US20220265458A1 - Resistance sensor for identifying leak locations in ostomy system - Google Patents
Resistance sensor for identifying leak locations in ostomy system Download PDFInfo
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- US20220265458A1 US20220265458A1 US17/617,672 US202117617672A US2022265458A1 US 20220265458 A1 US20220265458 A1 US 20220265458A1 US 202117617672 A US202117617672 A US 202117617672A US 2022265458 A1 US2022265458 A1 US 2022265458A1
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- electrode
- sensor device
- ostomy
- electrically conductive
- effluent
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
- A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
- A61F5/4404—Details or parts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
- A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
- A61F5/443—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices having adhesive seals for securing to the body, e.g. of hydrocolloid type, e.g. gels, starches, karaya gums
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
- A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
- A61F5/445—Colostomy, ileostomy or urethrostomy devices
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01M—TESTING STATIC OR DYNAMIC BALANCE OF MACHINES OR STRUCTURES; TESTING OF STRUCTURES OR APPARATUS, NOT OTHERWISE PROVIDED FOR
- G01M3/00—Investigating fluid-tightness of structures
- G01M3/02—Investigating fluid-tightness of structures by using fluid or vacuum
- G01M3/04—Investigating fluid-tightness of structures by using fluid or vacuum by detecting the presence of fluid at the leakage point
- G01M3/16—Investigating fluid-tightness of structures by using fluid or vacuum by detecting the presence of fluid at the leakage point using electric detection means
Definitions
- the following description relates generally to a sensor device for identifying leak locations for medical devices such as ostomy systems.
- An ostomy pouch system typically includes a pouch formed from opposing sidewalls defining an internal collection area, an inlet opening for receiving a stoma, and an ostomy appliance for attaching the pouch to a user.
- the ostomy appliance may include, for example, an ostomy barrier of a one-piece pouch system, which is attached to one of the pouch sidewalls proximate an inlet opening, a faceplate for a two-piece pouch system configured to releasably engage a pouch, and a barrier ring.
- the ostomy appliance may include a skin barrier material for adhering to and sealing against user's peristomal skin surrounding the stoma.
- the ostomy appliance may be susceptible to ostomy effluent leakage, and the seal formed between the skin barrier material and the user may weaken. Often times, the user may be unaware of or cannot easily assess an extent of weakening in the seal. Thus, the user may not become aware of a weakened seal, and consequently, the ostomy effluent may leak through to an exterior of the ostomy appliance.
- a sensor device for an ostomy system configured to identify a leak and/or a leak location.
- a sensor device for identifying an ostomy effluent leak location in an ostomy system may include a stoma opening and electrically conductive circuitry arranged in pattern around the stoma opening.
- the electrically conductive circuitry may include a first electrode and a second electrode spaced from the first electrode.
- the first electrode may be subdivided by a plurality of resistors spaced along a length of the first electrode.
- the second electrode may extend as a continuous strip of conductive material.
- the sensor device may be configured to detect electrical resistance in the electrically conductive circuit and identify a location of a leak based on the detected electrical resistance.
- the electrically conductive circuitry may be arranged in a spiral pattern around the stoma opening.
- the electrically conductive circuitry may be a sensor layer and the sensor device may further include a substrate layer on which the sensor layer is applied.
- the sensor device may further include an adhesive layer.
- the sensor layer may be disposed between the adhesive layer and the substrate layer.
- the resistors of the plurality of resistors each may have a resistance significantly higher than a generalized resistance of the leak.
- a sensor device for detecting an effluent leakage in a medical appliance may include an electrically conductive circuitry comprising a first electrode and a second electrode, which is arranged spaced apart from the first electrode, and an adhesive layer configured to attach the sensor device to user's skin.
- the first electrode may be subdivided by a plurality of resistors spaced along a length of the first electrode.
- the second electrode may extend as a continuous strip of conductive material.
- the sensor device may be configured to measure electrical resistance in the electrically conductive circuitry and determine a location of an effluent leakage based on a resistance measurement.
- the plurality of resistors may include R 1 , R 2 , and R 3 , wherein an effluent leakage may have a generalized leak resistance RL.
- the sensor device may be configured such that a total resistance (R total ) of the electrically conductive circuitry may drop significantly when an effluent leakage bridges the first and second electrodes.
- R total when no effluent leakage bridges the first and second electrodes may be at least 10 times greater than R total when an effluent leakage bridges the first electrode and the second electrode.
- R total when an effluent leakage bridges the first and second electrodes between R 1 and R 2 may be R 1 +RL.
- R total when an effluent leakage bridges the first and second electrodes between R 2 and R 3 may be R 1 +R 2 +RL.
- R total when an effluent leakage bridges the first and second electrodes beyond R 3 may be R 1 +R 2 +R 3 +RL.
- the sensor device may be configured to detect an ostomy effluent leakage and may include an opening for receiving a stoma.
- the first electrode and the second electrode may be arranged in a spiral pattern around the opening.
- the sensor device may be configured to determine a progress of an ostomy effluent leakage, wherein the ostomy effluent leakage may propagate from proximate the opening to an outer periphery of the sensor device.
- the first electrode may be arranged in a spiral pattern having a plurality wraps around the opening.
- the second electrode may extend between the wraps of the first electrode.
- the first electrode may be arranged to have more wraps than the second electrode, wherein the radially innermost wrap and the radially outermost wrap are both formed by the first electrode.
- the plurality of resistors may comprise R 1 , R 2 . . . R n-2 , R n-1 and R n , wherein the R n may be arranged on the radially innermost wrap of the first electrode.
- R n-1 may be arranged adjacent and spaced apart from R n .
- R n-2 may be arranged adjacent and spaced apart from R n-1 .
- R 1 may be arranged on the outermost wrap of the first electrode.
- the sensor device may be configured to detect a moderate leak when an ostomy effluent leakage bridges an innermost wrap of the first electrode and the second electrode.
- R total when an effluent leakage bridges the first and second electrodes between R n-1 and R n-2 may be R 1 +R 2 . . . +R n-2 +RL, which may indicate a moderate leak.
- the sensor device may also be configured to detect a critical leak when an ostomy effluent leakage bridges an outermost wrap of the first electrode and the second electrode.
- R total when an effluent leakage bridges the first and second electrodes between R 2 and R 3 may be approximately R 1 +R 2 , which may indicate a critical leak.
- the sensor device may further include a substrate layer, wherein the electrically conductive circuitry may be arranged between the substrate layer and the adhesive layer.
- the adhesive layer may be formed from a hydrocolloid adhesive.
- the sensor device may be provided as an ostomy accessory, wherein a distal side of the sensor device may be secured to a body side of an ostomy barrier.
- FIGS. 1A-1D are schematic diagrams illustrating examples of electrically conductive circuitry of a sensor device and ostomy effluent leaks at different locations along the circuitry according to embodiments;
- FIG. 2 is a diagram illustrating a plan view of a sensor device according to an embodiment.
- FIG. 3 is a diagram illustrating a plan view of a sensor device and an example of an ostomy effluent leak according to an embodiment
- FIG. 4 is a schematic diagram illustrating the sensor device of FIG. 3 with the ostomy effluent leak disposed relative to electrically conductive circuitry of the sensor device;
- FIG. 5 is a diagram illustrating a plan view of a sensor device and an example of an ostomy effluent leak according to an embodiment
- FIG. 6 is a schematic diagram illustrating the sensor device of FIG. 5 with the ostomy effluent leak disposed relative to electrically conductive circuitry of the sensor device;
- FIG. 7 is a simplified version of the schematic diagram of FIG. 6 ;
- FIG. 8 is a schematic diagram illustrating an example of a sensor device according to an embodiment.
- a sensor device for an ostomy appliance.
- the sensor device may be configured to detect an ostomy effluent leak and/or identify a location of the ostomy effluent leak.
- the sensor device may be part of a leakage detection system for an ostomy appliance.
- the sensor device may include electrically conductive circuitry.
- the electrically conductive circuitry may include a first electrode and a second electrode spaced from the first electrode.
- the first electrode may be subdivided by one or more resistors.
- the second electrode may extend continuously as a strip of highly conductive material. That is, the second electrode may be free of resistors.
- the electrically conductive circuitry may be arranged in a predetermined pattern relative to a stoma opening extending through the sensor device.
- the electrical resistance in the electrically conductive circuitry for example between the first electrode and the second electrode, is relatively high when there is no leakage of ostomy effluent. However, the electrical resistance may decrease significantly when leaking ostomy effluent bridges the first and second electrodes.
- the sensor device may detect the electrical resistance in the electrically conductive circuit.
- detecting the electrical resistance may include determining an electrical resistance value, for example, by calculating, approximating or measuring the electrical resistance value.
- the sensor device may also determine a change in electrical resistance as a function of time based on a series of detected electrical resistances. The sensor device may determine whether an ostomy effluent leak is present based on the detected electrical resistance. Alternatively, or in addition, the sensor device may identify a location of an ostomy effluent leak based on the detected electrical resistance.
- the sensor device may determine the total resistance in the electrically conductive circuitry based on the resistance of individual resistors and a generalized leak resistance (i.e., electrical resistance of an ostomy effluent leak).
- the sensor device may include or be operably connected to a power supply configured to apply a current to the electrically conductive circuitry.
- the sensor device may include or be operably connected to a controller.
- the controller may include, for example, a processor and a memory.
- the processor may be, for example, a microprocessor or other suitable computer processor or processor-like device.
- the processor may be configured to execute program instructions and perform operations based on the executed program instructions.
- the processor may be configured to perform various operations described in the embodiments herein, such as, but not limited to, detect the electrical resistance in the electrically conductive circuitry, determine a change in the electrical resistance between the first and second electrodes as a function of time based on the detected electrical resistance, determine whether an ostomy effluent leak is present based on the detected electrical resistance, and/or identify a location of an ostomy effluent leak based on the detected electrical resistance.
- the memory may be a non-transitory computer-readable storage medium configured to store the program instructions.
- the memory may also store other information, such as, but not limited to, resistor information.
- the resistor information may include, for example, a resistance and a position of each resistor.
- the memory may also store the detected electrical resistance including a series of detected electrical resistances detected as a function of time.
- the controller and sensor device may be provided as an integrated component. Alternatively, the sensor device and the controller may be separate components operably connected to one another to form at least a portion of a leakage detection system.
- descriptions of components and/or operations performed by the sensor device may include components and/or operations performed by sensor device, the controller or both.
- FIGS. 1A-1D are schematic diagrams illustrating examples of electrically conductive circuitry 20 of a sensor device 10 and ostomy effluent leaks L 1 , L 2 . . . Li at different locations P 1 , P 2 . . . Pi along the electrically conductive circuitry 20 according to embodiments.
- the electrically conductive circuitry 20 may include a first electrode 22 and a second electrode 24 spaced from the first electrode 22 .
- the electrically conductive circuitry 20 may also include at least one resistor R 1 , R 2 . . . Ri disposed along the first electrode 22 to subdivide the first electrode 22 .
- the second electrode 24 may be a continuous strip of highly conductive material.
- the first electrode 22 and the second electrode 24 may be arranged in a predetermined pattern or shape. In an embodiment, the first electrode 22 and the second electrode may be arranged in respective spiral patterns ( FIG. 2 ).
- electrical resistance in the electrically conductive circuitry 20 may decrease significantly when an ostomy effluent leak bridges the first and second electrodes 22 , 24 .
- An exact value of the electrical resistance depends on the circuit design and characteristics of the leaking effluent. For example, in an embodiment, the electrical resistance may drop to about 100 ⁇ or less in response to an ostomy effluent leak.
- the present description is not limited to such an example.
- the electrical resistance values of the resistors R 1 , R 2 . . . Ri may be selected to be significantly larger than the electrical resistance of an ostomy effluent leak, but small enough to minimize circuit impedance.
- the resistors R 1 , R 2 . . . Ri may have electrical resistance values of about 10 k ⁇ .
- the resistors R 1 , R 2 . . . Ri may be added to the electrically conductive circuitry as additional components or may be created using one or more printed inks.
- An ostomy effluent leak may have a generalized leak resistance RL.
- FIG. 1A schematically illustrates an example in which there is no ostomy effluent leak bridging the first electrode 22 and the second electrode 24 . Accordingly, the total electrical resistance R TOTAL is relatively high or approaches infinity. Based on the relatively high electrical resistance, the sensor device 10 may determine that an ostomy effluent leak is not present and thus, a location of an ostomy effluent leak is not present either.
- FIG. 1B schematically illustrates an example in which an ostomy effluent leak L 1 between the first electrode 22 and the second electrode 24 is present at a location P 1 beyond, for example, a third resistor R 3 .
- the total resistance R TOTAL may be calculated as:
- the sensor device 10 may detect the ostomy effluent leak L 1 and/or determine the location of the ostomy effluent leak L 1 to be at a position after the third resistor R 3 based on the total resistance R TOTAL .
- FIG. 1C schematically illustrates an example in which an ostomy effluent leak L 1 bridging the first electrode 22 and the second electrode 24 is present at a location P 1 , for example, between a second resistor R 2 and a third resistor R 3 .
- the total resistance R TOTAL may be calculated as:
- the sensor device 10 may detect the ostomy effluent leak L 1 and/or determine the location of the ostomy effluent leak L 1 to be at a position between the second and third resistors R 2 , R 3 based on the total resistance R TOTAL .
- the generalized electrical resistance RL is less than the electrical resistance of any of the resistors R 1 , R 2 . . . Ri connected in series.
- the sensor device 10 may distinguish the location of the ostomy effluent leak L 1 in the example of FIG. 1C from the location of the ostomy effluent leak L 1 in the example of FIG. 1B , for instance, based on the total resistance R TOTAL determined for each example.
- FIG. 1D schematically illustrates an example which ostomy effluent leaks L 1 , L 2 bridging the first electrode 22 and the second electrode 24 are present at multiple locations P 1 , P 2 .
- a first ostomy effluent leak L 1 may be located at a first position P 1 between a second resistor R 2 and a third resistor R 3 .
- a second ostomy effluent leak L 2 may be located at a second position P 2 beyond the third resistor R 3 .
- multiple ostomy effluent leaks may be difficult to distinguish from a single leak at a location closest to the point electrical resistance is measured.
- the total resistance R TOTAL may be calculated as:
- R TOTAL (R1+R2+1)/((1/RL)+1/(R3+RL))
- the total resistance may be approximated as:
- the electrically conductive circuitry 20 may include any suitable number of resistors, R 1 , R 2 . . . Ri, spaced at desired length intervals, some, all or none of which may be equal.
- any number of ostomy effluent leaks L 1 , L 2 . . . Li may be detected.
- the first electrode 22 and the second electrode 24 may extend in any suitable predetermined shape or pattern and may be spaced apart by any suitable distance. In an embodiment, the distance between the first electrode 22 and the second electrode 24 may be substantially the same along the respective lengths of the first and second electrodes 22 , 24 or may vary in a desired manner.
- FIG. 2 is a diagram illustrating a plan view of a sensor device according to an embodiment. Difficulty distinguishing multiple leaks may be mitigated in the present embodiments.
- the electrically conductive circuitry 20 may be arranged within an ostomy barrier so that ostomy effluent leaks with the highest risk are nearest to the point of electrical resistance measurement.
- the first and second electrodes 22 , 24 may be arranged in a spiral around a stoma opening 26 configured to receive a stoma. That is, the electrically conductive circuitry 20 may be designed so leaks typically progress from a distal end of the electrodes 22 , 24 nearest the stoma opening 26 to a proximal end, further from the stoma opening 26 .
- the first electrode 22 may be arranged in a spiral pattern having a plurality wraps around the stoma opening 26 .
- the first electrode 22 may generally be arranged in a spiral having two wraps.
- the spiral of the first electrode 22 may include fewer or additional wraps.
- the second electrode 24 may also be arranged as a spiral.
- the second electrode extends between wraps of the first electrode.
- the first electrode 22 may be arranged to have more wraps than the second electrode 24 .
- the electrically conductive circuitry 20 may be arranged in a spiral configuration in which in the radially innermost and radially outermost wraps, relative to the stoma opening 26 , are formed by the first electrode 22 .
- FIG. 3 is a diagram illustrating a plan view of a sensor device 10 and an example of an ostomy effluent leak L 1 according to an embodiment.
- the ostomy effluent leak L 1 may be located at a position P 1 and may have a generalized electrical resistance RL.
- the ostomy effluent leak L 1 as shown in FIG. 3 may be considered to be a moderate leak.
- FIG. 4 is a schematic diagram illustrating the sensor device 10 of FIG. 3 with the ostomy effluent leak L 1 disposed relative to electrically conductive circuitry 20 of the sensor device 10 .
- the ostomy effluent leak L 1 may extend from the stoma opening 26 across the first electrode 22 between a sixth resistor R 6 and a seventh resistor R 7 , and bridge the first and second electrodes 22 , 24 between a first wrap of the first electrode 22 and the wrap of the second electrode 24 .
- the total resistance R TOTAL may be calculated as:
- R TOTAL R1+R2+R3+R4+R5+R6+RL
- FIG. 5 is a diagram illustrating a plan view of a sensor device 10 and an example of an ostomy effluent leak L 1 according to an embodiment.
- the ostomy effluent leak L 1 may be located at multiple positions P 1 , P 2 and may have a generalized electrical resistance RL.
- the ostomy effluent leak L 1 as shown in FIG. 5 may be considered to be an extreme leak.
- FIG. 6 is a schematic diagram illustrating the sensor device 10 of FIG. 5 with the ostomy effluent leak L 1 disposed relative to electrically conductive circuitry 20 of the sensor device 10 .
- the ostomy effluent leak L 1 may extend from the stoma opening 26 across the first electrode 22 between a sixth resistor R 6 and a seventh resistor R 7 at location P 1 and between second resistor R 2 and third resistor R 3 at location P 2 .
- the ostomy effluent leak L 1 may bridge the first and second electrodes 22 , 24 between a first, or inner, wrap of the first electrode 22 and the wrap of the second electrode 24 , and further bridge between the second electrode 24 and a second, or outer, wrap of the first electrode 22 .
- the total resistance R TOTAL may be approximated as:
- FIG. 7 is a simplified version of the schematic diagram of FIG. 6 .
- the total resistance R TOTAL may be approximated as:
- RA and RB may be represented as:
- a single ostomy effluent leak L 1 may present itself as two bridges, as shown in the example of FIG. 6 .
- an extent of an ostomy effluent leak, and therefore the risk of leakage may be distinguished by the relatively low total resistance.
- a device monitoring a progression of leakage may identify the pattern of progression, for instance, from the example shown in FIGS. 3 and 4 to the example shown in FIGS. 5-7 to further confirm the location of the leak.
- an ostomy effluent leak bridging the first and second electrodes 22 , 24 and having a generalized electrical resistance RL may form an electrical circuit having one or more resistors R 1 , R 2 . . . Ri disposed in series or parallel with the generalized resistance RL of the ostomy effluent leak.
- the total resistance may be calculated, measured or estimated and compared to one or more stored resistance values corresponding to known ostomy effluent leak position, relative to the resistors R 1 , R 2 . . . Ri of the first electrode 22 .
- the locations of the resistors R 1 , R 2 . . . Ri on the sensor device 10 for example, relative to the stoma opening 26 may be known as well. Accordingly, the sensor device 10 may identify the location of an ostomy effluent leak.
- FIG. 8 is a schematic cross-sectional diagram illustrating an example of a sensor device 10 according to an embodiment.
- the electrically conductive circuitry 20 may be a sensor layer 12 of the sensor device 10 .
- the sensor device 10 may further include a substrate layer 14 onto which the electrically conductive circuitry 20 may be applied.
- the substrate layer 14 may be, for example, a film, such as a polymeric film or an adhesive material.
- the electrically conductive circuitry 20 may be applied on the substrate layer 14 in any known, suitable manner.
- the electrically conductive circuitry 20 may be printed on the substrate layer 14 using a suitable electrically conductive ink.
- the sensor device 10 may also include an adhesive layer 16 .
- the adhesive layer 16 may include, for example, a hydrocolloid material.
- the sensor layer 12 may be disposed between the adhesive layer 16 and the substrate layer 14 .
- the substrate layer 14 may be a distal side or pouch side of the sensor device 10 and the adhesive layer 16 may be a proximal side or body side of the sensor device 10 .
- the sensor device 10 may integrated with an ostomy appliance (not shown), such as an ostomy barrier or faceplate configured to secure an ostomy pouch to a user.
- the sensor device 10 may be provided as an ostomy accessory (not shown) which may be attached to an ostomy appliance.
- the distal side of the sensor device may be secured to a body side of an ostomy barrier, and the proximal side of the sensor device may be adhered to the user.
Abstract
Description
- The following description relates generally to a sensor device for identifying leak locations for medical devices such as ostomy systems.
- An ostomy pouch system typically includes a pouch formed from opposing sidewalls defining an internal collection area, an inlet opening for receiving a stoma, and an ostomy appliance for attaching the pouch to a user. The ostomy appliance may include, for example, an ostomy barrier of a one-piece pouch system, which is attached to one of the pouch sidewalls proximate an inlet opening, a faceplate for a two-piece pouch system configured to releasably engage a pouch, and a barrier ring. The ostomy appliance may include a skin barrier material for adhering to and sealing against user's peristomal skin surrounding the stoma.
- The ostomy appliance may be susceptible to ostomy effluent leakage, and the seal formed between the skin barrier material and the user may weaken. Often times, the user may be unaware of or cannot easily assess an extent of weakening in the seal. Thus, the user may not become aware of a weakened seal, and consequently, the ostomy effluent may leak through to an exterior of the ostomy appliance.
- Accordingly, it is desirable to provide a sensor device for an ostomy system configured to identify a leak and/or a leak location.
- In one aspect, a sensor device for identifying an ostomy effluent leak location in an ostomy system may include a stoma opening and electrically conductive circuitry arranged in pattern around the stoma opening. The electrically conductive circuitry may include a first electrode and a second electrode spaced from the first electrode. The first electrode may be subdivided by a plurality of resistors spaced along a length of the first electrode. The second electrode may extend as a continuous strip of conductive material. The sensor device may be configured to detect electrical resistance in the electrically conductive circuit and identify a location of a leak based on the detected electrical resistance.
- In an embodiment, the electrically conductive circuitry may be arranged in a spiral pattern around the stoma opening. The electrically conductive circuitry may be a sensor layer and the sensor device may further include a substrate layer on which the sensor layer is applied. The sensor device may further include an adhesive layer. The sensor layer may be disposed between the adhesive layer and the substrate layer.
- In an embodiment, the resistors of the plurality of resistors each may have a resistance significantly higher than a generalized resistance of the leak.
- In another aspect, a sensor device for detecting an effluent leakage in a medical appliance may include an electrically conductive circuitry comprising a first electrode and a second electrode, which is arranged spaced apart from the first electrode, and an adhesive layer configured to attach the sensor device to user's skin. The first electrode may be subdivided by a plurality of resistors spaced along a length of the first electrode. The second electrode may extend as a continuous strip of conductive material. The sensor device may be configured to measure electrical resistance in the electrically conductive circuitry and determine a location of an effluent leakage based on a resistance measurement.
- In an embodiment, the plurality of resistors may include R1, R2, and R3, wherein an effluent leakage may have a generalized leak resistance RL. The sensor device may be configured such that a total resistance (Rtotal) of the electrically conductive circuitry may drop significantly when an effluent leakage bridges the first and second electrodes. In such an embodiment, Rtotal when no effluent leakage bridges the first and second electrodes may be at least 10 times greater than Rtotal when an effluent leakage bridges the first electrode and the second electrode. In an embodiment, Rtotal when an effluent leakage bridges the first and second electrodes between R1 and R2 may be R1+RL. Rtotal when an effluent leakage bridges the first and second electrodes between R2 and R3 may be R1+R2+RL. Rtotal when an effluent leakage bridges the first and second electrodes beyond R3 may be R1+R2+R3+RL.
- In some embodiments, the sensor device may be configured to detect an ostomy effluent leakage and may include an opening for receiving a stoma. In such embodiments, the first electrode and the second electrode may be arranged in a spiral pattern around the opening. The sensor device may be configured to determine a progress of an ostomy effluent leakage, wherein the ostomy effluent leakage may propagate from proximate the opening to an outer periphery of the sensor device.
- In an embodiment, the first electrode may be arranged in a spiral pattern having a plurality wraps around the opening. The second electrode may extend between the wraps of the first electrode. In such an embodiment, the first electrode may be arranged to have more wraps than the second electrode, wherein the radially innermost wrap and the radially outermost wrap are both formed by the first electrode. The plurality of resistors may comprise R1, R2 . . . Rn-2, Rn-1 and Rn, wherein the Rn may be arranged on the radially innermost wrap of the first electrode. Rn-1 may be arranged adjacent and spaced apart from Rn. Rn-2 may be arranged adjacent and spaced apart from Rn-1. R1 may be arranged on the outermost wrap of the first electrode.
- In an embodiment, the sensor device may be configured to detect a moderate leak when an ostomy effluent leakage bridges an innermost wrap of the first electrode and the second electrode. For example, Rtotal when an effluent leakage bridges the first and second electrodes between Rn-1 and Rn-2 may be R1+R2 . . . +Rn-2+RL, which may indicate a moderate leak. The sensor device may also be configured to detect a critical leak when an ostomy effluent leakage bridges an outermost wrap of the first electrode and the second electrode. For example, Rtotal when an effluent leakage bridges the first and second electrodes between R2 and R3 may be approximately R1+R2, which may indicate a critical leak.
- The sensor device may further include a substrate layer, wherein the electrically conductive circuitry may be arranged between the substrate layer and the adhesive layer. The adhesive layer may be formed from a hydrocolloid adhesive.
- In any of the foregoing embodiments, the sensor device may be provided as an ostomy accessory, wherein a distal side of the sensor device may be secured to a body side of an ostomy barrier.
- Other objects, features, and advantages of the disclosure will be apparent from the following description, taken in conjunction with the accompanying sheets of drawings, wherein like numerals refer to like parts, elements, components, steps, and processes.
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FIGS. 1A-1D are schematic diagrams illustrating examples of electrically conductive circuitry of a sensor device and ostomy effluent leaks at different locations along the circuitry according to embodiments; -
FIG. 2 is a diagram illustrating a plan view of a sensor device according to an embodiment. -
FIG. 3 is a diagram illustrating a plan view of a sensor device and an example of an ostomy effluent leak according to an embodiment; -
FIG. 4 is a schematic diagram illustrating the sensor device ofFIG. 3 with the ostomy effluent leak disposed relative to electrically conductive circuitry of the sensor device; -
FIG. 5 is a diagram illustrating a plan view of a sensor device and an example of an ostomy effluent leak according to an embodiment; -
FIG. 6 is a schematic diagram illustrating the sensor device ofFIG. 5 with the ostomy effluent leak disposed relative to electrically conductive circuitry of the sensor device; -
FIG. 7 is a simplified version of the schematic diagram ofFIG. 6 ; and -
FIG. 8 is a schematic diagram illustrating an example of a sensor device according to an embodiment. - While the present disclosure is susceptible of embodiment in various forms, there is shown in the drawings and will hereinafter be described one or more embodiments with the understanding that the present disclosure is to be considered illustrative only and is not intended to limit the disclosure to any specific embodiment described or illustrated.
- According to embodiments described herein, a sensor device is provided for an ostomy appliance. The sensor device may be configured to detect an ostomy effluent leak and/or identify a location of the ostomy effluent leak. The sensor device may be part of a leakage detection system for an ostomy appliance.
- The sensor device may include electrically conductive circuitry. In an embodiment, the electrically conductive circuitry may include a first electrode and a second electrode spaced from the first electrode. The first electrode may be subdivided by one or more resistors. The second electrode may extend continuously as a strip of highly conductive material. That is, the second electrode may be free of resistors. The electrically conductive circuitry may be arranged in a predetermined pattern relative to a stoma opening extending through the sensor device. In use, the electrical resistance in the electrically conductive circuitry, for example between the first electrode and the second electrode, is relatively high when there is no leakage of ostomy effluent. However, the electrical resistance may decrease significantly when leaking ostomy effluent bridges the first and second electrodes.
- The sensor device may detect the electrical resistance in the electrically conductive circuit. In embodiments, detecting the electrical resistance may include determining an electrical resistance value, for example, by calculating, approximating or measuring the electrical resistance value. In embodiments, the sensor device may also determine a change in electrical resistance as a function of time based on a series of detected electrical resistances. The sensor device may determine whether an ostomy effluent leak is present based on the detected electrical resistance. Alternatively, or in addition, the sensor device may identify a location of an ostomy effluent leak based on the detected electrical resistance. In an embodiment, the sensor device may determine the total resistance in the electrically conductive circuitry based on the resistance of individual resistors and a generalized leak resistance (i.e., electrical resistance of an ostomy effluent leak).
- In an embodiment, the sensor device may include or be operably connected to a power supply configured to apply a current to the electrically conductive circuitry. In addition, the sensor device may include or be operably connected to a controller.
- The controller may include, for example, a processor and a memory. The processor may be, for example, a microprocessor or other suitable computer processor or processor-like device. The processor may be configured to execute program instructions and perform operations based on the executed program instructions. For example, the processor may be configured to perform various operations described in the embodiments herein, such as, but not limited to, detect the electrical resistance in the electrically conductive circuitry, determine a change in the electrical resistance between the first and second electrodes as a function of time based on the detected electrical resistance, determine whether an ostomy effluent leak is present based on the detected electrical resistance, and/or identify a location of an ostomy effluent leak based on the detected electrical resistance.
- The memory may be a non-transitory computer-readable storage medium configured to store the program instructions. The memory may also store other information, such as, but not limited to, resistor information. The resistor information may include, for example, a resistance and a position of each resistor. The memory may also store the detected electrical resistance including a series of detected electrical resistances detected as a function of time. In an embodiment, the controller and sensor device may be provided as an integrated component. Alternatively, the sensor device and the controller may be separate components operably connected to one another to form at least a portion of a leakage detection system. For ease of reference, in embodiments, descriptions of components and/or operations performed by the sensor device may include components and/or operations performed by sensor device, the controller or both.
-
FIGS. 1A-1D are schematic diagrams illustrating examples of electricallyconductive circuitry 20 of asensor device 10 and ostomy effluent leaks L1, L2 . . . Li at different locations P1, P2 . . . Pi along the electricallyconductive circuitry 20 according to embodiments. Referring generally forFIGS. 1A-1D , the electricallyconductive circuitry 20 may include afirst electrode 22 and asecond electrode 24 spaced from thefirst electrode 22. The electricallyconductive circuitry 20 may also include at least one resistor R1, R2 . . . Ri disposed along thefirst electrode 22 to subdivide thefirst electrode 22. Thesecond electrode 24 may be a continuous strip of highly conductive material. Thefirst electrode 22 and thesecond electrode 24 may be arranged in a predetermined pattern or shape. In an embodiment, thefirst electrode 22 and the second electrode may be arranged in respective spiral patterns (FIG. 2 ). - In embodiments, electrical resistance in the electrically
conductive circuitry 20, for example, between thefirst electrode 22 and thesecond electrode 24, may decrease significantly when an ostomy effluent leak bridges the first andsecond electrodes - The electrical resistance values of the resistors R1, R2 . . . Ri may be selected to be significantly larger than the electrical resistance of an ostomy effluent leak, but small enough to minimize circuit impedance. For example, the resistors R1, R2 . . . Ri may have electrical resistance values of about 10 kΩ. The resistors R1, R2 . . . Ri may be added to the electrically conductive circuitry as additional components or may be created using one or more printed inks. An ostomy effluent leak may have a generalized leak resistance RL.
-
FIG. 1A schematically illustrates an example in which there is no ostomy effluent leak bridging thefirst electrode 22 and thesecond electrode 24. Accordingly, the total electrical resistance RTOTAL is relatively high or approaches infinity. Based on the relatively high electrical resistance, thesensor device 10 may determine that an ostomy effluent leak is not present and thus, a location of an ostomy effluent leak is not present either. -
FIG. 1B schematically illustrates an example in which an ostomy effluent leak L1 between thefirst electrode 22 and thesecond electrode 24 is present at a location P1 beyond, for example, a third resistor R3. In the example ofFIG. 1B , the total resistance RTOTAL may be calculated as: -
RTOTAL=R1+R2+R3+RL - In the example of
FIG. 1B , thesensor device 10 may detect the ostomy effluent leak L1 and/or determine the location of the ostomy effluent leak L1 to be at a position after the third resistor R3 based on the total resistance RTOTAL. -
FIG. 1C schematically illustrates an example in which an ostomy effluent leak L1 bridging thefirst electrode 22 and thesecond electrode 24 is present at a location P1, for example, between a second resistor R2 and a third resistor R3. In the example ofFIG. 1C , the total resistance RTOTAL may be calculated as: -
RTOTAL=R1+R2+RL - In the example of
FIG. 1C , thesensor device 10 may detect the ostomy effluent leak L1 and/or determine the location of the ostomy effluent leak L1 to be at a position between the second and third resistors R2, R3 based on the total resistance RTOTAL. In an embodiment, the generalized electrical resistance RL is less than the electrical resistance of any of the resistors R1, R2 . . . Ri connected in series. Thus, thesensor device 10 may distinguish the location of the ostomy effluent leak L1 in the example ofFIG. 1C from the location of the ostomy effluent leak L1 in the example ofFIG. 1B , for instance, based on the total resistance RTOTAL determined for each example. -
FIG. 1D schematically illustrates an example which ostomy effluent leaks L1, L2 bridging thefirst electrode 22 and thesecond electrode 24 are present at multiple locations P1, P2. For instance, in the example ofFIG. 1D , a first ostomy effluent leak L1 may be located at a first position P1 between a second resistor R2 and a third resistor R3. A second ostomy effluent leak L2 may be located at a second position P2 beyond the third resistor R3. In some instances, multiple ostomy effluent leaks may be difficult to distinguish from a single leak at a location closest to the point electrical resistance is measured. The total resistance RTOTAL may be calculated as: -
RTOTAL=(R1+R2+1)/((1/RL)+1/(R3+RL)) - However, if RL is small relative to the resistance values of the resistors R1, R2, R3 . . . Ri, the total resistance may be approximated as:
-
RTOTAL≈R1+R2 - It will be appreciated that the diagrams of
FIGS. 1A-1D are provided for the purposes of illustrative examples, and the present description is not limited to these examples. For example, the electricallyconductive circuitry 20 may include any suitable number of resistors, R1, R2 . . . Ri, spaced at desired length intervals, some, all or none of which may be equal. In addition, any number of ostomy effluent leaks L1, L2 . . . Li may be detected. Further, thefirst electrode 22 and thesecond electrode 24 may extend in any suitable predetermined shape or pattern and may be spaced apart by any suitable distance. In an embodiment, the distance between thefirst electrode 22 and thesecond electrode 24 may be substantially the same along the respective lengths of the first andsecond electrodes -
FIG. 2 is a diagram illustrating a plan view of a sensor device according to an embodiment. Difficulty distinguishing multiple leaks may be mitigated in the present embodiments. For example, the electricallyconductive circuitry 20 may be arranged within an ostomy barrier so that ostomy effluent leaks with the highest risk are nearest to the point of electrical resistance measurement. - Referring to the example shown in
FIG. 2 , the first andsecond electrodes stoma opening 26 configured to receive a stoma. That is, the electricallyconductive circuitry 20 may be designed so leaks typically progress from a distal end of theelectrodes stoma opening 26 to a proximal end, further from thestoma opening 26. - In an embodiment, the
first electrode 22 may be arranged in a spiral pattern having a plurality wraps around thestoma opening 26. For example, as shown inFIG. 2 , thefirst electrode 22 may generally be arranged in a spiral having two wraps. However, it is understood that the spiral of thefirst electrode 22 may include fewer or additional wraps. Thesecond electrode 24 may also be arranged as a spiral. In an embodiment, the second electrode extends between wraps of the first electrode. In an embodiment, thefirst electrode 22 may be arranged to have more wraps than thesecond electrode 24. For example, the electricallyconductive circuitry 20 may be arranged in a spiral configuration in which in the radially innermost and radially outermost wraps, relative to thestoma opening 26, are formed by thefirst electrode 22. -
FIG. 3 is a diagram illustrating a plan view of asensor device 10 and an example of an ostomy effluent leak L1 according to an embodiment. The ostomy effluent leak L1 may be located at a position P1 and may have a generalized electrical resistance RL. The ostomy effluent leak L1 as shown inFIG. 3 may be considered to be a moderate leak. -
FIG. 4 is a schematic diagram illustrating thesensor device 10 ofFIG. 3 with the ostomy effluent leak L1 disposed relative to electricallyconductive circuitry 20 of thesensor device 10. As shown in the examples ofFIGS. 3 and 4 , the ostomy effluent leak L1 may extend from thestoma opening 26 across thefirst electrode 22 between a sixth resistor R6 and a seventh resistor R7, and bridge the first andsecond electrodes first electrode 22 and the wrap of thesecond electrode 24. In such an example, the total resistance RTOTAL may be calculated as: -
RTOTAL=R1+R2+R3+R4+R5+R6+RL -
FIG. 5 is a diagram illustrating a plan view of asensor device 10 and an example of an ostomy effluent leak L1 according to an embodiment. The ostomy effluent leak L1 may be located at multiple positions P1, P2 and may have a generalized electrical resistance RL. The ostomy effluent leak L1 as shown inFIG. 5 may be considered to be an extreme leak. -
FIG. 6 is a schematic diagram illustrating thesensor device 10 ofFIG. 5 with the ostomy effluent leak L1 disposed relative to electricallyconductive circuitry 20 of thesensor device 10. As shown in the examples ofFIGS. 5 and 6 , the ostomy effluent leak L1 may extend from thestoma opening 26 across thefirst electrode 22 between a sixth resistor R6 and a seventh resistor R7 at location P1 and between second resistor R2 and third resistor R3 at location P2. The ostomy effluent leak L1 may bridge the first andsecond electrodes first electrode 22 and the wrap of thesecond electrode 24, and further bridge between thesecond electrode 24 and a second, or outer, wrap of thefirst electrode 22. In the example ofFIG. 6 , the total resistance RTOTAL may be approximated as: -
RTOTAL≈R1+R2 -
FIG. 7 is a simplified version of the schematic diagram ofFIG. 6 . In the example ofFIG. 7 , the total resistance RTOTAL may be approximated as: -
RTOTAL≈R1+R2 - Further, in
FIG. 7 , RA and RB may be represented as: -
RA=R1+R2; and -
RB=1/((1/RL)+(1/(R3+R4+R5+R6+R7))≈RL - In an embodiment, a single ostomy effluent leak L1 may present itself as two bridges, as shown in the example of
FIG. 6 . However, an extent of an ostomy effluent leak, and therefore the risk of leakage may be distinguished by the relatively low total resistance. Additionally, a device monitoring a progression of leakage may identify the pattern of progression, for instance, from the example shown inFIGS. 3 and 4 to the example shown inFIGS. 5-7 to further confirm the location of the leak. - In embodiments, an ostomy effluent leak bridging the first and
second electrodes first electrode 22. In an embodiment, the locations of the resistors R1, R2 . . . Ri on thesensor device 10, for example, relative to thestoma opening 26 may be known as well. Accordingly, thesensor device 10 may identify the location of an ostomy effluent leak. -
FIG. 8 is a schematic cross-sectional diagram illustrating an example of asensor device 10 according to an embodiment. The electricallyconductive circuitry 20 may be asensor layer 12 of thesensor device 10. Thesensor device 10 may further include asubstrate layer 14 onto which the electricallyconductive circuitry 20 may be applied. Thesubstrate layer 14 may be, for example, a film, such as a polymeric film or an adhesive material. The electricallyconductive circuitry 20 may be applied on thesubstrate layer 14 in any known, suitable manner. For example, the electricallyconductive circuitry 20 may be printed on thesubstrate layer 14 using a suitable electrically conductive ink. - The
sensor device 10 may also include anadhesive layer 16. Theadhesive layer 16 may include, for example, a hydrocolloid material. In an embodiment, thesensor layer 12 may be disposed between theadhesive layer 16 and thesubstrate layer 14. Thesubstrate layer 14 may be a distal side or pouch side of thesensor device 10 and theadhesive layer 16 may be a proximal side or body side of thesensor device 10. - In an embodiment, the
sensor device 10 may integrated with an ostomy appliance (not shown), such as an ostomy barrier or faceplate configured to secure an ostomy pouch to a user. In an embodiment, thesensor device 10 may be provided as an ostomy accessory (not shown) which may be attached to an ostomy appliance. For example, the distal side of the sensor device may be secured to a body side of an ostomy barrier, and the proximal side of the sensor device may be adhered to the user. - All patents referred to herein, are hereby incorporated herein in their entirety, by reference, whether or not specifically indicated as such within the text of this disclosure.
- In the present disclosure, 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. In additions, various features described with respect to any of the embodiments above may be used together, implemented in, or replace features in any of the other embodiments described above.
- 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 invention. 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 (20)
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CA3143414A1 (en) | 2022-01-15 |
EP3968910A1 (en) | 2022-03-23 |
AU2021290310B2 (en) | 2022-08-25 |
CA3143414C (en) | 2022-04-19 |
US11432956B1 (en) | 2022-09-06 |
DK3968910T3 (en) | 2023-04-03 |
EP3968910B1 (en) | 2023-03-01 |
US20220362050A1 (en) | 2022-11-17 |
LT3968910T (en) | 2023-04-11 |
AU2021290310A1 (en) | 2022-02-03 |
US11839566B2 (en) | 2023-12-12 |
ES2941618T3 (en) | 2023-05-24 |
HUE062259T2 (en) | 2023-10-28 |
WO2022015649A1 (en) | 2022-01-20 |
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