WO2025006071A1

WO2025006071A1 - Sensing accessory for ostomy leakage detection system

Info

Publication number: WO2025006071A1
Application number: PCT/US2024/029292
Authority: WO
Inventors: Lauren M. LATTANZI; Anthony B. SMITH; Grace E. RHINEHART; Elise JAFFE
Original assignee: Hollister Incorporated
Priority date: 2023-06-28
Filing date: 2024-05-14
Publication date: 2025-01-02

Abstract

A sensing accessory for an ostomy leakage detection system includes a sensing member, a conductive sensor, a connection member, and a tail member. The sensing member may include a body side surface and a distal side surface. The sensing member may include an inlet opening that surrounds a stoma. The conductive sensor may be located on the body side surface of the sensing member. The conductive sensor may include at least two pairs of conductive traces arranged in at least two radial sensing levels. The connecting member may include one or more connection pads electrically connecting with an electronic device. The tail member may include electrical leads connecting the at least two pairs of conductive traces to the one or more connection pads.

Description

SENSING ACCESSORY FOR OSTOMY LEAKAGE DETECTION SYSTEM

BACKGROUND

[0001] This disclosure is related to an ostomy leakage detection system. More particularly, the present disclosure pertains to a sensing accessory of the ostomy leakage detection system.

[0002] Known ostomy leakage detection systems can include a sensor assembly for detecting the presence of ostomy effluent (or leakage) around a stoma of a user. Commonly, such sensor assemblies can be part of an accessory that attaches to an ostomy barrier appliance and a user’s abdomen using an adhesive. However, during wear, the sensor assembly may flow, move, slide or shift due to heat or moisture. For example, the accessory may be exposed to moisture resulting in the adhesive between the accessory and the user’s abdomen to loosen, further causing the sensor assembly to flow, move, shift or slide. A risk of the sensor assembly flowing, moving, shifting or sliding can include irritating or injuring the stoma by the ostomy barrier appliance coming into contact with the stoma and pulling on it.

[0003] Accordingly, it is desirable to provide an accessory that prevents the sensor assembly from flowing, moving, shifting or sliding and lessens the associated risks.

BRIEF SUMMARY

[0004] A sensing accessory for an ostomy leakage detection system is provided according to various embodiments.

[0005] In one aspect, the sensing accessory for an ostomy leakage detection system includes a sensing member, a conductive sensor, a connection member, and a tail member. The sensing member may include a body side surface and a distal side surface. The sensing member may include an inlet opening that surrounds a stoma. The conductive sensor may be located on the body side surface of the sensing member. The conductive sensor may include at least two pairs of conductive traces arranged in at least two radial sensing levels. The connecting member may include one or more connection pads electrically connecting with an electronic device. The tail member may include electrical leads connecting the at least two pairs of conductive traces to the one or more connection pads.

[0006] In an embodiment, a pair of conductive traces may include a conductive trace and a ground trace. A radial sensing level may include the pair of conductive traces.

[0007] In an embodiment, the at least two radial sensing levels may include a first pair of conductive traces that may detect a leak on a first radial sensing level of the sensing member and a second pair of conductive traces that may detect a leak on a second radial sensing level of the sensing member.

[0008] In an embodiment, the sensing member may include four quadrants.

[0009] In an embodiment, the at least two pairs of conductive traces may include at least six pairs of conductive traces arranged in at least three radial sensing levels.

[0010] In an embodiment, the six pairs of conductive traces may include a first pair of conductive traces that may detect a leak on a first radial sensing level of the sensing member, a second pair of conductive traces that may detect a leak on a first quadrant of a second radial sensing level of the sensing member, a third pair of conductive traces that may detect a leak on a second quadrant of the second radial sensing level of the sensing member, a fourth pair of conductive traces that may detect a leak on a third quadrant of the second radial sensing level of the sensing member, a fifth pair of conductive traces that may detect a leak on a fourth quadrant of the second radial sensing level of the sensing member, and a sixth pair of conductive traces that may detect a leak a third radial sensing level of the sensing member.

[0011] In an embodiment, the sensing accessory may comprise a dielectric masking layer that may prevent detection of a leak at non-radial sensing levels. The dielectric masking layer may be located on the sensing member.

[0012] In an embodiment, the masking layer may cover a conductive trace of the second pair of conductive traces at the second quadrant and a conductive trace of the fourth pair of conductive traces at the fourth quadrant.

[0013] In an embodiment, the tail member may include two ground electrical leads.

[0014] In an embodiment, the at least two pairs of conductive traces may be printed on a circuit substrate at 0.018 to 0.020 inches of thickness with 0.018-0.020 inches of spacing between traces. [0015] In another aspect, the sensing accessory may include a sensing member, a conductive sensor, an adhesive layer, a connection member, and a tail member. The sensing member may include a body side surface and a distal side surface. The sensing member may include an inlet opening that surrounds a stoma. The sensing member may include a dividing section. The conductive sensor may be located on the body side surface of the sensing member. The conductive sensor may include at least two pairs of conductive traces arranged in at least two semi-radial sensing levels. The at least two pairs of conductive traces may be separated at the dividing section. The adhesive layer may be located on the body side of the conductive sensor. The connecting member may include one or more connection pads electrically connecting with an electronic device. The tail member may include electrical leads connecting the at least two pairs of conductive traces to the one or more connection pads.

[0016] In an embodiment, the dividing section may include a split that entirely splits the sensing member at an end opposite the tail member. [0017] In an embodiment, the dividing section may include a perforated section that entirely splits the sensing member during a collision with the stoma. The perforated section may be located at an end of the sensing member opposite the tail member.

[0018] In an embodiment, a pair of conductive traces may include a conductive trace and a ground trace. A semi-radial sensing level may include the pair of conductive trace. The sensing member comprises four quadrants.

[0019] In an embodiment, the at least two pairs of conductive traces may include at least seven pairs of conductive traces arranged in at least three radial sensing levels. The seven pairs of conductive traces may include a first pair of conductive traces that may detect a leak on a first radial sensing level of the sensing member, a second pair of conductive traces that may detect a leak on a first quadrant of a second radial sensing level of the sensing member, a third pair of conductive traces that may detect a leak on a second quadrant of the second radial sensing level of the sensing member, a fourth pair of conductive traces that may detect a leak on a third quadrant of the second radial sensing level of the sensing member, a fifth pair of conductive traces that may detect a leak on a fourth quadrant of the second radial sensing level of the sensing member, a sixth pair of conductive traces that may detect a leak on a first half of a third radial sensing level of the sensing member, and a seventh pair of conductive traces that may detect a leak on a second half of a third radial sensing level of the sensing member.

[0020] In an embodiment, the connecting member comprises seven connection points, a conductive trace of the sixth pair of conductive traces and a conductive trace of the seventh pair of conductive traces can diverge and can connect to one of the seven connection points. The ground trace may connect to one of the seven connection points.

[0021] In another aspect, the sensing accessory may include a sensing member, a conductive sensor, a body-side hydrocolloid layer, a connection member, and a tail member. The sensing member may include a body side surface and a distal side surface. The sensing member may include an inlet opening that surrounds a stoma. The sensing member may include an outer patterned-shaped edge that makes contact with a barrier appliance. The conductive sensor can detect a leak. The conductive sensor may be located on the body side surface of the sensing member. The body-side hydrocolloid layer may be located on the body side of the sensing member and may be within the outer patterned-shaped edge. The connecting member may include one or more connection pads electrically connecting with an electronic device. The tail member may include electrical leads connecting the conductive sensor to the one or more connection pads.

[0022] In an embodiment, the sensing member may include an inner patterned-shaped edge that makes contact with a barrier appliance.

[0023] In an embodiment, the outer patterned-shaped edge may include a gear-shaped edge.

[0024] In an embodiment, the sensing member may include a distal-side hydrocolloid layer located on the distal side of the sensing member. The sensing member may include at least one opening that allows the body-side hydrocolloid layer to adhere to the distal-side hydrocolloid layer. [0025] 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

[0026] 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:

[0027] FIG. 1 is an illustration of an ostomy system, according to an embodiment. [0028] FIG. 2 is a front view of an ostomy system attached to a user, according to an embodiment.

[0029] FIG. 3 is a body-side elevation view of a sensor circuit, according to an embodiment.

[0030] FIG. 4 is a body-side elevation view of a sensor accessory, according to an embodiment.

[0031] FIG. 5 is an enlarged partial body-side elevation view of the sensor accessory of FIG.

4.

[0032] FIG. 6 is a body-side elevation view of a sensor accessory, according to an embodiment.

[0033] FIG. 7 is a body-side perspective view of the sensor accessory of FIG. 7.

[0034] FIG. 8 is a body-side elevation view of a sensor accessory, according to an embodiment.

[0035] FIG. 9 is a body-side elevation view of a sensor accessory, according to an embodiment.

[0036] FIG. 10 is a body-side perspective view of a sensor accessory, according to an embodiment.

[0037] FIG. 11 is a distal-side elevation view of a sensor accessory, according to an embodiment.

[0038] FIG. 12 is an enlarged partial distal-side elevation view of the sensor accessory of FIG.

11.

[0039] FIG. 13 is an enlarged partial body-side elevation view of a sensor accessory, according to an embodiment.

[0040] FIG. 14 is an enlarged elevation body-side view of the sensor accessory of FIG. 13.

[0041] FIG. 15 is a schematic view of a computing system, according to an embodiment.

DETAILED DESCRIPTION

[0042] 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.”

[0043] The present disclosure provides a sensing accessory for 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.

[0044] 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 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 connection region 26 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 a pouch coupling member 31 configured to attach to the sensing region 22.

[0045] 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.

[0046] 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 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.

[0047] 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 communicate electronically through a wire 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 installed 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.

[0048] 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.

[0049] 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 defining an opening or space for placement over a user’s stoma. The sensor circuit 34 in 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.

[0050] 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 spaced-apart from each other. The parameters of the conductive traces may be configured to provide a particular resistance of a sensor circuit.

[0051] 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 a 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. The sensing accessory 12 may also include a dielectric layer formed from a dielectric material configured to provide at least some elasticity to allow stretching of the sensing accessory 12. In an embodiment, the sensing accessory 12 may comprise a strechable circuit substrate, stretchable conductive ink, and a stretchable dielectric masking layer. 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.

[0052] 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 suitable for being applied to or flush against the skin side surface of 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.

[0053] Referring now to the figures, FIGS. 4-14 show a sensor accessory 112, 212, 312, 412, 512, 612, 712, or portions thereof, according to example embodiments. The sensor accessory 112, 212, 312, 412, 512, 612, 712 can generally include a sensing region 122, 222, 322, 422, 522, 622, 722 a tail region 124, 224, 324, 424, 524, 624, 724 a connector region 126, 226, 326, 426, 526, 626, 726 an inlet opening 128, 228, 328, 428, 528, 628, 728 a connector opening 130, 230, 330, 430, 530, 630, 730 and a sensor circuit 134, 234, 334, 434, 534, 634, 734. The connector opening 130, 230, 330, 430, 530, 630, 730 can be located on the connector region 126, 226, 326, 426, 526, 626, 726. The sensing region 122, 222, 322, 422, 522, 622, 722 can generally include a conductive sensor 136, 236, 336, 436, 536, 636, 736.

[0054] The tail region 124, 224, 324, 424, 524, 624, 724 can generally include a circuit substrate 142, 242, 342, 442, 542, 642, 742 a conductive trace 138, 238, 338, 438, 538, 638 and a masking layer 144, 244, 344, 444, 544, 644, 744. The masking layer 144, 244, 344, 444, 544, 644, 744 can be located over the conductive trace 138, 238, 338, 438, 538, 638 for insulating the conductive trace. According to an example, the masking layer 144, 244, 344, 444, 544, 644, 744 can be a dielectric masking layer applied over areas where exposure and detecting is not desired.

[0055] The connector region 126, 226, 326, 426, 526, 626, 726 can generally include a connection point 140, 240, 340, 440, 540, 640 an insulated layer 146, 246, 346, 446, 546 an insulated layer opening 148, 248, 348, 448, 548 an aligning opening 150, 250, 350, 450, 550, 650, 750 and a key opening 152, 252, 352, 452, 552, 652, 752. The insulated layer 146, 246, 346, 446,

546 can include a stiff surface for handling the connector region 126, 226, 326, 426, 526, 626, 726 for correctly connecting the connection region 26 to the wearable device 18 by preventing folding or tearing. The insulated layer opening 148, 248, 348, 448, 548 can be an opening in the insulated layer 148, 248, 348, 448, 548 for allowing the connection point 140, 240, 340, 440, 540, 640 to make contact with connection pads (not shown) on the wearable device 18. The key opening 152, 252, 352, 452, 552, 652, 752 and the aligning opening 150, 250, 350, 450, 550, 650, 750 can allow for the connector region 126, 226, 326, 426, 526, 626, 726 to be attached to the wearable device 18 in a correct position - the wearable device having a reciprocal connection member (not shown) that corresponds to the shape and configuration of the key opening and aligning opening whereby the connector region can be press fit onto the wearable device with the reciprocal connection member fitting through the key opening and aligning opening.

[0056] FIG. 4 shows a body-side view of a sensor accessory 112. According to example embodiments shown schematically in FIG. 4, the sensor accessory 112 can include an adhesive layer (not shown) on the sensing region 122 for attaching the sensing region 122 to an ostomy barrier appliance 14. The sensor accessory 112 can include a release liner (not shown) located on the adhesive layer and can be removed when the sensing region 122 is to be attached to the ostomy barrier appliance 14.

[0057] According to example embodiments, the sensing region 122 can be attached to the ostomy barrier appliance 14 and used to sense the presence of moisture on a user’s skin as an indicator of potential leakage. The sensing region 122 can have multiple conductive sensors 136 made up of pairs of concentric conductive ink traces that when bridged with fluid cause a detectable drop in resistance that can be processed by the connected wearable device 18 to determine leak events. The sensing elements can be arranged in such a way to monitor the progression of fluid outward from the stoma over time. [0058] FIG. 5 shows a partially enlarged body-side view of the sensing region 122. According to example embodiments shown schematically in FIG. 5, the sensing region 122 can be broken into four quadrants (for purposes of illustration - NE, SE, NW, SW). The sensing region 122 can include a first level conductive sensor 154, a second level conductive sensor 156, a third level NE conductive sensor 158, a third level SE conductive sensor 160, a third level NW conductive sensor 162, a third level SW conductive sensor 164, a fourth level conductive sensor 166, a fifth level conductive sensor 168, a first ground trace 170, a second ground trace 172, a third level SW masking layer 174, and a third level SE masking layer 176. The third level SW masking layer 174 can cover a portion of the third level NW conductive sensor 162 at the SW quadrant to insulate the third level NW conductive sensor 162 from a leakage event in the SW quadrant. The third level SE masking layer 176 can cover a portion of the third level NE conductive sensor 158 at the SE quadrant to insulate the third level NE conductive sensor 158 from a leakage event in the SE quadrant. Thus, it will be understood by persons of ordinary skill in the art that the use of masking layers 174 and 176 can enable leakage events in the SW and SE quadrants to be detectable by the corresponding third level SW and SE conductive sensors 164, 160 respectively with the third level NW and NE conductive sensors 162, 158 being responsive to leakage events in the NW and NE quadrants respectively.

[0059] According to example embodiments, the conductive sensor 136 can feature eight conductive traces 154, 156, 158, 160, 162, 164, 166, 168 that can be arranged in five radial sensing levels with level three broken into the four quadrants NE, SE, NW, SW of sensor pairs for detecting the direction of fluid progression. Each sensor level conductive trace 154, 156, 158, 160, 162, 164, 166, 168 can be adjacent to ground traces 170, 172 so that resistance may be measured between each sensor level conductive trace 154, 156, 158, 160, 162, 164, 166, 168 and their corresponding adjacent ground trace 170, 172. For example, the conductive trace 168 may be paired with an adjacent ground trace 170 and a resistance can be measured between them (168 and 170).

[0060] The resistance levels can be used to detect a leakage sensing event. A first level leakage event, near the inlet opening 128, can be detected based on the resistance value between the conductive trace 154 and the ground trace 172. A second level leakage event can be detected based on the resistance value between the conductive trace 156 and the ground trace 172. A NE level leakage event can be detected based on the resistance value between the conductive trace 158 and the ground trace 170. A SE level leakage event can be detected based on the resistance value between the conductive trace 160 and the ground trace 170. A NW level leakage event can be detected based on the resistance value between the conductive trace 162 and the ground trace 170. A SW level leakage event can be detected based on the resistance value between the conductive trace 164 and the ground trace 170. A fourth level leakage event can be detected based on the resistance value between the conductive trace 166 and the ground trace 170. A fifth level leakage event can be detected based on the resistance value between the conductive trace 168 and the ground trace 170.

[0061] The leakage level events can be used to determine where a leakage is starting from and where the leakage is progressing to. Thus, embodiments comprising the configuration of conducting sensors as presented herein have the capability of detecting the location and spread of stoma leakage radially outward from the stoma. This can be used for identifying and understanding the extent or significance of the leakage event.

[0062] According to example embodiments, the conductive traces can be printed at 0.018” - 0.020” thickness with 0.018” - 0.020” spacing between conductive traces/trace edge to substrate edge. [0063] FIG. 6 shows a body-side view of a sensor accessory 212. According to example embodiments shown schematically in FIG. 6, the sensor accessory 212 can include an adhesive layer 278, a barrier tail 280, and an adhesive layer opening 282. The adhesive layer 278 can be located on the sensing region 222 and can extend to the barrier tail 280. The adhesive layer opening 282 can align with the inlet opening 128. According to example embodiments, the adhesive layer 278 can be made out of hydrocolloid material.

[0064] In several embodiments, the sensor accessory 112, 212 can be designed to reduce the effects of “warm flow” and lessen the associated risks. Warm flow can be referred to as the shifting of the sensing region 122 and/or the ostomy barrier appliance 14 during wear. This is caused by the adhesive layer 278 used to attach the sensing region 122 to the user’s abdomen and/or the ostomy barrier appliance 14 having material that flows, detaches or shifts due to heat and/or moisture absorption during wear.

[0065] FIG. 7 shows the sensor accessory 212. According to example embodiments shown schematically in FIG. 7, the adhesive layer 278 can be on the body-side of the conductive sensor 136. According to example embodiments, the sensor accessory 212 can have a thin layer of hydrocolloid as the adhesive layer 278 on the body-facing side of the sensing region 222 and can be free of hydrocolloid on the distal side (barrier-facing side). A hydrocolloid-free barrier-facing side may prevent or reduce the progression of warm flow during wear as the sensing region 222 can directly adhere to the ostomy barrier appliance 14. For example, the barrier-facing side may include a non-woven material or a backing layer that can attach to an adhesive layer on the ostomy barrier appliance 14.

[0066] FIG. 8 shows a body-side view of a sensor accessory 312. According to example embodiments shown schematically in FIG. 8, the sensing region 322 can include a split 384 that can entirely bisect the circuit substrate 342 from an inner edge to an outer edge. The split 384 can reduce the risk of a user sustaining harm or pain from the occurrence of warm flow. For example, severe warm flow can cause the sensing region 322 to shift or detach from a user’s abdomen while the sensor accessory 312 can be attached around a stoma. In such instances, the sensing region 322 can shift and catch and pull on the stoma, potentially causing an injury. The split 384 can allow the sensing region 322 to pass around the stoma without catching or pulling on the stoma. The split 384 can be located at the end of the sensing region 322 opposite of the tail region 324 as the direction of warm flow tends to occur towards the tail region 324 due to tension from the wearable attached at the connector region 326 as seen in clinical and benchtop testing. According to example embodiments, the split 384 can be part of a dividing section.

[0067] FIG. 9 shows a body-side view of a sensor accessory, according to an embodiment. According to example embodiments shown schematically in FIG. 9, the sensing region 422 can include a perforation 484 that bisects the circuit substrate 442 from an inner edge to an outer edge. The perforation 484 may reduce the risk of harm or pain to a user from the occurrence of warm flow. More particularly, where the interior edge of the substrate exerts a pulling pressure or force on the stoma from movement of the sensor, such pulling pressure and/or force can facilitate the separation of sensing region 422 at perforation 484 to enable the sensing region 422 to split and pass around the stoma without catching or pulling on the stoma with undue pressure or force. The perforation 484 can allow the sensing region 322 to retain its ring shape during wear and split the perforated edge upon severe warm flow/collision with the stoma. According to example embodiments, the perforation 484 can be part of a dividing section.

[0068] FIG. 10 shows a body-side view of a sensor accessory according to an embodiment.

According to example embodiments shown schematically in FIG. 10, the sensing region 522 can include a split 584 and gear-shaped edges 586 with concave cuts 588.

[0069] According to example embodiments, the gear-shaped edges 586 with concave cuts 588 can make contact with the ostomy barrier appliance 14 such that the hydrocolloid material can be captured on the features, slowing or halting the movement of the sensing region 522 on the ostomy barrier appliance 14 during warm flow. According to example embodiments, the gear-shaped edges 586 with concave cuts 588 may be serration-like features along the outer edge of the circular portion of the circuit substrate similar to a gear pattern.

[0070] FIG. 11 shows a body-side view of a sensor accessory according to an embodiment. According to example embodiments shown schematically in FIG. 11, the sensing region 622 can include an outer patterned-shaped edge 686, an outer concave edge 688, a through-hole 690, an inner patterned-shaped edge 692, and an inner concave edge 694. The through-hole 690 can be an opening in the circuit substrate 642.

[0071] According to example embodiments, the outer patterned-shaped edge 686, the outer concave edge 688, the inner patterned-shaped edge 692, and the inner concave edge 694 can make contact with the ostomy barrier appliance 14 such that the hydrocolloid material can be captured on the features, slowing or halting the movement of the sensing region 622 on the ostomy barrier appliance 14 during warm flow. According to example embodiments, the outer patterned-shaped edge 686, the outer concave edge 688, the inner patterned-shaped edge 692, and the inner concave edge 694 may be wave-shaped features along the outer and inner edge of the circular portion of the circuit substrate similar to a wave pattern.

[0072] According to example embodiments, the sensing region 622 can include two adhesive layers (FIG. 6), each on a body-side and on a barrier-facing side. The adhesive layers may be hydrocolloid layers. In this embodiment, the through-hole 690 can allow the body-side hydrocolloid layer to adhere to the barrier-facing side hydrocolloid layer through the through-hole 690. Thus, potentially increasing the overall adhesion of the sensing region 622 to the ostomy barrier appliance 14 and reducing the progression of warm flow.

[0073] According to example embodiments, the conductive sensor 636 may be routed around the patterned shaped cuts 686, 688, 692, 694 and through-holes 690 in an undulating pattern to optimize the available substrate space, minimizing the ostomy barrier appliance 14 surface area covered by the sensing region 622. The undulating conductive sensor 636 may also allow for greater stretching of a stretchable circuit substrate 642 material prior to breaking the conductive traces.

[0074] FIG. 12 shows a body-side view of the sensor accessory of FIG. 11. According to example embodiments shown schematically in FIG. 12, the sensing region 622 can be broken into four quadrants (for purposes of illustration - NE, SE, NW, SW). The sensing region 622 can include a third level SW masking layer 674 and a third level SE masking layer 676. The third level SW masking layer 674 can cover a portion of the third level NW conductive sensor to insulate the third level NW conductive sensor from a leakage event in the SW quadrant. The third level SE masking layer 676 can cover a portion of the third level NE conductive sensor at the SE quadrant to insulate the third level NE conductive sensor from a leakage event in the SE quadrant. Thus, it will be understood by persons of ordinary skill in the art that the use of masking layers 674 and 676 can enable leakage events in the SW and SE quadrants to be detectable by the corresponding third level SW and SE conductive sensors, respectively, with the third level NW and NE conductive sensors being responsive to leakage events in the NW and NE quadrants respectively.

[0075] FIG. 13 shows a body-side view of a sensor accessory, according to an embodiment.

According to example embodiments shown schematically in FIG. 13, the sensing region 722 can be broken into four quadrants NE, SE, NW, SW. The sensing region 622 can include a first level conductive sensor 754, a second level first conductive sensor 756, a second level second conductive sensor 757, a third level NE conductive sensor 758, a third level SE conductive sensor 760, a third level NW conductive sensor 762, a third level SW conductive sensor 764, a fourth level first conductive sensor 766, a fourth level second conductive sensor 767, a fifth level first conductive sensor 768, a fifth level second conductive sensor 769, a ground conductive sensor 770, a third level SW masking layer 774, a fourth level masking layer 775, a third level SE masking layer 776, a split 784, an outer patterned-shaped edge 786, and an outer concave edge 788.

[0076] According to example embodiments, the third level SW masking layer 774 can cover a portion of the third level NW conductive sensor 762 at the SW quadrant to insulate the third level NW conductive sensor 762 from a leakage event in the SW quadrant. The third level SE masking layer 776 can cover a portion of the third level NE conductive sensor 758 at the SE quadrant to insulate the third level NE conductive sensor 758 from a leakage event in the SE quadrant. The fourth level masking layer 775 can cover a portion of the fourth level first conductive sensor 766 between the third NW and SW levels to insulate the fourth level first conductive sensor 766 from a leakage event in the third NW and SW levels. Thus, it will be understood by persons of ordinary skill in the art that the use of masking layers 774, 775, and 776 can enable leakage events in the SW and SE quadrants and the fourth level NW and SW quadrants to be detectable by the corresponding third level SW and SE conductive sensors 764, 760 and the fourth level first conductive sensor 766 respectively with the third level NW and NE conductive sensors 762, 758 being responsive to leakage events in the NW and NE quadrants respectively.

[0077] According to example embodiments, the conductive sensor 736 can be laid out to incorporate the split 784 through the sensing region 722. Levels two, four, and five are split into semi-circles (semi-radial) so that each level spans both halves of the sensing region that is separated by the split 784. The ground conductive sensor 770 can be routed around trace levels one to four adjacent to the split 784 on both halves of the sensing region 722 such that each sensing level trace can be paired with a ground trace at the same inter-trace spacing. According to example embodiments, the inter-trace spacing can be 0.018”.

[0078] FIG. 14 shows a body-side view of a sensor accessory of FIG. 13. According to example embodiments shown schematically in FIG. 13, the connector region 726 can include a plurality of conductive traces including a first level conductive trace 754A, second level first and second conductive traces 756A, 757A, third level NE and SE conductive traces 758A, 760A, third level NW and SW conductive traces 762A, 764A, fourth level first and second conductive traces 766A, 767A, fifth level first and second conductive traces 768A, 769 A, and a ground trace 770A. As shown schematically in FIG. 14, example embodiments can further include a first level connection point 754AA, second level first and second connection points 756AA, 757AA, third level NE and SE connection points 758AA, 760AA, third level NW and SW connection points 762AA, 764AA, fourth level first and second connection points 766AA, 767AA, fifth level first and second connection points 768AA, 769AA, and a first and second ground connection points 770AA, 770BB.

[0079] According to example embodiments, the first level conductive sensor 754 can connect to the first level conductive trace 754A, the second level first conductive sensor 756 can connect to the second level first conductive trace 756A, the second level second conductive sensor 757 can connect to the second level second conductive trace 757A, the third level NE conductive sensor

758 can connect to the third level NE conductive trace 758A, the third level SE conductive sensor

760 can connect to the third level SE conductive trace 760A, the third level NW conductive sensor 762 can connect to the third level NW conductive trace 762A, the third level SW conductive sensor 764 can connect to the third level SW conductive trace 764A, the fourth level first conductive sensor 766 can connect to the fourth level first conductive trace 766A, the fourth level second conductive sensor 767 can connect to the fourth level second conductive trace 767A, the fifth level first conductive sensor 768 can connect to the fifth level first conductive trace 768A, the fifth level second conductive sensor 769 can connect to the fifth level second conductive trace 769A, and the ground conductive sensor 770 can connect to the ground trace 770 A.

[0080] According to example embodiments, the first level conductive trace 754A can connect to the first level connection point 754AA, the second level first conductive sensor 756 and the second level second conductive sensor 757 can diverge into the second level first connection point 756AA, the third level NE conductive trace 758A can connect to the third level NE connection point 758AA, the third level SE conductive trace 760A can connect to the third level SE connection point 760AA, the third level NW conductive trace 762A can connect to the third level NW connection point 762AA, the third level SW conductive trace 764A can connect to the third level SW connection point 764AA, the fourth level first conductive sensor 766 and the fourth level second conductive sensor 767 can diverge into the fourth level first connection point 766AA, and the fifth level first conductive sensor 768 and the fifth level second conductive sensor 769 can diverge into the fifth level first connection point 768AA. The ground conductive sensor 770 can connect to the first ground connection point 770AA and the second ground connection point 770BB. This embodiment allows for the same connection points locations, size, and substrate dimensions of the connector region 726 that would be used for a non-split design (FIG. 4) while optimizing the circuit space available for trace routing within manufacturing tolerances.

[0081] FIG. 15 shows a computing environment 1510. According to example embodiments shown schematically in FIG. 15, the computing environment 1510 can be part of the wearable device 18. The computing environment 1510 can include a processor 1510, a memory 1540, a communication unit 1560, and an I/O interface 1580.

[0082] The processor 1520 typically controls overall operations of the computing environment 1510, such as the operations associated with one or more lights, data acquisition, and data communications. The processor 1520 can include one or more processors to execute instructions to perform all or some of the steps in the above-described methods. Moreover, the processor 1520 can include one or more modules that facilitate the interaction between the processor 1520 and other components. The processor may be a Central Processing Unit (CPU), a microprocessor, a single chip machine, a GPU, or the like.

[0083] The memory 1540 can store various types of data to support the operation of the computing environment 1510. Memory 1540 can include predetermine software 1542. Examples of such data comprise instructions for any applications or methods operated on the computing environment 1510, raw data, leak data, resistance values, etc. The memory 1540 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.

[0084] The I/O interface 1580 can provide an interface between the processor 1520 and peripheral interface modules and a connection pad on the wearable device 18 for connecting to the connection point 40 on the connector region 26.

[0085] Communication Unit 1560 provides communication between the processing unit and an external device. The communication can be done through, for example, WIFI or BLUETOOTH hardware and protocols. The Communication Unit 1560 can be within the computing environment or connected to it.

[0086] 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 1540, executable by the processor 1520 in the computing environment 1510, for performing the abovedescribed methods. For example, the non-transitory computer-readable storage medium may be a ROM, a RAM, or the like.

[0087] 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.

[0088] In some embodiments, the computing environment 1510 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.

[0089] 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 sensing accessory for an ostomy leakage detection system comprising: a sensing member, wherein the sensing member comprises a body side surface and a distal side surface, and wherein the sensing member comprises an inlet opening that surrounds a stoma; a conductive sensor that detects a leak, wherein the conductive sensor is located on the body side surface of the sensing member, and wherein the conductive sensor comprises at least two pairs of conductive traces arranged in at least two radial sensing levels; a connecting member, wherein the connecting member comprises one or more connection pads electrically connecting with an electronic device; and a tail member, wherein the tail member comprises electrical leads connecting the at least two pairs of conductive traces to the one or more connection pads.

2. The sensing accessory of claim 1, wherein a pair of conductive traces comprises a conductive trace and a ground trace, and wherein a radial sensing level comprises the pair of conductive traces.

3. The sensing accessory of any one of claims 1-2, wherein the at least two radial sensing levels comprises a first pair of conductive traces that detects a leak on a first radial sensing level of the sensing member and a second pair of conductive traces that detects a leak on a second radial sensing level of the sensing member.

4. The sensing accessory of any one of claims 1-3, wherein the sensing member comprises four quadrants.

5. The sensing accessory of any one of claims 1-2, wherein the at least two pairs of conductive traces comprise at least six pairs of conductive traces arranged in at least three radial sensing levels.

6. The sensing accessory of claim 5, wherein the six pairs of conductive traces comprise: a first pair of conductive traces that detects a leak on a first radial sensing level of the sensing member; a second pair of conductive traces that detects a leak on a first quadrant of a second radial sensing level of the sensing member; a third pair of conductive traces that detects a leak on a second quadrant of the second radial sensing level of the sensing member; a fourth pair of conductive traces that detects a leak on a third quadrant of the second radial sensing level of the sensing member; a fifth pair of conductive traces that detects a leak on a fourth quadrant of the second radial sensing level of the sensing member; and a sixth pair of conductive traces that detects a leak on a third radial sensing level of the sensing member.

7. The sensing accessory of claim 6, further comprising: a dielectric masking layer that prevents detection of a leak at non-radial sensing levels, wherein the dielectric masking layer is located on the sensing member.

8. The sensing accessory of claim 7, wherein the masking layer covers a conductive trace of the second pair of conductive traces at the second quadrant and a conductive trace of the fourth pair of conductive traces at the fourth quadrant.

9. The sensing accessory of any one of claims 1-8, wherein the tail member comprises two ground electrical leads.

10. The sensing accessory of any one of claims 1-9, wherein the at least two pairs of conductive traces are printed on a circuit substrate at 0.018 to 0.020 inches of thickness with 0.018- 0.020 inches of spacing between traces.

11. A sensing accessory for an ostomy leakage detection system comprising: a sensing member, wherein the sensing member comprises a body side surface and a distal side surface, wherein the sensing member comprises an inlet opening that surrounds a stoma, and wherein the sensing member comprises a dividing section; a conductive sensor that detects a leak, wherein the conductive sensor is located on the body side surface of the sensing member, and wherein the conductive sensor comprises at least two pairs of conductive traces arranged in at least two semi-radial sensing levels, and wherein the at least two pairs of conductive traces are separated at the dividing section; an adhesive layer located on the body side of the conductive sensor; a connecting member, wherein the connecting member comprises one or more connection pads electrically connecting with an electronic device; and a tail member, wherein the tail member comprises electrical leads connecting the at least two pairs of conductive traces to the one or more connection pads.

12. The sensing accessory of claim 11, wherein the dividing section comprises a split that entirely splits the sensing member at an end opposite the tail member.

13. The sensing accessory of claim 11, wherein the dividing section comprises a perforated section that entirely splits the sensing member during a collision with the stoma, and wherein the perforated section is located at an end of the sensing member opposite the tail member.

14. The sensing accessory of any one of claim 11-13, wherein a pair of conductive traces comprises a conductive trace and a ground trace, wherein a semi-radial sensing level comprises the pair of conductive trace, and wherein the sensing member comprises four quadrants.

15. The sensing accessory of any one of claims 11-14, wherein the at least two pairs of conductive traces comprise at least seven pairs of conductive traces arranged in at least three radial sensing levels, and wherein the seven pairs of conductive traces comprise: a first pair of conductive traces that detects a leak on a first radial sensing level of the sensing member; a second pair of conductive traces that detects a leak on a first quadrant of a second radial sensing level of the sensing member; a third pair of conductive traces that detects a leak on a second quadrant of the second radial sensing level of the sensing member; a fourth pair of conductive traces that detects a leak on a third quadrant of the second radial sensing level of the sensing member; a fifth pair of conductive traces that detects a leak on a fourth quadrant of the second radial sensing level of the sensing member; a sixth pair of conductive traces that detects a leak on a first half of a third radial sensing level of the sensing member; and a seventh pair of conductive traces that detects a leak on a second half of a third radial sensing level of the sensing member.

16. The sensing accessory of claim 15, wherein the connecting member comprises seven connection points, wherein a conductive trace of the sixth pair of conductive traces and a conductive trace of the seventh pair of conductive traces diverge and connect to one of the seven connection points, and wherein the ground trace connects to one of the seven connection points.

17. A sensing accessory for an ostomy leakage detection system comprising: a sensing member, wherein the sensing member comprises a body side surface and a distal side surface, wherein the sensing member comprises inlet opening that surrounds a stoma, and wherein the sensing member comprises an outer patterned-shaped edge that makes contact with a barrier appliance; a conductive sensor that detects a leak, wherein the conductive sensor is located on the body side surface of the sensing member; a body-side hydrocolloid layer located on the body side of the sensing member and within the outer patterned-shaped edge, a connecting member, wherein the connecting member comprises one or more connection pads electrically connecting with an electronic device; and a tail member, wherein the tail member comprises electrical leads connecting the conductive sensor to the one or more connection pads.

18. The sensing accessory of claim 17, wherein the sensing member comprises an inner patterned-shaped edge that makes contact with a barrier appliance.

19. The sensing accessory of any one of claims 17-18, wherein the outer patterned-shaped edge comprises a gear-shaped edge.

20. The sensing accessory of any one of claims 17-19, wherein the sensing member comprises a distal-side hydrocolloid layer located on the distal side of the sensing member, and wherein the sensing member comprises at least one opening that allows the body-side hydrocolloid layer to adhere to the distal-side hydrocolloid layer.