.

[0029] In one embodiment of the present disclosure, the sensing module may be configured to be detachably secured to an ostomy device, such as a lid for the ostomy implant or an ostomy pouch. This configuration may allow the sensing module to interface with an intermediate device that is connected to the ostomy implant, thereby providing a flexible and adaptable approach for integrating sensing functionality without requiring permanent modification of the ostomy device structure.

[0030] By allowing the sensing module to be removed while the ostomy device remains in place, this arrangement may enable continued use of the ostomy device when the sensing module is detached. For example, the ostomy device may continue to perform one or more primary functions, such as covering the stoma, sealing the ostomy implant, and / or collecting waste, even when the sensing module is detached. This may be beneficial in situations where the sensing module is charged, serviced, calibrated, updated, or replaced, since the user may remove the sensing module without necessarily removing or replacing the ostomy device.

[0031] The ability to detach the sensing module may also support situational or selective monitoring, where the user may choose when to engage sensing functionality. For example, the sensing module may be attached during selected activities, such as physical exercise, sleep, or when the user experiences gastrointestinal symptoms, and detached at other times. This flexibility may improve user experience compared to solutions in which monitoring electronics are fixedly integrated with the ostomy device. Additionally, the detachable configuration may facilitate independent maintenance and servicing of the sensing module. The sensing module may be removed for cleaning, sensor calibration, firmware and / or software updates, and / or replacement withoutrequiring handling of the entire ostomy device. This may be advantageous, for example, where the ostomy device is adhered to skin for extended periods or where replacement of the ostomy device is inconvenient or undesirable.

[0032] In some embodiments, separating the sensing module from the ostomy device may also reduce mechanical wear on the ostomy device. For example, repeated handling associated with charging or servicing may be applied primarily to the sensing module rather than the ostomy device, which may help preserve the structural integrity and longevity of the ostomy device.

[0033] In some embodiments, the detachable configuration may reduce long-term replacement costs by allowing the sensing module to be replaced, upgraded, or serviced independently of the ostomy device. For example, a user may avoid replacing the entire ostomy device in situations where servicing or replacement of the sensing module alone is sufficient. This may be relevant where the ostomy device and the sensing module have different service lifetimes.

[0034] Additionally, in some embodiments, attachment of the sensing module to an ostomy device may support standardized and / or interchangeable sensing solutions. For example, a sensing module may be configured to be used with multiple ostomy devices, such as different lids or pouches, which may improve compatibility across device configurations and reduce the need for multiple sensing modules. As used herein, a lid may refer to any component configured to close and / or seal an opening of the ostomy implant and may be detachably secured to the ostomy implant; in some embodiments, the lid comprises a base portion and a closing portion movable relative to the base portion, and in some embodiments the sensing module forms all or part of the lid.

[0035] The sensing module may be detachably secured to an ostomy device in a variety of configurations. In some embodiments, the sensing module may be attached to a lid for the ostomy implant, for example to a base portion of the lid and / or to a closing portion configured to move relative to the base portion to selectively open or close the ostomy device. In other embodiments, the sensing module may form at least part of the closing portion while remaining detachably secured. In further embodiments, the sensing module may be secured to an ostomy pouch or to another component of an ostomy device positioned adjacent to the ostomy implant.Detachable securement of the sensing module to the ostomy device, or to an intermediate adapter, may be achieved using one or more releasable attachment mechanisms. Such mechanisms may include, for example, mechanical coupling, magnetic coupling, adhesive coupling, elastic coupling, and / or other attachment techniques configured to allow intentional attachment and removal of the sensing module. The specific attachment mechanism may be selected based on device configuration, manufacturing considerations, and intended use.

[0036] In some embodiments, the sensing module may comprise a mounting interface configured to detachably engage a corresponding receiving interface on an ostomy device to provide detachable securement. As used herein, a mounting interface may include one or more mechanical features, magnetic elements, adhesive regions, and / or alignment structures configured to enable repeatable attachment and removal of the sensing module, and a receiving interface may comprise complementary features on the ostomy device. The mounting interface and the receiving interface may be integrated into the sensing module and the ostomy device, respectively, or may be provided via an adapter and / or retrofit component. The sensing module may be positioned externally on the ostomy device and / or within a compartment or recess of the ostomy device, and may optionally interface with a docking structure configured to facilitate attachment, removal, and reattachment of the sensing module.

[0037] In some embodiments, the sensing module may comprise a mounting interface configured to engage with a corresponding receiving interface on an ostomy device to provide detachable securement. The mounting interface and the receiving interface may be integrated into the sensing module and the ostomy device, respectively, or may be provided via an adapter and / or retrofit component. The sensing module may be positioned externally on the ostomy device and / or within a compartment or recess of the ostomy device, and may optionally interface with a docking structure configured to facilitate attachment, removal, and reattachment of the sensing module.

[0038] In one embodiment of the present disclosure, the ostomy device to which the sensing module is detachably secured comprises a lid configured to be detachably secured to an open end of an ostomy implant. The lid may be configured to function independently of the sensing module while providing an interface for attachment of the sensing module.The lid may be configured to close and / or seal the open end of the ostomy implant. In some embodiments, the sealing function is provided independently of the sensing module, such that the ostomy device maintains its primary function regardless of whether the sensing module is attached. In other embodiments, the sensing module may contribute to the sealing function when secured to the lid, for example by forming part of, or applying force to, a closure structure.

[0039] The lid may further serve as a support structure for the sensing module. The sensing module may be positioned on a base portion of the lid configured to interface with the ostomy implant and / or on a movable closure portion of the lid, such as a sliding, rotating, or pivoting element configured to selectively open and close access to the ostomy implant. In some embodiments, the sensing module may form part of, or the entirety of, the movable closure portion while remaining detachably secured.

[0040] In some embodiments, the lid may include one or more interface components configured to interact with the sensing module when attached, such as conductive elements, contacts, coupling features, and / or alignment structures configured to enable electrical coupling, power transfer, and / or data exchange between the lid and the sensing module.

[0041] In some embodiments, at least a portion of the sensing module may be implemented using printed electronics on a flexible and / or disposable substrate. Such implementations may provide a lightweight and scalable sensing solution suitable for disposable and / or periodically replaceable applications. Printed electronics may include conductive traces, sensing elements, power storage components, and / or communication circuitry formed on a flexible substrate.

[0042] In such embodiments, the sensing module may be configured to conform to different ostomy device geometries and may include sensors configured to collect ostomy data indicative of physiological conditions, device state, and / or user activity. The sensing module may be configured for low-power operation and may include a power source and / or energy-harvesting circuitry, as well as communication circuitry configured to transmit data wirelessly to an external device.

[0043] The sensing module may be attached to the ostomy device using one or more releasable attachment techniques, including adhesive attachment, mechanical attachment, magnetic attachment, and / or combinations thereof. In some embodiments,the sensing module may be implemented as a printed or flexible patch configured to attach to a surface of an ostomy device, while in other embodiments the sensing module may interface with a dedicated mounting structure provided by the lid or another ostomy device component.

[0044] This configuration supports a modular sensing module that may be selectively attached to an ostomy device, removed for servicing or replacement, and used across different ostomy device configurations, supporting both reusable and disposable monitoring implementations.

[0045] In one embodiment of the present disclosure, the sensing module may be provided as, or integrated into, an ostomy device, such as an ostomy pouch, a lid, a cap, a plug, or another ostomy-related device, and may be configured to be detachably secured to an open end of an ostomy implant. In such embodiments, the sensing module may form part of the ostomy device itself and may integrate waste-management functionality and sensing functionality in a single unit.

[0046] In some embodiments, the sensing module may alternatively be provided as part of an ostomy pouch. In such configurations, the pouch may comprise one or more sensing elements configured to collect ostomy data, for example data indicative of pressure, temperature, waste level, waste consistency, and / or gas presence. The pouch may be detachably secured to the ostomy implant using one or more releasable attachment mechanisms, such as mechanical engagement, adhesive coupling, frictional engagement, magnetic coupling, and / or combinations thereof. One or more sensing elements may be positioned at locations selected to monitor conditions within the pouch and / or at an interface between the pouch and the ostomy implant.

[0047] In some embodiments, an ostomy device comprising the sensing module may include a controllable outlet, valve, or drainage feature configured to allow selective release of waste. The sensing module may be configured to collect data indicative of conditions associated with such release, for example fluid level, pressure, or flow-related parameters. Such features may be manually actuated and / or controlled via interaction with an external device, without requiring removal of the ostomy device.

[0048] In other embodiments, the sensing module may be implemented as, or integrated into, a lid, cap, or plug configured to close and / or seal the open end of the ostomy implant. In such embodiments, the sensing module may incorporate one or more sensorsconfigured to collect data indicative of pressure buildup, leakage-related conditions, temperature variations, and / or other operational states of the ostomy system. In some embodiments, the sensing module may be arranged to cooperate with a venting, filtration, or gas-release element of the ostomy device, allowing collection of data indicative of gas presence and / or pressure changes.

[0049] In further embodiments, the sensing module may be configured for use with an ostomy device adapted for irrigation or cleansing procedures. In such embodiments, the sensing module may be configured to collect data indicative of fluid introduction, removal, pressure, flow rate, and / or temperature during irrigation, while remaining detachably secured to the ostomy device.

[0050] The sensing module may be secured to the ostomy device using one or more releasable attachment mechanisms, including threaded connections, snap-fit couplings, friction-based locking systems, adhesive interfaces, magnetic couplings, mechanical latches, and / or combinations thereof. In some embodiments, the sensing module may interface with a removable compartment or docking structure of the ostomy device, allowing replacement, upgrading, or servicing of the sensing module without replacing the entire ostomy device.

[0051] The sensing module may comprise a power source and a communication interface configured to transmit collected data to one or more external devices (i.e., devices external to the sensing module and the ostomy implant), such as smartphones, wearable devices, or clinical monitoring systems. In some embodiments, the power source may comprise a rechargeable power source and / or an energy-harvesting system. In some embodiments, the sensing module may be battery-less and the power source may comprise an RF energy-harvesting circuit configured to harvest energy from an interrogation field or wireless power signal transmitted by an external device, optionally in combination with a capacitor or supercapacitor configured to store harvested energy. The sensing module may be configured to operate continuously, intermittently, or according to a predefined schedule, depending on powermanagement considerations, and / or to operate on-demand in response to a prompt or interrogation from an external device.

[0052] The sensing module may be adapted for use with a variety of ostomy devices and device configurations while maintaining detachability and sensing functionality. As used herein, an ostomy device may include a lid, pouch, adapter, and / or other componentconfigured to couple to an ostomy implant and to manage waste flow and / or sealing. In some embodiments, the sensing module is arranged to collect data indicative of a device state of the ostomy implant and / or the ostomy device, including operational condition, status, and / or configuration information such as an open or closed state, seal integrity, attachment security, leakage-indicative conditions, internal pressure variation, fluid accumulation, gas buildup, temperature variation, wear or malfunction, and / or device identification. Such device state data may be stored and / or transmitted to an external device as ostomy data.

[0053] In one embodiment of the present disclosure, the sensing module may be provided as an ostomy device in the form of a lid. The lid may be configured to selectively open or close the open end of the ostomy implant without requiring detachment from the ostomy implant. The opening and closing functionality may be achieved through one or more movement mechanisms, including sliding, rotating, pivoting, lifting, expanding, contracting, or deforming structures. In some embodiments, the lid may comprise a movable closure portion configured to transition between open and closed states while remaining attached to the ostomy implant.

[0054] In some embodiments, the sensing module may be configured to detect whether the lid is in an open state or a closed state. Such detection may be achieved using one or more sensors, including magnetic, capacitive, mechanical, optical, and / or thermal sensors. By way of example, a magnetic element (e.g., a magnet) may be arranged on a movable closure portion or closing part and a magnetic field sensor (e.g., a Hall sensor or reed switch) may be arranged on a base portion of the lid and / or the sensing module such that relative movement between the open and closed states produces a change in a sensed magnetic field. In other examples, capacitive electrodes may be arranged on opposing portions of the lid such that capacitance varies with position; a mechanical switch or contact element may indicate latch engagement; an optical emitter / detector pair may indicate a blocked or unblocked condition; and / or a thermal sensor may detect temperature transients or airflow-related differences associated with a sealed versus unsealed state. Data indicative of the open or closed state may be stored and / or transmitted to an external device.

[0055] In one embodiment of the present disclosure, the sensing module may comprise or consist of a closing part (as defined herein), the closing part being operable to selectively switch the ostomy device between an open state and a closed state whileremaining attached to the ostomy implant. The closing part may be implemented as an integrated component of the sensing module and / or as part of an ostomy device to which the sensing module is attached.

[0056] As used herein, a closing part refers to any movable and / or deformable portion configured to selectively permit or inhibit flow through an opening or passage of the ostomy implant and / or an associated ostomy device, and may be implemented as part of the sensing module, as part of a lid or pouch, or as a separate component coupled thereto.

[0057] The closing part may be configured to close or seal off the open end of the ostomy implant either directly, by engaging the open end of the ostomy implant, or indirectly, by sealing a passageway or through-hole of an ostomy device attached to the implant. The closing part may transition between open and closed states through sliding, pivoting, rotating, expanding, contracting, or deforming motion, depending on the configuration of the ostomy system.

[0058] In one embodiment of the present disclosure, the sensing module may be configured to determine whether the open end of the ostomy implant is in an open state or a closed state. Such determination may be based on a position of a closing part relative to the open end of the ostomy implant and / or based on whether a passage of an ostomy device coupled to the implant is sealed. Various sensing technologies may be used to provide data indicative of the open or closed state, including magnetic sensing, capacitive sensing, mechanical sensing, optical sensing, and / or thermal sensing. The sensing module may be configured to collect ostomy data comprising data indicative of a status of the closing part, and such data may be stored and / or transmitted to an external device. In some embodiments, the data indicative of the open or closed state may be used to generate notifications, user feedback, and / or to support remote monitoring or system integration.

[0059] In some embodiments, magnetic sensing may be used to determine whether the closing part is in an open or closed position. For example, one or more magnetic elements may be positioned on the closing part and a corresponding magnetic sensor may be positioned on the ostomy device, the implant, and / or the sensing module, such that movement of the closing part produces a change in a sensed magnetic field.In some embodiments, capacitive sensing may be used, for example by measuring changes in capacitance associated with movement of the closing part between open and closed positions. Capacitive sensing may be implemented using one or more conductive elements arranged on or near the closing part and / or a corresponding region of the ostomy device.

[0060] In some embodiments, mechanical sensing may be used, for example by detecting contact, engagement, or latch position associated with the closing part reaching an open or closed position. Mechanical sensing may include switches, contact elements, or other position-indicating structures.

[0061] In some embodiments, optical sensing may be used to determine the state of the closing part, for example using reflectance-based detection, break-beam detection, and / or other optical techniques configured to indicate whether the closing part blocks an opening or seals a passage.

[0062] In some embodiments, thermal sensing may be used to provide data indicative of a sealed or unsealed state, for example by detecting temperature differences and / or thermal transients associated with airflow, exposure, or sealing at or near the open end of the ostomy implant.

[0063] In one embodiment of the present disclosure, at least a part of the one or more sensors may be arranged on a surface of the closing part that is positioned to be exposed to, or in fluid communication with, the open end of the ostomy implant when the closing part is in the closed state. Such sensor placement may allow collection of ostomy data indicative of conditions at an interface between the ostomy implant and the ostomy device.

[0064] The closing part may be arranged in various orientations depending on the geometry of the ostomy device. In some embodiments, the closing part may abut a portion of the open end of the ostomy implant to inhibit leakage and / or to establish a defined interface for sensing.

[0065] In other embodiments, the ostomy device may comprise an internal through-hole or passageway configured to redirect a waste flow path, such that the closing part does not directly face the open end of the ostomy implant but instead provides indirect closure. In such configurations, the closing part may be positioned within a curved,angled, or otherwise redirected passage while still inhibiting flow through the open end of the ostomy implant. One or more sensors may remain in fluid communication with the open end of the implant via the passageway.

[0066] In such embodiments, sensors may be positioned to collect data indicative of one or more parameters, such as pressure, temperature, gas presence, liquid accumulation, and / or leakage-related conditions. Where the closing part provides indirect sealing via an internal passage, one or more sensors may be arranged in connection with the passageway to collect data indicative of upstream conditions, such as flow restriction, accumulation, or pressure changes.

[0067] By allowing sensor placement on surfaces that are exposed to, or in fluid communication with, the open end of the ostomy implant, the sensing module may be implemented across a range of ostomy device geometries without being limited to a particular configuration, while still enabling collection of relevant ostomy data.

[0068] In one embodiment of the present disclosure, the closing part may comprise a sealing mechanism configured to inhibit fluid and / or gas flow when the closing part is in the closed state. The sealing mechanism may be arranged to interact with the open end of the ostomy implant and / or with a passage or interface of an ostomy device attached to the implant.

[0069] The sealing mechanism may be implemented using one or more sealing structures, including compression-based seals, gasket-type seals, magnetic sealing arrangements, and / or flexible membrane-based sealing structures. Such sealing structures may be configured to accommodate repeated transitions between open and closed states and to adapt to variations in device geometry or internal conditions. In some embodiments, compression-based sealing structures may be used, for example comprising deformable materials configured to conform to a mating surface of the ostomy implant or an internal passage of the ostomy device. In other embodiments, gasket-type seals or ring-shaped sealing elements may be used to provide engagement between the closing part and a corresponding sealing surface. In further embodiments, magnetic sealing arrangements and / or flexible membrane-based sealing structures may be used to provide contactless or adaptive closure.In some embodiments, the sensing module may be configured to collect data indicative of seal performance or seal integrity. For example, one or more sensors may be arranged to collect data indicative of pressure changes, flow conditions, or leakage-related conditions associated with the sealing mechanism. Such data may be stored and / or transmitted to an external device for further processing or presentation.

[0070] In a further aspect, the present disclosure relates to a sensing module for an ostomy system (for example including an ostomy implant and optionally a lid attachable thereto), wherein the sensing module comprises an energy-harvesting system configured to generate electrical energy from one or more ambient energy sources to supply energy to at least a portion of the sensing module.

[0071] This aspect may be implemented independently or in combination with any of the other aspects, embodiments, features, and configurations described herein. In particular, the energy-harvesting system may be implemented in sensing modules configured to be detachably secured to an ostomy implant and / or a lid, sensing modules configured to operatively communicate with one or more sensors provided in the implant and / or lid (optionally including sensors exposed to an internal lumen of the ostomy implant), sensing modules configured to detect an open or closed state of an ostomy device, and sensing modules configured for wireless communication, authentication, and / or alert generation, without being limited thereto.

[0072] In one embodiment of the present disclosure, the power source of the sensing module may comprise a rechargeable battery, a supercapacitor, a hybrid power source, and / or an energy-harvesting system. The selection of the power source may depend on energy requirements, intended operating mode, and device configuration. In some embodiments, the power source may comprise a rechargeable battery, which may be integrated with the sensing module or replaceable, and may be rechargeable via wired and / or wireless charging. In some embodiments, the power source may comprise a supercapacitor, for example to support rapid charge and discharge and / or to buffer power consumption. In some embodiments, the power source may be a hybrid power source combining two or more energy-storage elements, for example a rechargeable battery and a supercapacitor.

[0073] In some embodiments, the sensing module may additionally or alternatively comprise an energy-harvesting system configured to generate electrical energy from one or more ambient energy sources. In some embodiments, the energy-harvesting system maycomprise an energy transducer configured to convert an ambient energy source into an electrical signal, and power-conditioning circuitry configured to convert the electrical signal into a usable supply for the sensing module. The power-conditioning circuitry may comprise, for example, one or more of a rectifier, a charge pump, a DC-DC converter, a voltage regulator, and / or a power-management unit configured to control charging of an energy-storage element and distribution of power to one or more loads of the sensing module. For example, a piezoelectric transducer may be coupled to a rectifier and an energy-storage element, and a DC-DC converter and / or voltage regulator may provide a regulated supply rail for one or more sensors and / or a communication event (e.g., an NFC and / or BLE transmission burst).

[0074] In some embodiments, harvested energy may be used to directly supply energy to one or more functions of the sensing module and / or stored in an energy-storage element (e.g., a capacitor, supercapacitor, and / or rechargeable battery) for later use. In some embodiments, the sensing module may be configured to operate in an intermittent mode in which sensor measurements, processing operations, and / or wireless transmissions are performed when sufficient stored energy is available. In some embodiments, the sensing module may store ostomy data locally and transmit the ostomy data periodically and / or in response to an external interrogation (e.g., via NFC) to reduce average power consumption. In some embodiments, an operating mode (e.g., sampling rate, transmission frequency, and / or sensor duty cycle) may be adjusted based on an available harvested energy level and / or a state-of-charge of an energy-storage element.

[0075] In one embodiment of the present disclosure, the energy-harvesting system may be configured to generate electrical energy from thermal gradients, mechanical movement, piezoelectric activity, triboelectric effects, electromagnetic induction, galvanic reactions, solar energy, radiofrequency energy, enzymatic sources, and / or combinations thereof. The harvested energy may be conditioned and used to supplement stored energy and / or may extend an operational lifetime of the sensing module between charging or replacement events.

[0076] In some embodiments, thermal-gradient energy harvesting may be implemented using one or more thermoelectric elements configured to convert a temperature difference between a body-facing region and an external region into electrical energy. In some embodiments, mechanical-energy harvesting may be implemented using piezoelectric,triboelectric, and / or electromagnetic mechanisms configured to convert deformation, vibration, and / or pressure variation into electrical energy. In some embodiments, galvanic energy harvesting may be implemented using electrochemical reactions involving waste fluids and / or electrolytes. In some embodiments, solar energy harvesting may be implemented using one or more photovoltaic elements. In some embodiments, radiofrequency energy harvesting may be implemented using an antenna and associated circuitry configured to receive energy from an external electromagnetic field, for example from an NFC reader and / or other RF sources. In some embodiments, enzymatic energy harvesting may be implemented using biochemical reactions to generate electrical energy.

[0077] In one embodiment of the present disclosure, the energy-harvesting system may be configured to generate electrical energy based on user movement and / or physiological motion, such as walking, general body motion, and / or peristaltic activity. For example, one or more harvesting elements may be positioned on or within the sensing module and / or an associated ostomy device in a region configured to experience periodic movement and / or pressure variation during use, such that mechanical energy may be converted to electrical energy and used to charge an energy-storage element and / or supply energy for one or more sensor measurements and / or communication events.

[0078] Example energy-harvesting embodiment

[0079] In one non-limiting example embodiment, the energy-harvesting system comprises a mechanical energy harvester configured to generate electrical energy from periodic motion and / or pressure variation associated with user movement and / or physiological motion. The mechanical energy harvester may comprise a piezoelectric element arranged to deform in response to movement of the sensing module and / or an associated ostomy device during use, for example a lid, adapter, or mounting structure to which the sensing module is detachably secured.

[0080] The electrical output of the piezoelectric element may be coupled to power-conditioning circuitry comprising a rectifier and a charge-storage element, such as a capacitor or supercapacitor. The stored energy may be supplied to a voltage regulator and / or DC-DC converter configured to provide a regulated supply voltage to one or more components of the sensing module, for example one or more sensors, an analog frontend, a controller (e.g., an MCU and / or an NFC controller), and / or a communication interface.In this example, the regulated supply may be used to power one or more sensor measurements and / or a wireless communication event, such as an NFC interrogation response or a short-range radio transmission. The sensing module may be configured to accumulate harvested energy over time and perform sensing, processing, and / or communication operations when a stored energy level and / or a state-of-charge of an energy-storage element meets an operating condition, for example to support intermittent measurement and / or transmission bursts while maintaining reduced average power consumption.

[0081] This example embodiment may be implemented alone or in combination with an energy-storage element such as a rechargeable battery, such that harvested energy supplements stored energy and may reduce reliance on external charging.

[0082] In one embodiment of the present disclosure, the sensing module may include an energy management system configured to optimize power consumption and / or prolong operational life. The energy management system may be designed to regulate power distribution and / or reduce unnecessary energy use, such that the sensing module may operate efficiently over extended periods, for example with reduced reliance on frequent recharging or maintenance.

[0083] The energy management system may control power allocation based on energy availability and system demands. In some embodiments, the system may switch between different energy storage solutions, such as a rechargeable battery, a supercapacitor, or a hybrid power source, depending on current power levels and / or operating requirements. Additionally, the system may integrate one or more energy harvesting sources, including mechanical movement, thermal gradients, and / or RF-based energy harvesting, such that available energy may be utilized based on user activity and / or environmental conditions.

[0084] To further enhance efficiency, the energy management system may implement one or more power-saving features, including duty cycling, adaptive sensing modes, and / or low-power standby states. In such embodiments, one or more sensors, processing functions, and / or communication functions may be operated intermittently and / or at different activity levels depending on an operating mode of the sensing module.

[0085] The energy management system may support asynchronous or event-based wake-up from standby or deep sleep modes, allowing the sensing module to remain in a low-power state until activated by a relevant event. Wake-up triggers may include sudden pressure peaks, significant mechanical movements, and / or other physiological or environmental changes. In some embodiments, such triggers may be detected by one or more low-power and / or passive sensing elements, such as piezoelectric elements, pressure transducers, or similar components, which may generate a signal to activate a trigger input, thereby causing the sensing module to wake up and commence sampling at an elevated data rate.

[0086] Such an approach may enable the system to record and analyze short-duration events that may otherwise be under-sampled during lower-duty monitoring. For example, sneezing, coughing, sudden body movements, or external impacts can cause transient pressure fluctuations within the intestinal tract, which may be indicative of conditions affecting bodily tissues, the implant, and / or sealing integrity of the device. The ability to capture and process such transient events may support monitoring and / or generation of ostomy data indicative of device state and / or physiological conditions.

[0087] In some embodiments, duty cycling may be used to reduce power consumption by operating one or more sensors intermittently rather than continuously. This method may allow the sensing module to alternate between active measurement periods and low-power inactive phases while maintaining collection of ostomy data.

[0088] In some embodiments, adaptive sensing modes may be implemented, where a sampling frequency of one or more sensors is adjusted based on detected conditions. For instance, if sensor readings remain stable over a period of time, the system may reduce a sampling rate to reduce power consumption, whereas if the system detects fluctuations in one or more parameters, it may increase a sampling rate to capture higher-resolution data for a period of time.

[0089] In some embodiments, the wake-up event may be generated by a comparator or threshold circuit coupled to the sensing element, and may be used to enable a sensor front-end, a processor, and / or a communication interface for a predetermined period and / or until an operating condition is met.

[0090] Additionally, the energy management system may implement low-power standby states, where non-essential functions are temporarily disabled when no immediate sensing, processing, or data transmission is required. This may involve switching off or placing into a low-power mode one or more wireless communication modules, reducingprocessor activity, and / or deactivating one or more sensors until reactivation is triggered by an external event and / or a scheduled wake-up cycle.

[0091] In some implementations, the energy management system may incorporate predictive and / or adaptive algorithms to analyze historical energy availability and adjust power distribution accordingly. For example, if the system anticipates higher energy harvesting levels during certain periods (e.g., increased movement during active periods and / or increased light exposure), it may schedule comparatively powerintensive functions, such as wireless data transmission and / or higher-rate sensing, to align with periods of increased available energy.

[0092] In one embodiment of the present disclosure, the sensing module may be configured for wireless charging. The sensing module may, for example, comprise components for inductive and / or capacitive charging, or components for other types of wireless charging. Wireless charging may allow the sensing module to be recharged without requiring exposed physical connectors, which may reduce user handling and / or reduce contamination risk in medical environments.

[0093] In some embodiments, inductive charging may be employed, where a coil embedded in the sensing module receives power from an external inductive transmitter, for example an NFC-based charger and / or another inductive charging system. This charging method may be beneficial for low-profile sensing modules where space constraints limit the use of wired charging ports and / or where the sensing module is housed in a sealed enclosure.

[0094] Alternatively, capacitive charging may be utilized, where power is transferred via electric fields between conductive elements, enabling contactless power transfer without requiring precise alignment. This approach may be particularly useful in cases where the sensing module is sealed in a protective enclosure to support sterility and / or durability.

[0095] In some implementations, the sensing module may support multiple charging modes, allowing for both wired and wireless power input to accommodate different usage scenarios. Additionally, the wireless charging system may be integrated with an energy management system, such as disclosed herein, to regulate power intake, manage charging of one or more energy-storage elements, and / or optimize charging efficiency.In one embodiment of the present disclosure, the communication interface of the sensing module may be configured to transmit ostomy data wirelessly using one or more short-range communication protocols, including low-energy radiofrequency communication, near-field communication (NFC), and / or other wireless communication standards. Wireless data transmission may allow for on-demand and / or periodic monitoring, and integration with external devices, such as smartphones, wearable monitors, healthcare management systems, and / or cloud-based platforms.

[0096] The low-energy radiofrequency communication may include Bluetooth Low Energy (BLE), Zigbee, proprietary low-power radiofrequency (RF) protocols, and / or other short-range wireless protocols, allowing for transmission of ostomy data with reduced energy consumption. Such methods may be suitable for embodiments in which the sensing module periodically transmits ostomy data and / or transmits data in response to detected events.

[0097] In some embodiments, NFC may be utilized, enabling contactless data transfer and / or power transfer when the sensing module is placed near a compatible NFC reader. This approach may be particularly useful for intermittent data retrieval, for example when a user scans the sensing module with a mobile device, and / or for embodiments in which the sensing module transmits data in response to an interrogation.

[0098] Additionally, the communication interface may support other wireless communication standards, such as Wi-Fi, ultra-wideband (UWB), and / or radiofrequency identification (RFID), depending on desired transmission range, energy constraints, and system configuration. By implementing one or more wireless communication methods, the sensing module may support flexible connectivity and / or energy-efficient data transfer. In one embodiment of the present disclosure, the sensing module may be configured to transmit ostomy data to an external device in response to a prompt from the external device. This communication approach may reduce average power consumption, for example by transmitting data when requested rather than continuously. The external device, such as a smartphone, wearable monitor, or clinical monitoring system, may send a data request signal to the sensing module. Upon receiving the request, the sensing module may transmit relevant ostomy data, which may include sensor readings, timestamps, processed data derived from sensor data, and / or device state information.The prompt-based data transmission may be implemented using various communication protocols, including low-energy Bluetooth, NFC-based interrogation, and / or RFID-based techniques, depending on energy and connectivity requirements. In some embodiments, the external device may automatically schedule periodic data requests, and / or the user may manually trigger a request via an application interface and / or a dedicated hardware input.

[0099] In one embodiment of the present disclosure, the sensing module may comprise a data storage unit configured to store ostomy data. The data storage unit may be implemented using non-volatile memory, such as flash storage, EEPROM, and / or other solid-state storage solutions, such that data may remain available if power is lost and / or if wireless transmission is temporarily unavailable.

[0100] The stored ostomy data may include historical sensor readings, timestamps, system status logs, and / or processed data derived from sensor inputs. In some embodiments, the data storage unit may function as a buffer, temporarily storing data before transmission to an external device, for example when wireless connectivity is intermittent. In some embodiments, the data storage unit may support data compression, encryption, and / or selective logging, for example to support efficient memory usage and / or data security. In some implementations, the storage unit may be integrated into the sensing module, and in other implementations it may interface with external storage.

[0101] In one embodiment of the present disclosure, the ostomy data may comprise or consist of one or more of the following: timestamps, raw sensor data, and / or processed data derived from sensor data. The data collected by the sensing module may be used for monitoring, trend analysis, and / or integration into healthcare management systems. The timestamps may indicate when each data point was recorded, enabling chronological tracking of ostomy conditions. This may be useful for identifying trends over time, such as fluctuations in pressure, temperature, and / or waste flow patterns. The raw sensor data may include direct measurements from one or more sensors associated with the sensing module and / or the ostomy system. Such data may capture parameters such as pressure, temperature, viscosity, fluid volume, gas presence and / or composition, leakage-indicative measurements, and / or other physiological conditions and / or device state parameters, providing a snapshot of ostomy conditions.The processed data may be derived from raw sensor inputs, for example using one or more algorithms executed locally in the sensing module and / or in an external device. Processed data may include, for example, filtered and / or aggregated sensor values, trend information, event flags, and / or data indicative of one or more conditions (e.g., data indicative of a leakage event, an overfilling condition, or an abnormal pressure variation). In some embodiments, processed data may further include user notifications and / or recommendations generated based on recorded patterns, without being limited thereto.

[0102] In some embodiments, the sensing module may perform at least a portion of the data processing locally, for example analysis of one or more parameters and / or detection of one or more events, and may generate an output indicative of an abnormal condition. This may enable the sensing module to generate alerts or notifications autonomously and / or to transmit data indicative of the condition to an external device.

[0103] In alternative embodiments, an external device, such as a smartphone, wearable monitor, gateway device, and / or healthcare system, may process the data further. Such external processing may allow for comparatively more advanced analytics, including predictive analysis and / or machine-learning-based processing, for example when such processing is not performed locally in the sensing module. The external device may also be configured to display measurement data, trends, and / or feedback to the user, for example via a user interface configured to present current and / or historical values.

[0104] Additionally, in some configurations, the external device may provide user feedback or guidance based on processed data. This may include recommendations for ostomy management, alerts for conditions indicative of leakage or blockages, and / or suggested adjustments to a user’s care routine. In a healthcare setting, the processed data may be transmitted to medical professionals and / or a remote monitoring system, enabling review of ostomy data and / or remote monitoring when desired.

[0105] By defining the different types of ostomy data that may be collected, processed, stored, and / or displayed, this embodiment supports comprehensive monitoring capabilities while allowing for scalability and integration into various healthcare and user applications.In one embodiment of the present disclosure, the sensing module comprises one or more sensors configured to collect ostomy data. The ostomy data may, for example, comprise physiological conditions, user activity, and / or device state. The sensing module may be arranged to detect, process, store, and / or transmit data relevant to the functioning of an ostomy implant and / or an associated ostomy device. The collected ostomy data may support monitoring and management of ostomy care, for example by enabling detection of irregularities and / or generation of alerts or other outputs based on measured parameters.

[0106] The sensing module may be positioned in direct or indirect fluid communication with the ostomy implant, allowing it to acquire data indicative of internal conditions, operational status, and user interactions. The sensors may be located on an external surface of the sensing module, embedded within its structure, and / or integrated into an ostomy device, such as a lid or pouch, that interfaces with the ostomy implant. In some embodiments, the sensing module may be detachably secured to facilitate maintenance, sensor recalibration, replacement, and / or upgrades without requiring modification or replacement of the ostomy implant itself.

[0107] In some implementations, the sensing module may collect ostomy data continuously, periodically, and / or in response to one or more triggers, such as user actions, environmental changes, and / or detected events. The data may be processed within the sensing module and / or transmitted via a communication interface to an external device, such as a user’s mobile device and / or a healthcare management system. The ability to gather and analyze ostomy data may provide information regarding the status of the ostomy system and may support user confidence and / or caregiver oversight.

[0108] In one embodiment of the present disclosure, the ostomy system may comprise one or more sensors configured to detect physiological conditions associated with the ostomy system. Such physiological conditions may include, for example, pressure, temperature, viscosity, electrical conductivity, gas presence, leakage-indicative measurements, fluid volume, pH, and / or turbidity of liquid waste. The selection, arrangement, and functionality of the one or more sensors may vary depending on the embodiment and configuration of the ostomy system.

[0109] In some embodiments, the sensing module comprises one or more sensors. In other embodiments, additionally or alternatively, the sensing module is configured to operatively communicate with one or more sensors that are not comprised in thesensing module, for example one or more sensors provided in the ostomy implant and / or in an ostomy device (e.g., a lid) attachable to the implant. In such embodiments, the sensing module may function as a communicative and / or readout unit configured to obtain sensor signals and to store and / or transmit ostomy data derived from the sensor signals to an external device.

[0110] The one or more sensors may be positioned within the sensing module, the ostomy device, and / or the ostomy implant. In some embodiments, one or more sensors may be embedded in and / or coupled to the ostomy implant, for example on an internal surface and / or in an internal lumen region configured to contact waste and / or be in fluid communication with the waste flow. In such configurations, the sensing module and / or ostomy device may comprise one or more coupling elements configured to receive, read out, and / or transmit sensor signals associated with the implant-provided sensors. The coupling elements may comprise, for example, one or more electrical contacts, electrodes, conductive traces, connector elements, inductive and / or capacitive couplers, and / or wireless relay components.

[0111] In some embodiments, implant-provided sensors comprise one or more electrodes arranged to contact waste and generate a measurement signal indicative of one or more physiological conditions (e.g., electrical conductivity and / or pH). The sensing module may be detachably secured at or near an open end of the ostomy implant (directly or via a lid) and configured to electrically couple to the electrodes when attached, for example via spring contacts, conductive pads, a connector interface, and / or another readout interface. The sensing module may comprise signalconditioning circuitry (e.g., an analog front-end) configured to obtain and condition the electrode signals, and may further comprise a processor and / or controller configured to generate ostomy data based on the obtained signals. The sensing module may store the ostomy data locally and / or transmit the ostomy data via a communication interface to an external device.

[0112] For embodiments in which one or more sensors are positioned in the sensing module and / or ostomy device, placement may be selected to support measurement while maintaining ease of maintenance and replacement. Sensors intended to measure liquid properties, such as viscosity, electrical conductivity, pH, and / or turbidity, may be positioned in regions where waste tends to accumulate and / or pass during use. For example, one or more such sensors may be positioned in a lower portion of thesensing module and / or lid, for example where liquid waste may tend to collect when the user is upright. In other embodiments, such sensors may be arranged along an internal surface and / or flow path of a lid and / or another ostomy device.

[0113] For sensors that benefit from fluidic communication while limiting direct contact with waste, such as certain pressure sensors and / or gas sensors, one or more sensor elements may be positioned to access airflow and / or pressure variations while limiting exposure to liquids. In some embodiments, such sensor elements may be positioned in an upper region of the sensing module and / or ostomy device where gas may tend to accumulate. In alternative configurations, one or more sensor compartments, venting channels, and / or membrane-based interfaces may be used to provide fluidic communication while isolating a sensor from direct contact with solid and / or liquid waste.

[0114] In some embodiments, one or more leakage-related sensors may be positioned at one or more interfaces, such as a sealing interface between the sensing module and the ostomy implant and / or between a lid and the implant, and / or along one or more edges of an ostomy device. Such sensors may operate based on moisture detection, capacitance variation, conductivity changes, and / or other measurements indicative of the presence of fluid outside an intended containment region. In some implementations, multiple sensor inputs may be used in combination, for example correlating leakage-indicative measurements with pressure and / or temperature measurements to determine an event and / or a condition indicative of leakage and / or reduced seal integrity.

[0115] For implant-integrated sensors, wireless energy transfer and / or signal relay mechanisms may be implemented. In some embodiments, the sensing module and / or ostomy device may supply energy to and / or read out one or more implant-provided sensors using wireless energy transfer methods, such as passive RF communication and / or near-field coupling. This may support embodiments in which implant-provided sensors communicate with a detachable sensing module and / or lid, thereby supporting modularity and upgradeability.

[0116] In one embodiment of the present disclosure, the ostomy system may comprise one or more sensors configured to measure a viscosity and / or consistency of waste, for example to determine a physical state indicative of liquid, semi-solid, solid, and / or gaseous waste. Variations in viscosity and / or consistency may be used to generateostomy data indicative of waste characteristics and / or changes over time. For example, changes in measured viscosity and / or consistency may be indicative of changes in hydration, diet, and / or gastrointestinal conditions, without being limited thereto.

[0117] In some embodiments, the sensing module comprises the viscosity and / or consistency sensor. In other embodiments, additionally or alternatively, the viscosity and / or consistency sensor is provided in the ostomy implant and / or an associated ostomy device (e.g., a lid), and the sensing module is configured to operatively couple to the sensor to obtain measurement signals and store and / or transmit ostomy data derived from the measurement signals.

[0118] The placement of a viscosity and / or consistency sensor may be selected based on waste flow and accumulation patterns. In embodiments where the sensing module is secured to an open end of the ostomy implant (directly or via a lid), the sensor may be positioned in a lower portion of the sensing module and / or lid, for example where waste may tend to collect when the user is upright. In alternative configurations, where the sensor is integrated into a lid or pouch, the sensor may be arranged within a collection region and / or along a flow path such that it interacts with waste as it passes through and / or accumulates. In some embodiments, sensor placement may be selected to reduce interference from gas accumulation, occlusions, and / or inconsistent waste flow.

[0119] The sensor modality used for viscosity and / or consistency measurement may vary depending on system configuration. In some embodiments, viscosity and / or consistency may be determined by measuring resistance to shear and / or deformation, for example using one or more mechanical probes and / or strain-sensitive elements. In other embodiments, optical sensing may be used, for example optical scattering and / or absorption-based methods in which light is transmitted through or reflected from waste material and variations in detected optical characteristics are used as a proxy for consistency. In further embodiments, acoustic and / or ultrasonic techniques may be used, for example transmitting vibrations and analyzing attenuation and / or propagation characteristics. In some embodiments, an electrically and / or mechanically excited vibrating element (e.g., a membrane and / or a piezoelectric transducer) may be used, wherein a resonance characteristic varies with surrounding waste properties. In other embodiments, electrical impedance and / or capacitive sensing may be used, for example using electrodes and / or capacitive elements arranged to measure permittivity and / or conductivity changes associated with different waste states.In one embodiment of the present disclosure, the ostomy system may comprise one or more sensors configured to measure pressure within the ostomy implant and / or an associated ostomy device. Pressure measurements may be used to generate ostomy data indicative of flow conditions, waste accumulation, gas retention, and / or seal integrity, and may be correlated with other sensor measurements.

[0120] In some embodiments, the sensing module comprises one or more pressure sensors. In other embodiments, additionally or alternatively, one or more pressure sensors are provided in the ostomy implant and / or an associated ostomy device (e.g., a lid), and the sensing module is configured to operatively couple to the one or more pressure sensors to obtain pressure measurement signals and store and / or transmit ostomy data derived therefrom.

[0121] The sensing module may be configured to perform continuous, periodic, and / or event-triggered pressure measurements, depending on system requirements. In some embodiments, pressure data may be used to assess internal system status and / or detect pressure variations, for example changes indicative of waste flow resistance, fluid accumulation, gas retention, and / or seal integrity. The collected data may be processed within the sensing module and / or transmitted to an external device via a communication interface, for example for presentation, logging, and / or generation of alerts based on detected conditions.

[0122] The placement of pressure sensors may vary based on integration within the ostomy system. In some embodiments, a pressure sensor may be positioned at or near an open end of the ostomy implant to provide fluidic communication with an internal waste pathway. In alternative configurations, a pressure sensor may be housed in a protected compartment within the sensing module and remain in fluidic communication with the ostomy implant via one or more venting channels, conduits, and / or membrane-based interfaces, for example to reduce exposure to waste while maintaining pressure measurement capability.

[0123] The method of pressure measurement may depend on system requirements and integration constraints. In some embodiments, microelectromechanical systems (MEMS) pressure sensors may be implemented. Other implementations may utilize capacitive, piezoresistive, strain-gauge-based, and / or barometric pressure sensors. In some embodiments, multiple pressure sensors may be deployed in different regions, for example a sensor configured to measure pressure variations in a region moreexposed to liquid waste and another configured to measure pressure in a region where gas accumulates.

[0124] In one embodiment of the present disclosure, one or more sensors may be configured to measure gas pressure and / or liquid (hydrostatic) pressure within the ostomy implant and / or an associated ostomy device. Such measurements may be used to generate ostomy data indicative of waste blockages, peristaltic activity, waste accumulation, flow patterns, gas retention, leakage-indicative events, and / or gas buildup. In some embodiments, one or more thresholds and / or decision criteria used to generate an alert may be fixed, adaptive, and / or configurable, for example via an external device.

[0125] In one embodiment of the present disclosure, the ostomy system may comprise one or more sensors configured to measure temperature associated with an ostomy implant and / or an associated ostomy device. The temperature measurements may be used to generate ostomy data indicative of localized and / or systemic conditions, for example conditions associated with tissue adjacent to the implant and / or waste flow.

[0126] Temperature measurement may be performed as a single reading and / or as a series of measurements over time, depending on system configuration.

[0127] In some embodiments, the sensing module comprises one or more temperature sensors. In other embodiments, additionally or alternatively, one or more temperature sensors are provided in the ostomy implant and / or an associated ostomy device (e.g., a lid), and the sensing module is configured to operatively couple to the one or more temperature sensors to obtain temperature measurement signals and to store and / or transmit ostomy data derived therefrom.

[0128] The placement of a temperature sensor may vary depending on whether the sensor is integrated into the implant, the sensing module, and / or an ostomy device. In some embodiments, a temperature sensor may be thermally coupled to the implant and / or surrounding tissue, for example via direct placement on an implant structure and / or via a thermally conductive interface such as a metal heat bridge, a thermally conductive polymer, and / or a thermal gel layer. Such configurations may support acquisition of temperature data indicative of localized conditions while limiting direct exposure of the sensor to bodily fluids.

[0129] In other embodiments, a temperature sensor may be arranged in fluidic communication with a waste path, for example to measure the temperature of waste as it passesthrough the ostomy system. In some embodiments, waste temperature may be indicative of systemic conditions. In further embodiments, multiple temperature sensors may be used, for example to compare a temperature indicative of tissue conditions with a temperature indicative of waste conditions and / or to detect temperature gradients. Temperature sensing may be implemented using various sensor technologies, including thermistors, resistance temperature detectors (RTDs), and / or infrared (IR) temperature sensors, depending on integration constraints and energy considerations. In some embodiments, temperature data may be correlated with other ostomy data, for example pH, pressure, and / or gas-related measurements.

[0130] In one embodiment of the present disclosure, the ostomy system may comprise one or more sensors configured to measure electrical conductivity, for example to generate ostomy data indicative of waste composition, liquid content, and / or electrolyte concentration. Conductivity measurements may be performed as a single reading and / or as a series of measurements over time.

[0131] In some embodiments, the sensing module comprises one or more conductivity sensors. In other embodiments, additionally or alternatively, one or more conductivity sensors are provided in the ostomy implant and / or an associated ostomy device, and the sensing module is configured to operatively couple to the one or more conductivity sensors to obtain measurement signals.

[0132] The conductivity sensor may be positioned in direct contact with a waste path and / or in a fluidic sampling region. In some embodiments, conductivity sensing may be implemented using electrochemical electrodes, impedance-based sensing, and / or capacitive sensing techniques. In some configurations, conductivity measurements may be correlated with pH and / or turbidity measurements to generate ostomy data indicative of waste composition changes.

[0133] In one embodiment of the present disclosure, the ostomy system may comprise one or more sensors configured to generate ostomy data indicative of leakage, for example by detecting the presence of waste outside an intended flow path.

[0134] In some embodiments, leakage-indicative sensors may be positioned at one or more interfaces, such as a sealing interface between the sensing module and the ostomy implant, between a lid and the implant, and / or along one or more edges of an ostomydevice. Such sensors may operate based on moisture detection, capacitance variation, conductivity changes, and / or other measurements indicative of the presence of waste outside an intended containment region.

[0135] In some embodiments, detection of a leakage-indicative condition may trigger generation of an alert and / or transmission of ostomy data indicative of leakage to an external device.

[0136] In one embodiment of the present disclosure, the ostomy system may comprise one or more sensors configured to generate ostomy data indicative of fluid volume and / or fill level within the ostomy implant and / or an associated ostomy device.

[0137] In some embodiments, a fluid volume sensor may be positioned along a waste path to provide direct measurement of accumulation. In other embodiments, a fluid volume sensor may be positioned in a dedicated sensing chamber configured to monitor accumulation trends over time. Fluid volume sensing may be implemented using capacitive, ultrasonic, and / or pressure-based sensing techniques.

[0138] In some embodiments, ostomy data indicative of fluid volume may be used to generate an alert when a fill level approaches a threshold.

[0139] In one embodiment of the present disclosure, the ostomy system may comprise one or more sensors configured to measure pH of waste, for example to generate ostomy data indicative of acid-base balance and / or changes in waste chemistry.

[0140] The pH sensor may be positioned in direct contact with a waste path and / or in a fluidic sampling chamber. pH sensing may be implemented using electrochemical pH electrodes, ion-selective field-effect transistors (ISFETs), and / or optical pH indicators.

[0141] In one embodiment of the present disclosure, the ostomy system may comprise one or more sensors configured to measure turbidity of liquid waste, for example to generate ostomy data indicative of waste clarity and / or consistency.

[0142] In some embodiments, a turbidity sensor may be positioned in a direct flow path. In other embodiments, a turbidity sensor may be positioned in a sampling chamber configured to collect waste samples at intervals. Turbidity sensing may be implemented using optical scattering, absorbance-based measurement, and / or laser-based techniques.In one embodiment of the present disclosure, the sensing module may be configured to obtain ostomy data indicative of user activity and / or device usage associated with an ostomy implant and / or an associated ostomy device. User activity and / or usage data may include, for example, opening and closing events of a lid and / or other closing part, a positional and / or orientation state of at least a portion of the ostomy system, and / or user physical movement patterns, including movement, rest periods, postural changes, and interactions with the ostomy system. Data acquisition may be performed continuously, periodically, and / or in response to one or more triggers, depending on system configuration and energy considerations.

[0143] The sensors used to obtain user activity and / or device usage data may vary depending on the activity being detected. In some embodiments, the sensing module may comprise one or more position and / or motion sensors, proximity sensors, and / or switches, including mechanical, magnetic, capacitive, and / or optical sensors. In some embodiments, an orientation sensor (e.g., an inertial measurement unit) may be used to determine an orientation and / or motion state of the sensing module and / or a portion of the ostomy device. In some embodiments, a mechanical, magnetic, capacitive, and / or optical switch and / or proximity detector may be used to detect an opening and / or closing event of a lid and / or other closing part. In some embodiments, ostomy data indicative of opening / closing cycles may include a frequency, duration, and / or timing of such events, which may be stored and / or transmitted to an external device. For physical activity measurement, the sensing module may incorporate one or more accelerometers, gyroscopes, and / or other motion-tracking sensors to detect movement and / or postural changes. In some embodiments, the sensing module may generate ostomy data indicative of gross body movement states, such as walking, sitting, standing, and / or lying down, and / or changes between such states. In some embodiments, motion and / or orientation data may be correlated with other ostomy data (e.g., pressure, leakage-indicative measurements, and / or temperature measurements) to generate an output indicative of one or more conditions affecting device performance and / or user comfort.

[0144] In some embodiments, user activity and / or device usage data may be processed within the sensing module and / or transmitted to an external device, such as a smartphone, wearable monitor, gateway device, and / or healthcare management system, via a communication interface. In some embodiments, one or more algorithms may be usedto identify changes in usage patterns and / or to generate a notification and / or alert when a detected pattern satisfies one or more criteria. For example, an unusually high frequency of opening and / or closing events may be indicative of changes in device usage and / or a potential device-related issue, and prolonged inactivity or an abrupt change in motion pattern may be indicative of a change relevant to device usage and / or user status, without being limited thereto.

[0145] In a further aspect, the present disclosure relates to a sensing module (and / or an ostomy system comprising the sensing module) configured for device state monitoring, wherein the sensing module is configured to detect, monitor, identify, and / or verify one or more operational conditions, status parameters, and / or configurations of an ostomy implant and / or an associated ostomy device. This aspect may be implemented independently or in combination with any of the other aspects, embodiments, features, and configurations described herein, including detachably secured sensing modules, implant- and / or lid-provided sensors, lumen-exposed sensors, energy management and / or energy harvesting, wireless communication, authentication, and / or alert generation.

[0146] In some embodiments, device state monitoring may comprise generating ostomy data indicative of one or more of: an open or closed state of a lid and / or closing part; seal integrity and / or attachment security between the sensing module, a lid, and / or the implant; internal pressure and / or pressure variation; fluid accumulation and / or fill level; gas accumulation and / or gas-related parameters; temperature and / or temperature variation; leakage-indicative measurements; wear and / or malfunction; and / or identification of a device, component, and / or configuration currently in use.

[0147] In some embodiments, device state monitoring may include determination of an open or closed state of an ostomy device (e.g., a lid) and / or detection of opening / closing events. The sensing module may employ, for example, mechanical, optical, capacitive, and / or magnetic sensing elements to determine the state and / or to generate a signal indicative of an opening and / or closing event.

[0148] In some embodiments, device state monitoring may include generation of ostomy data indicative of seal integrity and / or attachment security, for example whether a lid and / or sensing module is positioned and / or secured relative to the implant. In some embodiments, one or more mechanical, capacitive, optical, and / or pressure-based sensing elements may be used to generate a signal indicative of a seated condition,misalignment, incomplete engagement, and / or seal degradation. In some embodiments, a detected condition indicative of reduced seal integrity and / or attachment security may trigger generation of a notification and / or alert.

[0149] In some embodiments, device state monitoring may include pressure monitoring, for example using hydrostatic pressure sensors, barometric pressure sensors, strainbased sensors, and / or other pressure transducers to generate ostomy data indicative of pressure fluctuations and / or pressure trends. In some embodiments, pressure data may be indicative of peristaltic activity, waste accumulation, gas buildup, and / or flow restrictions, and may be used alone or in combination with other sensor data.

[0150] In some embodiments, device state monitoring may include monitoring fluid accumulation and / or gas accumulation, for example using one or more pressure sensors, differential pressure sensors, gas pressure sensors, and / or gas-related sensors (e.g., gas presence and / or composition sensors). In some embodiments, detection of a condition satisfying one or more criteria may trigger a notification and / or alert.

[0151] In some embodiments, device state monitoring may include temperature monitoring, for example using thermistors, RTDs, and / or infrared temperature sensors to generate ostomy data indicative of temperature variation associated with the implant, waste flow, and / or surrounding tissue, optionally in combination with other sensor measurements.

[0152] In some embodiments, device state monitoring may include leakage-indicative sensing, for example using capacitive, optical, impedance-based, and / or conductivity-based sensing elements to detect waste outside an intended containment region. In some embodiments, detection of leakage-indicative measurements may trigger transmission of ostomy data indicative of leakage and / or generation of a notification.

[0153] In some embodiments, device state monitoring may include identification and / or tracking of a device, component, and / or configuration currently in use, for example via electronic tagging, RFID identifiers, digital authentication, mechanical coding, and / or embedded signatures. Identification of the device type, model, and / or configuration may support compatibility verification, maintenance tracking, and / or system configuration, without being limited thereto.The sensing module may employ various sensing elements to perform device state monitoring, including pressure sensors, strain gauges, capacitive proximity detectors, RFID readers, mechanical latch sensors, temperature sensors, gas-related sensors, and / or other sensing elements. These sensing elements may be positioned at sealing interfaces, attachment points, waste flow paths, and / or structural components of the ostomy system.

[0154] In some embodiments, ostomy data associated with user activity and / or device state monitoring may be stored locally and / or transmitted to an external device. In some embodiments, one or more notifications, alerts, and / or reports may be generated based on detected conditions and / or trends.

[0155] In a further aspect, the present disclosure relates to a sensing module (and / or an ostomy system comprising the sensing module) configured to identify and / or authenticate one or more components of an ostomy system, including an ostomy implant, an ostomy device (e.g., a lid and / or pouch), and / or the sensing module itself. This aspect may be implemented independently or in combination with any of the other aspects, embodiments, features, and configurations described herein, including detachably secured sensing modules, implant- and / or lid-provided sensors, lumen-exposed sensors, device state monitoring (e.g., open / closed detection and / or seal integrity), energy management and / or energy harvesting, wireless charging, wireless communication, and / or alert generation.

[0156] In some embodiments, the sensing module is configured to authenticate a component by obtaining identifier data from the component and generating an authentication result indicative of whether the component is authorized and / or compatible.

[0157] In some embodiments, the sensing module may be configured to obtain identification data associated with one or more components and to generate ostomy data indicative of an identification result and / or an authentication result. In some embodiments, such ostomy data may form part of device state data and may be stored locally and / or transmitted to an external device.

[0158] In some embodiments, the sensing module may be provided in or integrated into an ostomy device, such as a lid, and may be configured to authenticate that the ostomy device is authorized and / or compatible for use with a particular ostomy implant. In such embodiments, the sensing module may obtain identification data associated with theostomy device and / or the ostomy implant and may generate ostomy data indicative of a compatibility result. In some embodiments, the compatibility result may constitute device state data and may be used to enable or restrict one or more functions, to associate collected ostomy data with a particular device configuration, and / or to generate a notification or alert.

[0159] Authentication and / or identification may be implemented using one or more mechanisms depending on system requirements and constraints. In some embodiments, authentication may be performed using an embedded identifier and / or electronic tagging, such as an RFID tag, NFC component, passive electronic signature, uniquely coded memory, and / or another identifier associated with a component of the ostomy system. In some embodiments, the sensing module may read the embedded identifier upon attachment and / or during use and may compare the identifier to one or more stored identifiers and / or one or more rules indicative of compatibility and / or association.

[0160] In some embodiments, the sensing module is configured to read an identifier provided on or in another component of the ostomy system (e.g., an ostomy implant) to determine compatibility of the components.

[0161] In some embodiments, the identifier may be stored in a memory element, integrated circuit, tag, or other machine-readable structure provided on or in the ostomy implant, the ostomy device, and / or the sensing module. The sensing module may be configured to obtain the identifier data via electrical contacts, inductive coupling, capacitive coupling, near-field communication, radiofrequency interrogation, and / or optical reading (e.g., barcode or QR code), depending on the implementation. In some embodiments, the authentication result may comprise a binary result (e.g., authorized / unauthorized or compatible / incompatible) and / or a graded result (e.g., confidence score), and may be generated upon attachment, in response to a prompt from an external device, and / or periodically during use.

[0162] In some embodiments, authentication may be performed using cryptographic techniques, for example encrypted pairing, challenge-response verification, digital signatures, and / or other authentication protocols. For example, the sensing module may transmit a nonce or challenge value to a component, receive a cryptographic response generated using a stored secret or private key, and verify the response to determine the authentication result.In such embodiments, the sensing module and another component may exchange data indicative of one or more authentication keys and / or credentials prior to enabling one or more functions and / or prior to transmitting data. In some embodiments, authentication processing may be performed locally in the sensing module and / or with assistance from an external device (e.g., a smartphone and / or a gateway device). In some embodiments, authentication processing may additionally or alternatively involve communication with a remote service, for example to verify credentials and / or to obtain updated authorization data, without being limited thereto.

[0163] In addition to electronic and cryptographic mechanisms, some embodiments may employ mechanical, optical, and / or magnetic encoding techniques to identify and / or verify component compatibility. For example, an encoded mechanical feature, magnetic signature, and / or optically readable marking may be provided on an ostomy implant and / or an ostomy device and may be detected by one or more corresponding sensing elements of the sensing module, thereby providing a passive identification mechanism.

[0164] The authentication mechanism may operate in various modes. In some embodiments, authentication may be performed upon attachment of a sensing module and / or an ostomy device. In some embodiments, authentication may be performed periodically and / or in response to an event, for example a detected disconnection, a detected replacement of a component, a detected mismatch condition, and / or an update operation. In some embodiments, authentication may be initiated by an external device and / or a user command.

[0165] In some embodiments, the sensing module may store data indicative of previously associated components, for example identifiers of implants, lids, pouches, and / or sensing modules, such that ostomy data can be associated with a particular configuration over time. In some embodiments, an authentication log and / or identification history may be stored locally and / or transmitted, for example for device management, troubleshooting, and / or audit purposes.

[0166] If an authentication failure and / or mismatch condition is detected, the sensing module may perform one or more response actions. For example, the sensing module may generate an alert and / or transmit ostomy data indicative of the mismatch to an external device. In some embodiments, one or more functions may be restricted and / or operated in a limited mode until an expected association is restored, without being limited thereto.Authentication mechanisms may be implemented using passive or active techniques. Passive techniques may include RFID, NFC, mechanical interlocks, and / or optical encoding. Active techniques may include bidirectional cryptographic verification, secure handshake protocols, and / or periodic credential verification. In some embodiments, different techniques may be used in combination.

[0167] In a further aspect, the present disclosure relates to a sensing module (and / or an ostomy system comprising the sensing module) comprising an alert mechanism configured to generate an alert based on ostomy data satisfying one or more criteria. This aspect may be implemented independently or in combination with any of the other aspects, embodiments, features, and configurations described herein, including detachably secured sensing modules, implant- and / or lid-provided sensors, lumen-exposed sensors, device state monitoring, authentication, energy management and / or energy harvesting, and wireless communication.

[0168] In some embodiments, the alert mechanism may be configured to notify a user and / or another recipient (e.g., a caregiver and / or a healthcare provider) of a detected condition and / or event. In some embodiments, the alert mechanism may be implemented at least in part within the sensing module and / or at least in part within an external device configured to receive ostomy data. In some embodiments, the alert mechanism may be triggered by ostomy data indicative of one or more conditions, including but not limited to leakage-indicative measurements, fill-level and / or overfillingindicative measurements, sensor fault and / or self-diagnostic results, gas accumulation and / or pressure variation, temperature variation, attachment and / or seal integrity state, and / or an authentication and / or compatibility result. In some embodiments, data indicative of an alert condition and / or notification constitutes event or state data and may be stored and / or transmitted as part of ostomy data.

[0169] The alert mechanism may operate based on event detection and / or trend-based analysis, depending on system configuration. In some embodiments, an alert may be triggered in response to a measurement and / or state change satisfying one or more criteria, such as a detected opening / closing event, a detected leakage-indicative condition, a detected attachment and / or seal integrity condition, and / or an authentication mismatch. In some embodiments, an alert may be generated based on changes over time, for example increasing fill-level estimates, drift in one or moresensor signals indicative of degradation, and / or sustained changes in one or more measured parameters.

[0170] In some embodiments, the alert mechanism may be implemented at least in part within the sensing module and / or at least in part within an external device configured to receive ostomy data, for example such that alert criteria evaluation and / or notification generation is performed locally and / or remotely.

[0171] In some embodiments, leakage-indicative alerts may be generated when one or more sensors (e.g., capacitive, optical, conductivity, and / or impedance-based sensors) detect measurements indicative of waste outside an intended containment region. In some embodiments, fill-level alerts may be based on fluid volume and / or accumulation measurements, for example to generate a notification when an estimated fill level approaches a threshold. In some embodiments, sensor malfunction alerts may be triggered when self-diagnostic routines and / or signal-quality checks detect performance deviation, calibration drift, and / or hardware failure. In some embodiments, gas-related and / or pressure-related alerts may be generated when pressure data is indicative of gas accumulation, flow restriction, and / or abnormal pressure variation, optionally in combination with other sensor data. In some embodiments, temperature-related alerts may be generated when temperature data is indicative of an abnormal variation relative to a baseline and / or relative to other measured parameters.

[0172] In some embodiments, authentication-related alerts may be generated when the sensing module is unable to verify an identity and / or compatibility of an ostomy implant, ostomy device, and / or sensing module. In some embodiments, an authentication-related notification may indicate that a component is unrecognized, that a communication failure occurred, and / or that a mismatch condition was detected, without being limited thereto.

[0173] The alert mechanism may be implemented using various notification methods. In some embodiments, the sensing module may provide an on-device notification, such as an audible alert, a visual indicator (e.g., an LED), and / or haptic feedback (e.g., vibration). In some embodiments, the sensing module may transmit data indicative of an alert to an external device and / or remote system, for example via BLE, NFC, Wi-Fi, cellular communication via a gateway device, and / or other communication protocols. In some embodiments, notifications may be logged and / or displayed via an application and / or interface associated with the external device.In some embodiments, alerts may be categorized and / or prioritized, for example to distinguish between notifications indicative of a condition that may warrant prompt attention and notifications indicative of routine status and / or maintenance (e.g., battery status and / or scheduled calibration). In some embodiments, an alert policy (e.g., thresholds, timing, and / or prioritization) may be configurable and / or adjustable, for example via an external device.

[0174] Detailed description of Drawings

[0175] The embodiments illustrated in Fig. 1 and Fig. 2 represent examples of how the sensing module and its associated components may be configured within an ostomy monitoring system. These embodiments are provided for illustrative purposes and should not be construed as limiting to the present disclosure. Alternative implementations may involve different sensor configurations, power management strategies, attachment mechanisms, communication protocols, or structural adaptations to suit various ostomy device designs and user requirements. The disclosed features may be modified, combined, or substituted in ways that align with the scope of the invention while maintaining the fundamental principles of modularity, adaptability, and efficient ostomy monitoring.

[0176] FIG. 1 illustrates a networked ostomy monitoring environment (100) designed to facilitate data collection, transmission, and analysis for improved ostomy management, clinical support, and product optimization. The system enables bi-directional communication between the sensing module (106), a cloud-based system (102), and multiple interconnected entities, ensuring that relevant data can be accessed, analyzed, and utilized by different stakeholders.

[0177] A patient (104) is fitted with an ostomy implant and an ostomy device incorporating a sensing module (106). The sensing module is configured to collect ostomy data, including physiological conditions, device state, and user activity, allowing for continuous or event-driven monitoring. The collected data may be processed locally within the sensing module or transmitted wirelessly to a remote device (108), such as a smartphone, smartwatch, tablet, laptop, or dedicated receiver. The remote device provides an interface for users to review sensor data, receive notifications, configure device settings, and access ostomy management recommendations.Data from the sensing module and remote device may be uploaded to a cloud-based system (102), where it can be stored, accessed remotely, and integrated with additional analytics or external services. The cloud-based system serves as a central repository for aggregated sensor data, enabling users, caregivers, and relevant stakeholders to retrieve and analyze information over time.

[0178] The system allows for interaction with healthcare professionals (110), who may access stored data for medical review and treatment optimization. By integrating ostomy monitoring data with electronic health records or clinical systems, healthcare providers can track patient conditions, assess treatment effectiveness, and adjust care plans based on objective sensor data. The availability of longitudinal health trends supports early detection of potential complications and facilitates personalized ostomy management strategies.

[0179] A provider node (116) represents the manufacturer or supplier of the sensing module, ostomy device, or associated components. This entity may utilize aggregated and anonymized data to assess product performance, analyze usage trends, and identify potential areas for improvement. Insights derived from real-world device usage may inform design refinements, quality control measures, and the development of nextgeneration ostomy solutions. Additionally, the provider node may support direct communication with users, offering technical support, software updates, and access to replacement components or consumables such as lids, pouches, and sensors.

[0180] The system also incorporates a user support node (114), which connects individuals using ostomy implants and devices. This network allows users to share experiences, provide practical insights, and access peer-to-peer support. By integrating the user network with the cloud-based system (102), anonymized data may contribute to Al-driven analytics, leading to recommendations that reflect actual usage patterns. The user support node may also serve as a feedback channel, enabling individuals to communicate preferences, challenges, and potential areas for improvement in ostomy device design and usability.

[0181] The Al and analytics node (112) is responsible for processing collected data, identifying patterns, and generating predictive insights. By analyzing sensor data over time, Al-driven models may detect changes in ostomy function, predict potential complications, and provide recommendations for device adjustments or medical intervention. The system architecture enables bi-directional data exchange, where processed insightsfrom Al models can be sent back to users, healthcare providers, or manufacturers in a refined and actionable format.

[0182] Through bi-directional data transmission, information flows between the sensing module (106), the cloud-based system (102), and the interconnected nodes (110, 112, 114, and 116). Data from the sensing module may be sent to the cloud for storage or processing, while feedback, alerts, or optimization recommendations may be delivered back to the user via the remote device (108). Healthcare professionals may utilize stored data to refine treatment strategies, and manufacturers may receive insights to enhance product design and device performance. This interconnected system supports continuous monitoring, personalized healthcare recommendations, and ongoing improvements in ostomy device technology, contributing to a more efficient and usercentered approach to ostomy management.

[0183] FIG. 2 illustrates an example of a block design architecture for a sensing module (200), which is integrated into the closing part of an ostomy lid assembly. The lid assembly comprises a base portion (234) and a closing part, with the closing part housing the sensing module (200). This arrangement enables automated data collection, device interaction, and wireless communication. While in some embodiments the sensing module is fully integrated into the closing part, in alternative implementations, it may be a separate detachable unit that can be secured to another part of the ostomy device, such as an adapter, an external surface of the lid, or a dedicated mounting area within the device structure.

[0184] The base portion (234) includes a magnet (238) positioned to interact with a Hall-effect sensor (HAL) (222), which is part of a plurality of sensors (244) of the sensing module. This configuration enables positional tracking of the closing part relative to the base, allowing the system to detect whether the lid is in an open or closed position. The ability to track positional states supports automated logging of user interactions with the ostomy device, providing valuable insights into device usage patterns and potential care optimizations.

[0185] A thermal conductor (242) is integrated into the base portion (234) to facilitate efficient heat transfer from the peristomal tissue to the sensing module. This thermal conductor may be composed of a metallic strip, thermally conductive polymer, gel, or other high-conductivity material, ensuring effective heat transfer to a temperature sensor (T) (232) within the plurality of sensors (244). This setup allows for continuous or periodictemperature monitoring, supporting early detection of localized inflammation, infection risks, or deviations from normal physiological conditions.

[0186] The sensing module (200) incorporates multiple functional components for data acquisition, processing, power management, and communication. Wireless connectivity is facilitated by an NFC antenna (202) connected to an NFC transceiver and controller (204), which supports data exchange and, in some embodiments, power transfer. In some embodiments, RFID-based communication may supplement or replace NFC, enabling passive data transmission without requiring an onboard power source.

[0187] A power management unit (206) is connected to a Li-Ion battery or capacitor (208) to ensure sustained operation and energy efficiency. In certain embodiments, the sensing module may also incorporate alternative power sources, such as printed batteries, supercapacitors, or energy-harvesting technologies utilizing thermal gradients, motionbased generation, or radiofrequency energy collection.

[0188] An optional microcontroller unit (MCU) (212) may be included to facilitate sensor data processing and system management. The MCU (212) and / or the NFC transceiver and controller (204) interface with the plurality of sensors (244) to support real-time sensor integration, signal processing, and data handling. A control / timing circuit (210) may be provided to coordinate operation of the sensing module (200), for example by supplying one or more timing signals, enable signals, wake signals, interrupt routing, or synchronization functions for the sensor interfaces and / or for communication between the NFC controller (204) and the MCU (212). Sensor signals may be communicated via distinct interfaces to support structured signal processing and optimized power consumption.

[0189] An analog circuit (216) interfaces with an analog front-end (AFE) (224), which may be part of the plurality of sensors (244) and is responsible for fluid consistency measurements. The AFE may contain one or more sensing elements designed to assess the fluidic state within the ostomy system, distinguishing between air, liquid, and semi-solid waste. The AFE may include impedance-based, capacitive, or electrical impedance spectroscopy (EIS) sensing, allowing for measurements of viscosity, moisture content, or phase transitions between liquid and gas. This information may be used to detect blockages, monitor peristaltic activity, or analyze waste accumulation trends. The analog circuit (216) may connect to an analog-to-digital converter within theNFC controller (204) and / or the MCU (212), allowing for digitization of fluid consistency data.

[0190] A serial data bus (218), implemented as an l2C bus or another standard protocol, connects multiple digital sensors of the plurality of sensors (244) to the MCU (212) and / or the NFC controller (204). For example, a pressure sensor (226) detects variations in gas and / or liquid pressure, a real-time clock (RTC) (228) provides timing for sensor data logging, a three-axis accelerometer (230) detects movement and orientation, and a temperature sensor (232) monitors thermal variations that may indicate inflammatory responses or external environmental factors.

[0191] A GPIO interface circuit (220) facilitates discrete digital signaling and may interface with the Hall-effect sensor (222) of the plurality of sensors (244). The Hall-effect sensor (222) interacts with the magnet (238) to detect lid position changes, allowing for automated tracking of the opening and closing states of the ostomy device. The GPIO interface circuit (220) may also provide additional discrete signal pathways depending on system requirements.

[0192] The optional MCU (212) may be further connected to an optional BLE antenna (214), enabling wireless data transmission to external devices such as smartphones, cloudbased platforms, or healthcare monitoring systems. In some implementations, BLE communication may be supplemented or replaced by alternative low-power wireless protocols, such as Zigbee or proprietary short-range RF communication, depending on power efficiency requirements and system integration needs.

[0193] The ostomy implant (236) is surgically placed to create a controlled passage for waste excretion, while ileum content (240) naturally flows through the implant, as regulated by the ostomy lid. The sensing module is integrated into the closing part of the ostomy device such that the plurality of sensors (244) are positioned to monitor relevant physiological and environmental parameters. The system architecture supports continuous and / or periodic data acquisition and analysis, enabling detection of device status, waste characteristics, and user activity. By incorporating a modular design, the sensing module allows for flexible adaptation to different ostomy configurations, supporting variations in component selection, power availability, and communication protocols to ensure compatibility with evolving medical needs and user preferences.FIG. 3 illustrates an ostomy device (300) comprising a lid assembly (302) attachable to an ostomy implant (not shown). The lid assembly (302) comprises a base portion (304) and a controlling portion (306) movable relative to the base portion (304).

[0194] In the illustrated embodiment, the closure portion (306) is exemplified as a slider element (308) configured to move relative to the base portion (304) between at least a closed position and an open position. In other embodiments, the controlling portion may comprise another actuation arrangement, for example a button, lever, rotating element, hinged element, or other movable element configured to control opening and / or closing of the ostomy device.

[0195] In this embodiment, the controlling portion (306) forms or comprises a sensing module (310). The sensing module (310) is detachably secured to the lid assembly (302) and is configured to detect and / or generate ostomy data indicative of device state and / or user interaction with the ostomy device, including an open or closed state and / or opening and closing events. In some embodiments, the sensing module (310) comprises one or more sensing elements configured to detect movement, position, and / or engagement of the controlling portion (306) relative to the base portion (304) (or alternatively to the ostomy implant), thereby enabling logging of usage of the controlling portion (306), for example whether and / or when it is opened and closed, how often, and / or at what times.

[0196] The base portion (304) comprises an opening (312) (e.g., a through-hole) configured to provide fluidic communication with an interior of the ostomy implant when the lid assembly is mounted. In the closed position, the controlling portion (306) is arranged to cover the opening (312) to prevent passage of waste through the opening. In some embodiments, the controlling portion (306) is configured to assume an intermediate position between open and closed, for example a gas-release position in which gas is released while waste is substantially prevented from being released. In some embodiments, the base portion (304) and / or the controlling portion (306) defines a gas channel (314) configured to vent gas in the gas-release position. In some embodiments, the gas channel (314) comprises a shielding element configured to inhibit passage of liquid and / or solid waste, for example a hydrophobic element, filter, membrane, and / or baffle element.

[0197] In some embodiments, one or more sensing elements (316) are arranged on a patientfacing side of the controlling portion (306) (e.g., a bottom side) and are positioned such that, in the closed position, the sensing elements (316) are exposed to and / or in fluidcommunication with an interior of the ostomy implant. In some embodiments, such sensing elements may comprise lumen-exposed sensing elements configured to generate ostomy data indicative of waste and / or physiological conditions, for example conductivity, pH, viscosity, temperature, and / or other parameters.

[0198] In some embodiments, the controlling portion (306) further comprises one or more sensing elements (318) arranged on a side portion and positioned to couple with one or more sensing elements and / or contacts provided on the ostomy implant when the lid assembly is attached thereto. In some embodiments, such coupling enables the sensing module (310) to obtain measurement signals from implant-provided sensors and / or to detect attachment state and / or device identity, without being limited thereto. In some embodiments, one or more sensing elements may be arranged in the gas channel (314) and configured to measure gas pressure and / or gas content (e.g., gas presence and / or composition). The sensing module (310) may store ostomy data locally and / or comprise a communication interface configured to transmit ostomy data to an external device. In some embodiments, the sensing module (310) comprises a power source and / or is configured for wireless power transfer. In alternative embodiments, the sensing module (310) is configured as a passive module powered via near-field communication.

[0199] Although illustrated as the slider element (308) integrated into the closure portion (306), the sensing module (310) may alternatively be implemented as a separate detachable module attachable to another portion of the lid assembly (302) and / or to an adapter associated with the ostomy implant.

[0200] FIG. 4 illustrates an ostomy implant (400) comprising an implant body (402) defining an internal lumen (404) configured for passage of bodily waste.

[0201] In some embodiments, the ostomy implant (400) comprises one or more sensor elements (406) arranged on an internal surface (403) of the implant body (402) and / or in fluid communication with the internal lumen (404). The one or more sensor elements (406) may be configured to generate measurement signals indicative of physiological conditions and / or waste characteristics, such as pressure, temperature, electrical conductivity, pH, viscosity, gas presence, and / or other parameters, without being limited thereto.In the embodiment illustrated, the one or more sensor elements (406) are shown schematically and may comprise electrodes, conductive regions, resistive elements, capacitive elements, and / or other sensing structures integrated into and / or supported by the implant body (402). The illustrated sensor elements are exemplary and are not intended to limit the number, type, or arrangement of sensor elements.

[0202] In some embodiments, the ostomy implant (400) does not comprise active electronics. Instead, the one or more sensor elements (406) are configured to operatively communicate with a sensing module, for example a detachable sensing module as described with reference to FIG. 3, when the sensing module is secured to the ostomy implant and / or to a lid attached thereto. In such embodiments, operative communication may be achieved via electrical contacts, conductive paths, inductive coupling, capacitive coupling, and / or wireless coupling.

[0203] In alternative embodiments, a sensing module (407) may be provided on the ostomy implant (400) and configured to operatively communicate with the one or more sensor elements (406). In such embodiments, the sensing module (407) may be arranged on a portion of the ostomy implant that is exterior of the patient during use, for example at or near an open end of the implant and / or an attachment interface for a lid or adapter, thereby allowing for access, replacement, and / or detachment of the sensing module without disturbing the implanted portion of the ostomy implant.

[0204] In both configurations, the one or more sensor elements (406) may be exposed to and / or in fluid communication with the internal lumen (404) during use, while the sensing module is positioned outside the lumen and configured to obtain sensor signals and to store and / or transmit ostomy data.

[0205] Items

[0206] 1. A detachable sensing module for an ostomy implant, the sensing module comprising:

[0207] • one or more sensors;

[0208] • a power source;

[0209] • a communication interface configured to transmit ostomy data to an external device;wherein the sensing module is configured to be detachably secured to an open end of the ostomy implant, either directly to the implant or indirectly via an ostomy device.

[0210] The sensing module according to item 1 , wherein the sensing module is configured to be detachably secured to the ostomy device, such as a lid for the ostomy implant or an ostomy pouch.

[0211] The sensing module according to item 2, wherein the sensing module comprises a mounting interface configured to engage with a corresponding receiving interface on the ostomy device to detachably secure the sensing module to the ostomy device.

[0212] The sensing module according to item 3, wherein the mounting interface and the corresponding receiving interface on the ostomy device engage via a mechanical, magnetic, or elastic coupling mechanism.

[0213] The sensing module according to item 4, wherein the mechanical coupling mechanism secures the sensing module through snap-fit retention.

[0214] The sensing module according to any one of items 2-5, wherein the ostomy device comprises, or consists of, a lid for the ostomy implant, the lid being configured to be detachably secured to, and seal, the open end of the ostomy implant.

[0215] The sensing module according to any one of items 2-6, wherein at least a part of the sensing module is implemented as printed electronics on a flexible or disposable substrate, such as wherein the sensing module is configured to be attached to the ostomy device via an adhesive, mechanical interface, magnetic coupling, or another mounting interface.

[0216] The sensing module according to item 1 , wherein the sensing module is provided as an ostomy device, such as an ostomy pouch or a lid, configured to be detachably secured to the open end of the ostomy implant.

[0217] The sensing module according to item 8, wherein the ostomy device comprises, or consists of, a lid, the lid being configured to selectively open or close the open end of the ostomy implant without requiring detachment from the ostomy implant.10. The sensing module according to any one of the preceding items, wherein the sensing module comprises or consists of a closing part, the closing part being operable to selectively switch the ostomy device between an open state and a closed state while remaining attached to the ostomy implant.

[0218] 11. The sensing module according to item 10, wherein the closing part is configured to close or seal off the open end of the ostomy implant, either directly or indirectly through an ostomy device, by sliding, pivoting, rotating, deforming, lifting, expanding, or contracting.

[0219] 12. The sensing module according to any one of items 10-11, wherein the sensing module is configured to detect whether the ostomy device is in the open state or the closed state, such as by using magnetic, capacitive, mechanical, optical, or thermal sensing mechanisms.

[0220] 13. The sensing module according to any one of items 10-12, wherein at least a part of the one or more sensors are arranged on a surface of the closing part that is positioned to be exposed to, or in fluid communication with, the open end of the ostomy implant when the closing part is in the closed state.

[0221] 14. The sensing module according to any one of items 10-13, wherein the closing part comprises a sealing mechanism configured to provide a fluid-tight engagement, the sealing mechanism being arranged to interact with the open end of the ostomy implant and / or another part of the ostomy device to ensure proper sealing during use.

[0222] 15. The sensing module according to any one of the preceding items, wherein the power source comprises a rechargeable battery, a supercapacitor, a hybrid power source, and / or an energy harvesting system.

[0223] 16. The sensing module according to item 15, wherein the energy harvesting system is configured to generate power from thermal gradients, piezoelectric activity, galvanic reactions, mechanical movement, solar energy, radiofrequency, enzymatic sources, or combinations thereof.

[0224] 17. The sensing module according to item 16, wherein the energy harvesting system is configured to generate power from the user’s physical movements, such as walking or peristaltic activity.18. The sensing module according to any one of the preceding items, wherein the sensing module includes an energy management system configured to optimize power consumption and / or prolong operational life.

[0225] 19. The sensing module according to any one of the preceding items, wherein the sensing module is configured for wireless charging, optionally including components for inductive or capacitive charging.

[0226] 20. The sensing module according to any one of the preceding items, wherein the communication interface is configured to transmit the ostomy data wirelessly, such as using short-range communication protocols, including low-energy radiofrequency communication, near-field communication, or other wireless communication standards.

[0227] 21. The sensing module according to any one of the preceding items, wherein the module is configured to transmit the ostomy data to the external device in response to a prompt from the external device.

[0228] 22. The sensing module according to any one of the preceding items, comprising a data storage unit configured to store the ostomy data.

[0229] 23. The sensing module according to any one of the preceding items, wherein the ostomy data comprises or consists of one or more of the following: timestamps, raw sensor data, and / or processed data derived from the sensor data.

[0230] 24. The sensing module according to any one of the preceding items, wherein the one or more sensors are configured to collect ostomy data, the ostomy data comprising physiological conditions, user activity, and / or device state.

[0231] 25. The sensing module according to item 24, wherein the physiological conditions comprise one or more of pressure, temperature, viscosity, electrical conductivity, gas presence, leakage, fluid volume, pH, and / or turbidity of liquid waste.

[0232] 26. The sensing module according to item 25, wherein the one or more sensors are configured to measure the viscosity of waste to determine its physical state, such as distinguishing between liquid, solid, or gaseous waste, and / or to provide diagnostic insights regarding digestive health, blockages, or abnormal waste consistency.The sensing module according to any one of items 25-26, wherein the one or more sensors are configured to measure pressure within the ostomy implant and / or ostomy device.

[0233] The sensing module according to item 27, wherein the one or more sensors are configured to measure gas pressure and / or liquid (hydrostatic) pressure to detect waste blockages, peristaltic activity, excessive waste accumulation, abnormal flow patterns, abnormal gas retention, unintended leakage, and / or excessive gas buildup that may indicate digestive issues.

[0234] The sensing module according to any one of items 25-28, wherein the one or more sensors are configured to monitor temperature variations within the ostomy implant or waste flow to detect inflammation, infection, or deviations from normal physiological temperature ranges.

[0235] The sensing module according to any one of items 25-29, wherein the one or more sensors are configured to measure electrical conductivity to analyze the composition of waste, such as liquid content, electrolyte concentration, hydration status, or pH balance.

[0236] The sensing module according to any one of items 25-30, wherein the one or more sensors are configured to detect leakage by identifying the presence of waste outside the intended flow path, such as through capacitive sensing, optical detection, or changes in electrical impedance.

[0237] The sensing module according to any one of items 25-31 , wherein the one or more sensors are configured to measure fluid volume to determine the fill level of the ostomy implant and alert the user when it approaches capacity, wherein alerts may be transmitted via the communication interface.

[0238] The sensing module according to any one of items 25-32, wherein the one or more sensors are configured to monitor pH levels of waste to assess acidity or alkalinity, enabling detection of potential digestive health conditions, metabolic imbalances, or dietary impacts.

[0239] The sensing module according to any one of items 25-33, wherein the one or more sensors are configured to measure the turbidity of liquid waste to assess clarity,detect suspended particles, identify impurities, or monitor changes in waste consistency indicative of gastrointestinal health conditions.

[0240] 35. The sensing module according to any one of the preceding items wherein user activity comprises usage of the ostomy device, including but not limited to detecting opening and closing cycles, determining the positional state of the ostomy device, and / or monitoring the user’s physical activity, such as movement, rest periods, postural changes, and interactions with the ostomy system.

[0241] 36. The sensing module according to any one of the preceding items, wherein the device state comprises detecting, monitoring, identifying, or verifying information related to the operational condition, status, or configuration of an ostomy device and / or ostomy implant, including but not limited to the open or closed state of the ostomy device, seal integrity, attachment security, internal pressure variations, fluid accumulation, gas buildup, temperature variations, leakage detection, wear or malfunction, and / or identification of the ostomy device or the ostomy implant.

[0242] 37. The sensing module according to item 36, wherein the device state comprises verifying the identity of an ostomy implant, ostomy device, and / or sensing module using an authentication mechanism, including but not limited to an embedded identifier, electronic tagging, encrypted pairing, cryptographic verification, digital authentication protocols, or other secure identification technologies, wherein authentication is configured to ensure correct device-user association, verify compatibility, prevent unauthorized use, and / or maintain data integrity.

[0243] 38. The sensing module according to any one of the preceding items, wherein the sensing module includes an alert mechanism configured to notify the user and / or a healthcare provider of abnormal sensor readings, including but not limited to leakage, overfilling, sensor malfunctions, gas buildup, pressure anomalies, temperature deviations, and / or failed authentication.

[0244] 39. The sensing module according to any one of the preceding items, wherein the sensing module is configured to correlate data from multiple sensors to identify patterns, such as simultaneous changes in temperature, pressure, and pH, indicative of specific health conditions.

Claims

55Claims1. A detachable sensing module for an ostomy implant, the sensing module comprising:• a power source; and• a communication interface configured to transmit ostomy data to an external device;wherein the sensing module is configured to be detachably secured to a portion of the ostomy implant, or to a lid configured to be detachably secured to and seal an opening of the ostomy implant; andwherein the sensing module is configured to generate the ostomy data based on at least one sensor signal obtained from at least one sensing element, the at least one sensing element being provided in or on the ostomy implant and / or the lid.

2. The sensing module according to claim 1 , wherein the sensing module comprises a mounting interface configured to detachably engage a corresponding receiving interface provided on the ostomy implant or on the lid.

3. The sensing module according to claim 2, wherein the mounting interface and the corresponding receiving interface are configured to detachably engage via a mechanical coupling, a magnetic coupling, a resilient interference-fit coupling, an adhesive coupling, or a combination thereof.

4. The sensing module according to claim 3, wherein the mechanical coupling comprises snap-fit retention.

5. The sensing module according to any one of the preceding claims, wherein the lid is configured to be detachably secured to the ostomy implant and to seal the opening of the ostomy implant with a fluid-tight seal.

6. The sensing module according to any one of the preceding claims, wherein at least a portion of the sensing module is implemented as printed electronics on a flexible substrate and / or a disposable substrate.

7. The sensing module according to any one of the preceding claims, wherein the sensing module forms the lid and is configured to be detachably secured to the open end of the ostomy implant.

568. The sensing module according to any one of the preceding claims, wherein the lid is configured to selectively open or close the open end of the ostomy implant while remaining secured to the ostomy implant.

9. The sensing module according to any one of the preceding claims, wherein the sensing module is configured to detect whether the lid is in the open state or the closed state.

10. The sensing module according to any one of the preceding claims, wherein the sensing module comprises a closing part operable to selectively switch the lid between an open state and a closed state while the sensing module remains secured to the ostomy implant.

11. The sensing module according to claim 10, wherein the closing part is configured to close or seal off the open end of the ostomy implant, either directly or indirectly through the lid, by sliding, pivoting, rotating, deforming, lifting, expanding, or contracting.

12. The sensing module according to any one of claims 10-11, wherein at least a portion of the one or more sensors is arranged on a surface of the closing part that, when the closing part is in the closed state, is exposed to, or in fluid communication with, the open end of the ostomy implant.

13. The sensing module according to any one of claims 10-12, wherein the closing part comprises a sealing mechanism configured to provide a fluid-tight engagement, the sealing mechanism being arranged to interact with the open end of the ostomy implant and / or another part of the lid to ensure sealing during use.

14. The sensing module according to any one of the preceding claims, wherein at least one of the one or more sensors is exposed to, or fluidly coupled with, an internal lumen of the ostomy implant.

15. The sensing module according to any one of the preceding claims, wherein the power source comprises a rechargeable battery, a supercapacitor, a hybrid power source, and / or an energy harvesting system.5716. The sensing module according to claim 15, wherein the energy harvesting system is configured to harvest energy from at least one of thermal gradients, piezoelectric activity, galvanic reactions, mechanical movement, radiofrequency energy, enzymatic sources, or combinations thereof.

17. The sensing module according to claim 16, wherein the energy harvesting system is configured to harvest energy from user motion, including walking and / or peristaltic activity.

18. The sensing module according to any one of the preceding claims, wherein the sensing module includes an energy management system configured to optimize power consumption and / or prolong operational life.

19. The sensing module according to any one of the preceding claims, wherein the sensing module is configured for wireless charging.

20. The sensing module according to any one of the preceding claims, wherein the communication interface is configured to transmit the ostomy data wirelessly.

21. The sensing module according to any one of the preceding claims, wherein the sensing module is configured to transmit the ostomy data to the external device in response to a prompt received from the external device.

22. The sensing module according to any one of the preceding claims, wherein the sensing module further comprises a data storage unit configured to store the ostomy data.

23. The sensing module according to any one of the preceding claims, wherein the ostomy data comprises one or more of timestamps, raw sensor data, processed data derived from sensor data, and event or state data.

24. The sensing module according to any one of the preceding claims, wherein the one or more sensors are configured to collect sensor data indicative of one or more of physiological conditions, user activity, and device state.

25. The sensing module according to claim 24, wherein the sensing module is arranged to collect sensing data indicative of user activity.5826. The sensing module according to any one of claims 24-25, wherein the sensing module is arranged to collect sensing data indicative of physiological conditions.

27. The sensing module according to any one of claims 24-26, wherein the sensing module is arranged to collect sensing data indicative of device state.

28. The sensing module according to any one of claims 24-27, wherein the physiological conditions comprise one or more of pressure, temperature, waste consistency, electrical conductivity, gas presence, fluid volume, pH, and turbidity of liquid waste.

29. The sensing module according to claim 28, wherein the one or more sensors are configured to measure waste consistency.

30. The sensing module according to any one of claims 28-29, wherein the one or more sensors are configured to measure pressure within an internal lumen of the ostomy implant and / or within an internal volume of the lid.

31. The sensing module according to any one of claims 28-30, wherein the one or more sensors are configured to measure gas pressure and / or liquid pressure to detect waste accumulation, abnormal flow patterns, abnormal gas retention, excessive gas buildup, and / or a potential blockage condition.

32. The sensing module according to any one of claims 28-31 , wherein the one or more sensors are configured to monitor temperature within the ostomy implant and / or waste flow to provide an indication of temperature deviations from a baseline.

33. The sensing module according to any one of claims 28-32, wherein the one or more sensors are configured to measure electrical conductivity to analyze waste composition, including liquid content, electrolyte concentration, and / or hydration status.

34. The sensing module according to any one of claims 28-33, wherein the one or more sensors are configured to detect leakage by detecting waste outside an intended flow path based on capacitive sensing, optical detection, and / or a change in electrical impedance.

35. The sensing module according to any one of claims 28-34, wherein the one or more sensors are configured to determine a fill level of the ostomy implant based on a measured fluid volume and to trigger an alert when the fill level meets a threshold, wherein the alert is transmittable via the communication interface.

36. The sensing module according to any one of claims 28-35, wherein the one or more sensors are configured to measure pH of waste to assess acidity or alkalinity.

37. The sensing module according to any one of claims 28-36, wherein the one or more sensors are configured to measure turbidity of liquid waste to provide an indication of suspended solids and / or changes in waste consistency.

38. The sensing module according to any one of claims 24-37, wherein user activity comprises one or more of usage events of the ostomy implant or the ostomy device.

39. The sensing module according to any one of claims 24-38, wherein the device state comprises information indicative of an operational condition, status, or configuration of the ostomy implant, the lid and / or the sensing module.

40. The sensing module according to any one of the preceding claims, wherein the sensing module is configured to verify an identity of the ostomy implant, an ostomy device, and / or the sensing module using an authentication mechanism, and to generate ostomy data indicative of an authentication status as device state data.

41. The sensing module according to any one of the preceding claims, wherein the sensing module is configured to collect sensor data indicative of a component identifier and to verify an identity of the ostomy implant, an ostomy device, and / or the sensing module using an authentication mechanism.

42. The sensing module according to any one of the preceding claims, wherein the sensing module includes an alert mechanism configured to generate an alert in response to detected abnormal conditions or events.

43. The sensing module according to any one of the preceding claims, wherein the sensing module is configured to correlate data from multiple sensors to identify patterns associated with anomalous device operation and / or physiological changes.

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