WO2025006370A1

WO2025006370A1 - Method and appratus for detecting new ostomy leakage detection sensor

Info

Publication number: WO2025006370A1
Application number: PCT/US2024/035198
Authority: WO
Inventors: Lauren M. LATTANZI
Original assignee: Hollister Inc
Current assignee: Hollister Inc
Priority date: 2023-06-28
Filing date: 2024-06-24
Publication date: 2025-01-02
Anticipated expiration: 2025-12-28

Abstract

A method for detecting a new sensing accessory may include connecting the sensing accessory to a wearable device, connecting at least one accessory detection point to at least one accessory detection pad, and determining that the new sensing accessory status is detected based on a resistance value. The sensing accessory may include the least one accessory detection point. The wearable device may include a protruding member and the at least one accessory detection pad.

Description

METHOD AND APPRATUS FOR DETECTING NEW

OSTOMY LEAKAGE DETECTION SENSOR

BACKGROUND

[0001] This disclosure is related to a leakage detection system. More particularly, the present disclosure pertains to a method and apparatus for detecting a new ostomy leakage detection sensor. [0002] Known ostomy leakage detection systems can include sensors for detecting the presence of ostomy effluent (or leakage) around a stoma of a user. Commonly, such sensors can be part of an accessory that attaches to a barrier and surrounds a stoma and communicates with a wearable device that processes data acquired by the accessory. However, such wearable devices require determining when new accessories are used in order to adjust relevant parameters. For example, relevant parameters may include wear time and leak alerts.

[0003] Accordingly, it is desirable to provide a way to detect a new sensing accessory.

BRIEF SUMMARY

[0004] A method and apparatus for detecting a new ostomy leakage detection sensor are provided according to example embodiments.

[0005] In one aspect, the method may include connecting a sensing accessory to a wearable device, closing the wearable device, connecting at least one accessory detection point to at least one accessory detection pad, and determining that a new sensing accessory status is detected based on a resistance value. The sensing accessory may include the at least one accessory detection point. The wearable device may include a protruding member that may be configured to make contact with the sensing accessory and the at least one accessory detection pad. The at least one accessory detection pad may be configured to detect a status of the sensing accessory based on a resistance value detected by a connection between the at least one accessory detection pad and the at least one accessory detection point.

[0006] In an embodiment, determining that the new sensing accessory status is detected based on the resistance value may include determining that the new sensing accessory status is detected based on the resistance value being open. [0007] In an embodiment, closing the wearable device may include severing a conductive bridge with the protruding member. The at least one accessory detection point may include a first accessory detection point, a second accessory detection point, and a conductive bridge. The conductive bridge may connect the first accessory detection point to the second accessory detection point.

[0008] In an embodiment, the method may further include disconnecting the sensing accessory from the wearable device. Disconnecting the sensing accessory from the wearable device may include severing a conductive bridge. The at least one accessory detection point may include a first accessory detection point, a second accessory detection point, and a conductive bridge. The conductive accessory detection may connect the first accessory detection point to the second accessory detection point.

[0009] In an embodiment, the method may further include connecting a connection point with a connection pad and acquiring leak data from the sensing accessory through the connection point. The connection point may be located on the sensing accessory and the connection pad may be on the wearable device.

[0010] In an embodiment, determining that the new sensing accessory status is detected based on the resistance value may include determining that the new sensing accessory status is detected based on the resistance value and the leak data.

[0011] In another aspect, the sensing accessory may include a sensing region, a tail region, a connector region, and at least one accessory detection point. The sensing region may include a sensor for detecting a leak around a stoma. The tail region may include a conductive trace for communicating leak data from the sensor to a connection point. The connector region may include a connection point for communicating the leak data with a wearable device. The at least one accessory detection point may be located on the connector region and can detect a status of the sensing accessory based on a resistance value of the at least one accessory detection point.

[0012] In an embodiment, the status of the sensing accessory may include a new sensing accessory status and a used sensing accessory status.

[0013] In an embodiment, the at least one accessory detection point may include a first accessory detection point, a second accessory detection point, and a conductive bridge. The conductive bridge may connect the first accessory detection point to the second accessory detection point.

[0014] In an embodiment, when the resistance value is open the status of the sensing accessory may be a used sensing accessory status.

[0015] In an embodiment, the resistance value is open when the conductive bridge may be cut or punched.

[0016] In an embodiment, when the resistance value is not open the status of the sensing accessory may be a new sensing accessory status.

[0017] In another aspect, a wearable device may include a top housing, a bottom housing, a hinge, a protruding member, and at least one accessory detection pad. The bottom housing may include a connection pad configured to communicate to a sensor accessory. The hinge connects the top and bottom housing and allows the top and bottom housing to close on each other. The protruding member is located on the top housing and configured to cut the sensor accessory when the wearable device is closed. The at least one accessory detection pad is located on the bottom housing and configured to detect a status of the sensing accessory based on a resistance value detected by the at least one accessory detection pad.

[0018] In an embodiment, the status of the sensing accessory may include a new sensing accessory status and a used sensing accessory status.

[0019] In an embodiment, the at least one accessory detection pad may include a first and second accessory detection pad configured to connect to a first and second accessory detection point on the sensing accessory.

[0020] In an embodiment, the protruding member may cut a conductive bridge connecting the first and second accessory detection point.

[0021] In an embodiment, when the resistance value is open the status of the sensing accessory may be a used sensing accessory status.

[0022] In an embodiment, the resistance value is open when the conductive bridge may be cut or punched.

[0023] The foregoing general description and the following detailed description are examples only and are not restrictive of the present disclosure. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] The benefits and advantages of the present embodiments will become more readily apparent to those of ordinary skill in the relevant art after reviewing the following detailed description and accompanying drawings, wherein:

[0025] FIG. 1 is an illustration of an ostomy system, according to an embodiment.

[0026] FIG. 2 is an illustration of an ostomy system attached to a user, according to an embodiment.

[0027] FIG. 3 is a body-side view of a sensor circuit, according to an embodiment.

[0028] FIG. 4 is a distal-side perspective view of a sensor accessory, according to an embodiment.

[0029] FIG. 5 is a top perspective view of a wearable device, according to an embodiment.

[0030] FIG. 6 is a body-side perspective view the sensor accessory of FIG. 4 and the wearable device of FIG. 5.

[0031] FIG. 7 is a schematic illustration of a computing environment according to embodiments presented herein.

DETAILED DESCRIPTION

[0032] While the present disclosure is susceptible of embodiment in various forms, there is shown in the drawings and will hereinafter be described presently preferred embodiments with the understanding that the present disclosure is to be considered an exemplification and is not intended to limit the disclosure to the specific embodiments illustrated. The words “a” or “an” are to be taken to include both the singular and the plural. Conversely, any reference to plural items shall, where appropriate, include the singular. The words “first,” “second,” “third,” and the like may be used in the present disclosure to describe various information, such information should not be limited to these words. These words are only used to distinguish one category of information from another. The directional words “top,” “bottom,” up,” “down,” front,” “back,” and the like are used for purposes of illustration and as such, are not limiting. Depending on the context, the word “if’ as used herein may be interpreted as “when” or “upon” or “in response to determining.”

[0033] The present disclosure provides methods and an apparatus for determining when a new sensing accessory is attached to an ostomy leakage detection system. The ostomy leakage detection system can be configured to detect ostomy effluent leakage under a skin barrier and to alert a user. The ostomy leakage detection system can provide multiple benefits to the user. For example, the system can allow the user to intervene and change a skin barrier and/or ostomy pouch system before a leak progresses which can cause embarrassment and inconvenience to the user. Further, the ostomy leakage detection system can assist in maintaining a user’s skin health by detecting a leakage in its early stage to prevent prolonged skin exposure to ostomy effluent, which can lead to skin health complications. The ostomy leakage detection system can also support a user’s emotional well-being by reducing anxiety associated with a risk of leakage. The ostomy leakage detection system may be applied to an ostomy barrier of a one-piece pouch system or a faceplate for a two-piece pouch system.

[0034] FIG. 1 illustrates an ostomy two-piece pouch system 10. According to example embodiments shown schematically in FIG. 1, the ostomy system 10 can generally include a sensing accessory 12, an ostomy barrier appliance 14, an ostomy bag 16, a wearable device 18, and a mobile electronic device 20. The sensing accessory 12 can include a sensing region 22, a tail region 24, and a connection region 26. The sensing region 22 can include an inlet opening 28 configured to surround a stoma (not shown). The tail region 24 can include a connector opening 30 configured to electrically and mechanically connect with the wearable device 18. The ostomy bag 16 can receive and hold bodily waste and may include an pouch coupling member 31 configured to attach to the sensing region 22.

[0035] FIG. 2 illustrates the ostomy pouch system 10 mounted to a user. According to example embodiments shown in FIG. 2, the sensing accessory 12 can be mounted to a user using an adhesive and the inlet opening 28 can surround the stoma. The ostomy barrier appliance 14 can be mounted over the sensing region 22 with an adhesive and can surround the stoma. The ostomy pouch 16 can be mounted on the ostomy barrier appliance 14 using the pouch coupling member 31 and the ostomy barrier coupling member 15. The wearable device 18 can be attached to the sensing accessory 12 using the connector opening 30. The wearable device 18 can be mounted on a user using a patch or an adhesive.

[0036] According to example embodiments, the ostomy leakage detection system may comprise three subsystems - the sensing accessory 12, the wearable device 18, and a mobile application on the mobile electronic device 20. The sensing accessory 12 may be provided as an accessory for an ostomy pouch system. The sensing accessory 12 may include sensors for detecting the presence of ostomy effluent. The sensing accessory 12 may be configured to communicate leakage detection signals to the wearable device 18.

[0037] The wearable subsystem 18 may be a wearable device configured to perform at least some processing of leakage detection signals and to alert a user of a leakage event. The wearable subsystem 18 may be configured to electronically communicate through a wired or wireless communication system with the mobile application. Such electronic communications may include raw data as acquired from the sensing accessory 12 or a leak status for all or part of the sensing accessory 12. The mobile application may be a digital subsystem and/or software application installed and able to run on the mobile device 20. The mobile application may be configured to further process leak detection data and provide an alert or other information about an ostomy appliance to a user.

[0038] FIG. 3 shows a body-side view of a sensor circuit 34. According to example embodiments shown schematically in FIG. 3, the sensor circuit 34 can generally include a conductive sensor 36, a conductive trace 38, and a connection point 40. The sensor circuit 34 can be located on the sensing region 22 of sensing accessory 12 and be configured to detect a leak around a stoma. The conductive trace 38 can be located on the tail region 24 of sensing accessory 12 and may be configured to connect the conductive sensor 36 to the connection point 40. The connection point 40 can be located on the connection region 26 of sensing accessory 12 and may be configured to connect to a connection pad on the wearable device 18.

[0039] The conductive sensor 36 may be arranged in a predetermined pattern in the sensor region 22. For example, the sensor circuit 34 may be generally arranged in a circular or semicircular pattern. Other suitable patterns are envisioned as well, such as an oval or oblong pattern, or other closed or substantially closed loop pattern. Portions or segments of the sensor region 22 may be arranged at one or more radial distances from the inlet opening 28. For example, the sensor circuit 34 may include a plurality of electrically conductive traces arranged at a plurality of different, radial distances from the inlet opening 28.

[0040] The sensor circuit 34 may include conductive traces and conductive pads or points that may be formed by printing on a circuit substrate using a conductive ink via a conventional printing process, for example, screen printing. The conductive ink may comprise carbon black, graphite, silver(Ag), or a silver and silver chloride blend (Ag/AgCl). Each of the plurality of conductive traces may have a width and be arranged in a spaced-apart orientation relative each other. The parameters of the conductive traces may be configured to provide a particular resistance of a sensor circuit.

[0041] According to example embodiments, suitable materials for the circuit substrate may include, but are not limited to polyester (PET), polyethylene (PE), polyurethane film (PU), or thermoplastic polyurethane (TPU) film. The circuit substrate may be configured to provide an excellent bonding surface for the conductive ink, prevent mechanical damage to the conductive ink, and adhere to hydrocolloid adhesive layer. In some embodiments, the circuit substrate and the conductive ink may be configured to provide at least some degree of elasticity to allow stretching of the sensing accessory 12. According to example embodiments, the sensing accessory 12 may comprise a PET circuit substrate having a thickness of about 0.001 inches to about 0.010 inches, preferably about 0.003 inches.

[0042] According to example embodiments, the sensing accessory 12 may be configured to be molded to conform to the convexity of a convex ostomy barrier. According to example embodiments, the sensing accessory 12 may comprise a stretchable printed circuit system to conform to a convex ostomy barrier. In such an embodiment, a circuit substrate, printed conductive traces, and masking layers may be formed from stretchable materials, such as the Dupont INTEXAR system. In another embodiment, the sensing accessory may include slits and voids configured and arranged in a nonstretchable circuit substrate, such as PET, to conform the sensing accessory to a convex barrier.

[0043] FIG. 4 illustrates a distal-side view of a sensor accessory 112. According to example embodiments shown schematically in FIG. 4, the sensor accessory 112 can include a sensing region 122, a tail region 124, a connection region 126, a sensor circuit 134, and a circuit substrate 142. The sensing region 122 can include an inlet opening 128, a conductive sensor 136, an adhesive layer 144, and a release liner 146. The tail region 124 can include a conductive trace 138. The connection region 126 can include a connector opening 130, a connection point 140, a key opening 148, an aligning opening 150, a first accessory detection point 152, a second accessory detection point 154, and a conductive bridge trace 156. [0044] The adhesive layer 144 can be used to attach the sensing region 122 to an ostomy barrier appliance 14. The release liner 146 can be located on the adhesive layer 144 and can be removed when the sensing region 122 is to be attached to the ostomy barrier appliance 14.

[0045] The first and second accessory detection points 152, 154 and the conductive bridge trace 156 can be printed on the circuit substrate 142 with the sensor circuit 134. The first and second accessory detection point 152, 154 can be connected by the conductive bridge trace 156 and can contact with first and second accessory detection pads 166, 168 on the wearable device 118 (FIG. 5) to conduct signals communicating the status of the sensor accessory 112.

[0046] FIG. 5 illustrates a top perspective view of a wearable device 118. According to example embodiments shown schematically in FIG. 5, the wearable device 118 can include a top housing 158, a bottom housing 160, a hinge 162. Bottom housing 160 can comprise a connection pad 164, a first accessory detection pad 166, a second accessory detection pad 168, a center raised member 172, a key member 174, and an aligning member 176. The top housing 158 can comprise a protruding member extending from an interior surface and be rotatably connected to the bottom housing 160 on the hinge 162. The hinge 162 can allow the top housing 158 and bottom housing 160 to rotate at the hinge towards and away from each other to open and close the wearable device 118.

[0047] The first and second accessory detection pads 166, 168 can be located on the bottom housing 160. The first and second accessory detection pads 166, 168 can make contact with the first and second accessory detection points 152, 154 of sensor accessory 112 to conduct signals to communicate the status of the sensor accessory 112 to the wearable device 118.

[0048] The protruding member 170 can be located on an inner surface of the top housing 158 and can align with the first and second accessory detection pads 166, 168 so that when the top housing 158 closes on the bottom housing 160, the protruding member 170 can make contact with the bottom housing 160 between the first and second accessory detection pads 166, 168. The protruding member 170 can include a sharp edge for making a cut on or punching through the connection region 126 of sensing accessory 112.

[0049] FIG. 6 illustrates a body-side view of the sensor accessory 112 inserted in the wearable device 118. According to example embodiments shown schematically in FIG. 6, the connection region 126 can be connected to the bottom housing 160. The center opening 130, the key opening 148, and the aligning opening 150 can respectively receive the center raised member 172, the key member 174, and the aligning member 176 so as to correctly connect the connection region 126 to the bottom housing 160.

[0050] The connection pad 164 can align with and make a connection with the connection point 140 to communicate leakage data from the conductive sensor 136 to the wearable device 118. The first and second accessory detection points 152, 154 can align and make contact with the first and second accessory detection pads 166, 168 to communicate a status of the sensor accessory 112. The wearable device 118 can send a signal to one of the first and second accessory detection points 152, 154 and read if there is a signal from the other accessory detection point to determine if the bridge is unbroken or uncut. The protruding member 170 can cut or break the conductive bridge trace 156 and cutting or breaking the electrical connection between the first and second accessory detection points 152, 154 when the top housing 158 closes on the bottom housing 160 and the protruding member 170 makes contact with the conductive bridge trace 156.

[0051] In this embodiment, the sensor accessory 112 can have a NEW status when the conductive bridge trace 156 is unbroken and an electrical connection between the first and second accessory detection points 152, 154 remain. The sensor accessory 112 can have a USED status when the conductive bridge trace 156 is broken and there is no electrical connection between the first and second accessory detection points 152, 154. The status of the sensor accessory 112 can then be used to determine when a new sensor accessory 112 is connected to the wearable device or if the same accessory is being used. As a new sensor accessory may be applied to an ostomate when the ostomy barrier appliance is changed, this status may allow the wearable device to detect when a user has changed their ostomy barrier appliance and subsequently adjust parameters such as resetting wear time and leak alerts.

[0052] In another embodiment, the conductive bridge trace 156 may also be cut or severed upon pulling the sensor accessory 112 off the wearable device 118 during the first removal. Subsequent attachments of the same sensor to the wearable can result in an open resistance reading between the indicating pads, and in conjunction with a value of the connection point 140, the wearable device 118 can recognize such condition as reflecting the presence of the same sensor and parameters such as the current wear time and leak alerts can continue to be tracked and resume from the last state without being reset. For example, the bottom housing 160 can have an additional member that can cut or sever the sensor accessory 112 when pulled.

[0053] An open resistance value can include an infinite resistance value or a large value compared to a resistance value measured when the conductive bridge 156 is uncut.

[0054] In another embodiment, the bottom housing 160 can include an opening that can receive the protruding member 170 when the wearable device 118 is closed. The opening can help cut the conductive bridge 156 as the protruding member 170 punches through into the opening.

[0055] FIG. 7 illustrates a computing environment 210. According to example embodiments shown schematically in FIG. 7, the computing environment 210 can be part of the wearable device 118. The computing environment 210 can include a processor 220, a memory 240, a communication unit 260, and an VO interface 280.

[0056] The processor 220 can control overall operations of the computing environment 210, such as the operations associated with one or more lights, data acquisition, and data communications. The processor 220 can include one or more programmable processors to execute instructions to perform all or some of the steps in the above-described methods. Moreover, the processor 220 can include one or more modules that facilitate the interaction between the processor 220 and other components. The processor may be a Central Processing Unit (CPU), a microprocessor, a single chip machine, a GPU, or the like.

[0057] The memory 240 can store various types of data to support the operation of the computing environment 210. Memory 240 can include predetermine software 242. Examples of such data comprise instructions for any applications or methods operated on the computing environment 210, raw data, leak data, resistance values, etc. The memory 240 may be implemented by using any type of volatile or non-volatile memory devices, or a combination thereof, such as a static random access memory (SRAM), an electrically erasable programmable read-only memory (EEPROM), an erasable programmable read-only memory (EPROM), a programmable read-only memory (PROM), a read-only memory (ROM), a magnetic memory, a flash memory, a magnetic or optical disk.

[0058] The I/O interface 280 can provide an interface between the processor 220 and peripheral interface modules and the connection pad 164, and accessory detection pads 166, 168. [0059] Communication Unit 260 provides communication between the processing unit and an external device. The communication can be accomplished via wired or wireless connections through, for example, WIFI or BLUETOOTH hardware and protocols.

[0060] In some embodiments, there is also provided a non-transitory computer-readable storage medium comprising a plurality of programs, such as comprised in the memory 240, executable by the processor 220 in the computing environment 210, for performing the abovedescribed methods. For example, the non-transitory computer-readable storage medium may be a ROM, a RAM, or the like.

[0061] The non-transitory computer-readable storage medium has stored therein a plurality of programs for execution by a computing device having one or more processors, where the plurality of programs, when executed by the one or more processors, cause the computing device to perform the above-described method for motion prediction.

[0062] In some embodiments, the computing environment 210 may be implemented with one or more application-specific integrated circuits (ASICs), digital signal processors (DSPs), digital signal processing devices (DSPDs), programmable logic devices (PLDs), field-programmable gate arrays (FPGAs), graphical processing units (GPUs), controllers, micro-controllers, microprocessors, or other electronic components, for performing the above methods.

[0063] From the foregoing it will be observed that numerous modifications and variations can be effectuated without departing from the true spirit and scope of the novel concepts of the present disclosure. It is to be understood that no limitation with respect to the specific embodiments illustrated is intended or should be inferred. The disclosure is intended to cover by the appended claims all such modifications as fall within the scope of the claims.

Claims

CLAIMS What is claimed is:

1. A method of detecting a sensing accessory comprising: connecting a sensing accessory to a wearable device, wherein the sensing accessory comprises at least one accessory detection point, and wherein the wearable device comprises: a protruding member, wherein the protruding member is configured to make contact with the sensing accessory, and at least one accessory detection pad, wherein the at least one accessory detection pad is configured to detect a status of the sensing accessory based on a resistance value detected by a connection between the at least one accessory detection pad and the at least one accessory detection point; closing the wearable device; connecting the at least one accessory detection point to the at least one accessory detection pad; and determining that a new sensing accessory status is detected based on the resistance value.

2. The method of claim 1, wherein determining that the new sensing accessory status is detected based on the resistance value comprises: determining that the new sensing accessory status is detected based on the resistance value being open.

3. The method of any one of claims 1-2, wherein closing the wearable device comprises: severing a conductive bridge with the protruding member, wherein the at least one accessory detection point comprises a first accessory detection point, a second accessory detection point, and the conductive bridge, wherein the conductive bridge connects the first accessory detection point to the second accessory detection point.

4. The method of any one of claims 1-2, further comprising: disconnecting the sensing accessory from the wearable device, wherein disconnecting the sensing accessory from the wearable device comprises severing a conductive bridge, wherein the at least one accessory detection point comprises a first accessory detection point, a second accessory detection point, and the conductive bridge, wherein the conductive accessory detection connects the first accessory detection point to the second accessory detection point.

5. The method of any one of claims 1-4, further comprising: connecting a connection point with a connection pad, wherein the connection point is located on the sensing accessory and the connection pad is on the wearable device; and acquiring leak data from the sensing accessory through the connection point.

6. The method of claim 5, wherein determining that the new sensing accessory status is detected based on the resistance value comprises: determining that the new sensing accessory status is detected based on the resistance value and the leak data.

7. A sensing accessory for an ostomy leakage detection system comprising: a sensing region, wherein the sensing region comprises a sensor for detecting a leak around a stoma; a tail region, wherein the tail region comprises a conductive trace for communicating leak data from the sensor to a connection point; a connector region, wherein the connector region comprises a connection point for communicating the leak data with a wearable device; and at least one accessory detection point, wherein the at least one accessory detection point is located on the connector region and configured to detect a status of the sensing accessory based on a resistance value of the at least one accessory detection point.

8. The sensing accessory of claim 7, wherein the status of the sensing accessory comprises a new sensing accessory status and a used sensing accessory status.

9. The sensing accessory of any one of claims 7-8, wherein the at least one accessory detection point comprises a first accessory detection point, a second accessory detection point, and a conductive bridge, wherein the conductive bridge connects the first accessory detection point to the second accessory detection point.

10. The sensing accessory of claim 9, wherein when the resistance value is open the status of the sensing accessory is a used sensing accessory status.

11. The sensing accessory of claim 10, wherein the resistance value is open when the conductive bridge is cut or punched.

12. The sensing accessory of any one of claims 9-11, wherein when the resistance value is not open the status of the sensing accessory is a new sensing accessory status.

13. Awearable device for an ostomy leakage detection system comprising: a top housing; a bottom housing, wherein the bottom housing comprises a connection pad configured to communicate to a sensor accessory; a hinge, wherein the hinge connects the top and bottom housing and allows the top and bottom housing to close on each other; a protruding member, wherein the protruding member is located on the top housing and configured to cut the sensor accessory when the wearable device is closed; and at least one accessory detection pad, wherein the at least one accessory detection pad is located on the bottom housing and configured to detect a status of the sensing accessory based on a resistance value detected by the at least one accessory detection pad.

14. The wearable device of claim 13, wherein the status of the sensing accessory comprises a new sensing accessory status and a used sensing accessory status.

15. The wearable device of any one of claims 13-14, wherein the at least one accessory detection pad comprises first and second accessory detection pads configured to connect to first and second accessory detection points on the sensing accessory.

16. The wearable device of claim 15, wherein the protruding member is configured to cut a conductive bridge connecting the first and second accessory detection point.

17. The wearable device of claim 16, wherein the resistance value is open when the conductive bridge is cut or punched.

18. The wearable device of any one of claims 14-17, wherein when the resistance value is open the status of the sensing accessory is a used sensing accessory status.