Ostomy monitoring system and method

Abstract

An ostomy pouch can include one or more sensors for measuring one or more indicators. An ostomy wafer can also include one or more sensors for measuring one or more indicators. For example, the sensors can be temperature sensors and / or capacitive sensors, and the indicators can include pouch fill, leakage, skin irritation, and equality of ostomy output.

Description

[0001] By citing any priority claims in the merger

[0002] Pursuant to 37 CFR 1.57, any and all applications with foreign or domestic priority claims identified in the application data sheet filed together with this application are incorporated herein by reference. This application claims priority to U.S. Provisional Application No. 62 / 779,351, entitled “Ostomy Monitoring System and Method,” filed December 13, 2018, and U.S. Provisional Application No. 62 / 845,201, entitled “Ostomy Monitoring System and Method,” filed May 8, 2019, pursuant to 35 USC §119(e). Background Technology

[0003] Skin inflammation is a common symptom of sensitive skin, caused by exposure to ultraviolet radiation, ionizing radiation, allergens, chemical irritants, biological irritants, or mechanical damage. This skin inflammation (also known as “acute” inflammation) is a complex process and involves responses that help the skin fight infection. However, it is well known that when the skin is exposed to triggering stimuli such as radiation, irritants, or allergens, vasodilation of the skin's blood vessels due to signaling from cytokines and chemokines increases blood flow to the irritated site, leading to redness and elevated skin temperature. As a result of the initial triggering event, a significant inflammatory response is stimulated, which, while helping the skin fight off invading bacterial infections, can actually cause considerable damage to the skin if left untreated. Summary of the Invention

[0004] In some configurations, the stoma bag may include: two walls joined together along a seam surrounding at least a portion of the edge of the stoma bag, a first wall configured to face the user's skin, and a second wall configured to face away from the user when the first wall faces the user's skin; an opening in the first wall configured to be arranged around the user's stoma and to receive outflow from the stoma, wherein the opening may be located near a portion of the seam and further away from a portion of a defined discharge opening of the two unsealed walls; and a sensor layer disposed in, on, or between one of the two walls of the stoma bag, the sensor layer having a first portion located closer to the opening and a second portion located further away from the opening and closer to the discharge opening. The sensor layer may include a plurality of temperature sensors and a plurality of capacitive sensors, wherein the plurality of temperature sensors may be distributed on the first and second portions, and wherein the plurality of capacitive sensors may be distributed on the second portion. The sensor layer may also include one or more wireless communication antennas, wherein, in use, the one or more antennas may be in electrical communication with one or more antennas on a stoma chip and / or one or more processors on a user device, the stoma chip being configured to attach the first wall of the stoma bag to the user's skin.

[0005] In some configurations, the stoma bag may include: two walls joined together around at least a portion of the edge of the stoma bag; a first wall configured to face the user's skin; a second wall configured to face away from the user when the first wall faces the user's skin; an opening in the first wall configured to be arranged around the user's stoma and to receive outflow from the stoma, wherein the opening may be located near a portion of the seam and further away from a portion of the demarcated discharge opening of the two unsealed walls; and a sensor layer disposed in, on, or between one of the two walls of the stoma bag, the sensor layer having a first portion located closer to the opening and a second portion located further away from the opening and closer to the discharge opening. The sensor layer may include a plurality of temperature sensors and a plurality of capacitive sensors, wherein the plurality of temperature sensors may be distributed on the first and second portions, and wherein the plurality of capacitive sensors may be distributed on the second portion. The sensor layer may also include one or more wireless communication antennas, wherein, in use, the one or more antennas may be in electrical communication with one or more antennas on a stoma chip and / or one or more processors on a user device, the stoma chip being configured to attach the first wall of the stoma bag to the user's skin.

[0006] In some configurations, the sensor layer can be roughly rectangular.

[0007] In some configurations, the sensor layer can be less than two walls.

[0008] In some configurations, capacitive sensors can be arranged in a pattern of lines, with the lines at angles other than 90 degrees relative to each other.

[0009] In some configurations, capacitive sensors can be arranged in a pattern of lines, with at least some lines at non-90-degree angles to each other.

[0010] In some configurations, temperature sensors can be arranged as a matrix circuit.

[0011] In some configurations, the plurality of capacitive sensors may include 24 capacitive sensors.

[0012] In some configurations, the plurality of temperature sensors may include 48 temperature sensors.

[0013] In some configurations, the discharge opening can be closed by a Velcro connector.

[0014] In some configurations, at least one of a plurality of capacitive sensors may be located on a surface of the sensor layer opposite to the temperature sensor and the rest of the capacitive sensors, with at least one of the plurality of capacitive sensors facing away from the user.

[0015] In some configurations, the first portion of the Velcro connector may include a metal strip. At least one of the plurality of capacitive sensors may be configured to detect a change in capacitance to detect an emission event when the first portion separates from the second portion of the Velcro connector.

[0016] In some configurations, the bag may include multiple layers, and when the first part of the Velcro connector is attached to the second part, the layer located between the metal strip and at least one of the multiple capacitive sensors facing away from the user includes one or more openings to allow direct contact between the metal strip and at least one of the multiple capacitive sensors facing away from the user.

[0017] In some configurations, the first direct or indirect contact between the metal strip and at least one of the plurality of capacitive sensors facing away from the user can be configured to electronically activate the bag.

[0018] In some configurations, the bag further includes an accelerometer.

[0019] In some configurations, the bag further includes a Bluetooth module.

[0020] In some configurations, the stoma bag may include: two walls joined together along a seam surrounding at least a portion of the edge of the stoma bag, a first wall configured to face the patient's skin, and a second wall configured to face away from the user when the first wall faces the user's skin; an opening in the first wall configured to be arranged around the user's stoma and to receive drainage from the stoma, wherein the opening may be located near a portion of the seam and further away from portions defining drainage openings of the unsealed two walls; a connector having a first portion extending from the drainage openings of the two walls and a second portion located on a surface of the second wall, the first and second portions being complementary to each other such that when the first portion is folded onto the second wall, it can be releasably secured to the second portion; and a sensor layer disposed in, on, or between one of the two walls of the stoma bag. The sensor layer may include a sensor located near the drainage opening and facing the second wall, the sensor being configured to detect when the first portion separates from the second portion of the connector to detect a drainage event. The sensor layer may also include one or more wireless antennas, wherein, in use, the one or more antennas may be in electrical communication with one or more antennas on the ostomy chip and / or one or more processors on the user device, the ostomy chip being configured to attach a first wall of the ostomy bag to the user's skin.

[0021] In some configurations, the stoma bag may include: two walls joined together around at least a portion of the edge of the stoma bag, a first wall configured to face the user's skin and a second wall configured to face away from the user when the first wall faces the user's skin; an opening in the first wall configured to be arranged around the user's stoma and to receive drainage from the stoma, wherein the opening may be located near a portion of the seam and further away from a portion of the demarcated drainage opening of the two unsealed walls; a connector having a first portion extending from the drainage opening of the two walls and a second portion located on the surface of the second wall, the first and second portions being complementary to each other such that when the first portion is folded onto the second wall, it can be releasably secured to the second portion; and a sensor layer disposed in, on, or between one of the two walls of the stoma bag. The sensor layer may include a sensor near the drainage opening and facing the second wall, the sensor being configured to detect when the first portion separates from the second portion of the connector to detect a drainage event. The sensor layer may also include one or more wireless antennas, wherein, in use, the one or more antennas may be in electrical communication with one or more antennas on the ostomy chip and / or one or more processors on the user device, the ostomy chip being configured to attach a first wall of the ostomy bag to the user's skin.

[0022] In some configurations, the connector may include a magnet.

[0023] In some configurations, the connector can be a Velcro connector.

[0024] In some configurations, the first part of the connector may include a metal component.

[0025] In some configurations, the sensor may include a distance sensor.

[0026] In some configurations, the sensor near the exhaust opening can be configured to detect changes in capacitance when the metal component is no longer in contact with the sensor, as the first part separates from the second part.

[0027] In some configurations, the sensor may include at least one capacitive sensor.

[0028] In some configurations, the sensors may include two capacitive sensors positioned substantially symmetrically about the longitudinal axis of the bag.

[0029] In some configurations, the bag may include multiple layers, and when the first part of the Velcro connector is releasably secured to the second part, the layer between the metal element and the sensor near the discharge port includes one or more openings to allow direct contact between the metal element and the sensor near the discharge port.

[0030] In some configurations, the initial direct or indirect contact between the metal element and the sensor near the discharge opening can be configured to electronically activate the bag.

[0031] In some configurations, the sensor layer can be essentially rectangular.

[0032] In some configurations, the sensor layer can be less than two walls.

[0033] In some configurations, the sensor layer may have a first portion located closer to the opening and a second portion located further away from the opening and closer to the discharge opening. The sensor layer includes multiple temperature sensors and multiple capacitive sensors facing the first wall in the wall. The multiple temperature sensors may be distributed across the first and second portions, and the multiple capacitive sensors may be distributed across the second portion.

[0034] In some configurations, capacitive sensors can be arranged in a pattern of lines, with the lines at angles other than 90 degrees relative to each other.

[0035] In some configurations, capacitive sensors can be arranged in a pattern of lines, with at least some lines at angles other than 90 degrees.

[0036] In some configurations, temperature sensors can be arranged as a matrix circuit.

[0037] In some configurations, the plurality of capacitive sensors may include 24 capacitive sensors.

[0038] In some configurations, the plurality of temperature sensors may include 48 temperature sensors.

[0039] In some configurations, the bag further includes an accelerometer.

[0040] In some configurations, the bag further includes a Bluetooth module.

[0041] In some configurations, the ostomy device may include: any previously configured ostomy bag; and an ostomy chip including multiple sensors.

[0042] In some configurations, the ostomy chip may include multiple temperature sensors.

[0043] In some configurations, the stoma wafer may include a capacitive sensor configured to detect leakage from the stoma.

[0044] In some configurations, the ostomy chip may include an accelerometer.

[0045] In some configurations, the stoma bag may include: an inner portion of the stoma bag configured to receive effluent and an outer portion of the bag, the inner portion having an inward wall and the outer portion having an outward wall; and an opening between the inward and outward walls, the opening being configured to be arranged around the user's stoma and to receive effluent from the stoma, wherein the inward wall may include a lubricating coating configured to reduce friction between the inner wall and the effluent contained in the stoma bag.

[0046] In some configurations, the lubricating coating may include biocompatible materials.

[0047] In some configurations, the lubricating coating may include silicone oil.

[0048] In some configurations, the lubricating coating may include non-biocompatible materials.

[0049] In some configurations, the lubricating coating may include fluorinated silicone oil.

[0050] In some configurations, the lubricating coating may include hydrophilic or hydrophobic materials.

[0051] In some configurations, the stoma bag may also include one or more sensor layers located between the inward and outward walls, the one or more sensor layers including multiple temperature sensors and multiple capacitance sensors, wherein the multiple temperature sensors measure temperature changes caused by the inflow of effluent into the bag, and wherein the multiple capacitance sensors measure capacitance changes caused by the inflow of effluent into the bag.

[0052] In some configurations, one or more sensor layers may include one or more wireless communication antennas, wherein, in use, the one or more antennas are in electrical communication with one or more antennas on a stoma chip and / or one or more antennas on a hub, the stoma chip being configured to attach a first wall of the stoma bag to the user's skin, and the hub being configured to attach to a second wall of the stoma bag within the wall.

[0053] In some configurations, the capacitive sensor can be arranged in a pattern of lines, with at least some lines at angles other than 90 degrees.

[0054] In some configurations, the capacitive sensor is configured to detect the fill level of the outflow in the bag when the bag is in an upright position and tilted.

[0055] In some configurations, the plurality of capacitive sensors may include 12-48 capacitive sensors.

[0056] In some configurations, the plurality of temperature sensors may include 20-64 temperature sensors.

[0057] In some configurations, multiple temperature sensors and multiple capacitive sensors can be located on a single sensor layer.

[0058] In some configurations, the fabrication pocket may also include a processor configured to receive signals from a temperature sensor or a capacitance sensor.

[0059] In some configurations, the stoma bag may also include a wireless transmitter configured to transmit signals to the user equipment.

[0060] In some configurations, the processor may be located in an electronic hub, which may be positioned at any of the following locations: at the outward wall, at approximately the center of the outward wall, at the top of the stoma pouch, or in a sac formed on the outward wall.

[0061] In some configurations, the stoma bag may also include a temperature sensor configured to measure ambient temperature.

[0062] In some configurations, the pocket may also include one or more of the following: a capacitive sensor, a bending sensor, an odor sensor, a microfluidic sensor, a camera, an infrared camera, an audio sensor, or a gas sensor.

[0063] In some configurations, temperature sensors can be arranged as a matrix circuit.

[0064] In some configurations, the medical kit may include three sets of any of the stoma bags disclosed herein, the first set of stoma bags including a diagnostic bag, the second set of stoma bags including an analytical bag, and the third set of stoma bags including a maintenance bag.

[0065] In some configurations, a method for detecting the total volume of output material in a stoma bag may include, under the control of a hardware processor, sensing temperature readings of multiple temperature sensors arranged in the stoma bag and capacitance readings of multiple capacitive sensors arranged in the stoma bag, the multiple temperature sensors being distributed and configured to measure the temperature of the infusion entering the bag; classifying the infusion type based on the temperature readings, including residual infusion and flowing infusion; and outputting a total volume value of output material in the stoma bag based on the classified infusion type, the temperature readings of the multiple temperature sensors, and the capacitance readings of the multiple capacitive sensors.

[0066] In some configurations, classification can include applying a classification machine learning model.

[0067] In some configurations, the classification machine learning model may include a first neural network model.

[0068] In some configurations, the method may also include detecting an infusion in response to a change in the temperature reading at the user's stoma exceeding an infusion temperature change threshold.

[0069] In some configurations, the method may also include adding the residual infusion volume to a previous value of the total residual volume when the infusion type is classified as a residual infusion to output the current value of the total residual volume.

[0070] In some configurations, the method may further include calculating the level value in the stoma bag based on capacitance readings.

[0071] In some configurations, a level-based computational machine learning model can be used to calculate level values.

[0072] In some configurations, horizontal computational machine learning models may include a second neural network model.

[0073] In some configurations, the method may further include comparing changes in level values ​​when classifying the infusion type as a flowing infusion.

[0074] In some configurations, if the change in the level value is below the level threshold, the current value of the total flow volume can be calculated as the level value; if the change in the level value exceeds the level threshold, the current value of the total flow volume can be calculated by adding the flow delivery volume to the previous value of the total flow volume.

[0075] In some configurations, if the current value of the total flow volume exceeds a horizontal threshold, the total volume value can be calculated as the current value of the total flow volume; if the current value of the total flow volume is below a horizontal threshold, the total flow volume value can be calculated as the sum of the current value of the total flow volume and the current value of the total residual volume.

[0076] In some configurations, the method may further include detecting a discharge event in response to a change in temperature reading near the discharge opening of the ostomy bag falling below a discharge temperature change threshold and a change in capacitance reading near the discharge opening of the ostomy bag exceeding a discharge capacitance change threshold.

[0077] In some configurations, the method may also include outputting a zero value for the total volume when an emission event is detected.

[0078] In some configurations, the method may also include detecting that the stoma bag is attached to the patient's body in response to a temperature reading at the stoma exceeding a body temperature threshold.

[0079] In some configurations, a method for detecting the total volume of the output material in a stoma bag may include: under the control of a hardware processor, sensing temperature readings from multiple temperature sensors disposed within the stoma bag, the multiple temperature sensors being distributed to be configured to measure the temperature of the infusion entering the bag; determining that the temperature readings pass an infusion standard and are not due to noise; classifying the actual infusion type based on the temperature readings according to the characteristics of the output flow; and outputting a total volume value of the output material in the stoma bag according to the classified actual infusion type.

[0080] In some configurations, the actual infusion type may include residual infusion, flowing infusion, and high-flow infusion.

[0081] In some configurations, it can be assumed that the residual infusion has an infusion volume of approximately 10 ml.

[0082] In some configurations, it can be assumed that the flow infusion has an infusion volume of approximately 50 ml.

[0083] In some configurations, it can be assumed that the high-flow infusion has an infusion volume of approximately 100 ml.

[0084] In some configurations, the total volume can be calculated as the infusion volume of each actual infusion type multiplied by the total number of each actual infusion type.

[0085] In some configurations, infusion criteria may include: changes in substomostomy temperature readings exceeding a substomostomy temperature change threshold, and stoma temperature readings exceeding a stoma temperature threshold.

[0086] In some configurations, the infusion criteria can vary based on the actual infusion type of the classification.

[0087] In some configurations, when the actual infusion type is residual infusion, the substomosal temperature change threshold can be lower than that for flowing or high-flow infusions.

[0088] In some configurations, the stoma temperature threshold can be the lowest when the actual infusion type is residual infusion, and the stoma temperature threshold can be the highest when the actual infusion type is high-flow infusion.

[0089] In some configurations, this feature may include the velocity of the output center mass in the direction along the length of the stoma bag from the stoma opening to the bag's discharge opening.

[0090] In some configurations, the features may include a first rate when the infusion criteria are met and a second rate one minute after the infusion criteria are met.

[0091] In some configurations, the velocity of the central mass can be approximated as the movement of heat distribution along the length of the stoma bag.

[0092] In some configurations, the infusion may be identified as noise when the rate is not significant.

[0093] In some configurations, the velocity of the center mass can be positive when the actual infusion type is flowing or high-flow infusion.

[0094] In some configurations, when the actual infusion type is residual infusion, the absolute value of the velocity of the center mass can be higher than the velocity threshold.

[0095] In some configurations, the method may also include detecting an emission event in response to the following: a change in temperature reading near the emission opening of the stoma bag is below an opening temperature change threshold; a change in capacitance reading near the emission opening of the stoma bag exceeds an opening capacitance change threshold; a change in all capacitance readings of the stoma bag exceeds an all capacitance change threshold; a time interval between two emission events exceeds a time interval threshold; and a total volume reading exceeds a minimum threshold.

[0096] In some configurations, the method may also include outputting a zero value for the total volume when an emission event is detected.

[0097] In some configurations, the method may also include detecting that the stoma bag is attached to the patient's body in response to a temperature reading at the stoma exceeding a body temperature threshold.

[0098] In some configurations, methods for detecting changes in the bag fill level of a stoma bag may include: receiving, under the control of a hardware processor, temperature readings from multiple temperature sensors disposed within the stoma bag and capacitance readings from multiple capacitance sensors disposed within the stoma bag; combining the temperature and capacitance readings to obtain a current normal distribution of the variable; performing statistical analysis to compare the mean of the current normal distribution of the variable with the mean of a previous normal distribution of the variable obtained at an earlier time; and determining that a change in the bag fill level has been detected based on the following: the difference between the mean of the current normal distribution of the variable and the mean of the previous normal distribution of the variable is statistically significant.

[0099] In some configurations, the method may also include outputting an estimate of the bag fill level based on statistically significant differences.

[0100] In some configurations, the bag fill level estimate can be obtained through calibration.

[0101] In some configurations, temperature and capacitance readings can be combined in a weighted manner.

[0102] In some configurations, capacitance readings from capacitance sensors located at or near the drainage opening of the stoma bag can be ignored before assembly.

[0103] In some configurations, the differences can include z-values ​​from statistical analysis.

[0104] In some configurations, when the z-value is greater than a critical value, the difference between the mean of the current normal distribution of the variable and the mean of the previous normal distribution of the variable is statistically significant.

[0105] In some configurations, the output detecting changes in bag fill level can be further based on determining the current normal distribution of the variable at predetermined time intervals after obtaining the previous normal distribution of the variable.

[0106] In some configurations, statistical analysis may include two-tailed tests.

[0107] In some configurations, the methods disclosed herein can be performed on any of the aforementioned stoma bags or stoma devices.

[0108] For the purposes of summarizing this disclosure, certain aspects, advantages, and novel features of several embodiments have been described herein. It should be understood that not all of these advantages can necessarily be achieved by any particular embodiment of the embodiments disclosed herein. Therefore, the embodiments disclosed herein may be implemented or performed in a manner that achieves or optimizes one or more advantages as taught herein without necessarily achieving other advantages as taught or suggested herein. Attached Figure Description

[0109] This patent or application document contains at least one color drawing. A copy of this patent or application disclosure with a color drawing will be provided by the Patent Office upon request and payment of the necessary fees.

[0110] Figure 1A schematically illustrates an example ostomy bag in the prior art.

[0111] Figures 1B-1D A schematic overview of an exemplary ostomy monitoring environment according to this disclosure is shown.

[0112] Figure 2 An example sensor layer of a stoma wafer is shown.

[0113] Figure 3 Another example of a sensor layer for a stoma wafer is shown.

[0114] Figure 4 An example layer of a stoma wafer is shown.

[0115] Figure 5 Another example of a sensor layer that can be included in a stoma wafer is shown.

[0116] Figure 6 It shows Figure 5 Example implementation of the sensor layer.

[0117] Figure 7 An example circuit diagram is shown that may be included in a sensor layer in a stoma wafer.

[0118] Figure 8 An example sensor is shown on or inside a stoma bag.

[0119] Figure 9 An exemplary ostomy bag with a sensor layer is shown.

[0120] Figure 10 A front or top view of an exemplary sensor layer of a stoma bag is shown.

[0121] Figure 11 An exemplary rear view or bottom view (user contact side) of an exemplary sensor layer of an ostomy bag is shown.

[0122] Figure 12 Example wiring of the sensor layer of a stoma bag is shown.

[0123] Figure 13 An example ostomy bag with a sensor layer connected to the ostomy wafer layer is shown.

[0124] Figure 14A A sample stoma bag is shown. Figure 4 Layered ostomy chip.

[0125] Figure 14B An exemplary ostomy bag with a sensor layer is shown facing away from the user.

[0126] Figure 14C A side view of the layers of an exemplary ostomy bag with an isolation layer is shown.

[0127] Figure 14D An exemplary ostomy bag with a sac for an electronic hub is shown.

[0128] Figures 15A-15G An exemplary ostomy chip is shown, which is attached to an exemplary ostomy bag having a different exemplary electronic hub arrangement.

[0129] Figure 16 An example thermal diagram is shown, which represents the thermal signature of the thermistor layer of the ostomy wafer.

[0130] Figure 17 An exemplary procedure for detecting leakage in a stoma bag is illustrated.

[0131] Figure 18A An example device worn by a patient is shown.

[0132] Figure 18B An example heatmap is shown, which illustrates Figure 18A The ostomy discharge flow in the equipment.

[0133] Figures 19A-19F The illustration shows applesauce being infused in different volumes while in a standing position.

[0134] Figures 20A-20G The diagram shows the infusion of water in 50 mL increments from 50 mL to 350 mL in the standing position.

[0135] Figure 21 An exemplary ostomy bag filling detection process is shown.

[0136] Figure 22 An example user interface for a patient application that communicates electrically with an electronic hub for an ostomy bag is shown.

[0137] Figure 23 A sample alert user interface for the patient application is shown.

[0138] Figure 24 An example user interface for the hydration tracker feedback feature of a patient application is shown.

[0139] Figure 25 The user interface of a sample hydration progress screen for a patient application is shown.

[0140] Figure 26A An example of an additional user interface for the patient application's bathroom locator feature is shown.

[0141] Figures 26B-26C An example of a user interface illustrating patient outputs and toilet location features is shown.

[0142] Figure 26D An exemplary user interface is shown, illustrating additional information related to the output.

[0143] Figure 26E An example user interface is shown, illustrating the application overview display page.

[0144] Figure 27 An example test setup for a stoma bag on an anatomical model using a thermal imaging camera is shown.

[0145] Figure 28 An example thermal image of a patient's stoma is depicted using a test thermal imaging camera.

[0146] Figures 29A-29D Depicting Figure 27 Example thermal image of applesauce infusion via stoma bag.

[0147] Figures 30A-30D Depicting Figure 27 Example thermal image of oatmeal infusion via stoma bag.

[0148] Figures 31A-31D Depicting Figure 27 Example thermal image of potato mash infusion via stoma bag.

[0149] Figure 32 A temperature sensor on an example sensor layer of a stoma wafer is schematically shown.

[0150] Figures 33A-33B It shows Figure 32 Top and bottom views of the sensor layer.

[0151] Figure 34A A top view of an example sensor layer of a stoma wafer is shown.

[0152] Figure 34B It shows Figure 34A A 3D view of the sensor layer.

[0153] Figure 34C It shows Figure 34A A side view of the sensor layer.

[0154] Figure 34D It shows Figure 32 and Figure 34C Another example is a top view of the sensor layer.

[0155] Figure 34E It shows Figure 34D A top view of the sensor layer.

[0156] Figure 35A An exemplary schematic circuit diagram of a chip PCB is shown.

[0157] Figure 35B An exemplary schematic circuit diagram of a temperature sensor on the sensor layer of a stoma wafer is shown.

[0158] Figure 35C An exemplary schematic circuit diagram of a battery on the sensor layer of a stoma chip is shown.

[0159] Figure 36 A temperature sensor is schematically shown on an exemplary sensor layer of a stoma bag.

[0160] Figure 37 A capacitive sensor on an exemplary sensor layer of a stoma bag is schematically shown.

[0161] Figure 38 A temperature sensor and a capacitance sensor are schematically shown on an example sensor layer of a stoma bag.

[0162] Figures 39A-39B An example of the sensor layer of a stoma bag is shown.

[0163] Figures 40A-40B It shows Figure 39A Top and bottom views of the sensor layer.

[0164] Figure 41A It shows Figure 39B A top view of the sensor layer.

[0165] Figure 41B It shows Figure 39B A 3D view of the sensor layer.

[0166] Figure 41C It shows Figure 39B A side view of the sensor layer.

[0167] Figure 42A An exemplary schematic circuit diagram of a bag PCB is shown.

[0168] Figure 42B An exemplary schematic circuit diagram of a temperature sensor on the sensor layer of a stoma bag is shown.

[0169] Figure 42C An exemplary schematic circuit diagram of a capacitive sensor on the sensor layer of a stoma bag is shown.

[0170] Figure 42D An exemplary schematic circuit diagram of a battery on the sensor layer of a stoma bag is shown.

[0171] Figure 43 Another example of the stoma bag filling determination process is shown.

[0172] Figures 44A-44B Example top and bottom views of the electronic hub for the stoma bag are shown.

[0173] Figure 45 The connection to the stoma bag is shown. Figures 44A-44B Hub.

[0174] Figures 46A-46D The front, rear, bottom, and perspective views of another example electronic hub for a stoma bag are shown.

[0175] Figure 46E It shows Figures 46A-46D Exploded view of an electronic hub.

[0176] Figure 47A Multiple capacitive sensors on an exemplary ostomy bag are schematically shown.

[0177] Figure 47B Multiple temperature sensors on an exemplary ostomy bag are schematically shown.

[0178] Figure 48 An example neural network model for calculating the output volume of a stoma bag is illustrated schematically.

[0179] Figure 49A An exemplary reading from the capacitive sensor on the stoma bag is shown after the first measurement.

[0180] Figure 49B An exemplary reading of the capacitive sensor on the ostomy bag is shown after the bag has been emptied.

[0181] Figure 50 An example algorithm logic is shown for detecting the infusion, discharge, and output of a stoma bag using a capacitive sensor and a temperature sensor.

[0182] Figure 51A The residual volume in the stoma bag is shown schematically.

[0183] Figure 51B The flow volume within the stoma bag is schematically shown.

[0184] Figure 52 An exemplary flowchart for a volume calculation algorithm is shown.

[0185] Figure 53AAn example ostomy chip is shown.

[0186] Figure 53B It shows Figure 53A A cross-sectional view of the ostomy chip.

[0187] Figure 54A A temperature sensor and a capacitance sensor are schematically shown on the first side of an example sensor layer of a stoma bag.

[0188] Figure 54B The combination is shown Figure 54A The first view of the sensor layer in the example sensor.

[0189] Figure 55A A capacitive sensor on the second side of an example sensor layer of a stoma bag is schematically shown.

[0190] Figure 55B The combination is shown Figure 55A The second view of the sensor layer in the example sensor.

[0191] Figure 56 It shows Figure 54B and Figure 55B A side view of the sensor layer.

[0192] Figures 57A-57B It shows Figure 56 A 3D view of the sensor layer.

[0193] Figures 57C-57D It shows Figures 54A-56 Another example of a sensor layer in a stereoscopic view.

[0194] Figure 58 A cross-sectional view of an example sensor layer of a stoma bag is schematically shown.

[0195] Figure 59A An example schematic circuit diagram of a temperature sensor on the sensor layer of a stoma bag is shown.

[0196] Figure 59B An example schematic circuit diagram of a capacitive sensor in the sensor layer of a stoma bag is shown.

[0197] Figures 60A-60B A first view of an example ostomy bag being assembled is shown.

[0198] Figure 60C It shows Figure 60A The second view of the stoma bag.

[0199] Figure 60D It shows Figure 60A An exploded view of the stoma bag.

[0200] Figure 60E It shows Figure 60A A side view of the stoma bag.

[0201] Figure 60F It shows Figure 60A An exploded view of a variant of the stoma bag.

[0202] Figure 61 It shows Figure 60A Example layer of the stoma bag.

[0203] Figure 62 It shows Figures 60A-60F The thin film layer of the stoma bag.

[0204] Figure 62A It shows Figure 60F Example layer of the stoma bag.

[0205] Figure 62B An example of a female chip interface is shown.

[0206] Figure 62C It shows Figure 62B Cross-sectional view of the female chip interface.

[0207] Figure 62D An example seal is shown.

[0208] Figure 62E The configuration is shown to be with Figures 62B-62C An example of a male chip interface combined with a female chip interface.

[0209] Figure 62F It shows Figure 62E A cross-sectional view of the male chip interface.

[0210] Figure 62G It shows Figure 62F A detailed diagram of the male chip interface.

[0211] Figures 63A-63B Multiple temperature sensors on an example ostomy bag are illustrated schematically.

[0212] Figure 63C The coordinate system of multiple temperature sensors on an example ostomy bag used to calculate "central mass" is schematically shown.

[0213] Figure 64A An example flowchart of the volume calculation algorithm is shown schematically.

[0214] Figure 64B It is a summary used for Figure 64A The flowchart in the document contains a table of multiple infusion indicators.

[0215] Figure 65An example flowchart is shown for a statistics-based algorithm used to determine whether changes in the filling level of a stoma bag alter its function. Detailed Implementation

[0216] introduce

[0217] The systems and examples herein relate to systems and methods for detecting skin inflammation, such as skin inflammation around a wound. The systems and examples also relate to detecting peristaltic skin inflammation, for example, due to leakage at the stoma site.

[0218] For skin wounds, such as postoperative injuries, skin inflammation can be the first indication of infection. Because infected wounds can cause serious local and systemic complications, rapid detection and treatment of infection are crucial. However, patients often fail to recognize the initial signs of skin inflammation and become uncomfortable before seeking medical advice.

[0219] In particular, ostomy patients are at risk of developing skin inflammation due to irritation and infection. Any waste expelled from the body through the stoma (e.g., "ostomy output") that leaks onto the surrounding skin can cause irritant dermatitis, fungal infections, fungal dermatitis, or folliculitis. Additionally, the use of ostomy devices can cause inflammation of the skin on the external abdominal wall due to mechanical trauma from inappropriate instruments and / or frequent removal and reattachment of ostomy devices.

[0220] This disclosure describes examples of systems and methods for detecting peristaltic skin inflammation and peristaltic leakage. These systems and methods can be used in the context of stoma systems used to detect peristaltic skin inflammation in colostomies, ileostomies, urethrostomies, etc. An example system may include a stoma wafer comprising one or more sensors that provide outputs in response to skin inflammation and / or leakage. The sensors may be temperature sensors, capacitive sensors, or other types of sensors, many examples of which will be discussed in detail below.

[0221] An increase in temperature output from the temperature sensor in the stoma chip can correspond to effusion leaking onto the peristaltic skin (e.g., leakage below the stoma chip). An increase in temperature output from the temperature sensor can also correspond to increased skin irritation due to effusion leakage. Therefore, the system can detect temperature changes that indicate effusion leakage and / or potential skin irritation before the user notices the leakage or skin irritation. The system can output an indication to the user based on the detected temperature change, etc. This indication can include an audible and / or visual representation of the temperature change, a warning, alert, or alarm regarding impending or detected skin irritation. As will be described in more detail below, a capacitive sensor can be used in place of a temperature sensor and / or in addition to a temperature sensor to detect the presence of moisture.

[0222] Another problem faced by patients with ostomies is leakage at the stoma site, for example, due to overfilling of the stoma bag. For some users, it can be difficult to detect when the stoma bag is full, especially since it often reaches its designed capacity before it appears full to the user. The stoma bag may be designed to be less than its apparent capacity to prevent leakage back into the stoma. Additionally, users may forget to check the stoma bag, potentially causing it to overflow accidentally. Leakage can be uncomfortable, embarrassing, and damage clothing and skin, causing the irritation discussed above.

[0223] This disclosure also describes systems and methods for detecting stoma bag filling. An example system includes a stoma bag comprising one or more sensors for detecting bag filling. The one or more sensors may include a temperature sensor. The temperature sensor may output a temperature measurement indicating a temperature change in response to effluent entering the stoma bag. The system may output an indication to a user based on the detected temperature change. This indication may include an audible and / or visual representation of the temperature change, a warning, alert, or alarm.

[0224] The system may also include one or more volume sensors (e.g., capacitive sensors or others). The system can output instructions to the user to empty and / or replace the bag based on, for example, capacitance changes detected in one or more capacitive sensors that may be located on the ostomy bag. For example, the capacitive sensor may include electrodes that are in electrical communication with a capacitive sensor chip for monitoring the capacitance of the electrodes.

[0225] The stoma chip described above can be used with the stoma bag described above. The stoma chip can also be integrated with the stoma bag. Furthermore, the example system may include one or more wireless transmitters that transmit data from the stoma chip and / or stoma bag to another device, such as a hub, user device, clinician device, and / or back-end system. For example, the stoma chip and / or stoma bag can wirelessly transmit data to a hub connected to the stoma bag, and the hub can transmit the received data to a back-end system (e.g., a cloud server). The user device (e.g., a smartphone or tablet) can download data and other information from a remote server.

[0226] This disclosure also describes many other example sensors, parameters that can be detected by those sensors, and variations of ostomy wafers and ostomy bags.

[0227] Overview

[0228] This section provides a detailed overview of various problems affecting patients undergoing ostomy, as well as an overview of some of the solutions provided in this disclosure. More detailed example features are described below with respect to the accompanying drawings, under the title "Example Ostomy Monitoring System".

[0229] A stoma bag can be a medical bag that collects human waste (feces, urine, or both) from patients who are unable to excrete waste naturally due to medical problems, including cancer, trauma, inflammatory bowel disease (IBD), intestinal obstruction, infection, and fecal incontinence. In such cases, surgery is performed to create a waste passage. This waste passage can be a ureter (called a urethrostomy), the small intestine or ileum (called an ileostomy, which is part of the small intestine), or the large intestine or colon (called a colostomy, which is part of the large intestine), which can be diverted into an artificial opening in the abdominal wall, thus forming a portion of a specific internal anatomical structure that is partially located outside the body wall. This procedure can be called a stoma, and the externally visible portion of the waste passage can be called a stoma.

[0230] An example prior art image of an ostomy bag is shown in Figure 1A. Two ostomy bags are shown in Figure 1A. These bags include a one-piece bag on the left and a two-piece bag on the right. The one-piece bag (on the left) has a substrate (sometimes called a panel or ostomy wafer, or simply wafer) already attached and integrated onto the bag. The two-piece bag has a separate wafer and bag (therefore including an attachment or flange). In the case of the one-piece bag, it can only be used once, and the entire device needs to be handled when the bag needs to be replaced. In the case of the two-piece bag, the bag can be handled without removing the wafer. Some people prefer this two-piece setup, leaving the wafer on their body and only removing the bag, because removing the wafer (which may contain high-tac adhesive) can be a form of mechanical strain on the skin, and some people prefer to avoid this form. When the bag is worn on the user's body, the wafer side of the one-piece bag or the wafer-abutting side of the two-piece bag can face the user's body. The chip can be located around the stoma (therefore, the stoma is located in the stoma hole within the chip) and can be made of a biocompatible hydrocolloid or hydrocolloid adhesive-based material, both of which are skin-friendly and can be easily adhered to the skin through the stoma hole once the stoma is in place. Many other exemplary chip and bag materials are described in more detail below. Both figures are examples of drainable bags, as they have a drain port at the bottom of the bag so that the patient can remove waste when the bag is emptied. Some bags do not have a drain port and therefore cannot drain. Therefore, such bags are disposed of when full without the ability to drain. The average wear time for a stoma bag / bag is 1–3 days or 3–5 days. The average wear time for the substrate is approximately 3–5 days.

[0231] The types of waste released by patients undergoing the three different types of stomas (urethrostomy, ileostomy, and colostomy) can differ. Stoma waste includes urine, ileostomy waste may include porridge-like stool, and colostomy waste may include solid stool. The size of the stoma performed by the stoma surgeon can be determined by the specific type of stoma the patient is undergoing. For example, a colostomy is a divergence of the colon (large intestine) to the abdominal wall opening, so the stoma size (e.g., diameter) can be expected to be large. This is in contrast to ileostomy patients, who have their ileum (part of the small intestine) diverted to the abdominal wall opening. Because the small intestine is smaller, the stoma size may be smaller.

[0232] Currently, bags in the medical bag industry (including ostomy bags, blood bags, saline bags, tubing, etc.) are only used as plastic bag-type collection containers that can be emptied and reused, or disposed of and replaced with new bags. Beyond this, they lack advanced functions or uses, such as clinical diagnostic functions. Therefore, for example, current laboratory practices involve physically collecting patient samples for urine and stool testing, then sending them to various diagnostic laboratories for clinical laboratory analysis.

[0233] This disclosure describes several different example bags and chips that may include sensors and optional electronics. The electronics on the bag and / or chip can perform a wide range of analytical analyses (e.g., calculating at least some of the leakage and / or skin irritation detection indicators disclosed herein). The sensors and electronics on the bag and / or chip can transmit sensor signals (which may be unprocessed and / or minimally processed or adapted signals) to a back-end system (e.g., a cloud server) to calculate indicators (e.g., temperature and / or capacitance changes). Using a system with such bags and chips, additional indicators can be measured and analyzed within the bag itself (optionally with an external device, such as the patient's phone) without third-party intervention, such as a laboratory. Thus, this disclosure describes some examples of "laboratory on a bag." The bag can effectively provide in-situ patient clinical information to each patient and his / her physician and / or nurse and / or caregiver.

[0234] An example of such clinical information could be electrolyte levels, such as sodium (Na+), calcium (Ca2+), or potassium (K+) levels, the loss of which can indicate a patient's hydration level and serve as a marker for diabetes, kidney and liver dysfunction, as well as heart disease and other conditions. Another clinical marker that can be used in the bag described in this article is, for example, the pH level in urine, which can indicate UTIs (urinary tract infections) as well as ketosis and severe diarrhea. Other types of substances in the output, such as the presence of medications, can be monitored.

[0235] Other metrics are of incredible value to patients, their responsible healthcare teams, and potential caregivers. In response, bags and / or wafers can also measure physical information relevant to daily events in the life of an ostomy patient. This physical information can include data on bag fullness, as well as monitoring the volume of output material in the ostomy bag, the flow rate of the effluent / output, its physical phase and viscosity, and the irritation and leakage of the peristaltic skin by the effluent around the stoma site and in the colloidal wafer. Below is a brief overview of examples of these metrics.

[0236] Bag filling and volume measurement:

[0237] Data and indicators regarding the bag's fullness are useful for patients, providing early indication that their bag needs to be emptied. This can prevent potentially unfortunate and embarrassing events, such as overfilling of the bag, and can prevent effluent from contacting the skin around the stoma site, causing irritation or infection. Such events can have social and psychological impacts on patients. Furthermore, volumetric output is strongly correlated with a patient's diet and hydration, thus serving as a good direct indicator of the function of the GI (gastrointestinal) system and its ability to absorb nutrients (such as vitamins, proteins, glucose, minerals, etc.), while also indicating the amount of waste it processes from the patient's body. Therefore, quantitative measurement of stoma volumetric output can indirectly provide clinical guidance for the function of the GI system.

[0238] However, each patient's output can be a highly subjective indicator, with some patients having significantly more output and others significantly less. The relationship between inputs and outputs is not always linear, and some patients have more outputs relative to the amount entering their bodies. Therefore, information combining a patient's inputs and outputs may reveal early signs of dehydration, such as (e.g., by measuring outputs, the amount of water lost is significantly greater than the amount of water entering the body through fluid intake).

[0239] Mobile applications and / or websites can be provided to patients, which may include platforms with various trackers such as food and hydration trackers. Using an application that optionally records indicators such as diet and hydration (via user interaction and trackers within the application) and a bag sensor that indicates bag volume, this integrated platform can work together to provide early signs of dehydration, eating problems, or even gastrointestinal (GI) dysfunction in patients. Dehydration can be a critical indicator, as it is one of the most common reasons for readmission within the first three months after stoma surgery. Therefore, providing information that helps patients understand the characteristics of their output can enable better monitoring and prevention of dehydration, significantly improving care and quality of life, and potentially reducing postoperative costs associated with readmission after the initial stoma surgery.

[0240] Flow rate, physical phase and viscosity of the effluent

[0241] Understanding the physical phase (solid, semi-solid, liquid, and gas) of the outflow from the bag can be clinically important. In the cases of urethrostomy and colostomy, the outflow is usually constant relative to both groups of patients, consisting of a liquid and a solid phase, respectively. However, in the case of ileostomy patients, the outflow may have a porridge-like consistency, meaning it can be a mixture of solid, liquid, or semi-solid. Furthermore, both colostomy and ileostomy patients may have gas in their outflow. Understanding the phase of the outflow can provide early signs of dehydration, information about the patient's gastrointestinal function, and information about the patient's lifestyle, such as their dietary or hydration habits. Using a mobile application discussed above, clinically significant data and events can be identified and quickly forwarded to physicians. Moreover, the detection of gaseous outflow can make bag filling calculations more accurate, as discussed in more detail below.

[0242] Skin irritation and leakage of peristaltic discharge:

[0243] As a phenomenon, leakage is particularly common in patients with more fluid-like output, but it can also occur in colostomy patients with more rigid output, through what is known as "flattening" of feces around the stoma. Leakage can occur when a patient's effluent / output does not completely enter the bag. Instead, some of it bypasses the bag and begins to accumulate between the adhesive side of the chip (the side facing the skin) and the skin around the stoma (also known as peristaltic skin, which is located behind the chip). The output includes biological and chemical enzymes, which, when in prolonged contact with the skin, begin to "erode" as they accumulate, thus irritating the skin and causing scarring. This type of skin irritation can be termed irritant contact dermatitis (ICD) or incontinence-associated dermatitis (IAD). For ease of description, this instruction manual often refers to ICD and IAD interchangeably.

[0244] Leakage can be caused by a variety of reasons, some of the main ones being that the hydrocolloid adhesive loses its stickiness with prolonged wear or the accumulation of sweat and / or moisture between the pouch and the skin behind it. The accumulation of such enzymatic outputs behind the pouch can also promote the erosion and breakdown of the hydrocolloid. In this case, this erosion also breaks down the adhesive, thus destroying its stickiness and ultimately rendering it unusable. Prolonged wear of ostomy bags is common, with an average wear time of 3–5 days per patient before being processed for use with a new bag. Therefore, it is conceivable that during prolonged continuous wear, the hydrocolloid may be exposed to significant amounts of moisture, ultimately rendering it unusable without leakage.

[0245] Moisture and sweat can also act as catalysts to exacerbate leakage symptoms because as these forms of moisture begin to saturate the hydrocolloids, which have a maximum saturation limit beyond which they cannot absorb any more moisture, they effectively prevent the hydrocolloids from absorbing the leaking fluid. As a result, the leaking fluid accumulates between the peristaltic skin and the back of the endoscopic flap, leading to ICD (intracytoplasmic disc herniation).

[0246] ICD is a major concern and problem for many patients, but to date, major bag manufacturers have implemented interventions to prevent leakage and subsequent skin irritation. These include products such as leak-limiting Eakin seals or wipes that form a protective barrier against adhesives, exudates, and enzymes, or incorporating ingredients like ceramides into the barrier to maintain good skin and peristaltic skin health. Despite these interventions, many patients still struggle with peristaltic skin complications. One disadvantage patients face is a lack of awareness of leakage. By the time patients realize leakage has occurred, it may be too late, as active enzymes may have already caused significant damage to their peristaltic skin. Skin irritation can be graded in several levels, which WOCN (Wound and Stoma Care Nurse) can score using the DET (Discoloration, Erosion, and Tissue Overgrowth). This scoring system is described as a stoma skin tool that nurses use as a standardized way to assess the peristaltic skin condition and complications in stoma patients. As seen in previous citations, this scoring tool scores skin irritation induced by chemical irritation associated with IAD or ICD, mechanical trauma (due to frequent changes in the bag-shaped microchip), disease-related irritation, and infection-related irritation. Periostomal infection may be the initial skin irritation symptom, accompanied by the presence of moisture and sweat.

[0247] To date, based on the inventors' knowledge, no commercial intervention has been provided to offer a technical solution that can indicate in-situ leakage, saturation and / or damage of hydrocolloids, or potential skin irritation at an early stage. However, the example devices and algorithms described herein can alert users to replace their flanges / chips and thus take preventative measures to minimize the deterioration of their skin condition.

[0248] Furthermore, based on the inventors' knowledge, there are currently no commercially available technical solutions for detecting volume, physical phase, and flow rate within the bag, where temperature is used as a marker. A solution capable of technically detecting these indicators would be of immense value to healthcare and patient populations, with the overall motivation being to transmit this information (e.g., in real-time) to a variety of stakeholders (e.g., patients, nurses, doctors, care providers, caregivers) via smartphone or tablet platforms, as further described below.

[0249] An exemplary smart stoma bag (or “smart bag”) that may also include a chip may have integrated sensors that can track one or more in-situ physical events within the bag. These events may include volumetric analysis, flow rate, physical phase of the effluent, viscosity of the effluent, possible skin irritation and / or peristaltic leakage and / or saturation of hydrocolloids. The smart bag may also track more detailed clinical / analytical parameters of the bag, such as electrolysis measurements, pH, and other markers, which will be described in detail below.

[0250] One physical marker that allows for the detection of some or all of the above indicators is heat / temperature. The next section will explain why heat can serve as a relevant marker for the detection of one or more relevant indicators.

[0251] As mentioned earlier, peristaltic skin irritation is one of the most common complications for patients undergoing stoma surgery. This can be caused by frequent chip replacements, allergies, folliculitis, or leakage of the skin barrier / chip (leakage can occur when stoma output leaks between the skin and the skin barrier / chip, which can eventually extend beyond the skin barrier / chip).

[0252] Although the factors that cause ICD are diverse and can be collectively referred to as irritants, each of these factors can lead to increased subcutaneous blood flow, resulting in elevated skin surface temperature. While specific clinical data on peristaltic skin temperature are lacking in the literature, other studies on chronic wounds and ulcers have demonstrated a 3-4°C temperature difference between irritated skin and the unaffected contralateral reference skin. Therefore, in situ monitoring of the peristaltic skin surface temperature, as well as areas away from the peristomal region (for measuring the unaffected reference area), can provide information about skin health and indicate early symptoms of skin irritation.

[0253] Because stoma output, at least in the initial stage as it leaves the stoma, can be associated with an internal temperature (37°C or approximately 37°C) higher than the external skin temperature (specifically, the abdominal skin surface (approximately 32-35°C)), temperature can also serve as a warning sign of leakage behind the skin barrier / lamellae, thus alerting to impending early-stage peristaltic skin irritation. When leakage occurs, it can be expected that the temperature within the laminar flow can rise very rapidly—even appearing instantaneously. This rapid or instantaneous temperature change can be monitored based on the occurrence of leakage to detect leakage in situ.

[0254] The advantages of using stoma bags made from hydrocolloid-based materials include, but are not limited to: 1) adhesion to the skin around the stoma, regardless of whether the skin is wet or dry; 2) absorption of fluid and swelling, protection of the wound, reduction of pain, and acceleration of healing in cases of wound exudate common in stoma procedures; and 3) considering that in stoma applications, most bags typically take approximately 1–1 minutes in the United States. 1 Replace after 2 days, 1-3 days or 3-5 days (usually about 1-2 days in the UK), and the substrate is replaced after about every 5-6 days. The wear life of the hydrocolloid dressing is long enough that once worn, the dressing does not need to be changed between dressing changes, thus reducing damage to the wound.

[0255] Given that hydrocolloids absorb bodily exudates and moisture, such as sweat, they are expected to swell with the absorption of fluids. This swelling of the hydrocolloids upon absorption indicates a temperature change between the hydrocolloid adhesive and the peristaltic area, as the hydrocolloids effectively move away from the skin with the absorption of exudates. Therefore, one way to detect hydrocolloid saturation is by detecting changes in temperature over time, which can provide an early indication of hydrocolloid saturation. This is important because many patients do not perceive leakage or hydrocolloid saturation until they visually see or feel the flange detach from their body (which occurs naturally as the viscosity of the hydrocolloid adhesive decreases).

[0256] Besides temperature, another useful indicator for detecting one or more metrics of interest via a wafer or bag can be pH. pH can be useful due to the leakage of exudate and its contribution to the saturation of the hydrocolloid wafer. Given that the exudate contains enzymes with biological and chemical properties, and that these enzymes can erode hydrocolloids and cause chemical damage to the skin, this indicates the acidity or alkalinity of the exudate. Essentially, the chemistry of the skin, as well as the properties of the hydrocolloid wafer, change with chemical and / or biological attack. A powerful combination of sensors (temperature and pH) can provide early indications of leakage / skin irritation / hydrocolloid wafer saturation by detecting changes in pH of the hydrocolloid as a result of leakage or its saturation and / or alternatively, detecting the pH of the skin as a result of enzymatic attack. Supersaturation as well as leakage can be detected by embedding, for example, a thread-based microfluidic pH sensor into the wafer. Of course, pH monitoring is optional.

[0257] The heat / temperature will be described in more detail below as an example indicator for measuring from the front (and possibly the rear) of the bag body.

[0258] Some stoma bags may include a volume sensor based on a resistive flex sensor, which can measure the volume of the bag and alert the patient to the point of drainage (e.g., when the bag is emptied). The nature of the flex sensor makes it susceptible to noise from the patient's natural movements (sitting, standing, sleeping, running) and the movement of the contents within the stoma bag.

[0259] As mentioned above, the effluent may initially be at the body's internal temperature (37°C or approximately 37°C), which is higher than the temperature of the external skin (especially the abdominal skin surface) (approximately 32-35°C). Therefore, using heat / temperature as a marker to understand the volume filling within the bag can be used to determine the volume within the bag. The effluent is likely hottest when it leaves the stoma and gradually cools as it moves from the top of the bag to the bottom where it resides. The movement of the effluent from the top to the bottom of the bag, and optionally the residence of the effluent, can be displayed thermally, thus indicating the volume within the bag. 2D or 3D thermal images of the bag can be used to understand the volumetric activity within the bag.

[0260] Temperature measurements allow visualization of thermal signals and patterns as effluent enters the bag, passing through the front and / or back of the bag. Therefore, the thermal characteristics of the effluent can be tracked from its entry point to its final resting position. Considering that the output can be of different physical forms depending on the type of ostomy, such as urethrostomy (fluid urine), colostomy (hard fecal solids), and ileostomy (porridge-like semi-solid / solid-liquid output), flow rate can be visually mapped by understanding the rate at which the thermal sensor array fires up, as the effluent traverses its path while heat dissipates / dissipates from the waste.

[0261] The rate of heat dissipation, or more specifically, the rate of heat dissipation and cooling, can vary between different physical stages, and the flow rate can also vary. The rate of heat dissipation may depend on the heat capacity of the different phases and whether the waste is in motion or stagnant. The flow of each phase can depend on viscosity. Because particles in a liquid are somewhat free-flowing, the viscosity of a liquid urine sample may be lower, allowing the phase to flow rapidly into the bag and pass through the path of the thermal sensor very quickly. In the case of solid waste, the flow rate can be significantly slower due to fewer free-flowing particles in the phase, and therefore, this phase may pass through the path of the thermal sensor more slowly where a temperature sensor array is present. Thus, the response time of the sensor to the rate of movement of the effluent as it enters the bag at internal body temperature and passes through the path of the thermal sensor array, the viscosity, and therefore the phase of the effluent can be known from the rate at which the thermal sensor array essentially starts up, for example, the response time of the sensor to the rate of movement of the effluent as it enters the bag and passes through the path of the thermal sensor array. The duration of the thermal signal of the volumetric output can also allow for indirect determination of the phase (e.g., liquid, solid, semi-solid, and gas) and viscosity of the effluent. It can be expected (depending on the heat dissipation rate) that the temperature of the output material will drop to baseline within a certain time period, but this time period can vary for different phases and viscosities.

[0262] Integrating thermal sensor arrays into stoma bags and / or wafers can help patients, as well as their caregivers, nurses, and specialists, manage peristaltic skin complications and take early action to prevent skin deterioration in stoma patients. Furthermore, patients and caregivers can gain a better understanding of the patient's output and the functionality of their GI system. Specific temperature sensor technologies used in the wafers and bags, along with other sensor technologies, are described in more detail below with reference to the accompanying drawings.

[0263] The smart ostomy bag can also detect the volume / fill within the bag, for example, by using the same thermistor technology described above. The thermistor technology described above can detect volume from the thermal signal output by the effluent; for example, by placing a thermistor plate at the front or back of the bag (e.g., in the front or back wall of the bag). The time interval of the thermal signal output by the volume can indirectly indicate the viscosity of the effluent and ultimately the phase of the effluent (e.g., liquid, solid, semi-solid, and possibly even gas).

[0264] Thermistor-based sensor technology can serve a dual function in smart bags: 1) indicating skin irritation and leakage in the peristaltic region, and 2) indicating the volumetric filling of the bag and the phase of released effluent. Two datasets can be generated based on heat. The following is a description of the process and principles by which the device generates outputs for each of these measurements.

[0265] Because the thermistor's switching principle can be based on temperature changes, rather than bending as in the bending sensor described in U.S. Patent 9,642,737, thermistor technology can better avoid noise caused by motion and thus could be a new candidate for indicating volume within the bag. Furthermore, in an example embodiment where the thermistor is placed at the front of the bag, it can detect the temperature distribution / diffusion of the contents within the bag and the flow pattern of the ostomy output. This could further allow for analysis of the rheological properties of the ostomy output and potentially allow for identification of the phase of the output.

[0266] The temperature reading itself can be derived from the resistance reading of a thermistor as a function of time at a specific temperature. The thermistor can be a semiconductor-based device that changes its resistance according to the applied temperature. The resistance value can then be converted to a temperature value using the Steinhart–Hart equation:

[0267]

[0268] Where T is the temperature (in Kelvin), R is the resistance at T (in ohms), and A, B, and C are Steinhart-Hart coefficients, which can vary depending on the type and model of the thermistor and the temperature range of interest.

[0269] The sensor can transmit data to an electronic hub, which can package the data and send the packets to a cloud server and / or a mobile application on the user's device. The mobile application can read the wireless packets and convert them into their appropriate data type. The mobile application can also communicate electrically with the cloud server to download data. The mobile application can output a thermal distribution map of the entire wafer and bag front, a temperature scatter plot over time, and / or a visualization of the total volume of the output in the bag for presentation to the user.

[0270] Exemplary stoma monitoring system

[0271] exist Figures 1B-1D The diagram provides a schematic overview of an ostomy monitoring environment 100 in which an ostomy device 102 and a patient (not shown) optionally using the device 102 can be monitored. In this environment 100, a hub 122 of the ostomy device 102 is shown communicating with a user device 130 (see [link to documentation]). Figure 1B The user equipment 130 can transmit data from the hub to the backend system 170 (e.g., a remote server or cloud server) via network 140, or the hub 122 can communicate directly with the backend system 170 via network 140 (see [link to relevant documentation]). Figure 1C User equipment 130, backend system 170, and other devices can communicate via network 140. In some cases, such as... Figure 1B and Figure 1C As shown, after hub 122 sends data to backend system 170 for further processing, user equipment 130 can download the processed data from backend system 170 (although in Figure 1C In this example, backend system 170 can communicate directly with hub 122 (instead of communicating with hub 122 through user device 130). In the illustrated example, these other devices may include clinician device 160 and third-party system 150. Stoma monitoring environment 100 depicts an example environment, and more or fewer devices may communicate with stoma device 102 in other systems or devices. Stoma monitoring environment 100 enables users and others (e.g., clinicians) to monitor various aspects related to the user's stoma device 102, such as stoma bag filling, leakage, and skin irritation. Figure 1D The ostomy monitoring environment 100 is connected without a hub. Figure 1B The ostomy monitoring environment 100 differs from that in this case; that is, the processor 123, which communicates with the sensor 124, also communicates with the user equipment 130. For further processing, after the bag processor 123 sends data to the backend system 170, the user equipment 130 can download the processed data from the backend system 170.

[0272] The stoma device 102 can be a one-piece or two-piece device, including a stoma chip 104 and a stoma bag 120.

[0273] The stoma chip 104 may include a patient-facing side and a bag-facing side opposite to the patient-facing side, the patient-facing side having an adhesive pad, flange, etc., which attach to the skin surrounding the patient's stoma 110. The stoma 110 may include any stoma disclosed herein, such as a suture or opening in the patient's abdomen (or other location) formed due to a colostomy, ileostomy, urethrostomy, or other similar medical procedure. The stoma bag 120 is removably attached to the bag-facing side of the stoma chip 104 (e.g., via an adhesive or Tupperware click mechanism) and receives and stores outputs (e.g., effluent) from the stoma 110. The stoma bag 120 may be flexible such that it can be substantially flat when empty and can expand when effluent enters the bag 120. Once the stoma bag 120 reaches its designed capacity, the patient (or caregiver) can remove the stoma bag 120 from the stoma chip 104, discard and / or empty it, and attach a new stoma bag 120 (or clean and reattach the old stoma bag 120). In another example, the stoma bag 120 is provided or sold as a single device with the stoma chip 104, which is integrally formed with the stoma bag 120. The stoma bag 120 collects human waste (e.g., feces and / or urine) from patients who are unable to excrete waste naturally due to medical problems (including cancer, trauma, inflammatory bowel disease, intestinal obstruction, infection, and incontinence). In these cases, a procedure is performed to create a waste passage (colostomy, ileostomy, or urethrostomy) and direct it to the abdominal wall portion. The stoma bag 120 may be made of a non-porous, sterile plastic material, such as, but not limited to, polyvinyl chloride, polyethylene, ethylene vinyl acetate, polypropylene, and copolyester ether.

[0274] The stoma bag 120 may include one or more sensors 124 and an optional hub 120, which may be located on the side facing away from the wafer 104. Sensors 124 may include any sensors described herein. For example, sensors 124 may include multiple temperature sensors, capacitive sensors, cameras (infrared or visible light), gas sensors, magnetic sensors such as AMR sensors, and / or microfluidic sensors, etc. The bag 120 may include multiple layers. One or more sensor layers may be provided, in which sensors are embedded or otherwise attached. Different types of sensors may be located on different layers, or different types of sensors may be located on a single layer. Sensors may also be located on the same and / or different sides of a single layer.

[0275] The stoma bag 120 may include a measuring sheet. The side of the stoma bag 120 opposite to the wafer 104 may include the measuring sheet. The measuring sheet may include multiple layers (such as layers made of polyimide, polyurethane, etc.). As will be described in more detail below, four or two layers may be used. Other numbers of layers may be used. For example, a temperature sensor layer and / or a capacitance sensor layer may be provided to detect changes in temperature and / or capacitance as effluent enters the bag 120 and disperses within the bag 120. The temperature and / or capacitance sensors may each be arranged in a matrix or similar matrix manner. A processor, whether in hub 122 (discussed below), user equipment 130, or back-end system 170, may process the temperature and / or capacitance data obtained from the temperature and / or capacitance sensors to detect leakage and / or skin irritation indicators, such as temperature rise and / or bag filling. Electronic equipment communicating with the sensors may also be disposed on one or more layers. Other examples of sensors for the bag are discussed in more detail below.

[0276] The stoma wafer 104 may be a flexible sheet having one or more layers, and optionally multiple layers including one or more sensor layers. These layers may be made of the same or similar materials as the layers of the bag 120 described above. One or more layers of the stoma wafer 104 may include one or more of the following sensors: temperature sensors (e.g., thermistors, temperature sensing integrated circuits (ICs), thermocouples, infrared (IR) temperature sensors, etc.), capacitive sensors, bending sensors, odor sensors, microfluidic sensors, leakage sensors, combinations thereof, etc. The stoma wafer 104 may also be a moldable barrier.

[0277] Sensors for the stoma wafer 104 (e.g., temperature sensors and / or other types of sensors disclosed herein) may be arranged in a sensor layer (described in detail below). The sensor layer may have a shape profile similar to or the same as that of the stoma wafer 104. For example, if the stoma wafer 104 is shaped like a donut or ring, the sensor layer may include a generally annular shape. The sensor layer may also have a shape different from the overall shape of the wafer 10, such as a partially annular or partially ring-shaped shape. Optionally, the stoma bag 122 may include a carbon filter port to allow gas to escape. Optional gas sensors placed on or near the port may detect characteristics of the gas (e.g., the irritancy of the gas) to determine the state of the user's intestines.

[0278] The stoma chip 104 can be of any size. The size of the stoma chip 104 can depend on the type of stoma used with it. For example, a colostomy stoma can be larger than a urethrostomy stoma. Therefore, the size of the stoma chip 104 for some colostomy stomas can be larger than the size of the stoma chip for some urethrostomy stomas. The stoma chip 104 can be a "one-piece" chip with punch-out sections at the center for accommodating various stoma sizes. The stoma chip 104 can also be available in different versions with stoma holes 110 of different sizes to accommodate different stoma sizes.

[0279] The stoma wafer 104 can also be in any of a variety of different shapes. For example, the stoma wafer 104 can have a generally annular, oval, or circular shape, such as a ring, a donut, etc. The stoma wafer 104 can also have a more rectangular, rectangular, or square shape (optionally with rounded corners).

[0280] As described above, the ostomy wafer 104 can be structurally layered to encapsulate the sensor. Encapsulation can improve the fixation of the temperature sensor's position within the flexible sheet and / or reduce the corrosive effects of the external environment on the sensor. Alternatively, the temperature sensor can be protected from corrosion by a coating such as a conformal coating. Some exemplary wafers (and pouches, discussed below) may have at least one temperature sensor in a second region of the flexible sheet, which is protected by a conformal coating.

[0281] As described above, the patient-facing side of the stoma wafer 104 may have an adhesive side that adheres to the skin surrounding the stoma 110 and / or directly to the stoma 110. The adhesive may be a double-sided adhesive. The adhesive may be a water-soluble colloidal adhesive.

[0282] Sensors in stoma wafer 104 and / or bag 120 can detect information based on the output of stoma 110. Sensors can sense the composition of the effluent or output of stoma 110. Temperature sensors can be used to determine the likelihood of inflammation at the stoma site and / or leakage site. Temperature sensors can also be used to detect the phasing of components, which can be used to determine, for example, how much gas and / or solids are in the bag. Capacitive sensors in wafer 104 (and / or bag 120) can serve as backups, providing redundancy and / or supplement to the temperature sensors to determine the presence of leakage. For example, the temperature sensor on wafer 104 can detect leakage due to effluent not entering the bag for the various reasons described above, in addition to detecting overfilling of bag 120 (e.g., when bag 120 is relatively empty but the adhesive on the wafer is loose). As another example, the temperature sensor and / or capacitive sensor on bag 120 can detect bag filling and output an indication of impending overfilling or leakage before actual leakage occurs. In another example, capacitive sensors can be used instead of temperature sensors to detect leakage or skin irritation.

[0283] If a microfluidic sensor is used on the chip 104 and / or the bag 120, the sensor can be used to detect electrolytes or inflammatory markers within the components. This data can be used to show the user what he or she can ingest or do to achieve a healthier balance of electrolytes and other chemical components in the user's body. An odor sensor can be incorporated into the bag 120 and / or the chip 104 to determine the presence of bacterial growth in the digestive tract. An inertial measurement unit (“IMU”) sensor (in the form of a position indicator) can also be integrated into the bag 120 and / or the chip 104. An optical sensor (e.g., a camera) can also be integrated into the bag 120 and / or the chip 104, where the sensor looks down into the stoma and / or into the bag to detect a degenerated stoma, blood in feces, etc. An acoustic sensor (e.g., a microphone) can be included in the bag and / or the chip to detect gas outputs and / or defecation sounds. A pH sensor can also be integrated into the bag 120 and / or the chip 104 to determine the acidity of the components in the bag.

[0284] The stoma chip 104 and one or more stoma bag sensors 124 can collect patient data related to stoma outputs and can transmit the data wirelessly or wiredly to a hub 122 or a processor in electrical communication with the sensors. The hub 122 may include electronics that facilitate one or both of (1) processing sensor data and (2) transmitting sensor data. For example, the hub 122 may include a hardware processor, memory, and a wireless transmitter. The hub 122 may also optionally have a display for outputting sensor-related data (e.g., indications of leakage, bag filling, etc.). The hub 122 may also optionally include a speaker that outputs audible warnings indicating leakage, bag filling, etc.

[0285] The optional wireless transmitter of hub 122 can transmit data received from sensors (chip or pouch) to user equipment 130. The data can then be transmitted to network 140, third-party system 150, clinician device 160, back-end system 170, or patient data storage device 180 (each of which will be discussed in detail below). To conserve battery life, the wireless transmitter can switch between active and idle modes. Hub 122, or a wireless transmitter in a pouch without a hub, can also transmit data received from sensors on chip 104 and / or pouch 120 to back-end system 170, such as… Figure 1C As shown. Chip 104 and / or pouch 120 can periodically transmit data, for example, via Bluetooth. Data transmitted via hub 122 or processor 123 of the pouch (excluding hub) may include unprocessed or adjusted (e.g., filtered, demodulated, etc.) signal data. The memory device in hub 122, or processor 123 of the pouch (excluding hub), may be configured to optionally temporarily store sensor data for a period of time (e.g., between 1 hour and approximately 12 hours, or between 10 hours and 12 hours, or more) before transmitting data to back-end system 170 via user equipment 130. The data storage capacity of the memory device in hub 122 or processor 123 allows for data connectivity, that is, prevents data loss when the user wearing pouch 120 cannot connect pouch 120 to user equipment 130, or otherwise cannot use user equipment 130. When reconnected to user equipment 130, the data stored on the memory device can be sent to back-end system 170. Hub 122 and / or processor 123 are able to collect data from the sensor at different intervals, for example, from approximately every 10 seconds to every minute.

[0286] Backend system 170 can process received signal data to calculate metrics disclosed herein, such as temperature and / or capacitance values, bag fill volume, and / or leakage detection. User equipment 130 and / or other devices can download the calculated metrics from backend system 170. Performing calculations on backend system 170 reduces the processing power requirements in hub 122, which in turn reduces battery consumption and / or the frequency of battery replacement or charging in hub 122.

[0287] The hub 122 or the optional wireless transmitter of the bag, excluding the hub, may include a Near Field Communication (NFC) reader and / or writer, a Bluetooth transmitter, a radio transmitter, or a Wi-Fi (802.11x) transmitter. The NFC reader and / or writer may be coupled to an NFC antenna on the hub to communicate with an NFC antenna on the bag 120 and / or the chip 104 to receive sensor data from sensors on the bag 120 and / or the chip 104. The NFC reader and / or writer may have sufficient power or current (e.g., an output current up to approximately 250 mA) to receive data transmitted by the NFC antenna on the chip 104 (and / or the antenna on the bag) when the bag 120 is filled to its apparent capacity and / or when the chip 104 is separated from the hub 122 by a certain (e.g., maximum) distance. The NFC reader and / or writer may be used as the primary wireless communication tool with sensors on the bag 120 and / or the chip 104, and Bluetooth communication may be optionally used as a backup tool. Different wireless communication protocols may also be optionally used to transmit data between hubs, ostomy bags, and / or chips. Bluetooth transmitters may include Bluetooth modules and / or Bluetooth Low Energy (BLE) modules. Bluetooth modules may be, but are not limited to, Bluetooth version 2.0 + EDR (Enhanced Data Rate) modules. Bluetooth Low Energy modules may be Bluetooth modules, such as, but not limited to, Bluetooth version 4.0 (Bluetooth Smart), Bluetooth version 4.1, Bluetooth version 4.2, or Bluetooth version 5. Bluetooth sensor modules may include Bluetooth modules using the IPv6 Internet Protocol Support Profile (IPSP) or later.

[0288] The hub 122 can be located at various positions on the device 102. The hub 122 can be placed in many areas of the stoma bag 120. The hub 122 can be located at the front, back, close to the gas filter (not shown), etc. The hub 122 can also be placed in a pouch on the stoma bag 120, or the hub 122 can be a replaceable feature on the stoma bag 120. The hub 122 can also take different forms. When the hub is removed from the stoma bag 120, it can use previously collected data and carry that data to the next subsequent stoma bag 120 where it is placed. Hub removability can save money for the user.

[0289] Hub 122 may include multiple electronic devices, including but not limited to wireless transmitters and / or receivers, motion sensors (e.g., triaxial accelerometers), temperature sensors (e.g., far-infrared (FIR) temperature sensors, ambient temperature sensors, etc.), camera modules, lighting for the camera (e.g., LED lighting), microphones (e.g., microelectromechanical (MEMS) microphones), battery charging circuitry, and / or other electronic devices. An ambient temperature sensor, which can be of any type, may be mounted on the back side of hub 122 facing the bag and the patient. Temperature measurements from the ambient temperature sensor may be close to room temperature or ambient temperature and / or used as a reference for temperature sensors on bag 120 and / or chip 104. The microphone may record audio information related to stoma outputs and / or monitor indicators related to stoma outputs (e.g., gas outputs, defecation, or others).

[0290] User equipment 130 can be any device having a processor and a wireless receiver capable of communicating with hub 122 or a processor 123 without a hub. For example, user equipment 130 can be a telephone, smartphone, tablet, laptop, desktop computer, audio assistant, or smart speaker (such as Amazon Echo). TM Google Home TM Apple HomePod TM User equipment 130, including devices such as televisions, can automatically pair with a wireless transmitter and may include a mechanism to notify the user that a wireless link exists between the wireless receiver and the wireless transmitter. User equipment 130 may have software and algorithms to process data to display to the user the bag's filling status, the nearest toilet, the nearest electrolyte source, the nearest food source, the pattern and content of excrement, hydration levels, and suggestions for improving the user's condition. User equipment 130 can also wirelessly transmit data to network 140. Network 140 may be a local area network (LAN), a wide area network (WAN), the Internet, an intranet, or a combination thereof.

[0291] The third-party system 150 may be a data processing tool / feature; a backend server for an audio assistant; or a fitness tracker, personal health monitor, or any third-party system that can use or manipulate the data collected by device 102. These third-party systems 150 may also include algorithms and software to compute and process the data.

[0292] Third-party system 150 and audio assistant can acquire data from ostomy device 102 to issue reminders or alerts to users, such as emptying the bag, changing the bag, changing the hub, ingesting or stopping certain types of food, water intake, and / or providing regular checkups. Other third-party systems can use data collected from other users to create better feedback systems or identify statistical patterns in ostomy patients and / or bag users.

[0293] Clinician device 160 can be a data processing tool or monitoring program used by clinicians. These clinician devices 160 can receive data from device 102 to provide remote clinicians with information for diagnosing users, suggesting actions to users, or serving as an augmented reality system for clinicians. These clinician devices 160 may also include algorithms and software for calculating and processing data.

[0294] Backend system 170 (e.g., a cloud server) can also use algorithms and software to perform data processing. For example, backend system 170 can process any data received from sensors on the chip and / or bag and return information based on that processing to user device 130 or other devices. Another optional feature is the inclusion of a patient data storage system 180. From here, the backend system can wirelessly transmit data to a patient data storage device, or the patient data storage device can access the data from network 140.

[0295] Algorithms and software can display when a user should change their bag, alerting them when the bag is nearly full, or when there is a chip or leakage. Software features include, but are not limited to, identifying the nearest restroom within the user's radius, the volume of the user's bag, alerts for different fill levels, and a hydration and electrolyte tracker that uses algorithms to calculate the user's recommended daily hydration goals. The hydration and electrolyte software can also inform the user of their dietary needs throughout the day based on their excrement output or composition.

[0296] Exemplary stoma chip and stoma chip layer

[0297] Ostomy wafers (also known as ostomy flanges or ostomy barriers, which can optionally be moldable barriers) are examples of articles designed to adhere to the peristaltic skin of ostomy patients. The wafers protect the skin from chemical and biological erosion caused by ostomy output.

[0298] Figure 2 An ostomy chip (e.g.) is shown Figures 1B-1C The example sensor layer 200 (on wafer 104) includes a sensor 202 such as a temperature sensor (e.g., a thermistor) or any other sensor discussed herein. The sensor layer 200 includes a body 212 and a neck 214 surrounding a hole 210 (which may be punched or cut to fit a user's stoma). The example sensor layer 200 may be made of a flexible sheet.

[0299] The sensor 202 shown is positioned in the body 212 in a generally circular path around the orifice 210. Any number of sensors 202 may be included. Arranging the sensors 202 in a generally circular distribution concentric with the orifice 210 can help detect leaks or irritations in different or any directions. For example, in some embodiments, more sensors may be provided to increase the granularity of the measurement, potentially allowing for a more accurate prediction of the direction in which a leak or irritation is occurring.

[0300] A sensor 204 is also depicted disposed on a neck 214 extending away from the orifice 210. The neck 214 is elastically deformable, allowing it to elongate in response to movement of the ostomy patient and subsequently return to its original shape. Sensor 204 can be used as a reference sensor to compare the temperature difference between sensor 202 and sensor 204. Since sensor 204 is further away from the orifice 210 than the other sensors 202 in this example, the temperature detected by sensor 204 can represent the baseline temperature of the patient's skin. Therefore, a comparison of the temperature output of sensor 202 with the temperature output of sensor 204 can indicate leakage or irritation. More generally, to detect the presence of inflammation in the peristaltic skin, at least one temperature sensor in sensor layer 200 can be positioned away from the orifice 210 (once formed). This can be, for example, in the peripheral region of body 212 or in neck 214. In some cases, using a sensor in the peripheral region of body 212 to measure the user's reference body temperature signal may be less expensive than fabricating sensor 204 in neck 214.

[0301] Although the body 212 of sensor layer 200 is shown to have a circular or annular shape, sensor layer 200 can have other shapes. For example, sensor layer 200 can be rectangular, square, or oval. Other example shapes of sensor layers are described in more detail below.

[0302] Furthermore, sensor layer 200 may be one layer of a multilayer material forming ostomy wafer 104. For example, sensor layer 200 may be sandwiched between two or more layers to form ostomy wafer 104. For example, ostomy wafer 104 may include at least one layer formed of a protective plastic, such as, but not limited to, polyethylene, polypropylene, polystyrene, polyvinyl chloride, polyurethane, acrylonitrile butadiene styrene, phenolic resin, polyetheretherketone, polyamide, or combinations thereof. In some examples of the device, ostomy wafer 104 includes at least two layers of protective plastic material, sized to completely encapsulate at least a plurality of temperature sensors within a first body 212 and / or neck 214. Encapsulation ensures, or attempts to ensure, that the temperature sensors remain in place within sensor layer 200 and protect them from external environmental influences.

[0303] For example, encapsulation can be achieved by sandwiching the temperature sensor between two layers of protective plastic material, and then heat-welding or adhering these two protective layers together to form a stoma wafer 104. To encapsulate the temperature sensor while still conforming to the shape of the body, the thickness of the stoma wafer 104 can be from 0.15 mm to 0.7 mm or other ranges. Alternatively, the temperature sensor can be protected from corrosion by a coating such as a conformal coating. In some systems, a conformal coating can be used to protect at least one temperature sensor in a second region (e.g., in the neck 214).

[0304] To detect inflammation by measuring temperature changes during ostomy, a temperature sensor can be used at the location of sensor 202. The temperature sensor can be a thermistor, a resistance temperature detector (RTD), a thermocouple, an integrated circuit sensor, or an infrared temperature sensor. The temperature sensor can be a thermistor. Thermistors are particularly suitable temperature sensors due to their high sensitivity. The thermistor can be a commercially available thermistor that provides a large temperature coefficient of resistance, for example, in the range of approximately 30°C to approximately 50°C or some other range. Such thermistors are widely commercially available, such as those from Panasonic, Murata Manufacturing Co., Ltd. (NTC thermistors NCP15WF104D03RC or NCP15XH103D03RC), or TDK (NTC thermistors NTCG103JX103DT1). When the temperature sensor is a thermistor, the system (e.g., hub 122) can include a processor capable of periodically polling the resistance of each thermistor.

[0305] Figure 3 An example sensor layer 300 is shown. Like sensor layer 200, sensor layer 300 can be part of a stoma wafer, such as wafer 104. Therefore, sensor layer 300 can be sandwiched between two or more layers to form a stoma wafer.

[0306] Sensor layer 200 can be a "pre-cut," "cut-to-fit," or "molded" wafer. When the wafer is a "pre-cut" wafer, the size of the opening 210 can range in diameter from approximately 20 mm to approximately 100 mm. Other sizes are possible. When the wafer is a "cut-to-fit" wafer, the stoma wafer may include a marking pattern defining at least one cutting region. This arrangement allows a user to determine the size of the opening in their stoma by selecting the appropriate portion of the stoma wafer to be removed. Sensor layer 200 may include cutting regions that may include multiple concentric circles or partial circles (or concentric ellipses or partial ellipses), such that cutting at each concentric circle or partial circle (or concentric ellipse or partial ellipse) of sensor layer 200 can provide an opening of a different size. For example, the cutting regions may include a pattern of three, four, five, or more concentric circles or partial circles.

[0307] Sensor layer 300 includes a plurality of thermistors, indicated by letters and numbers in the accompanying drawings. Specifically, these thermistors are numbered A1 to D10. The thermistors are arranged in a ring around hole 210 (or a cutout 210 that can be removed to form a hole). Specifically, the thermistors are arranged in concentric rings 304, 306, and 308. These rings are connected by wiring shown in blue and red. Thus, although the thermistors are arranged in a generally circular pattern around hole 210, the connections formed by the conductors connected to the thermistors form an approximately partial circle or partial ring around hole 210. The area 310 of the conductor represents... Figure 2 The neck 214 is shown as an example bottom and is shown as truncated for illustrative purposes.

[0308] In this example, sensor layer 300 has multiple temperature sensors in three rings 304, 306, and 308 for measuring the temperature in an inner region of sensor layer 300 (e.g., in ring 304 or neck 310); and at least one temperature sensor in an outer region of sensor layer 300 for measuring the temperature in an outer region of sensor layer 300 (e.g., ring 308), which is remote from the inner region. Although not shown, a comparator or processor (e.g., in hub 122 and / or back-end system 170) may be provided to compare the temperature in a first region of sensor layer 300 with the temperature in a second region of sensor layer 300, thereby generating a differential signal indicating the presence or absence of skin inflammation in the skin region in contact with the first region of sensor layer 300.

[0309] In some systems, the system can be arranged to facilitate the detection of skin inflammation around a wound. For example, temperature sensors can be positioned in sensor layer 300 such that when a wafer 104 including sensor layer 300 is applied to the skin surface around a stoma, multiple temperature sensors in a first region of sensor layer 300 can detect the temperature of the skin adjacent to the wound, and at least one temperature sensor in a second region of sensor layer 300 can detect the temperature of the skin distant from the wound. This arrangement allows temperature differences between the skin near and away from the wound to be attributed to inflammation. By providing a system capable of comparing the temperature in the first region of sensor layer 300 with the temperature in the second region of sensor layer 300 distant from the wound and sending a signal corresponding to the detected temperature difference to a receiver, the system can detect the presence or absence of skin inflammation in the skin area in contact with the first region of sensor layer 300 and report the detection results to a user.

[0310] Figure 4 Exemplary components of the sensor layer 200 in an exemplary ostomy chip 400 are shown. The ostomy chip 400 may have all the functionality of the ostomy chip 140 and other exemplary ostomy chips discussed herein. Although the sensor layer 200 is incorporated for illustrative purposes, the sensor layer 300 may be used in the exemplary implementation.

[0311] The exemplary stoma wafer 400 also has an adhesive layer 406 at least on the peristaltic skin contact side 408 of the stoma wafer 400 for adhesion to the skin. The bag docking layer 402 of the stoma wafer 400 may also have an adhesive (on the opposite side of the figure; not shown) that can be adhered to a stoma bag, such as stoma bag 120.

[0312] The encapsulation sheet 404 can be a protective plastic, such as, but not limited to, polyethylene, polypropylene, polystyrene, polyvinyl chloride, polyurethane, acrylonitrile-butadiene-styrene, phenolic resin, polyetheretherketone, polyamide, or combinations thereof. Prior to encapsulation, the sensor 202 can be mounted on or integrated into the support sheet 401. The support sheet 401 can be formed from a plastic material such as polyethylene terephthalate (PET), polyurethane (PU), or combinations thereof, or it can be formed from a polyimide film, such as Kapton (a condensation product of phenylene dianhydride and 4,4'-oxodiphenylamine). The use of the support sheet 401 ensures or attempts to ensure that the temperature sensor is held in place during the encapsulation process. This allows the temperature sensor to be strategically positioned on the wafer. An exemplary cut circle 408, depicted with an inner circle 410, a middle circle 412, and an outer circle 414, can serve as a guide for the user to determine the size of the manufacturing aperture 210 by cutting along the cut circle trace. In some variations, the wafer may not include a package, but may include other types of protective materials to protect the wafer's electronics.

[0313] Adhesive 406 can be a hydrocolloid adhesive. Hydrocolloids can be, for example, biocompatible materials composed of pectin, carboxymethyl cellulose (CMC), gelatin, polymers, and other binders. The use of hydrocolloid adhesives is suitable for stoma applications because they can adhere to the skin around the stoma, whether the skin is moist or dry. In cases of wound exudate, which is very common in stoma applications, the polymers in hydrocolloid dressings can absorb fluid and swelling, thereby protecting the wound, reducing pain, and accelerating healing. Hydrocolloid dressings can be beneficial in stoma applications where the bag is only changed after 2 or 3 days because they have a long lifespan once worn, thus reducing damage to the wound. Furthermore, compared to other materials, it may be impermeable or poorly permeable to bacteria.

[0314] Figure 5 Another example of a sensor layer 500 is shown, which may be included in the stoma wafer 104 described herein or any other stoma wafer. Sensor layer 500 is similar to sensor layers 200 and 300 in some respects but differs in others. Typically, sensor layer 500 may include many features of sensor layer 200 or sensor layer 300. For example, sensor layer 500 includes a sensor 502, which may be a thermistor or other sensor described herein. Sensor 502 is disposed within a body 512 of sensor layer 500. Body 512 is connected to neck 514. Sensor layer 500 may also be disposed between two or more other layers to form a stoma wafer, as described above. Figures 2-4 As stated above.

[0315] The sensor layer 500 differs from the previously described sensor layer in that it includes a gap 501 between its portions. This gap 501 creates a structure that roughly resembles a candlestick. The sensor layer 500 may include multiple partial rings formed by cut regions or portions. The sensor layer 500 may include a first cut portion 504, a second cut portion 506, a third cut portion 508, and a fourth cut portion 508. These cut portions, similar to the cut region 408 of the stoma wafer described above, can assist in customizing the stoma hole 210. The user can use the cuts as guides to adjust the size of the stoma hole 210.

[0316] Neck 514 has a serpentine design with bends 507 to aid flexibility. Neck 514 may include a conductor very similar to neck 214 described above.

[0317] Figure 6 Example embodiments of sensor layers 500 and 600 are shown. Sensor layer 600 includes all the functions of sensor layer 500 and also depicts wiring between thermistors 502. This wiring includes curved wiring between thermistors, which is semi-circular in shape, some of which are alternately oriented.

[0318] Figure 7 An exemplary circuit diagram 700 is shown, illustrating a schematic arrangement of sensors 202 (and 302 or 502). In the illustrated example diagram 700, a 4×4 matrix of sensors 202 is shown. Any sensor layer described herein can be arranged as follows... Figure 7 The matrix shown connects the sensors together. Although Figure 7 The matrix in the diagram is depicted as a rectangle, but this is an option and merely illustrative, and the layout can vary. For example, the sensor layout in the previous figures differs from the rectangular layout shown, but the sensors in those figures are arranged as shown in the diagram. Figure 7 The matrix topology shown can have the same interconnections.

[0319] Figures 32-35C An example sensor layer 3200 of an ostomy wafer (e.g., wafer 104 described above) is shown. Sensor layer 3200 may have any of the features of sensor layers 200, 300 described above. Sensor layer 3200 may be incorporated into wafers 104, 400 described herein. For example, a wafer including sensor layer 3200 may include an adhesive layer on the patient contact side, an adhesive layer on the ostomy bag contact side, and / or a polyimide film (e.g., Kapton). TM One or more encapsulation sheets made of polyurethane, etc.

[0320] like Figures 32-33BAs illustrated in the schematic diagram, sensor layer 3200 may include a body 3212 and a neck 3214. The body 3212 may be generally circular or oval. The neck 3214 may be substantially rectangular and may extend from the body 3212. The relative position of the neck to the body is not limited. The body 3212 may include an ostomy orifice 3210 configured to fit over a user's ostomy. The orifice 3212 may have a variable diameter (e.g., about 38 mm or about 45 mm or others) depending on the size of the ostomy. The body of the adhesive layer, as well as the bodies of the optional sensor layer and / or encapsulation layer described herein, may also have different sizes and / or shapes, for example, to accommodate different ostomy sizes, provide different amounts of surface area for adhesion to the skin, or otherwise. In some configurations, the wafer examples described herein may have increased boundary dimensions and / or boundary bands to reduce wafer peeling from the user's skin. The wafer may include a boundary ring surrounding the adhesive layer. In some embodiments, the outer dimensions of the boundary ring may be larger than the outer dimensions of the adhesive layer. The boundary ring of the wafer may include an acrylic adhesive and / or a hydrocolloid adhesive. The thickness of the aqueous adhesive at the boundary can differ from the thickness of the aqueous adhesive on the rest of the wafer. The boundary ring can also be referred to as a tapered edge.

[0321] The main body 3212 can accommodate multiple temperature sensors 3202 (e.g., thermistors disclosed herein). Figure 32 As shown, the main body 3212 may include forty temperature sensors 3202. The temperature sensors 3202 may be generally distributed on the main body 3212. The temperature sensors 3202 may be arranged in a generally circular pattern, which is substantially concentric with the holes 3210. Figure 32 As shown, temperature sensor 3202 can be arranged in inner ring 304 and outer ring 306. Different numbers and / or different arrangements of temperature sensors can also be used. The surface on which temperature sensor 3202 is mounted can face the patient.

[0322] Body 3212 may also optionally house one or more capacitive sensors. Any other wafer examples described herein may include one or more capacitive sensors. For example, one or more capacitive sensors may monitor the moisture content of the aqueous colloid in the adhesive, which may provide an indication that the adhesive has dried and / or the wafer needs to be replaced.

[0323] like Figures 33A-33B As shown in the schematic diagram, it illustrates the surface of layer 3200 opposite to the surface where the temperature sensor 3202 is mounted, on which the neck 3214 can accommodate electronic components 3222 and / or a power supply 3224. Electronic components 3222 can be mounted (e.g., surface-mounted) on a printed circuit board (PCB) 3223, such as... Figure 33BAs shown. PCB 3223 can be mounted on layer 3200. PCB 3223 can have sufficient rigidity to protect electronic components 3222 and / or circuitry on PCB 3223 from damage due to bending of the flexible layer 3200. Electronic components can be directly mounted on layer 3200 (e.g., without using a PCB), wherein reinforcing material (e.g., fiberglass, plastic, or other material more rigid than the material of layer 3200) is mounted on layer 3200 adjacent to the electronic components to prevent damage to the electronic components. Mounting electronic components 3222 on PCB 3223 can reduce the number of packaging layers in the sensor layer of the chip (e.g., from four layers for direct-mount electronics to two layers for PCB-mount electronics), which can reduce the use and / or waste of packaging materials, and / or make the chip more affordable for users.

[0324] Electronic component 3222 may be electrically connected to temperature sensor 3202 (described in more detail below). Electronic component 3222 may receive data from temperature sensor 3202. When temperature sensor 3202 includes a thermistor, the resistance of the thermistor may change with temperature variations (e.g., when exudate leaks from the stoma). Electronic component 3222 may receive resistance signals and / or adjustment resistance signals from temperature sensor 3202. Electronic component 3222 may send ADC values ​​and / or other minimally processed signals to a hub, such as hub 122 described above, to calculate temperature values ​​on the cloud and / or user device, thereby reducing the power consumption of chip electronics 3222. Chip electronics 3222, user device, and / or hub may also optionally perform temperature value calculations. Electronic component 3222 may optionally include an accelerometer and / or Bluetooth module.

[0325] like Figure 33B As shown, power source 3224 may include a battery (such as a button cell battery). More than one battery may also be optionally mounted to neck 3214. The battery may be surface-mounted to neck 3214 adjacent to electronic component 3222. Figure 33B As shown, one or more mounting arms 3225 may be attached to the neck 3214 to hold the battery in place.

[0326] Figures 34A-34CA top view, perspective view, and side view of an example sensor layer 3200 are shown. As shown, the sensor layer 3200 may also include multiple NFC antenna loops 3208. The NFC antenna loops 3208 may be positioned radially outward from the outer loop 3206 of the temperature sensor 3202. The NFC antenna loops 3208 may be substantially concentric with the inner loop 3204 and / or outer loop 3206 of the temperature sensor 3202. The NFC antenna loops 3208 may be fabricated onto the layer 3200 (e.g., printed or etched). In use, a stoma bag, such as the stoma bag 120 described above, may be coupled (e.g., adhesively attached) to the wafer such that the NFC antenna loops 3208 on the sensor layer 3200 substantially coincide with the NFC antenna loops on the sensor layer of the bag (described in detail below) and / or the NFC antenna loops on the hub. The NFC antenna loops on the wafer, bag, and hub may have substantially the same dimensions to facilitate better data transfer between the wafer and hub, and between the bag and hub. The NFC antenna on the chip, pouch and / or hub may also optionally have other shapes and / or sizes, such as oval, square, rectangular or polyhedral shapes.

[0327] For example Figures 34A-34B As shown, conductive traces 3230 (e.g., copper traces) can connect temperature sensor 3202, NFC antenna loop 3208, and / or power supply 3222 to electronic components on PCB 3223. The sensor layer may also include more loops, such as more NFC antenna loops and / or conductive trace loops as shown. Figures 35A-35C An exemplary schematic circuit diagram of the sensor layer 3200 is shown. Figure 35A An exemplary schematic circuit diagram 3510 of the chip PCB 3223 is shown. The actual arrangement of electronic components can vary in the chip PCB layout. Figure 35B An exemplary schematic circuit diagram 3520 of temperature sensor 3202 is shown. As mentioned above, the actual arrangement of the temperature sensor can vary on the wafer. However, those temperature sensors can be arranged via conductive traces 3230 or wires, such as... Figure 35B The matrix topology shown has the same interconnections. Figure 35C An exemplary schematic circuit diagram 3530 of a battery is shown.

[0328] For example Figures 34A-34BAs shown, the trace 3230 connected to the temperature sensor 3202 and the trace 3230 connected to the NFC antenna loop 3208 can cross at multiple locations. When the hub needs to communicate with the electronics 3222, the hub uses the NFC antenna on the hub to communicate with the NFC antenna loop 3208 to establish a connection between the hub and the electronics 3208. The hub can turn on its NFC, which powers the antenna to allow the hub to communicate with the ostomy bag and the chip. The electronics 3222 can read data from the temperature sensor 3202 (e.g., ADC value or other values ​​mentioned above). The hub can then turn off the temperature sensor circuitry on the chip before the electronics 3208 sends the temperature sensor data to the hub via NFC communication. The hub can also turn on the temperature sensor circuitry when the chip stops transmitting data to the hub. Disabling the temperature sensor circuitry during data transmission between the chip and the hub can reduce interference caused by trace crossings. The chip may optionally have its own Bluetooth module (e.g., with...). Figure 55B (Similar to the Bluetooth module 5423 in the chip). The Bluetooth module on the chip communicates wirelessly with another processor, such as a hub, or a processor on the user device or ostomy bag.

[0329] Figures 34D-34E The bottom and top views of another example sensor layer 3200 are shown. Figures 34D-34E The features of the sensor layer shown are similar to Figures 34A-34B The features of the sensor layers shown can be combined with each other. For example, Figures 34D-34E The sensor layer shown has Figures 34A-34B The sensor layer shown includes all features and also contains different and / or additional conductive traces 3230 that connect the temperature sensor 3202, the NFC antenna loop 3208, and / or the power supply 3222 to electronic components on the PCB 3223.

[0330] As described above, sensor layer 3200 (or other sensor layers disclosed herein) may include one or more polyimide films. The sensor layers disclosed herein may also be made of polyurethane. The use of polyurethane allows for the use of silver traces instead of copper traces. Compared to copper traces, silver traces may have improved biocompatibility, lower toxicity, and / or better antibacterial properties. Therefore, silver traces may reduce irritation for certain patients who are sensitive to or allergic to metals.

[0331] Figures 53A-53B It shows a way to be with Figures 32-35CThe example stoma chip 5300 is combined with the sensor layer 3200 shown. The chip 5300 may have rounded corners 5302. The chip 5300 may include a connector 5304 on a first side (facing away from the patient) for attachment to a stoma bag, which may be any of the example stoma bags disclosed herein. The chip may also include an adhesive layer on a second side (facing the patient), which may be, for example, a hydrocolloid for attaching the chip 5300 to the patient's body.

[0332] The hydrocolloid layer 5306 may initially be protected by a pad 5308, which can be peeled off to expose the hydrocolloid layer 5306. The thickness of the hydrocolloid layer 5306 may be between about 0.5 mm and about 2.0 mm, or between 0.7 mm and about 1.5 mm, or about 1.0 mm. Compared to a thinner adhesive layer, the thickness of the hydrocolloid layer 5306 allows for the absorption of more moisture (e.g., leakage, sweat, or others), thus allowing the chip 5300 to remain on the patient's body for a longer period. The thickness of the hydrocolloid layer 5306 also allows the chip 5300 to remain flexible and / or allows heat to be transferred from the patient's skin surface to the thermistor on the sensor layer 3200, thus allowing the thermistor to measure the patient's body temperature more accurately, as... Figure 53B As shown, the hydrocolloid layer 5306 is thinner at the edge of the wafer 5300. Alternatively, the hydrocolloid layer may have a thickness gradient, wherein the layer is thinner at or near the center (i.e., at the location of the sensor).

[0333] The chip may also optionally include one or more capacitive sensors to detect whether the chip is attached to the patient's body, using an algorithm similar to that described below for capacitive sensors on ostomy bags. The chip may also optionally include an accelerometer for measuring the patient's body posture and / or orientation, for example, when the patient is moving around, standing, sitting, lying down, and / or otherwise. The chip may also optionally include a button battery that can last for approximately one week.

[0334] Example of a stoma bag and bag layer

[0335] Figure 8 It shows that it can be layered in Figure 1B Example sensors on or within the stoma bag 120. This allows for multiple different readings to be provided by utilizing a limited amount of space on device 102. The layer sensor 800 may have, but is not limited to, a bending sensor 802, an odor sensor 804, a microfluidic sensor 806, a capacitive sensor 808, a memory foam layer 810, and a thermal sensor layer 812. The layer sensor 800 may also have a hub 814, which may be an electronic hub and is an example of hub 122.

[0336] Hub 814 may have Figures 1B-1C The hub 122 may contain any of the following features. For example, the hub may include, among other components, a hardware processor (e.g., a microcontroller / SoC) and wireless circuitry or modules. The hub 814 may transmit data collected by the layered sensor 800 to another device, cloud, server, or any other kind of data storage or data processing system (e.g., see [link to relevant documentation]). Figure 1B ).

[0337] An optional bend sensor 802 can be used to help determine if the bag is nearing full level. An odor sensor 804 can determine the presence of intestinal bacterial growth, as reflected in the effluent.

[0338] Microfluidic sensor 806 can be used to detect electrolyte concentrations, inflammatory biomarkers, pH values, etc., in fluids. Microfluidic sensor 806 may include a sensor with a slot configured to receive fluid in the output. The size of the microfluidic sensor can be small compared to the size of a stoma bag. This data can be used to show a user what he or she may need to ingest to achieve a healthy electrolyte balance. Data can be obtained from optical and / or electrical sensors with chemical analysis capabilities. Electrical sensors can detect different electrical charges generated based on the concentration of the electrolyte of interest. Optical sensors (e.g., cameras or photodiodes) can detect color changes in chemical analysis.

[0339] An exemplary capacitive sensor 808 may have an onboard microcontroller / SoC (System-on-a-Chip) or capacitive sensor chip that reads values ​​received from the capacitive sensors and converts them into an "output presence / absence" statement. Multiple capacitive sensors may be polled. This data can be processed on the microcontroller / SoC and converted into volume, then sent to an application running on the phone, or unprocessed data can be sent directly to an application on the phone for processing. The data can also be sent via a hub to a back-end system to calculate volume values.

[0340] The capacitive sensor 808 can also be used as a backup for one or more temperature sensors and / or in combination with one or more temperature sensors to determine the presence of leakage. For example, two layers of capacitive sensors can be used with a cloth-like material between them. When the stoma interface becomes saturated due to leakage, the cloth-like material may become wet and provide a conduit for the capacitive sensor to activate and alert the user to the leakage.

[0341] Example thermistors in the thermal sensor layer 812 can be used to determine leakage and irritation. Leakage may have a sudden, direct-path pattern thermogram signal. Irritation may have a gradually radiating thermogram signal. The thermal sensor layer 812 can also detect the phase of the material collected in the bag. When a substance is phase-determined between liquid, gas, and solid, the rate of temperature change can be correlated. Gases often give erroneous volume readings, so detecting gas can help filter out erroneous volume readings. In currently available ostomy products, there is no good way to determine how much gas is in the output, resulting in many erroneous readings and wasted, underutilized bags. Temperature monitoring allows the device and user to distinguish between liquid or gaseous volume filling. This detection allows the device to estimate how much gas is in the bag using the temperature sensor 812. A bag filling algorithm can subtract the estimated gas volume from the bag's filling.

[0342] The thermal sensor layer 812 can have an onboard microcontroller / SoC (System-on-a-Chip) that can poll each thermistor in the array individually using a multiplexer / demultiplexer. (Alternatively, this chip could be located in the electronic hub 814.) The signal from the multiplexer / demultiplexer can then be fed into a series of operational amplifiers that can generate a voltage. The microcontroller / SoC can read this voltage using an analog-to-digital converter. Based on this voltage, the device can calculate the resistance of the polled thermistor. Based on this resistance, the device can calculate the temperature at that particular thermistor. This process is repeated for all thermistors. Data from some or all of these sensors can be sent to an application on the user device at any stage. For example, to offload processing from the hub to a back-end system and / or a phone, the resistance values ​​of the thermistors or just the ADC values ​​can be sent. The user device can then acquire the resistance value and calculate the temperature. The application on the user device can determine which data is associated with which thermistor by the location of the data in the data packet being sent.

[0343] Additional sensors, such as any of those disclosed herein, can be integrated into the bag. For example, an inertial measurement unit (“IMU”) sensor, a form of position indicator, can be integrated. Data received from the IMU sensor can be read into the microcontroller / SoC using data lines such as I2C or SPI. The data is then processed and sent outside the application, or alternatively, it can be processed internally and used for volumetric calculations. An accelerometer can also be integrated. An accelerometer can be used to determine whether the patient is engaged in physical activity, such as running (and therefore should have a higher expected skin temperature), and can also help distinguish whether the user is supine, sitting, or standing. This collected data can then be used to modify an algorithm to determine the user's reference temperature and compare it with temperature data collected by a temperature sensor.

[0344] Optical sensors can also be integrated where the sensor looks down at the stoma and into the bag to detect a degenerated stoma, blood in the stool, etc. The optical sensor can use infrared light or a camera. This optical sensor can provide clinicians with augmented reality or 3D mapping features. For example, patients can be prompted to take a picture of the stoma after discharge, at intervals (e.g., every morning), or whenever they wear a new bag. Patients can be prompted to upload the image to a central server (e.g., a cloud server) via an application on their user device described herein. This application can process the image to cross-check the infusion volume estimated using any of the algorithms described herein to improve the accuracy of output estimates. Users can also point the optical sensor or the camera in their user device at the bag or stoma to allow clinicians to assist in diagnosing problems. This feature can be used in conjunction with operational telediagnostic centers where clinicians can use augmented reality to help patients determine how to manage their problems. Stoma images can allow doctors to examine the condition of the stoma, such as signs of infection, the presence of blood in the output, etc. Stoma images can be added to a stoma image database, which helps clinicians build a knowledge base and / or analyze information about the stoma (e.g., infection or inflammation). Machine learning algorithms or other types of mathematical models can be used to construct the knowledge base. Clinician input on stoma images can also be fed into the algorithm to further improve the accuracy of the knowledge base.

[0345] Audio sensors, such as microphones, can also be integrated. Audio sensors can be used to monitor stoma gas output and / or bowel sounds. For example, the absence of bowel sounds may indicate constipation or intestinal obstruction. Bowel sounds can also indicate when a user is hungry and should eat. Bowel sounds collected by a microphone can also be used to build a knowledge base on how certain bowel sounds relate to certain intestinal motility and to predict certain intestinal motility. Audio sensor output can be used to correlate the timing of the user's eating and stoma output. Optical and audio sensors can be used in combination to detect stoma site observations, such as blood, new wounds, etc. In some implementations, alarms can be triggered according to preset protocols based on certain stoma site observations. In some implementations, audio sensors (e.g., microphones) and / or optical sensors (e.g., cameras) can be selectively turned on and / or off. For example, optical sensors can be deactivated until audio sensors detect gas output. Selective activation of optical and / or audio sensors can save battery usage and increase the hub's battery life.

[0346] As described above, the microfluidic sensor can include not only electrolyte detection but also the detection of inflammatory markers, such as C-reactive protein, fecal calprotectin, and other inflammatory markers. Furthermore, a pH sensor can also be integrated into the microfluidic sensor to determine the acidity of the bag 902's components. The microfluidic sensor can also detect other biomarkers, such as dehydration markers, inflammatory markers, and certain medications. Using the microfluidic sensor described herein advantageously allows electrolytes and other parameters of stoma outputs to be measured at the stoma site, rather than using a separate procedure with a patient's urine sample in a laboratory setting.

[0347] Figure 9 An exemplary bag with a single sensor layer 900 is shown. The bag 902 has sensors 202 arranged in an array 904. Sensor 202 can be any sensor discussed herein, including temperature sensors or the above-mentioned sensors. Figure 8 Any sensor described.

[0348] Figure 10 A front view of an example sensor layer 1000 is shown. The side of the example sensor layer 1000 facing away from the user shows an example hub 1002 placed on the sensor layer 200. The hub receives data from the sensor layer.

[0349] Figure 11 An example side of the example sensor layer 1100, facing the user, is shown. The example sensor layer 1100 may have multiple sensors 202 placed on the sensor layer 200. Figure 12 Example wiring for layer 1200, which can be placed on bag 902, is shown. This wiring can be curved or have a semi-circular shape between different sensors to provide flexibility for patient movement.

[0350] Figure 13 An example bag 902 with a sensor layer 800 is shown, which can be connected to a partially annular stoma wafer layer 500. The partially annular wafer layer 500 can be connected to the sensor layer 800 at a hub 814. An example sensor layer 500 of a stoma wafer is also shown. Both sensor layers 500 and 800 are connected to an exemplary electronic hub 814. Other layers, not shown but included, may cover the sensor layers 500 and 800 as described above.

[0351] Figure 14A The example stoma bag 902 is shown. Figure 4 Example layered ostomy chip 400. Example layered ostomy chip 400 can perform all the functions of the ostomy chips discussed above.

[0352] Figure 14BAn exemplary ostomy bag 902 is shown, which has a sensor layer 1400 facing away from the user. The ostomy bag 902 is... Figure 1B Another example of bag 120. Generally, a bag may include two walls, one facing the patient and one away from the patient. The walls may be sewn, pressed, glued, welded, or otherwise joined together at the seam. The bottom of the bag may be sealed or may have a selectively openable portion for dispensing. Any one or both walls may comprise one or more layers.

[0353] In this example, sensor layer 1400 is connected to example hub 1410, which is crescent-shaped in this example to improve weight distribution (e.g., to prevent the weight of the hub from causing the bag to tip over, which could irritate the user). The hub may have a generally circular cross-section, for example... Figures 44A-44B The diagram shows exemplary front and rear views of a generally circular hub 4400. The hub may have a generally circular cross-section with flat sides, for example... Figures 46A-46E As shown. Connection port 4602 can be accessed on the flat side. (See diagram) Figure 46E As shown, hub 4600 may include a hub top 4604 and a hub base 4606, the hub base 4606 enclosing electronic components 4608 between the top 4604 and the base 4606. The hub may also include a lens cap 4610 configured to surround a camera opening 4612 to protect the lens of a camera mounted in the hub 4600.

[0354] The external dimensions of the hub can accommodate an NFC antenna ring, the size of which can be substantially the same as the NFC antenna ring on the ostomy bag. Sensor layer 1400 can collect data from the material (effluent) collected from bag 902. In this example, layer 11401 is the outermost layer without sensors. In this example, layer 21402 has no sensors, but in other examples, this layer may contain sensors. In this example, layer 31403 contains a capacitive sensor array to detect volume filling (this is not fixed, and the sensors may change, or their position in the bag may change). In this example, layer 41404 has no sensors, but in other examples, this layer may contain sensors. In this example, layer 51405 is the layer closest to the bag. In this example, layer 5 has a thermistor sheet to detect volume filling and sensors to detect the phase and viscosity of the effluent. The positions of layers 3 and 5 can be switched. The capacitive sensor array and the thermistor sensor array can also be located on the same layer. This layer of the bag can also use an analytical microfluidic sensor (because it is closest to the output), and then a thermistor can be placed in another location within the bag. In this example, the ostomy output can be located between layers 3 and 4.

[0355] In this example, the neck 1406 of each layer of the sensor sheet may be coated with a conformal coating, such as a protective plastic, including but not limited to polyethylene, polypropylene, polystyrene, polyvinyl chloride, polyurethane, acrylonitrile butadiene styrene, phenolic resin, polyetheretherketone, polyamide, or combinations thereof.

[0356] In this example, the gas sensor 1408 can also be positioned above the carbon filter gas valve 1504. The carbon filter gas valve allows gas to escape from the bag 902 while processing the odor. The gas sensor 1408 can be used to detect the composition of the gas. An excessively irritating gas can be an indicator of bacterial overgrowth. Strong irritation may be associated with excessively high effluent output, which could be dangerous for the user. The more irritating the odor, the more likely the user's gut may have problems requiring potential medical care.

[0357] In this example, the crescent-shaped hub 1410 is used on the top of the bag. The placement of the hub can affect the weight distribution of the bag. In some examples, a circular hub concentrates the weight in a single area with the gas sensor 1408, which may be too heavy for the device and cause the bag to move. If the weight is distributed in a crescent shape, the weight can be distributed more evenly on the top of the bag, thus reducing bag movement.

[0358] Figure 14C Another exemplary stoma bag 1430 is shown, having multiple layers including an insulating layer 1432 located between an outer cover layer 1434 and a stoma bag layer 1436. The stoma bag layer 1436 can be made of any material disclosed herein, such as non-porous sterile plastic materials, including but not limited to polyvinyl chloride, polyethylene, ethylene vinyl acetate, polypropylene, and copolyester ether. A sensor layer 1438 can be located on one side of the stoma bag 1436, for example, the side away from the user. In this way, a sensor sheet can be placed in front of the layer behind which the output occurs, thus allowing monitoring of the output as it is produced. This arrangement of the layers can, of course, vary. The sensor layer 1438 can have any sensor array disclosed herein. In some configurations, sensors and electronics can be printed on the stoma bag layers, such that the bag does not include a separate sensor layer. The patient-facing insulating layer 1432 of the bag protects the sensor layer from heat from the patient's body. The patient-repellent insulating layer 1432 of the bag also protects the sensor layer from ambient noise. The insulating layer can be made of any non-conductive material with high insulating properties, such as PET felt (polyester), polyurethane or polyester foam, any insulating fabric or textile, Styrofoam, etc. TM Or aerogel. The isolation layer may also include memory foam material to allow the bag to better conform to the patient's body contours.

[0359] like Figures 14C-14D As shown, the outer covering 1434 on the patient-negative side of the bag may include a pouch 1440 configured to accommodate an electronic hub. The hub can be removed from the bag 1430 to be discarded and used on a subsequent new bag. The hub can use previously collected data from the previous anterior ostomy bag to improve algorithmic processing of subsequent bags.

[0360] Figures 15A-15G An example ostomy chip 400 is depicted attached to an example ostomy bag 902, which has additional, different example electronic hub arrangements 814. As mentioned above, different hub arrangements can affect the weight distribution of the bag, which may affect the movement of the bag. Different hub arrangements can also affect the abrasion resistance of the device. These figures depict a patient surface view 1500 with an exemplary ostomy chip 400 and a front surface 1502 with a sensor layer 800. A carbon filter 1504 is also present in this example. The carbon filter can help gas escape from the bag and eliminate odors. Additionally, some examples have a gas sensor 1408, which can be used to determine the bacterial activity of the user's gut. Some examples include hook and loop patches 1503 in a circular or rectangular shape with neck flaps 1505, so that the bottom of the bag can be selectively opened to empty and closed to receive outflow.

[0361] Figure 15A An example device is shown, which has a hub 814 in the middle of the bag. Figure 15B An example device with a hub 814 is shown, which has two USB ports 1506 and 1508. Among other variations, the USB ports can be MicroUSB or USB-C ports. The USB port feature provides some rigidity in the center of the bag. The hub 814 can also be plugged in and unplugged like a USB device. This modularity allows the hub 814 to be reused in different bags. This modularity also allows for alternative methods of communication between the sensor and the hub. The connection between the sensor and the hub can be via USB. In this case, some or all of the circuitry from different sensors can be fixed to a single port, and the USB entry point can be fixed to the USB entry point in the hub. Other connection methods can include connecting the hub to a bag sensor or a chip sensor using a mezzanine connector and / or an FPC / FFC connector, and many other possible variations exist.

[0362] Other devices can also be plugged into the USB connector to give the device additional functionality. For example, visualization devices such as monitors, speakers, batteries, USB sticks for acquiring hub data, external data sources, or hard drives with updated or custom algorithms can be plugged into these USB ports 1506 and 1508. One USB port can be provided instead of two, or more than two USB ports can be provided.

[0363] Figure 15C An exemplary hub 814 is shown, placed above a carbon filter 1504 on top of a bag 902. Figure 15D Hub 814 is shown, which is placed next to carbon filter 1504 near the top of the bag. Figure 15E The arrangement of hub 814 is shown, which is behind the hydrocolloid layer of the example ostomy chip 400 but on top of the bag 902. Figure 15F A hub 814 is shown in sac 1510. This design is another example of a reusable hub. The hub can be removed from the bag 902 to be placed and then used on a subsequent new bag 902. The hub can use data previously collected on the previous ostomy bag 902 to improve algorithmic processing of subsequent bags.

[0364] Figure 15G An example of an approximately crescent-shaped hub 1410 placed on top of a stoma bag 902 is shown. For the example hub arrangement shown on top of the bag, visualization elements such as optical sensors, cameras, or IR cameras can be connected to the hub via a USB port and lowered into the bag to provide visual input of the contents of the bag 902. Figures 14A-15G The example add-ons and device components mentioned can be seamlessly integrated to create virtually no difference in the user experience when using and installing them. These components can be standardized for ease of use and designed for modular functionality, allowing users to select which sensors are more relevant to their conditions.

[0365] In some examples, device 102 can be manufactured in different configurations. In one configuration, several sensors may be used in the bag and / or wafer. The device can be targeted at new ostomy patients and new users, where collecting a large amount of data may be beneficial to the user. The ostomy bag according to this disclosure may include any (e.g., all) of the following: sensors, biomarkers (e.g., for cancer cells, blood, etc.), and / or electronics. Such a bag may be a diagnostic bag configured to be worn by the patient after surgery and before discharge. Monitoring various parameters of the patient immediately after surgery may be more critical. However, diagnostic bags may be expensive. Other configurations allow the user to select which sensors are relevant to their condition and offer cheaper options. For advanced patients whose ostomy condition may be suitable, other configurations may have very few sensors, such as only temperature sensors in the wafer and / or bag. In addition to detecting output volume and leakage, simpler and less expensive stoma bags can be used, such as analytical bags with fewer sensors, biomarkers, and / or electronics than diagnostic bags, which monitor the phase of stoma output, changes in skin temperature (and thus skin infection), and / or stoma / output images / sound via a camera and / or microphone in an electronic hub. Analytical bags can be used for a predetermined period post-surgery, such as two weeks, one month, three months, six months, twelve months, or any range between these values, or after discharge. Patients can also optionally switch to another stoma bag, namely a maintenance bag, which includes only sensors and electronics for volume and leakage detection. The maintenance bag may also optionally include sensors and electronics for tracking patient hydration or dehydration. Patients can switch to the maintenance bag at a predetermined post-surgery time, such as six months, nine months, twelve months, eighteen months, twenty-four months, or any range between these values. In some embodiments, the medicine kit may contain one or more diagnostic bags, one or more analytical bags, and one or more maintenance bags.

[0366] Figures 36-42D An example sensor layer 3600 of an ostomy bag such as bag 120 described above is shown. Sensor layer 3600 may have any of the features of sensor layers 800, 1100 described above. Sensor layer 3600 may be incorporated into bags 120, 902 described herein. For example, an ostomy bag incorporating sensor layer 3200 may include multiple sensors, a hub interface, an ostomy chip interface, and / or an encapsulation sheet made of polyimide film, polyurethane, etc.

[0367] like Figures 36-40B As shown in the schematic diagram, the bag sensor layer 3600 may have a generally similar outline shape and size to an ostomy bag. The sensor layer 3600 may have a first portion 3612 and a second portion 3614. In use, the first portion may substantially coincide with the ostomy opening of the wafer, for example, as shown in the reference diagram. Figure 32-34BAs described, and / or substantially coincide with the outflow outlet of the bag. When in use, the second part 3614 may substantially coincide with the rest of the bag configured to receive the outflow.

[0368] In use, the bag can be attached to the hub, generally within the first part 3612. For example... Figures 36-40B As shown, the first portion 3612 may include an opening 3632 (such as a rectangular opening extending along the longitudinal axis of the sensor layer 3600). The opening 3632 may allow light to travel unobstructed between cameras on the hub from one side of layer 3600 to the opposite side of layer 3600, or allow a camera on the hub to protrude at least partially through the opening 3632. The opening 3632 can be used to monitor the stoma via a camera on the hub. The camera may be configured to capture the central portion of the stoma due to the proximity of the camera lens and the stoma. A camera with a wide-angle or smaller focusing lens may also be used to capture an image showing a larger area of ​​the stoma.

[0369] like Figure 36 As shown, at least a portion of the second portion 3614 and the first portion 3612 immediately adjacent to the second portion 3614 may accommodate a plurality of temperature sensors 3602 (e.g., thermistors disclosed herein). The sensor layer 3600 may include 64 temperature sensors 3602. The temperature sensors 3602 may be arranged in an 8×8 matrix, which can improve the uniform distribution of the temperature sensors on a portion of the sensor layer 3600 more likely to be close to the effluent during normal use of the stoma bag to detect temperature changes due to variations in bag filling level. Alternatively, different numbers and / or different arrangements of temperature sensors may be used. In some configurations, fewer temperature sensors (e.g., about 20) may be used. As disclosed herein, the temperature sensors can measure multiple parameters related to the stoma output.

[0370] like Figure 37 As shown, at least a portion of the second portion 3614 and the first portion 3612 immediately adjacent to the second portion 3614 may accommodate a plurality of capacitive sensors 3604. The sensor layer 3600 may include twelve capacitive sensors 3604. Each capacitive sensor 3604 may include an electrode (e.g., a silver or gold electrode) coupled to a capacitive sensor chip, which will be described in more detail below. The capacitive sensors 3604 can measure the capacitance change as effluent enters the bag, because the capacitance value of the solid and / or liquid contents of the effluent differs from the capacitance value of the bag or the capacitance value of the air in the bag.

[0371] like Figure 37 As shown, capacitive sensors 3604 can be distributed on sensor layer 3600, such that at least some of the capacitive sensors 3604 can detect the bag's fill level when the bag is in an upright and / or tilted position at various angles. For example, as Figure 37 As shown, the capacitive sensors 3604 can be symmetrically distributed about the central longitudinal axis of the sensor layer 3600. The capacitive sensors 3604 can be located in different vertical and / or horizontal positions on the sensor layer 3600. For example... Figure 37 As shown by the dotted lines, some capacitive sensors 3604 can be roughly aligned in straight lines tilted at various angles to detect the bag's fill level when the bag is tilted at different angles (see...). Figure 39B These angles can be, for example, approximately 30° to approximately 70°, or approximately 40° to approximately 60°, or approximately 50° to approximately 55°, or approximately 52.57°, or approximately 52.79°, or approximately 53.02°, or approximately 53°. The angles are not limited to these. Figure 39B The values ​​shown. In addition, more capacitive sensors 3604 than those in the first part 3612 (e.g., four, two or others) are located in the second part 3614 (e.g., eight, ten or others), which allows for the formation of more lines at different angles by the capacitive sensors 3604 in areas of the bag that are more likely to contain effluent.

[0372] The arrangement of capacitive sensors 3604 allows for more accurate detection of bag fill levels, for example, compared to arranging the same number of capacitive sensors in a conventional matrix row-column arrangement. For instance, a matrix row-column arrangement of the same number of capacitive sensors can result in a pattern of sensor lines with less angular variation, leading to lower accuracy in detecting bag fill when the bag is tilted. In the matrix row-column arrangement, there is also a more uniform distribution of capacitive sensors in the first portion 3612 and the second portion 3614 of the sensor layer, resulting in fewer sensors in the second portion 3614, in which case the bag is more likely to contain outflow. To enable capacitive sensors in a conventional matrix row-column arrangement to detect bag fill levels at different locations with the same or substantially similar accuracy as the capacitive sensor arrangement disclosed herein, a larger number of capacitive sensors would be required. Therefore, the capacitive sensor arrangement disclosed herein allows for more accurate detection of bag fill levels using a smaller number of capacitive sensors.

[0373] The capacitive sensor 3604 can also be positioned such that a "bag full" (or nearly full) indication can be output by the user equipment, for example, before the bag has reached its design capacity (e.g., approximately 5 mL, approximately 10 mL, or any volume before the bag reaches its design capacity). For example, the user equipment can warn the user when a capacitive sensor 3604 (e.g., CS1, CS0, CS2, CS3) closer to the opening 3632 detects a change in capacitance indicating the outflow. Detection of outflow around those capacitive sensors 3604 can indicate that the bag is approaching its design capacity. Warning the user before the bag reaches its design capacity provides time for the user to prepare for emptying and / or replacing the bag, thereby reducing the risk of leakage. Alternatively, different numbers (e.g., sixteen or other numbers) and / or different arrangements of capacitive sensors (including electrodes and / or capacitive sensor chips) can be used. In some configurations, more capacitive sensors (e.g., approximately 36 to 48) can be used.

[0374] like Figure 38 As shown, sensor layer 3600 (e.g., on the top layer) may include a reference. Figure 36 The description includes multiple temperature sensors 3602 and references. Figure 37 The description includes multiple capacitive sensors 3604. For example... Figure 39A As shown, Figure 38 The sensor layer 3600 shown may further include a plurality of openings 3634. The openings 3634 may vary in size, location, and / or number. A plurality of openings 3634 may improve the flexibility of the sensor layer 3600.

[0375] like Figures 40A-40B As shown in the schematic diagram, a surface of layer 3600 opposite to the surface on which temperature sensor 3602 and / or capacitor sensor 3604 are mounted is depicted. Electronic components 3622 and / or power supply 3624 may be housed on this surface. The electronic components 3622 and / or power supply 3624 may be located approximately at the center of layer 3600.

[0376] Electronic component 3622 can be mounted (e.g., surface mounted) on printed circuit board (PCB) 3623, such as Figure 40BAs shown. PCB 3623 can be mounted on layer 3600. PCB 3623 can be rigid enough to protect the electronic components 3622 and the circuitry on PCB 3623 from damage due to bending of the flexible layer 3600. The electronic components can also optionally be directly mounted on layer 3600, wherein a reinforcing material (e.g., fiberglass, plastic, or other material more rigid than the material of layer 3600) is mounted adjacent to the electronic components on layer 3600 to protect them from damage. Mounting the electronic components 3622 on PCB 3623 reduces the number of encapsulation layers in the bag sensor layer (e.g., from four layers for direct mounting to two layers for PCB mounting), which can reduce the use and / or waste of encapsulation material, and / or make the ostomy bag more affordable for the user. The PCB can also optionally include two rigid sections placed adjacent to each other. The PCB can be folded along the adjacent sides of the two sections to increase the flexibility of the bag. In some implementations, circuitry, including temperature sensors and any other sensors, can be printed onto the stoma bag layer instead of having a separate sensor layer. Reducing the need for a separate sensor layer can further improve the bag's flexibility and allow it to better conform to the user's skin.

[0377] Electronic component 3622 may be electrically connected to temperature sensor 3602. Electronic component 3622 may also include a capacitance sensor chip 3621 electrically connected to capacitance sensor 3604. Electronic component 3622 may receive data from temperature sensor 3602 and / or capacitance sensor 3604. For example, electronic component 3622 may receive resistance signals from temperature sensor 3602 and / or capacitance sensor 3604, and / or adjust the resistance signals from temperature sensor 3602 and / or capacitance sensor 3604. Electronic component 3622 may also send ADC values ​​and / or other adjusted signals to a hub to calculate temperature and / or capacitance values ​​on the cloud and / or user equipment, thereby reducing the power consumption of electronic component 3622 in the bag. Electronic component 3622 of the bag, the hub, and / or user equipment may also optionally perform the calculation of temperature and / or capacitance values.

[0378] like Figure 40B As shown, the power supply 3624 may include a battery (e.g., a coin cell battery). Alternatively, more than one battery may be mounted to the sensor layer 3600. The battery may be surface-mounted to the sensor layer 3600 adjacent to the electronic component 3622. Figure 40B As shown, one or more mounting arms 3625 can be attached to the sensor layer 3600 to hold the battery in place.

[0379] Figures 41A-41BA top view, perspective view, and side view of an exemplary sensor layer 3600 are shown. As shown, the sensor layer 3600 may also include multiple NFC antenna loops 3608. The NFC antenna loops 3608 may extend around the camera opening 3632. A portion of the NFC antenna loops 3608 may also be located near the electronics 3622 and the power supply 3624. The NFC antenna loops 3608 may be generally concentric with each other. Similar to the NFC antenna 3208 on the wafer sensor layer 3200, the NFC antenna loops 3608 may be fabricated onto the sensor layer 3600 (e.g., printed or etched). When used, as... Figure 45 As shown, the stoma bag 4500 with the sensor layer 3600 can be attached to (e.g., adhesively or via Velcro) the hub 4400, such that the NFC antenna ring 3608 on the sensor layer 3600 substantially overlaps with the NFC antenna ring on the hub.

[0380] For example Figures 41A-41B As shown, conductive traces 3630 (e.g., copper traces, such as copper plated with ENIG (electro-free nickel immersion gold), or immersion gold or silver traces, and hard gold or any other PCB surface polished, depending on the material of layer 3600 as described above) can connect temperature sensor 3602, capacitance sensor 3604, NFC antenna loop 3608 and / or power supply 3622 to electronic components 3622 on PCB 3623. Figures 42A-42D An exemplary schematic circuit diagram of the bag sensor layer 3600 is shown. Figure 42A An exemplary schematic circuit diagram 4210 of the bag PCB 3623 is shown. The actual arrangement of electronic components can be varied in the bag PCB layout. Figure 42B An exemplary schematic circuit diagram 4220 of a temperature sensor 3602 on a bag sensor layer is shown. As mentioned above, the actual arrangement of the temperature sensors can be changed. However, these temperature sensors are connected via conductive traces 3630 or wires in a manner similar to... Figure 42B The matrix topology shown can have the same interconnections. Figure 42C An exemplary schematic circuit diagram 4230 of a capacitive sensor 3604 on a bag sensor layer is shown. As described above, the actual arrangement of the capacitive sensors can be changed. However, those capacitive sensors can have, for example, the following via conductive traces 3630 or wires: Figure 42C The same interconnects are shown. Figure 42D An exemplary schematic circuit diagram 4240 of a battery is shown.

[0381] For example Figures 41A-41BAs shown, the sensor layer 3600 may further include a ground plane grid 3628 that extends circumferentially around the plurality of capacitive sensors 3604 and between the capacitive sensors 3604. The ground plane grid 3628 can reduce noise in the readings from the capacitive sensors 3604.

[0382] Figure 54A-5 Figure 9D illustrates an example sensor layer 5400 of an ostomy bag, such as bag 120 described above. Sensor layer 5400 has any of the features of sensor layers 800, 1100, and 3600 described above. Sensor layer 3600 may be incorporated into bags 120 and 902 described herein, or into bag 6000 described below and shown in Figures 60-62. For example, an ostomy bag incorporating sensor layer 5400 may include multiple sensors, an ostomy chip interface, and / or an encapsulation sheet made of polyimide film, polyurethane, etc. Since an ostomy bag may not include a hub, an ostomy bag incorporating sensor layer 5400 may optionally omit a hub interface.

[0383] like Figures 54A-55B As shown, the bag sensor layer 5400 can have a substantially rectangular shape with optional rounded corners. The sensor layer 5400 can have a first portion 5412 (above the horizontal dashed line) and a second portion 5414 (below the horizontal dashed line). In use, the first portion 5412 can substantially coincide with the ostomy port of the wafer, for example, regarding... Figure 32-34B As described herein, and / or substantially coincides with the outflow inlet of the bag. In use, the second portion 5414 substantially coincides with the remainder of the bag, which is configured to receive outflow and for discharging the bag. Since the bag optionally does not include a hub, the first portion 5412 does not include, for example, the rectangular opening shown in sensor layer 3600.

[0384] The second part 5414 and the first part 5412 can accommodate multiple temperature sensors 5402 (e.g., thermistors disclosed herein). Sensor layer 5400 can include 84 temperature sensors 5402. The temperature sensors 5402 can be arranged in a 6×8 matrix, which can improve the uniform distribution of temperature sensors throughout sensor layer 5400. Compared to sensor layer 3600, sensor layer 5400 can have a similar length to accommodate the same number of rows of thermistors, but can have a narrower width so that each row of the matrix includes six thermistors instead of eight. Different numbers and / or different arrangements of temperature sensors can also be optionally used. In some configurations, fewer temperature sensors (e.g., approximately 20) can be used. The temperature sensors can measure multiple parameters related to ostomy output as disclosed herein.

[0385] The second part 5414 may accommodate multiple capacitive sensors 5404. Sensor layer 5400 may include 24 capacitive sensors 5404. Each capacitive sensor 5404 may include electrodes (e.g., silver or gold electrodes) coupled to a capacitive sensor chip, as described in more detail below. For example, when effluent enters the bag, the capacitive sensor 5404 can measure the change in capacitance because the capacitance of the solid and / or liquid contents of the effluent differs from the capacitance of the bag or the air within it.

[0386] like Figure 54A As shown, 22 capacitive sensors 5404 can be arranged on the first side (facing the patient) of the sensor layer 5400. As indicated by the dotted lines (not a comprehensive discussion of all possible arrangements of the capacitive sensors 5404 on the first side of the layer 5400), the distribution of the capacitive sensors 5404 on the first side of the sensor layer 5400 can facilitate the detection of the bag fill level when the bag is in a vertical position and / or tilted at various angles. For example, the capacitive sensors 5404 can be symmetrically distributed about the central longitudinal axis of the sensor layer 5400. The capacitive sensors 5404 can be located in different vertical and / or horizontal positions on the second portion 5414 of the sensor layer 5400. Some of the capacitive sensors 5404 can be generally aligned in a straight line tilted at one or more angles to detect the bag fill level when the bag is tilted. These angles can be, for example, approximately 30° to approximately 70°, or approximately 40° to approximately 60°, or approximately 50° to approximately 55°, or approximately 30°, or approximately 45°, or approximately 53°. More than 12 capacitive sensors 5404 located in the second part 5414 can allow more lines to be formed at different angles in areas of the bag that are more likely to contain effluent.

[0387] The capacitive sensor 5404 can also be positioned such that a "bag full" (or nearly full) indication can be output, for example, by a user device, before the bag has reached its design capacity (e.g., approximately 5 mL, approximately 10 mL, or any volume before the bag reaches its design capacity). For example, when a capacitive sensor 5404 (e.g., CS23, CS9, CS0) closer to the intersection of the first portion 5412 and the second portion 5414 detects a change in capacitance indicating the outflow, a user device can, for example, warn the user. Detection of outflow around those capacitive sensors 5404 can indicate that the bag is approaching its design capacity. Warning the user before the bag reaches its design capacity provides time for the user to prepare for emptying and / or replacing the bag, thereby reducing the risk of leakage. Alternatively, different numbers (e.g., sixteen or other numbers) and / or different arrangements of capacitive sensors (including electrodes and / or capacitive sensor chips) can be used. In some configurations, more capacitive sensors (e.g., approximately 36 to 48) can be used.

[0388] like Figure 54B and Figure 55B As shown, the sensor layer 5400 further includes a plurality of openings 5434 in the layer. The openings 5434 also... Figures 57A-57D As shown in the diagram. The opening 5434 can vary in size, location, and / or number. Multiple openings 5434 can improve the flexibility of the sensor layer 5400. Figures 57A-57B In the sensor layer 5400, there are also openings 5434 near the two corners of the layer 5400 close to the antenna ring 5408 (described in detail below) and four larger openings in the central portion of the layer 5400. Figure 57C-57D In the sensor layer 5400, there may be smaller openings 5434 near the four corners of the layer 5400 and four larger openings near the central portion of the layer 5400.

[0389] Figures 55A-55B The second side (facing away from the patient), i.e., the surface of layer 5400 opposite the first side, is shown, on which temperature sensor 5402 and 22 of the 24 capacitive sensors 5404 are mounted. On the second side, two capacitive sensors 5404 (e.g., CS8 and CS17) may be mounted near the edge of the bag, where the discharge occurs. The two capacitive sensors 5404 may be substantially symmetrical about the longitudinal axis of layer 5400. As will be described below, those two capacitive sensors 5404 can work in conjunction with a metal strip (e.g., by detecting changes in capacitance when the metal strip contacts or does not contact those capacitive sensors 5404) to automatically detect discharge events.

[0390] like Figure 55B As shown, the sensor layer 5400 may house electronic components 5422 and / or power supply 5424 on the second side. Figure 56A side view of sensor layer 5400 is shown, having a temperature sensor 5402 on a first side and electronic components 5422 and / or a power supply 5424 on a second side. Electronic components 5422 and / or power supply 5424 may be positioned within a first portion 5412 of layer 5400. Electronic component 5422 may be mounted (e.g., surface mounted) on a printed circuit board (PCB), which in turn is mounted on the second side of layer 5400. The PCB may have sufficient rigidity to protect electronic components 5422 and the circuitry on the PCB from damage due to bending of the flexible layer 5400. Alternatively, electronic components may be optionally mounted directly on layer 5400, wherein a reinforcing material (e.g., fiberglass, plastic, or other material more rigid than the material of layer 5400) is mounted adjacent to the electronic components on layer 5400 to protect them from damage. Mounting the electronic component 5422 onto the PCB reduces the number of encapsulation layers in the bag's sensor layer (e.g., from four layers for direct-mount electronics to two layers for PCB mounting), which reduces the use and / or waste of encapsulation material and / or makes the stoma sheet more flexible. The PCB may also optionally include two rigid sections placed adjacent to each other. The PCB can be folded along the adjacent sides of the two sections to improve the bag's flexibility. Circuitry, such as that including temperature sensors and any other sensors, may also optionally be printed on the stoma bag layer instead of having a separate sensor layer. Reducing the need for a separate sensor layer further improves the bag's flexibility and allows it to better conform to the user's skin.

[0391] Electronic component 5422 may include a controller or processor, such as a microprocessor. Electronic component 5422 may optionally include an accelerometer. Electronic component 5422 may be electrically connected to temperature sensor 5402, for example via... Figures 57A-57D The conductive trace 5430 is shown. Electronic component 5422 may also include a capacitance sensor chip (on both the first and second sides of sensor layer 5400) electrically connected to capacitance sensor 5404 via conductive trace 5430. Electronic component 5422 may receive data from temperature sensor 5402 and / or capacitance sensor 5404. For example, electronic component 5422 may receive resistance signals from temperature sensor 5402 and / or capacitance sensor 5404, and / or adjust the resistance signals from temperature sensor 5402 and / or capacitance sensor 5404. Electronic component 5422 may also send ADC values ​​and / or other adjusted signals to another processor electrically communicating with electronic component 5422 to calculate temperature and / or capacitance values ​​on cloud and / or user devices, thereby reducing the power consumption of electronic component 5422 in the bag. Electronic component 5422 in the bag may also optionally perform the calculation of temperature and / or capacitance values.

[0392] The power source 5424 may include a battery (e.g., a coin cell battery). Optionally, more than one battery may be mounted to the sensor layer 5400. The battery may be surface-mounted to the sensor layer 5400 adjacent to the electronic component 5422. Figure 55B As shown, one or more mounting arms 5425 may be attached to the sensor layer 5400 to hold the battery 5424 in place.

[0393] like Figures 57A-57D As shown, sensor layer 5400 may also include multiple NFC antenna loops 5408. NFC antenna loops 5408 may be positioned near electronic component 5422 and power supply 5424. NFC antenna loops 5408 may be generally concentric with each other. Similar to the NFC antenna 3608 on sensor layer 3600, NFC antenna loops 5408 may be fabricated onto sensor layer 5400 (e.g., printed or etched). NFC antenna loops 5408 allow the ostomy bag of sensor layer 5400 to be optionally used with a hub. NFC antenna loops 5408 may also be used to wirelessly turn the circuitry of sensor layer 5400 on and / or off.

[0394] When using, such as Figure 45 As shown, the stoma bag combined with sensor layer 5400 may include its own Bluetooth module 5423 (see...). Figure 55B This may include its own antenna or may be adjacent to a Bluetooth antenna, thereby enabling the processor and / or sensor on the stoma bag to communicate wirelessly with another processor, such as a processor on the user device and / or a processor or sensor on the stoma chip.

[0395] For example Figures 57A-57D As shown, conductive traces 5430 (e.g., copper traces, such as copper plated with ENIG (electro-free nickel immersion gold), or immersion gold or silver traces, and hard gold or any other PCB surface polished, depending on the material of layer 5400 as described above) can connect temperature sensor 5402, capacitance sensor 5404, NFC antenna loop 5408 and / or power supply 5424 to electronic components 5422 on the PCB. Figures 57A-57B Conductive trace 5430 in Figure 57C-57D The conductive traces 5430 operate differently. Temperature sensor 5402, capacitance sensor 5404, NFC antenna loop 5408, and / or power supply 5424 can be optionally connected via conductive traces 5430 of different and / or different shapes. Figures 57A-57B Sensor layer 5400 and Figure 57C-57D Electronic component 5422 on the PCB of sensor layer 5400. Figure 58The material layers of sensor layer 5400 are schematically shown, which, by non-limiting examples, include an identification layer (e.g., printed using ink), a surface material, an encapsulation sheet (using any material disclosed herein), and copper traces.

[0396] Figures 59A-59B An example schematic circuit diagram of the bag sensor layer 5400 is shown. Figure 59A An example schematic circuit diagram 5930 of a temperature sensor 5402 on a bag sensor layer 5400 is shown. As mentioned above, the actual arrangement of the temperature sensors can be changed. However, those temperature sensors can have, for example, the conductive traces 5430 or wires. Figures 57A-57D The same interconnections in the matrix topology shown. Figure 59B An example schematic circuit diagram 5940 of a capacitive sensor 5404 on a bag sensor layer 5400 is shown. As mentioned above, the actual arrangement of the capacitive sensors can be varied. However, those capacitive sensors can have, for example, the arrangement of the capacitive sensors via conductive traces 5430 or wires. Figures 57A-57D The same interconnects are shown.

[0397] For example Figures 57A-57D As shown, sensor layer 5400 further includes a ground plane grid 5428 that extends circumferentially around capacitive sensors 5404 and between capacitive sensors 5404. The ground plane grid 5428 can reduce noise in the readings from capacitive sensors 5404.

[0398] Figures 60A-60F An example ostomy bag 6000 incorporating sensor layer 5404 is shown. Bag 6000 has rounded corners. Bag 6000 may include multiple layers. Figure 60A An example of a stoma bag 6000 with an inner layer as shown by the dashed line is shown. Figure 60D The exploded view shows the layers of bag 6000. Figure 60F The exploded view shows the layers of another example of bag 6000.

[0399] like Figures 57A-57D As shown, when the PCB is printed and / or when it has the installed sensors disclosed herein, the sensor layer 5400 may also include one or more holes 5432 for assisting in the alignment of the electronic components 5422 in the form of a PCB during the manufacturing process.

[0400] The pouch 6000 may include a chip interface 6002 that can be coupled to a stoma chip, such as chip 5300 on connector 5304. The pouch 6000 may include a first set of layers, such as a top first layer 6004 and a bottom first layer 6006. The first set of layers may optionally be made of the same material. The bottom first layer 6006 may include an opening for receiving a stoma. The bottom first layer 6006 may also be coupled to the chip interface 6002 surrounding the opening on layer 6006. The chip interface 6002 may be a female chip interface configured to coupled to a male chip interface connected to chip 5300. Alternatively, a male chip interface may be coupled to the pouch 6000, and a female chip interface may be coupled to chip 5300.

[0401] Figure 62B-62C An example female endoscopic interface is shown. The female endoscopic interface 6002 may include a generally central opening 6112 configured to receive a bag-like ostomy opening 6114 (see [link to image]). Figure 61 A generally central opening 6112 may surround an inner wall 6116 and an outer wall 6118 connected near one end of the wall. The gap between the inner wall 6116 and the outer wall 6118 has a first distance. The inner wall 6116 and the outer wall 6118 are generally concentric. The outer wall 6118 may include an extension 6120 that extends radially inward or outward from the outer wall 6118. The gap between the radially inward end 6121 of the extension 6120 and the inner wall 6116 may have a second distance less than the first distance. Figure 62D The seal 6102 shown, such as an O-ring, gasket, and / or the like, may optionally be located between the inner wall 6116 and the outer wall 6118.

[0402] like Figure 62E-62G The example anode chip interface shown is configured to connect with... Figure 62B-62C The female wafer interface shown mates to provide a connection between the ostomy bag and the wafer. The male wafer interface 6202 may include a generally central opening 6212 configured to receive the ostomy opening 6114 of the bag (see [link to image]). Figure 61 The generally central opening 6212 can be surrounded by an inner wall 6216 and an outer wall 6218 connected at one end near the wall. The gap between the inner wall 6216 and the outer wall 6218 is smaller at the connected end near the wall than at the free end of the wall. Figure 62F-62GAs shown, the gap gradually increases from the connection end of walls 6216 and 6218 to the free end of walls 6216 and 6218. The free end of outer wall 6218 can extend radially outward from outer wall 6118 to form cover 6220. When connected to male wafer interface 6202, cover 6220 can at least partially overlap with extension 6120 of female wafer interface 6002. Bracket 6222 can be formed at the connection end of walls 6216 and 6218. Bracket 6222 can extend radially outward from the connection end of outer wall 6218 to form overhang 6224. The width of bracket 6222 can be greater than the second distance described above, but less than the first distance or at least approximately the same as the first distance.

[0403] The free ends of walls 6216 and 6218 can be compressed closer together by external force, thereby temporarily deforming the bracket 6222 to allow the bracket 6222 to pass through the gap between the radially inward end 6121 of the extension 6120 and the inner wall 6116 of the female wafer interface 6002. When the external force is removed, the bracket 6222, the inner wall 6216, and the outer wall 6218 return to their rest shape, thereby preventing the bracket 6222 from detaching from the female wafer interface 6002 through the extension 6120, so as to releasably connect the male wafer interface 6202 to the female wafer interface 6002. Optional seal 6102 can improve the liquid sealing at the interface between the male wafer interface 6202 and the female wafer interface 6002.

[0404] The ledge 6222 may alternatively have a width greater than the first distance and be made of an elastomer or other deformable material. When the external force is released from the free ends of the walls 6216, 6218, the elastomer or deformable ledge 6222 can form a seal within the gap between the inner wall 6216 and the outer wall 6218. In this configuration, a separate seal may not be required.

[0405] The connection between the male and female wafer interfaces can be alternatively achieved using other types of connection mechanisms. The structure of the male and female wafer interfaces can be tailored to the type of connection mechanism used, such as... Figure 62B-62G The example variation is shown.

[0406] The bag 6000 may include a second set of layers sandwiched between the first set of layers. The second set of layers may provide isolation between the sensor layer 5400 and the patient's body or between the sensor layer 5400 and the surrounding environment. The second set of layers may optionally be made of the same material. The second set of layers may include a top second layer 6008 and a bottom second layer 6010. A plastic film 6009 or 6009A, such as a polymer layer, may be sandwiched between the top first layer 6004 and the top second layer 6008. Figure 60D , Figure 60F , Figure 61 and Figure 62AAs shown, membrane 6009 or 6009A may have a region 6011 on its top surface configured to receive (e.g., by adhesion, welding, or other means) a hook or loop 6018 of a Velcro connector. Furthermore, as... Figure 60F and Figure 62A As shown, membrane 6009A may include two openings 6007. When bag 6000 is assembled, the two openings 6007 may substantially overlap with two capacitive sensors 5404 near an exhaust opening on the patient-rejected side of sensor layer 5400.

[0407] The bag 6000 may include a third layer that can be sandwiched between the second layer. The third layer may optionally be made of the same material. The third layer may include a top third layer 6020 and a bottom third layer 6022. Figure 60D , Figure 61 F and Figure 62 As shown, the bottom third layer 6022 has a first region 6021, a second region 6023, and a third region 6025 on its bottom surface. The first region 6021 is configured to engage with the hook or loop 6012 (e.g., a loop) of a Velcro connector complementary to the hook or loop 6018. The second region 6023 is configured to engage with the metal strip 6014. The third region 6025 is configured to engage with a bottom discharge lug 6016 located at or near the discharge position of the pouch 6000. The Velcro hook or loop 6012, the metal strip 6014, and the bottom discharge lug may be adjacent to each other. The first region 6021, the second region 6023, and the third region 6025 may be located on an extension 6026. The top third layer 6020 may have a corresponding extension 6026.

[0408] Sensor layer 5400 may be located on top third layer 6020 and between top second layer 6008 and top third layer 6020. Sensor layer 5400 may be attached to top third layer 6020 by adhesion or other means. Sensor layer 5400 may also optionally be located between other layers or at other locations in the ostomy bag. Top third layer 6020 may include a region 6027 located on its top surface configured to attach to top discharge lug 6024. During assembly, as... Figure 60B-60CAs shown, the top discharge lug 6024 and the bottom discharge lug 6016 are aligned to sandwich the top third layer 6020 and the bottom third layer 6022 between the two lugs 6024 and 6016. During assembly, the hook or loop portion 6018 and the loop or hook portion 6012 can be located on opposite sides of the bag 6000, but adjacent to each other. Thus, when the extensions 6026 of the top third layer 6020 and the bottom third layer 6022 are folded over the remainder of the bag 6000, the two portions 6018 and 6012 can engage with each other to secure the extensions 6026 to the remainder of the bag 6000. Alternatively, the Velcro fastener can be replaced with any reusable or quick-release connector, such as a magnet, a conductive Velcro connector, a button, and a suitable adhesive.

[0409] The folded extension 6026 can close or seal the discharge opening of the bag 6000. The length of the extension 6026 can be approximately 30 mm to approximately 80 mm, or approximately 40 mm to approximately 70 mm, or approximately 55 mm to approximately 60 mm. The width of the extension 6026 can be approximately 50 mm to approximately 110 mm, or approximately 65 mm to approximately 95 mm, or approximately 80 mm. When the extension 6026 is folded, the top discharge lug 6024 and the bottom discharge lug 6016 can be folded first, so that the top discharge lug 6024 and the bottom discharge lug 6016 are located on the side of the third layer opposite to the metal strip 6014. Then the top discharge lug 6024, the bottom discharge lug 6016, and the metal strip 6014 are folded, so that the top discharge lug 6024, the bottom discharge lug 6016, and the metal strip 6014 are located on the side of the third layer opposite to the hook or loop 6018. In order to releasably close the discharge opening, the hook or ring 6018 is folded up to engage with the ring or hook 6012.

[0410] When the extension 6026 is folded, the length of the bag 6000 can be approximately 150 mm to approximately 250 mm, or approximately 180 mm to approximately 220 mm, or approximately 205 mm. When the extension 6026 is folded, the width of the bag 6000 can be approximately 100 mm to approximately 160 mm, or approximately 110 mm to 150 mm, or approximately 120 mm to approximately 140 mm, or approximately 135 mm.

[0411] When the extension 6026 is folded to close the discharge opening, the metal strip 6014 can contact two capacitive sensors 5404 near the discharge opening on the patient-facing side of the sensor layer 5400 (either indirectly through multiple layers of the bag 6000, or alternatively, directly through the opening 6007 in the membrane 6009A). When the extension 6026 is unfolded, the metal strip 6014 can disengage from those two capacitive sensors 5404. Because the metal strip 6014 has a different capacitance value than the bag material and / or the fluid inside the bag, the capacitive sensors 5404 can output different signals between when the metal strip 6014 is in contact with the sensors 5404 and when the metal strip 6014 is not in contact with the sensors 5404. A change in the capacitance reading of at least one of the two capacitive sensors 5404 can indicate that a discharge event has been detected. Having two capacitive sensors 5404 or two electrodes for detecting whether the metal strip 6014 is in contact can provide redundancy in the event that one of the two sensors fails or malfunctions. Optionally, the capacitive sensor 5404 can also be used to activate the bag electronics (including but not limited to sensors, PCBs, etc.) in the bag 6000 upon first contact with the metal strip 6014. Before use, the extension 6026 can be unfolded and the bag electronics can be disconnected, thereby saving energy in the power supply 5402. Optionally, the capacitive sensor 5404 can also act as a pressure sensor for output readings to be used in any of the algorithms disclosed herein. The reading of the capacitive sensor 5404 can vary as greater pressure can be applied to it due to the accumulation of more fluid in the bag 6000.

[0412] Optionally, the capacitive sensor 5404 on the top side of the sensor layer 5400 can be replaced with any distance sensor capable of detecting the distance of the metal band 6014 from the distance sensor to detect whether the discharge opening of the bag 6000 has been opened. Since the bag expands when gas is discharged, the distance sensor can also optionally be configured to detect the release of gas from the stoma. Optionally, the capacitive sensor 5404 on the patient-facing side of the sensor layer 5400 can be replaced with a magnetic sensor capable of detecting whether the metal band 6014 is magnetically attracted to or detached from the magnetic sensor (e.g., a digital or analog AMR (Anisotropic Magneto Resistive) sensor) to determine whether a discharge event has occurred. The bag sensor layer may include a magnetic field sensor that detects changes in the magnetic field when the discharge opening is opened or closed. Optionally, the discharge detection sensor can be directly coupled to a Velcro connector (e.g., a conductive hook-and-loop connector) so that whether the hook and loop are engaged or disengaged can indicate whether a discharge event has occurred.

[0413] An ostomy bag may have at least two or more layers. The number of layers, their arrangement, and the types of materials can be varied. One or more layers of material can be joined together using suitable joining and / or bonding mechanisms, such as adhesives or welds.

[0414] Another challenge in accurately electronically detecting the fill level of stoma bags is the issue of residue. When stoma output is more viscous, such as when the output includes feces or other more solids, the more viscous components can adhere to the inner surface of the bag. The drying (“flattening”) of solids on the inner surface of the bag can lead to false or incorrect level readings, and thus false or incorrect volume calculations. The dried solids can also cause the bag's reverse inner surface to become stuck, hindering the entry and / or downward movement of output that has been drained or injected into the bag. Prolonged exposure of the stoma to “flattened” output can also lead to infection.

[0415] As will be explained below, recalibrating capacitive sensors to update their baselines can help reduce the impact of residue issues on level and volume determination. Alternatively and / or additionally, more capacitive sensors (such as more than 12, for example, from about 36 to about 48) can be used on the sensor layer of the ostomy bag to mitigate the impact of residue issues on level readings. Because residue can have a more random shape compared to the contents of the output material that falls to the bottom of the bag, more capacitive sensors and / or increased capacitive sensor density can provide higher resolution sensor readings, which can help detect residue or “flattened” output material. Therefore, more capacitive sensors and / or increased capacitive sensor density can improve the accuracy of predicting output volume. In some configurations, a sensor layer including more than 12 capacitive sensors may also include fewer than 64 temperature sensors (e.g., about 20 temperature sensors).

[0416] Alternatively and / or additionally, the inner surface of the stoma bag layer can be coated with a material that reduces the coefficient of friction of the inner surface of the stoma bag and guides the stoma output towards the bottom of the bag. For example, the material can be hydrophilic or hydrophobic. The coating can be achieved in multiple ways, such as spraying, impregnation, etc. The coating can be effective throughout the bag's lifespan and is more convenient than having to clean the inner surface of the bag with a lubricating material after each emptying. Coating is also more convenient than applying an adhesive layer of hydrophilic lubricating material to the inner surface of the bag, where a large amount of water is required to become hydrated and smooth; therefore, the beneficial effect of reducing residue problems may not be achieved unless the output discharged into the bag is liquid enough to activate the hydrophilic coating material.

[0417] The coating of this material may be biocompatible or non-biocompatible. A biocompatible coating may be one that inserts biological materials, has minimal toxicity or harmful effects on biological systems, or is approved for biomedical applications. For example, the coating may be a medical-grade silicone oil. A non-biocompatible material may be any other type of coating. For example, a non-biocompatible coating may be a fluorinated silicone oil or a fluorosilicone oil.

[0418] The coating of this material can also be used in other medical applications and devices. For example, the coating can be used to coat the inner surfaces of medical bags, medical bottles (e.g., bottles containing viscous medications), medical containers, catheter surfaces, injection needles, surgical instruments, or any other medical devices with a lower coefficient of friction and / or requiring lubrication.

[0419] Example Algorithm

[0420] Figure 16 A thermal map 1600 generated by an algorithm representing the thermal characteristics of the thermistor layer 812 of the stoma wafer 400 is shown. This thermal map can be output to be displayed to a user, for example, on a user device. Device 102 can use this thermal map to determine whether the heat is an indication of leakage or inflammation. The user can use the thermal image to see how stoma discharge enters the bag. The user's experience of extracting data from the interface, or more simply, interpreting data, can be visual. The visual effect may vary depending on the type of sensor. A current example that can be provided is temperature data from the thermistor layer. Here, the output can be in the form of a visual thermal map. Each coordinate in the thermal map (in the software interface) can be located so that it represents each thermistor at approximately the same location in the map. Thus, the temperature sensed by the thermistors can be visually seen on a map.

[0421] Data from software originating from hubs, user devices, or the cloud (e.g., at a backend server) can also be extracted into a spreadsheet format, allowing for more detailed data analysis by plotting graphs using Excel or other graphing software such as Origin. During each inflammation episode, the temperature at the center near stoma 1601 may be higher than the temperature at the outer edge and most of the area within the stoma wafer 400. The higher temperature at the center of the ring may indicate an area near the stoma where inflammation or leakage may occur. In some examples, the reference sensor may be placed on the neck, or the reference sensor may be the outer edge of the device. Using an outer edge sensor that is already part of the device as a reference sensor can be a cost-effective approach, rather than implanting a separate sensor on the neck.

[0422] Visual effects in the software can include: temperature range values, quantitative indicators of temperature in each coordinate, and log update intervals: 1) whether it should be on or off, or 2) at what frequency data is collected and recorded. The software can also have the ability to drag across elapsed time to view changes in the thermistor over time.

[0423] Figure 17 An example leak detection process 1700 is illustrated. The leak detection process 1700 can be implemented by a hub, user equipment, or backend server as described above. More generally, the process 1700 can be implemented by a hardware processor in any one or more of those devices.

[0424] The leak detection process can begin at box 1702, where the temperature is sensed by one or more temperature sensors in the stoma chip. The temperature can be sensed by a hub, or the temperature sensor output signal can be obtained from the hub and sent to the user equipment or back-end server to obtain the temperature from the temperature sensor output signal.

[0425] At box 1704, the processor determines whether a rapid temperature change is detected, such as a temperature change occurring within a threshold time. If so, at box 1706, the processor outputs an indication of potential leakage. Leakage under or within the stoma wafer can cause a rapid, even near-instantaneous, increase in temperature. Therefore, detecting such a rapid temperature change enables rapid leakage detection, which can provide audible and / or visual alerts to the patient wearing the user device. The patient can then address the leakage, for example, by replacing the stoma wafer and / or bag. By doing so, the patient can potentially avoid skin irritation and alleviate potentially embarrassing situations.

[0426] Figures 18A-18B An exemplary device 1800 worn by a patient is shown, and a thermal map 1810 illustrating the stoma drainage flow is shown. This thermal map corresponds to a stoma bag sensor layer, as shown in any stoma sensor bag layer disclosed herein. The drainage flow is represented by a collection of higher temperature readings on the thermal sensor map. The drainage flow moves towards the bottom of the bag as effluent flows into the bag near the top. This flow can be tracked by tracking temperature changes over time in individual rows or columns of the sensor matrix to predict when effluent has entered the bag. As a result, the volume of effluent in the bag can be tracked. Furthermore, faster-flowing effluent may correspond to liquids and / or gases, while slower-flowing effluent may correspond to solid or semi-solid substances. Therefore, using a hardware processor to monitor temperature changes over time in the sensors can indicate the type of effluent discharged from the stoma. Furthermore, since gases can change temperature so rapidly, gases can be detected and their volume excluded from bag filling calculations.

[0427] Figures 19A-19F and Figure 20A-20G An example of injecting test material into a bag is shown, and the algorithm is allowed to display a heat map. Figures 19A-19F The illustration shows applesauce being dispensed at different volumes in a standing position 1900. The volume increases with increasing heat dissipation. Thicker applesauce leaves a larger heat mark on the bag because it is more viscous. Figure 20A-20G The infusion of water in a standing position 2000 is illustrated with volumes ranging from 50 mL to 350 mL (in 50 mL increments). Visual thermal data (and algorithms) can potentially provide an indication of the patient's position. This is specifically indicated by a thermistor, which can be integrated into the front of the bag to detect the volume inside the bag, as well as other physical parameters (such as phase and viscosity). For example, in the case of a stoma bag, changing the position from standing to supine causes a change in the orientation of the thermal signal (specifically, through rotation). This is because the thermistor is in a fixed position and orientation on the bag, and the software is also fixed relative to the specific orientation of the thermistor. Thus, a change in the patient's orientation changes the orientation of the thermistor by default, and therefore also changes the thermal signal, so the change in the patient's position can be seen from the data.

[0428] Visual data, combined with the capabilities of artificial intelligence, algorithms, and software, can not only interpret the occurrence of outputs but also their phases. This is based on the fact that different types of outputs are associated with different viscosities. For example, liquids have low viscosity and are fluid. Therefore, when a liquid travels through the path of a thermistor (in an array) and falls into the ostomy bag, it may light up the thermistor at a rate that is faster than a solid or semi-solid. Conversely, solids may have higher viscosity and may not flow as quickly as liquids. This suggests that the rate at which the thermistor lights up can be one way to determine the phase of the output. Heat dissipation can also vary with viscosity, as can the cooling rate. AI and algorithms (such as neural network models or any other machine learning algorithms) can be developed to distinguish between different phases. Machine learning algorithms can be trained to identify sharp boundaries between thermal imprints on a thermogram caused by different phases. The resolution of boundary recognition can be improved by increasing the number of temperature sensors on the ostomy bag.

[0429] The accumulation of volume within the bag can also be viewed as a change in volume due to increasing output over time. Further increases in volume within the bag can be distinguished from existing volume, distinguishing between fresh "waste" and waste already present in the bag. Thermal changes in the thermistor can be used to assess and modify heat distribution over time by assessing leakage and anticipated skin irritation that would raise the temperature around the observed stoma. While factors such as humidity and sweat can also influence temperature changes, reference sensors, along with AI and algorithms, can be used to differentiate temperature increases due to background noise (sweat, humidity) and focus on active noise (occasional active leakage and skin inflammation due to active skin irritation).

[0430] Figure 21 An example bag filling detection process 2100 is illustrated. Process 2100 can be implemented by a hub, user equipment, or back-end server as described above. More generally, process 2100 can be implemented by a hardware processor in any one or the other of those devices.

[0431] At box 2102, the hardware processor uses a temperature sensor in the ostomy bag to sense the temperature. At box 2104, the temperature change with flow is detected. For example, referring to the foregoing figures, the processor can detect the flow of effluent by detecting the temperature change over time in different rows or columns of the bag. Process 2100 may output an indication of potential increase in bag filling and / or a warning that the bag may be full at box 2106.

[0432] Figure 43 An example bag filling determination process 4300 is shown. Process 4300 can be implemented by a hub, user equipment, or the aforementioned back-end server. More generally, process 4300 can be implemented by a hardware processor in any one or the other of those devices.

[0433] Process 4300 may begin at box 4302, where the processor receives data from the aforementioned example regarding... Figure 37-42D The readings are from one or more capacitive sensors and / or one or more temperature sensors. The readings may include resistance readings from the capacitive and / or temperature sensors or calculated capacitance and / or temperature values ​​(e.g., performed by electronic components on the ostomy bag), and the processor may calculate the capacitance and / or temperature values ​​from the resistance readings.

[0434] At box 4304, the processor can measure the effluent volume based on readings from a capacitance sensor and / or a temperature sensor. The processor can calculate the effluent volume based solely on changes in capacitance, solely on changes in temperature, and / or a combination of changes in capacitance and / or temperature (e.g., using statistical methods). At box 4306, the processor can output the bag fill level.

[0435] At determination box 4308, the processor can also optionally determine whether the bag is full or nearly full (e.g., at a volume close to the design capacity, capacitive and / or temperature sensors at certain locations have detected outflow, or other conditions disclosed herein). If the bag is full or nearly full, the processor can optionally output a "bag full" indication in box 4310. The output indication can be displayed on the user equipment. If the bag is not full or nearly full, the processor can return to box 4302 to repeat the bag filling determination process 4300.

[0436] Smart ostomy bags can also detect the volume / fill level within the bag, for example, by using an array of capacitive sensors. At least some of the capacitive sensors on the bag can be used to detect the level of filler material within the bag, which can be converted into the volume of the output material. For example... Figure 47A As shown, an exemplary stoma bag may include twelve capacitive sensors CS0 to CS11 (which can be as follows) Figure 37-39B (As shown in the diagram). The capacitive sensor within dashed line 4702 can be used for level and / or volume detection.

[0437] At least some capacitive sensors can also be used to detect bag discharge. For example... Figure 47A As shown, the capacitive sensor within the dashed line 4704 can be used for emission detection. This capacitive sensor can be positioned towards the lower part of the sensor layer of the ostomy bag. The processor can use the first emission standard ∑ i＝7，8 ΔCS i >C3 determines whether the bag is discharging, where CS i This is the capacitive sensor reading, and C3 is a constant that can be determined empirically (e.g., based on analysis of patient study data). In some implementations, C3 can be 3. The processor can stop detecting the level while the bag is being discharged. After discharge is complete, the processor can also automatically calibrate the capacitive sensor.

[0438] When calculating the internal volume / fill and / or bag discharge, readings from the temperature sensor can optionally be combined with readings from the capacitive sensor. Capacitive sensors are often superior to temperature sensors in terms of detection level because they are more resistant to noise, such as that caused by residue issues. Figure 47B As shown, an exemplary stoma bag may include sixty-four temperature sensors RT1 to RT64 (which can be as follows) Figure 36 and Figures 38-39B (Arranged as shown). The temperature sensor within dashed line 4702 can be used for horizontal detection. The temperature sensor within dashed line 4704, which can be positioned towards the lower part of the sensor layer of the stoma bag, can be used for discharge detection (e.g., with...). Figure 47A (The capacitive sensor within the dashed line 4704 is used in conjunction with this). The processor can meet the second emission standard. To determine whether the bag is discharging, Ti is a temperature sensor reading, and C4 is a constant that can be determined empirically (e.g., based on analysis of patient study data). In some implementations, C4 may be -15. The processor may use a first discharge criterion and / or a second discharge criterion when determining whether the bag is discharging.

[0439] At least some temperature sensors can also be used to detect whether a patient is wearing a bag and / or whether an infusion is being administered into the bag. For example... Figure 47B As shown, the temperature sensor within dashed line 4706, positioned above the sensor layer of the stoma bag, can be used for infusion detection and / or detection of bag attachment to the patient's body. The temperature sensor within dashed line 4706 can be located near or in front of the stoma. The processor can use standard body-mounted... To determine whether the bag is on the patient's body, T i This is the temperature sensor reading, and C2 is a constant that can be determined empirically (e.g., based on analysis of patient study data). In some implementations, C2 can be 525. The processor can use infusion standards. To determine whether the bag is on the patient's body, T i This is the temperature sensor reading, and C1 is a constant that can be determined empirically, such as a constant determined based on patient study data analysis. In some implementations, C1 may be 3.5. When the patient is wearing the bag, detecting the start of infusion triggers the capacitive sensor (and optionally the temperature sensor) to initiate level detection. Performing level detection after detecting infusion can reduce erroneous readings as level readings caused by an increase in the contents of the stoma bag. For example, erroneous readings can be caused by a variety of reasons, such as residue on the inner surface of the stoma bag, temporary pressure changes, or other reasons.

[0440] Machine learning can be used to train a computer to detect the fill level in a bag, thereby predicting the actual output based on a set of data from a capacitive sensor. Examples of machine learning paradigms can include neural networks, regression analysis, and more. Figure 48 An example neural network model for calculating the volume of an output in a bag is shown. Although the example shown uses only capacitive sensor readings, such as from eight capacitive sensors (which could be...) Figure 47A The readings are from the eight capacitive sensors within the dashed line 4702, but also from temperature sensors (such as...). Figure 47B The readings within the dashed line 4702 can also be used for volume calculations. The elastic backpropagation (RPROP) algorithm can be used for supervised training of feedforward artificial neural networks (multilayer perceptrons). Neural network models can employ a multilayer perceptron architecture. For example... Figure 48 As shown, Principal Component Analysis (PCA) 4802 can be applied to the capacitive sensor data in the input layer 4812 to derive linearly uncorrelated variables (principal components) and reduce the dimension from eight to four. A sigmoid filter 4804 can be applied to the hidden layer of the four neurons 4814 obtained from the PCA application to reduce the dimension from four to three. A linear filter 4806 can be applied to the hidden layer of three neurons 4816 to derive the output layer of one neuron 4818, which can be used to determine the value of volume 4808.

[0441] Since each capacitive sensor can be different, calibration can be performed on each sensor to obtain a baseline value for each. Each capacitive sensor can have its own calibration value. Calibration can be performed after the first measurement when the patient first wears the bag. The timing of calibration can reduce the influence of moisture from the stoma, which can cause baseline drift in the capacitive sensors when the patient first wears the bag. The bag-on detection described above can also be used to notify the processor to perform the first measurement and then calibrate the capacitive sensors. Output residue on the stoma bag can also cause baseline drift in the capacitive sensors. Figures 49A-49B The capacitive sensor readings 4900 are shown after the first measurement and after the bag is emptied. As shown, at least four capacitive sensor readings, defined by dashed line 4902, have already shifted their baseline values ​​between the first measurement (when the bag was empty) and after the bag was emptied (and therefore empty). Each capacitive sensor can be recalibrated to reduce baseline drift. Recalibration can be performed after each emptying and / or before the first infusion. The emptying detection algorithm described above can be used to determine when recalibration is needed.

[0442] Figure 50 Some of the algorithmic logic used in the volume calculation is illustrated. When raw measurements 5000 are obtained from a sensor (which may be a capacitive sensor and / or a temperature sensor as described herein), the processor can perform infusion detection and / or emission detection analysis 5002, for example, using the criteria described above. The processor may optionally create infusion and / or emission markers. The processor can check whether calibration or recalibration of the capacitive sensor baseline is required based on the previously created markers (e.g., bag-on-bag detection, emission detection, and / or infusion detection markers) 5004. After performing any necessary calibration or recalibration, the processor can perform the raw volume calculation 5006. As mentioned above, various machine learning tools (e.g., Figure 48The processor performs the raw volume calculation using a neural network model (as shown). The processor can perform spike smoothing based on previously created markers (e.g., infusion and / or discharge detection markers 5008). Certain logic derived from clinical observations can also be used for spike smoothing. For example, spikes in volume calculations performed at rates exceeding any possible infusion rate may not be caused by an increase in output volume. In some implementations, spikes may be caused by patient movement or sudden pressure changes. Smoothing can be performed in various ways, such as by applying a low-pass filter, a median filter, or other methods. The processor can also perform moving average smoothing 5010 before the observations 5012 for output volume calculation to improve the accuracy of the volume calculation.

[0443] Capacitive sensor measurement technology can present several challenges that may compromise measurement accuracy. One challenge is the viscosity of the stoma discharge. As described in this article, stoma patients often have sticky discharge that adheres to the bag, resulting in residue remaining on the walls even after the bag is emptied. The effect of this residue, often referred to as "flattening," can make bag discharge predictions unreliable. Furthermore, if the sticky discharge soils the sensor as it passes through, level sensing will be inaccurate. Besides reducing sensor accuracy within the stoma bag, flattening can sometimes cause discomfort for the patient while wearing the bag. Additionally, flattening can increase the risk of stoma infection and reduce the bag's lifespan (e.g., patients undergoing flattening should not use the bag for more than one day).

[0444] Additionally and / or alternatively, regarding the slippery, non-stick coating in the bag discussed above, the algorithm described herein can improve the ability to distinguish whether the output material is sticky or flows to the bottom of the bag. Figure 51A The “residual infusion” 5110 is shown when the output sticks to or soils the wall. Figure 51B The “flow” of the infusion 5120 is shown when the output material reaches the bottom and produces a level that can be sensed by a capacitive sensor.

[0445] Figure 52 Algorithm 5200 shown assumes that residual infusion results in residual volume entering the bag, and flowing infusion results in flowing volume. Because these two volume types are calculated differently in Algorithm 5200, they can be distinguished.

[0446] In Algorithm 5200, the average temperature at the stoma (via...) Figure 47B The temperature sensor detection within the dashed line 4706 is represented as T. 造口 The average temperature variation of the stoma (via Figure 47B The temperature detected by the sensor within the dashed line 4706 is represented as ΔT. 造口 The average temperature change near the bag's discharge opening (via...) Figure 47B The temperature detected by the sensor within the dashed line 4704 is represented as ΔT. 开口 The change in capacitor readings near the opening of the bag (via...) Figure 47A The temperature sensor detection within the dashed line 4704 is represented as ΔCS. 开口 .

[0447] The volume of output material accumulated inside the bag is expressed as V. 总 The volume of residual infusion accumulation is expressed as V. 残留 The volume accumulated by the flowing infusion is expressed as V. 流动 The output material level calculated using the ML Volumetric Model based on a capacitive sensor is represented as V. 水平 .

[0448] In step 5202 of algorithm 5200, the controller or processor connected to the sensor can receive sensor data as an array of capacitive sensor readings and thermistor sensor readings. In decision step 5204, the controller or processor can determine whether the bag is attached to the patient's body. By comparing T... 造口 and threshold T 身体上造口 To determine whether the bag is attached to the body. Optionally, T 身体上造口 It can be approximately 28.

[0449] If the stoma bag is not attached to the patient's body, the controller or processor can stop continuing algorithm 5200 or return to step 5202. If the bag is on the body, the controller or processor can check for a discharge event at decision step 5206 and / or check for an infusion event at decision step 5208.

[0450] The controller or processor can provide the ability to check the changes in readings of the capacitive and thermistor sensors between the current time point and a previous time point (ΔT, respectively). 开口 and ΔCS 开口 To check for emission events. If ΔT 开口 Less than the threshold ΔT 开口排放 And ΔCS 开口 Greater than the threshold ΔCS 开口排放 If ΔT occurs, an emission event occurs. Optionally, ΔT 开口排放 It can be approximately -1. Optionally, ΔCS 开口排放 It can be approximately 3. If an emission event is detected, the controller or processor can set the volume value V at step 5216. 残留 and V 流动 Specify 0 and return to step 5202.

[0451] In decision step 5208, the controller or processor can check the change ΔT in the temperature sensor reading between the previous time point and the current time point. 造口 To determine if an infusion event exists. If ΔT 造口 Greater than the threshold ΔT 造口输注 If so, an infusion event occurs. Optionally, ΔT 造口输注 It can be approximately 0.2.

[0452] If no infusion is detected, the controller or processor may return to step 5202. If the controller or processor detects an infusion event, it may continue to step 5210 to classify the infusion into two categories: residual infusion or flowing infusion (see [link to relevant documentation]). Figures 51A-51B Classification can be performed by machine learning model 5210 based on temperature sensor readings.

[0453] Machine learning models can include neural network models. This model can be trained on labeled data required during patient studies. Data points corresponding to infusion events are selected and used as the dataset. Data points corresponding to flowing infusions (with an observed clear flow pattern) are selected and labeled with the value 1. Data points corresponding to infusions without a flow pattern (i.e., residual infusions) are labeled with the value 0. The dataset size is approximately 600 data points. The neural network model architecture follows a pattern similar to... Figure 48 The neural network model shown is similar to those with varying numbers of input and hidden layer neurons. This model may include an input layer of 24 input neurons (those used for the vector input to the thermistor), a first hidden layer of 10 neurons, a second hidden layer of 8 neurons, a third hidden layer of 7 neurons, and a final output that gives the target value (which is 0 or 1 on the training data). The model is trained on 80% of the training dataset and tested for validation on the remaining 20%. When trained on data points labeled 0 or 1, the final result of the model on actual data points (which differ from the training dataset) is not exactly 0 or 1, but rather a value in between. Assuming the output value is greater than 0.5, the inlet is a flowing inlet (labeled 1 in the training data); if the value is less than 0.5, the inlet is a residual inlet (labeled 0 in the training data).

[0454] Based on the classification at step 5210, the controller or processor can separately calculate the residual volume (which reaches the bag with residual infusion) and the flow rate (which reaches the bag with flow infusion).

[0455] In step 5212, if the infusion is classified as a residual infusion, the controller or processor may add a minimum residual volume fraction V to the total residual volume accompanying the residual infusion. R In other words, the total residual volume can be calculated as follows: V残留 (t)=V 残留 (t-1)+V R .

[0456] In step 5214, if the infusion is classified as a flow infusion, the controller or processor may consider the following different scenarios. The controller or processor may first use capacitive sensor readings (such as from...) Figure 47A The eight capacitive sensors in dashed line 4702 calculate the level (or volume) in the bag. The volume calculation can be performed using machine learning model 5220.

[0457] Machine learning models can include, for example Figure 48 The neural network model is shown. Data obtained from laboratory experience was used to train the neural network model. For example, an experience was designed to obtain the volume value corresponding to each specific vector of a capacitor. Infusions of 50 ml into a bag were performed multiple times to produce volumes ranging from 50 ml to 350 ml. This experience was repeated multiple times with water and apple juice to obtain a training dataset of approximately 1500 data points. This yielded a vector of 1500 capacitance sensor readings corresponding to the 1500 volume values. The neural network model was trained using this dataset. As mentioned above, since the model includes multiple layers, Figure 48 The architecture of the neural network is called a multilayer perceptron. This model has one layer with 8 neurons as input (carrying the capacitive sensor readings), two hidden layers with 4 neurons and 3 neurons respectively, and an output layer with a value of 1 (which is the calculated volume value).

[0458] As mentioned above, the Resilient Backpropagation (RPROP) algorithm is used for supervised training of multilayer perceptrons. Principal Component Analysis (PCA) is applied to derive linearly uncorrelated variables (principal components) and reduce the dimension from eight to four. The model is trained on 80% of the training dataset and tested on the remaining 20% ​​for validation.

[0459] If the volume V calculated from machine volume model 5220 水平 The change, i.e., the change ΔV between the current event point and the previous time point. 水平 Above the threshold V 阈值 Then the controller or processor can add a minimum flow volume fraction V to the total flow volume of the accompanying flow delivery. F In other words, the total residual volume can be calculated as: V 流动 (t)=V 流动 (t-1)+V F If ΔV 水平 Higher than V 阈值Then the controller or processor can calculate that the total flow volume accompanying the flow delivery is equal to V. 水平 .

[0460] In step 5218, the controller or processor may further determine V 流动 Is it higher than the threshold V? 阈值 When the volume of flow accompanying the infusion is less than a preset threshold (V) 流动 <V 阈值 When this occurs, the controller or processor can output the total cumulative volume as the sum of the volume accompanying residual infusion and the volume accompanying flowing infusion. That is, V. 总 =V 流动 +V 残留 When the flow volume accompanying the infusion exceeds a preset threshold (V) 流动 >V 阈值 When V is used, the controller or processor can define the total cumulative volume as the sum of the volumes accompanying the flow infusion. 总 =V 流动 After accumulating the volume of the output in the output bag, the controller or processor can return to step 5202.

[0461] Optionally, the algorithm can be used to estimate the volume of ostomy output in the ostomy bag using readings from temperature sensors (such as temperature sensor 5402 in sensor layer 5400, or temperature sensor 3602 in sensor layer 3600) instead of non-capacitive sensor readings. The algorithm can also distinguish between residual and flowing infusions. Infusion type differentiation can be performed without machine learning, but based on the physical characteristics of the output stream.

[0462] Figures 63A-63B The diagram illustrates temperature sensors, for example, arranged in sensor layers 3600 and 5400 respectively (the left and right columns of the matrix in sensor layer 5400 are omitted). The temperature sensors can be divided into three regions, each detecting slightly different infusion characteristics. The same region in... Figures 63A-63B Used in China Figure 63B The sensors form a narrower matrix (fewer columns). The sensor within dashed line 6302 can surround the stoma region and detect whether the ostomy bag is attached to the patient's body. The sensor within dashed line 6304 can be located below or beneath the stoma region on the patient's body and can detect whether new output enters the bag or whether an infusion event has occurred. The sensor within dashed line 6306 can be used to analyze the infusion flow, ensuring that infusion detected below the stoma region is real and not noise, and / or detecting whether the infusion is a flowing infusion or a residual infusion. Figure 64A The algorithm can apply readings from temperature sensors in those three regions.

[0463] Figure 64A The algorithm was developed based on patient studies in which sensor data was acquired along with visual images of the accumulated output. These studies contribute to a better understanding of the sensor data, such as allowing for a visual observation of the type of temperature change as the output accumulates. Different parameters describing the dynamics of the bag's temperature are compared with the visual increase in output levels to determine the appropriate parameters for infusion detection.

[0464] for Figure 64A The algorithm in the text, the average temperature at the stoma (from Figures 63A-63B The temperature sensor detection within the dashed line 6302 in the figure is represented as T. 造口 The average temperature change below the stoma (by...) Figures 63A-63B The temperature sensor detection within the dashed line 6304 is represented as T. 造口下 .

[0465] The dynamics of the ostomy output within the ostomy bag can be analyzed by applying the concept of the central mass of a physical body. The concept of central mass can be used to analyze the motion of irregularly shaped objects and complex systems, which may be applicable to ostomy output collected in an ostomy bag. Temperature can be considered an equivalent of mass to simplify tracking changes in heat distribution within the bag. The “central mass” can be calculated and its position and velocity tracked. In other words, velocity is an approximation of the transfer of heat distribution within the bag.

[0466] "Central quality" can be used as follows: Figure 63B The coordinates of the central mass are calculated using the coordinate system shown inside the bag. The coordinates of the central mass can be calculated using the following formula:

[0467]

[0468]

[0469] The velocity of the central mass along the vertical axis X (since the flow proceeds along this direction, we are concerned with the dynamics along the X-axis) can be calculated using the following formula:

[0470]

[0471] Analysis of patient study data and visual images of the cumulative output showing the following three parameters may be suitable or best suited for infusion analysis: T 造口 ΔT 造口下 and V XCM In addition to the parameters defined above, thresholds were also defined to provide reliable infusion detection standards.

[0472] In step 6402 of algorithm 6400, a controller or processor coupled to the sensor can receive sensor data as an array of sensor capacitance readings and thermistor temperature sensor readings (e.g., from sensor layer 3600 or sensor layer 5400). In decision step 6404, the controller or processor can determine whether the bag is attached to the patient's body. By comparing T... 造口 and threshold T 身体上造口 To determine if the bag is attached to the body. If T 造口 Higher than T 身体上造口 The bag is then attached to the body. Optionally, the T... 身体上造口 It can be approximately 28.

[0473] If the stoma bag is not attached to the patient's body, the controller or processor may stop algorithm 6400 or return to step 6402. If the bag is on the body, the controller or processor may check for a discharge event at decision step 6406 and / or check for an infusion event at decision step 6408.

[0474] A controller or processor can determine the presence of an infusion event by examining changes in the readings of a thermistor sensor below the stoma. The following thresholds for temperature changes below the stoma (RT11, RT12, RT13, RT14, RT19, RT20, RT11, RT22, RT27, RT28, RT29, RT30, RT35, RT36, RT37, RT38) allow for the capture of most infusions occurring in most cases: ΔT 造口下 >0.15.

[0475] Furthermore, during infusion, temperatures (RT6, RT5, RT4, RT3) above 34 degrees Celsius were observed in the stoma region. Therefore, if ΔT is detected... 造口下 >0.15 and T 造口 If the value is >34.0 (first infusion standard), an infusion may be present. However, if ΔT is detected... 造口下 >0.15 and T 造口 If the value is less than 34.0, it may be impossible to distinguish between noise and infusion.

[0476] The controller or processor can then determine how much additional volume has accumulated during a specific infusion. Infusions can be categorized as: (1) Noise (no accumulated volume, the controller or processor returns to step 6402), (2) Residue (small accumulated volume, the controller or processor proceeds to step 6810), (3) Flow (medium accumulated volume, the controller or processor proceeds to step 6812), and (4) High Flow (high accumulated volume, the controller or processor proceeds to step 6814).

[0477] The classification method is based on "central mass," specifically by monitoring the velocity V of the central mass. XCM Or, in other words, the measurement of heat distribution and transfer within the bag. V XCM It can be detected when infusion is detected (when ΔT is detected). 造口下 >0.15 and T 造口 Tracking was performed when the flow rate was >34.0 and one minute after the first infusion criterion was met (to add extra buffer time, since the flow under the stoma may only be detected one minute after the infusion was detected).

[0478] To determine that the "infusion" is actually noise and no actual infusion has occurred, the controller or processor determines that the first infusion criterion is met (when ΔT is detected). 造口下 >0.15 and T 造口 When the temperature is >34.0, the change in temperature distribution is not significant, i.e., (|V XCM (t)|<0.00025 and|V XCM (t+1)|<0.00025).

[0479] To classify an infusion as a residual (small volume) infusion, the controller or processor determines that a first infusion criterion is met (when ΔT is detected). 造口下 >ΔT 造口下R And T 造口 >T 造口R When, where >ΔT 造口下R It can be 0.15 or other values, and T 造口R (It could be 34.0 or other values). The controller and processor also determine that the temperature distribution changes are small but significant, i.e., |V XCM (t)|>0.00025 or |V XCM (t+1)|>0.00025).

[0480] For residual infusions, the change in "central mass" position can be negative, meaning the change in heat distribution is concentrated in the upper part of the stoma bag. The change in "central mass" position can also be positive, meaning the change in heat is concentrated in the lower part of the bag. Because the changes in the thermogram are not significant and only occur with small (residual or only low-flow) infusions, both cases can be considered together.

[0481] To classify an infusion as a flowing (medium or large volume) infusion, the controller or processor determines the first infusion that meets the criteria (when ΔT is detected). 造口下 >ΔT 造口下F And T 造口 >T 造口F When, where >ΔT 造口下F It can be 1 or other, T 造口F(This could be 34.3 or others). The controller or processor also determines that the change in temperature distribution is positive and significant, i.e., V. XCM (t)>0 or V XCM (t+1)>0. V XCM The positive value ensures that the increase in heat occurs in the lower part of the bag, which is consistent with the downward flow of the infusion into the bag.

[0482] To classify an infusion as a high-flow (high or high-volume) infusion, the controller or processor determines whether a first infusion criterion is met (when ΔT is detected). 造口下 >ΔT 造口下F and T 造口 >T 造口HF When, where >ΔT 造口下F It can be 1 or other, T 造口HF (This could be 35 or other values). The controller or processor also determines that the change in temperature distribution is positive and large, i.e., VV. XCM (t)>0.00025 or V XCM (t+1)>0.00025. V XCM The positive value ensures that the increase in heat occurs in the lower part of the bag, which is consistent with the downward flow of the infusion into the bag.

[0483] The infusion standards for the four situations are also summarized in Figure 64B Based on the infusion type, the controller or processor can proceed to step 6816 to estimate the volume of output in the bag. The volume estimate for each infusion type is empirically determined based on an analysis of the infusion type and frequency and the measured output during the patient study.

[0484] In step 6816, V represents the total volume. R V represents the residual infusion volume. F V is expressed as the flow delivery volume. HF This is expressed as the high-flow delivery volume. R Indicates the number of residual infusions, n F This indicates the number of flow infusions, with nHF representing the number of high-flow infusions.

[0485] The following approximate values ​​of infusion volume measurements can be used. Residual infusion per dose (V) R (or R) will increase the volume by approximately 10 ml. Each flow infusion (V) F Or F) increase by approximately 50 ml. Each high-flow infusion (V HF (Or HF) increases by approximately 100ml. Noise adds zero volume to the bag. The total output accumulated inside the bag can be estimated as follows:

[0486] V = n R R+n F F+n HFHF, where R = 10, F = 50, HF = 100

[0487] After outputting the total infusion volume, the controller or processor can return to step 6402.

[0488] To check for emission events in step 6406, the average temperature change at the bottom of the bag ( Figure 63A The 8th row in the middle has the thermistor temperature range of RT57-RT64 or... Figure 63B The thermistor temperature (RT59-RT62) in the 8th row is represented as ΔT. 开口 The sum of the changes in the capacitors near the opening (rows 7 and 8 of the capacitance sensor) is expressed as ΔCS. 开口 The total change in capacitance is expressed as ΔCS. 全部 (ΔCS all The time interval between two emissions is denoted as Δt. 排放 The total current output in the bag is expressed as V. 总 (V total ).

[0489] If ΔT 开口 Less than the threshold ΔT 开口排放 ΔCS 开口 Greater than the threshold ΔCS 开口排放 ΔCS 全部 Greater than the threshold ΔCS 全部 , Δt 排放 Greater than the threshold Δt discon , or V 总 Greater than threshold V min Then the controller or processor can determine that emissions have occurred.

[0490] Optionally, ΔT 开口排放 It can be approximately -1. Optionally, ΔCS 开口排放 It can be approximately 0. Optionally, ΔCS 全部 It can be approximately 0. Optionally, Δt discon It can take approximately 20 minutes. Optionally, V min It can be approximately 20ml.

[0491] If any of the above conditions are detected, the controller or processor can determine that an emission event has occurred and set the volume value to zero in step 6818 and return to step 6402.

[0492] Alternatively and / or additionally, the bag fill change detection algorithm can use a statistical method scheme. Data collected from two types of sensors on the bag, such as the capacitive sensor and temperature sensor disclosed herein, can be considered as independent random variables with a normal distribution. Therefore, summing the variables from both types of sensors is expected to produce another normally distributed random variable. Optionally, readings from capacitive sensors located at or near the vent lug (e.g., the Velcro connector 6018 disclosed above) can be removed before being combined with readings from the temperature sensor. Readings near or at the vent lug may be unrelated to the liquid level in the bag and could serve as outliers in the normal distribution.

[0493] When combining these two variables from a capacitance sensor and a temperature sensor, the two different types of readings can be weighted to adjust the relative strength of the capacitance and temperature readings, for example, using constants a and b. The values ​​of a and b can vary. The values ​​of a and b do not have to be the same, but optionally they can be the same. Let “T” represent a normally distributed random variable representing the data from the temperature sensor. Let “C” represent a normally distributed random variable representing the data from the capacitance sensor (optionally, readings without or near the discharge tab). The combined data can be written in the form R = aT + bC. Since R is the sum of two normally distributed random variables, R is also normally distributed with a mean of μ and a standard deviation of σ, and can be expressed as R ~ Normal(μ, σ). 2 For each reading, the stoma system's processor can calculate the mean and standard deviation of the temperature sensor reading and the capacitance sensor reading, and combine their mean and standard deviation in a weighted manner using constants a and b.

[0494] When a change in bag filling occurs, the distribution of a normally distributed random variable R may change significantly compared to the last reading before the change. When the change in the mean of R is not statistically significant, the stoma system's processor can determine that no change in bag filling has occurred. When the change in the mean of R is statistically significant, the processor can determine that a change in bag filling has occurred. (See below for reference.) Figure 65 More details are provided regarding the algorithm based on the example statistical method.

[0495] like Figure 65 As shown. At time T1, the processor of the stoma system can receive first data from the temperature sensor and the capacitance sensor in step 6500. In step 6502, the processor can obtain a first distribution R1 of a normally distributed random variable by combining the first data from the temperature sensor and the first data from the capacitance sensor in a weighted manner as described above. The mean μ of the first distribution R1 of the normally distributed random variable can be a default value indicating the bag filling state before a change in bag filling is detected.

[0496] In step 6504, at time T2 after T1, the processor can receive second data from the temperature sensor and the capacitance sensor. In step 6506, the processor can obtain a second distribution R2 of the normally distributed random variable by combining the second data from the temperature sensor and the second data from the sensor capacitance in a weighted manner as described above.

[0497] In step 6508, the processor can perform statistical analysis on the mean and standard deviation of the first distribution R1 and the second distribution R2 of the normally distributed random variable. A two-tailed test can be performed. The significance level of the two-tailed test can vary, for example, between about 0.001% and about 10%, or between about 1% and about 8%, or between about 5% and about 6%. The z-value of the two-tailed test can be calculated using the mean and / or standard deviation of the first distribution R1 and the second distribution R2 of the normally distributed random variable, using the following equation:

[0498]

[0499] The standard error can be calculated using the following equation:

[0500]

[0501] In decision step 6510, the processor can determine whether the z-value is higher than a critical value. The critical z-value can be determined experimentally. For example, the critical z-value may be between about 1.9 and about 1.99, or between about 1.92 and about 1.98, or between about 1.95 and about 1.96. If the z-value is not higher than the critical value, then in step 6512, the processor can output a determination that no change in bag filling was detected.

[0502] If the z-value exceeds a critical value, then at optional decision step 6514, the processor can determine whether the time interval between T1 and T2 meets the threshold. The threshold can vary, for example, between approximately 5 minutes and approximately 30 minutes, or between approximately 8 minutes and approximately 25 minutes, or between approximately 10 minutes and approximately 20 minutes. Using a time interval threshold in the algorithm reduces the number of false positive detections. This is because if two readings are too close in time (i.e., below the time interval threshold), the difference between the readings is not expected to be statistically significant.

[0503] If the time interval between T1 and T2 does not meet the threshold, the processor may proceed to step 6512 to output a determination that no change in bag filling was detected. If the time interval between T1 and T2 meets the threshold, the processor may optionally proceed to step 6516 to output a determination that a change in bag filling has been detected.

[0504] Once the processor determines that a change in bag fill has occurred, it can proceed to step 6518 to convert the z-value from the statistical method into an estimate of the bag fill level. The estimate can be a number in the range of 0 to 1, or it can be a different range. The conversion can be based on a calibration curve, a lookup table, or any other calibration method. One end of the range can indicate that the bag is substantially empty, while the other end can indicate that the bag is substantially full; the number between the two ends of the range represents the approximate degree of fullness of the bag. For example, in the range of 0 to 1, an estimate of 0 can indicate that the bag is substantially empty; an estimate of 1 can indicate that the bag is substantially full; an estimate of 0.25 can indicate that the bag is about one-quarter full; and so on. In step 6520, the processor can output the bag fill level estimate.

[0505] The algorithm can optionally run continuously. If no change is detected, after step 6512, the processor can return to step 6504 to receive new data from the sensor. The time interval between the new data and the first data received in T1 will be longer. This new data can be compared with the data received in T1. If the processor still does not detect a change in the bag fill level, the algorithm can continue to loop back to step 6504 until a change is detected.

[0506] If a change in bag fill level has been detected, the processor can return to step 6500 to begin a new loop after outputting the estimated bag fill level. Time T1 can be reset in the new loop, at which point the processor can receive new data from the sensor.

[0507] Using statistical methods to detect bag fill variation can optionally be used for cross-checking with the different bag fill levels and / or total output volume determination algorithms disclosed herein to further reduce false positives.

[0508] Example User Interface

[0509] Figure 22 An example user interface for a "Status Screen" 2200 or "Alfred Alert" is shown. The Status Screen 2200 can display the current volume of the user's bag. In this example, there is a volume tracking circle 2202, a calibration button 2204, an eject button 2206, and an update tracker 2208. The volume tracking feature can be implemented using Apple's native iOS library, Core Bluetooth, or an equivalent native library from another device. Core Bluetooth is the library responsible for communication between iOS devices and sensor devices. The application can receive Bluetooth data packets of 7 to 11 bytes. The application can use... Figure 21The process 2100 is used to perform volume bag fill tracking. Alternatively, the application can perform volume bag fill tracking based on data received from a resistance sensor (instead of a temperature sensor array), or data received from a resistance sensor in addition to the temperature sensor array. The application can also be based on the above reference. Figure 47A-50 The multiple capacitive sensors and / or multiple temperature sensors are used to perform bag filling and / or volume calculation.

[0510] In the temperature and capacitance examples, the application can use the algorithms disclosed herein to convert temperature and / or capacitance sensor readings into volume. As described above, the controller of the ostomy device can perform discharge detection and / or calibration or recalibration of the sensors based on the detection of discharge, infusion, etc. Furthermore, the user can manually instruct the controller of the ostomy device to calibrate the sensors by pressing the calibration button 2204, and / or notify the controller that the pouch is empty by pressing the discharge button 2206.

[0511] A user device can pair with a sensor device, assuming the user device is the master and the sensor device is the slave. The device may send a specific UUID to the sensor to allow its data to be read. This can be done after the device and sensor are paired. When the user disconnects from the device, the application may call the `DisconnectPeripheral` method from the core Bluetooth or native library. This handles disconnection and unpairing of the device. If the sensor device goes out of range of the user device, it may disconnect but not unpair. Once the device returns to range, it can re-pair with the sensor. This is accomplished using the following methods from the core Bluetooth or native library framework.

[0512] Figure 23 An example alarm user interface 2300 is shown. In this example, there is an alarm volume slider 2302, a vibration mode toggle 2304, and red and orange toggles 2306 and 2308. Users can set alarms for different fill levels of the bag. When each measurement is taken and recorded, the application can check if the measurement should trigger any current alarms. If a measurement should trigger one or more alarms, the application can display a notification to the user that one of their alarms has been triggered. Other alarm features may include alarms for manually checking the bag, replacing a reusable hub, reminding the user not to be in a supine position, etc.

[0513] The application can also have additional feedback features. For example, an additional feedback feature could be called "Alfred Connectivity." This feature provides additional feedback to the user. This feature uses the same functionality described above. The additional feedback feature allows multiple Bluetooth sensors to connect to multiple patients simultaneously. This can be achieved by assigning a unique ID to each patient and sensor for pairing. Figure 24 An example user interface for the additional hydration tracker 2400 feedback features is shown. The exemplary hydration tracker 2400 includes a daily hydration target counter 2402, a water tracker 2404, a caffeine beverage tracker 2406, an alcoholic beverage tracker 2408, and another beverage tracker 2410. Other types of liquid intake, such as soup, soda, sports drinks, etc., can also be used. Figure 25 The user interface of a sample hydration progress screen 2500 is shown. The sample hydration progress screen 2500 indicates whether the user's hydration goals have been met. The sample screen 2500 may display one or more bar graphs 2502 to track different types of fluid intake the user has taken. A hydration summary can be retrieved using an API that obtains the user's hydration data from a backend server. Data retrieval can be from a selected date (which may be displayed at the top of the screen) to the current date. Hydration features can also be used in conjunction with an alert page 2300 to remind the user of fluid intake throughout the day or to notify the user when they need to take more fluids or electrolytes.

[0514] Figure 26A An example of an additional user interface for the toilet locator 2600 is shown. This feature displays the user's nearest toilet, allowing him or her to empty their ostomy bag. The application's user interface may display a map 2602. The map 2602, displaying the nearest toilets 2604, may also provide directions, for example, using a "GO" button 2608 or a button with similar instructions. When the user taps the "GO" button 2604 or taps one of the locations 2610 in the table view, the user can be directed to the map application, where the toilet location is set as their desired destination. The toilet locator may work as follows: 1) A backend server may contain a data table containing all toilet locations and / or their coordinates and intersections. 2) The application retrieves a set number of toilet locations based on the user's desired radius. This is implemented via an API that returns toilet locations based on the user's radius and coordinates. 3) An algorithmic function is used to calculate the distance between the user's current location and each toilet.

[0515] like Figures 26B-26C Example user interfaces 2360 and 2640 are shown, displaying both the estimated stoma output 2632 and the toilet location 2634. The user can view the animated graphical indicator 2636 displaying the output. Figure 26B) and an animated graphic indicator showing the distance to the nearest restroom 2638 ( Figure 26C Switching between () and (). The animated graphic indicator 2636 for output may include a circle 2637 with varying fill levels to visually inform the user about the estimated volume of the bag. The user can click the information icon 2633 in Figure 26 to be guided to the output measurement user interface 2650, for example Figure 26D As shown, to obtain more information related to the output. The distance value in the animated graphical indicator 2638 for the distance to the restroom can change as the user moves toward or away from the target restroom. The user can also click the location icon 2635 to be taken to a map interface, such as... Figure 26A As shown. The user interface may also include other icons, such as "Status" 2642 for checking the status of the connected stoma bag, "Care" 2644 for connecting with healthcare professionals, "Inbox" 2646 for connecting to the stoma bag user community, and / or "Overview" 2648 for setting a user profile. Users can change the bag size by accessing "Overview". The names of these icons are provided as examples and are not restrictive. Other icons may be included in the user interface. Figures 26B-26C The user interface example may also optionally include a hydration tracker so that the application can provide tracking of outputs, toilet locators, and hydration status, for example in... Figure 26E The application overview shown is as explained on page 2660.

[0516] Each of the example user interfaces shown may include one or more user interface controls that a user can select, for example, using a browser or other application software (such as a mobile application). Therefore, each of the displayed user interfaces can be output to be rendered as a graphical user interface by electronic hardware, which may optionally include a browser or any other application software installed thereon that outputs a user interface.

[0517] The user interface controls shown are merely illustrative examples and are subject to change. For instance, any user interface control shown can be replaced with other types of user interface controls that provide the same or similar functionality. Some examples of user interface controls that can be used include buttons, drop-down lists, selection boxes, text boxes or text fields, check boxes, radio buttons, toggle switches, breadcrumbs (e.g., identifying the page or interface being displayed), sliders, search fields, pagination controls, labels, icons, tooltips, progress bars, notifications, message boxes, image carousels, modal windows (e.g., pop-ups), date and / or time pickers, accordions (e.g., vertically stacked lists with show / hide functionality), and so on. Other user interface controls not listed here may be used.

[0518] Furthermore, user interface controls can be grouped or divided into other sets of user interface controls, allowing similar or identical functionality to be provided with user interfaces that have very different appearances. Additionally, users can select each user interface control using one or more input options, such as mouse, touchscreen input (e.g., finger or pen), or keyboard input. Although each of these user interfaces is displayed on a mobile device, a user interface or similar user interface can be output by any computing device, examples of which are described above.

[0519] Thermal imaging examples

[0520] As described above (for example, regarding Figure 1 and...) Figure 2 The temperature sensor in the stoma wafer and / or stoma bag can be an infrared (IR) temperature sensor, which can be a thermal imaging sensor or an infrared thermometer. An IR temperature sensor can provide a temperature output similar to that of a thermistor described above. Therefore, any algorithm described herein for analyzing the temperature output from a thermistor or other temperature sensor can be applied to an IR temperature sensor. For example, a potential advantage of using an IR temperature sensor for thermal imaging compared to a thermistor is that temperature measurement using a thermal imaging sensor requires no contact. Therefore, if the stoma wafer is detached from the skin, the IR temperature sensor in the stoma wafer can still detect the skin temperature.

[0521] like Figure 27-32 As shown, the example output of an IR temperature sensor can be conceptualized by analyzing the example output of a test thermal imaging camera. Figure 27 The image shows a test setup 2700 for an ostomy bag 2720 using a thermal imaging camera 2730. The ostomy bag 2720 is attached to a mannequin 2722, which can be filled with food or liquid from the back (not shown), allowing the food or liquid to enter the ostomy bag 2720. The thermal imaging camera 2730 captures thermal images of the ostomy bag 2720 to identify temperature changes in the bag as food or liquid enters and as the food or liquid remains in the bag over time. The test setup 2700 shown can be used to verify the use of temperature sensors in the ostomy bag.

[0522] Figure 28 A sample thermal image 2800 depicts the patient's stoma 2810. Thermal image 2800 may have been taken using a camera such as camera 2730. Thermal image 2800 provides an indication of the sample temperature at and around the stoma.

[0523] Figure 29A-31D Depicting Figure 27 Example thermal image of stoma bag 2720. Figures 29A-29DImages 2910-2940 depict applesauce infusion. Image 2910 shows the material currently in the bag. Image 1920 depicts the applesauce during infusion. Image 1930 depicts the bag immediately after infusion. Finally, image 1940 depicts the bag five minutes after infusion. Figures 30A-30D Similar images 3010-3040 and 3110-3140 of oatmeal and mashed potatoes are depicted in 31A-31D, respectively.

[0524] An ostomy wafer or ostomy bag may include one or more IR temperature sensors. Multiple IR temperature sensors may be distributed around the ostomy wafer or ostomy bag. These sensors are typically larger than... Figure 27 The thermal imaging camera 2730 is positioned closer to the patient's skin. Therefore, the image or temperature output from each sensor in the wafer and / or bag can individually depict only a portion of the temperature at the wafer and / or bag. Collectively, multiple IR temperature sensors can provide temperature data over a large area of ​​the wafer and / or bag.

[0525] Hub 122 can periodically poll IR temperature sensors, such as every second, every minute, every five minutes, or at some other interval. The output of these sensors can be provided to a processor, which can average or otherwise combine the images or temperatures into a single image for further analysis. The processor can also analyze images or temperatures individually without combining them. The processor can be located at hub 122, user equipment 130, or extension system 170 (possibly in the cloud). The processor can use any leak detection, stimulus detection, bag filling, or other algorithms described herein to analyze the output of the IR temperature sensors.

[0526] Other example combinations of features

[0527] In some configurations, a system for detecting skin inflammation may include: a flexible sheet having an adhesive on at least a first surface for adhesion to the skin; a plurality of temperature sensors located in a first region of the sheet for measuring the temperature in the first region of the flexible sheet; at least one temperature sensor in a second region of the flexible sheet for measuring the temperature in the second region of the flexible sheet, the second region being remote from the first region; a wireless transmitter configured to transmit data derived from the temperature sensors to a wireless receiver; and a comparator adapted to compare the temperature in the first region of the flexible sheet with the temperature in the second region of the flexible sheet, thereby generating a differential signal indicating the presence of skin inflammation in a skin region in contact with the first region of the flexible sheet.

[0528] In one configuration, the system may further include a wireless receiver for receiving signals transmitted by the wireless transmitter and transmitting the detected presence of skin inflammation to the user.

[0529] In one configuration, the wireless receiver may include a visual display for presenting a visual representation to a user of the temperature difference between a first region and a second region of the flexible sheet.

[0530] In one configuration, the wireless receiver may include an alarm to warn a user when the temperature difference between a first region and a second region of the flexible sheet exceeds a preselected threshold.

[0531] In some configurations, the data transmitted from the wireless transmitter to the wireless receiver may be data indicating a comparison between the temperature in a first region of the flexible sheet and the temperature in a second region of the flexible sheet, and the comparator is mounted on or near the flexible sheet.

[0532] In some configurations, the data transmitted from the wireless transmitter to the wireless receiver may be data indicating the temperature in a first region of the flexible sheet and the temperature in a second region of the flexible sheet, and a comparator is included in the wireless receiver.

[0533] In some configurations, a system for detecting skin inflammation may include: a flexible sheet having an adhesive on at least a first surface for adhesion to the skin; a plurality of temperature sensors in a first region of the flexible sheet for measuring temperature in the first region of the flexible sheet; at least one temperature sensor in a second region of the flexible sheet for measuring temperature in the second region of the flexible sheet, the second region being remote from the first region; an electrical connector for connecting a processor to the temperature sensors, wherein each of the temperature sensors can be connected to the electrical connector via at least one electrical conductor; and a marking pattern defining at least one cutting region, such that cutting the flexible sheet in the cutting region removes a portion of the flexible sheet along with one or more temperature sensors, thereby forming an opening in the flexible sheet, such that any electrical conductors connected to temperature sensors not thereby removed remain intact after the cutting process.

[0534] In some configurations, the cutting area may include multiple concentric circles or partial circles, such that cutting the flexible sheet at each of the concentric circles or partial circles provides a circular opening of a different size.

[0535] In some configurations, the system may include a processor connected to an electrical connector for obtaining temperature values ​​reported by each of the temperature sensors.

[0536] In some configurations, the system may include a wireless generator that is configured to send data derived from a temperature sensor to a wireless receiver.

[0537] In some configurations, the system may include a wireless receiver for receiving signals transmitted by a wireless transmitter and transmitting data derived from the temperature sensor to the user.

[0538] In some configurations, the wireless receiver includes a visual display for presenting a visual representation of the temperature difference between a first region and a second region of the flexible sheet to the user.

[0539] In some configurations, the wireless receiver includes an alarm to warn the user when the temperature difference between a first region and a second region of the detected flexible sheet exceeds a preselected threshold.

[0540] In some configurations, the system may include a comparator adapted to compare the temperature in a first region of the flexible sheet with the temperature in a second region of the flexible sheet, thereby generating a differential signal indicating whether there is skin inflammation in the skin region in contact with the first region of the flexible sheet.

[0541] In some configurations, the system may include a wireless transmitter, wherein the data transmitted from the wireless transmitter to the wireless receiver is data indicating a comparison between the temperature in a first region of the flexible sheet and the temperature in a second region of the flexible sheet, and the comparator is mounted on or near the flexible sheet.

[0542] In some configurations, the system may include a wireless transmitter and a wireless receiver, wherein the data transmitted from the wireless transmitter to the wireless receiver may be data indicating the temperature in a first region of the flexible sheet and the temperature in a second region of the flexible sheet, and a comparator may be incorporated into the wireless receiver.

[0543] In some configurations, temperature sensors can be positioned within a flexible sheet such that when the device is applied to a wound on the skin surface, multiple temperature sensors in a first region of the flexible sheet detect the temperature of the skin adjacent to the wound, and at least one temperature sensor in a second region of the flexible sheet detects the temperature of the skin distant from the wound.

[0544] In some configurations, the flexible sheet can form part of the stoma chip and be sized to be positioned around a colostomy stoma, ileostomy stoma, or urethrostomy stoma.

[0545] In some configurations, the temperature sensor can be a thermistor or an IR temperature sensor.

[0546] In some configurations, an ostomy system for detecting peristaltic skin inflammation may include an ostomy wafer comprising a flexible sheet having an adhesive on at least a first surface for adhesion to the skin; a plurality of temperature sensors in a peristaltic region of the ostomy wafer for measuring temperature in that region; at least one temperature sensor in a second region of the ostomy wafer, the second region being located away from the peristaltic region, for measuring temperature in that region; an electrical connector capable of connecting a processor to the temperature sensors, wherein each of the temperature sensors is connected to the electrical connector via at least one electrical conductor; and an ostomy bag having means for housing a wireless transmitter configured to transmit data derived from the temperature sensors to a wireless receiver.

[0547] In some configurations, the system may include a processor connected to an electrical connector for acquiring temperature values ​​reported by each of the temperature sensors.

[0548] In some configurations, the system may include a wireless transmitter mounted on the stoma bag and configured to send data derived from the temperature sensor to a wireless receiver.

[0549] In some configurations, the system may include a wireless receiver for receiving signals transmitted by a wireless transmitter and transmitting data derived from a temperature sensor to the user.

[0550] In some configurations, the wireless receiver may include a visual display for presenting a visual representation to the user of the temperature difference between the peristomal region of the stoma wafer and a second region of the stoma wafer.

[0551] In some configurations, the wireless receiver includes an alarm that alerts the user when the temperature difference between the peristomal region of the stoma wafer and a second region of the stoma wafer exceeds a preselected threshold.

[0552] In some configurations, the system may include a comparator adapted to compare the temperature in the peristomal region of the stoma wafer with the temperature in a second region of the stoma wafer, thereby generating a differential signal indicating the presence of skin inflammation in the peristomal skin.

[0553] In some configurations, the system may include a wireless transmitter, wherein the data transmitted from the wireless transmitter to the wireless receiver may be data indicating a comparison of the temperature in the peristomal region of the stoma wafer with the temperature in a second region of the stoma wafer, and the comparator is mounted on or near the flexible sheet.

[0554] In some configurations, the system may include a wireless transmitter and a wireless receiver, wherein the data transmitted from the wireless receiver to the wireless receiver may be data indicating the temperature in the peristomal region of the stoma wafer and the temperature in a second region of the stoma wafer, and a comparator is incorporated in the wireless receiver.

[0555] In some configurations, the system may include a marking pattern defining at least one cutting region, such that cutting the stoma wafer in the cutting region enables the removal of a portion of the stoma wafer along with one or more temperature sensors, thereby creating an opening in the stoma wafer such that any electrical conductors connected to the temperature sensors not thereby removed remain intact after the cutting process.

[0556] In some configurations, the cutting area may include multiple concentric circles or partial circles, such that cutting the stoma wafer at each of the concentric circles or partial circles provides a circular opening of a different size.

[0557] In some configurations, a method for detecting skin inflammation may include: adhering a flexible sheet to the skin, the flexible sheet having: a plurality of temperature sensors in a first region for measuring the temperature in the first region of the flexible sheet, and at least one temperature sensor in a second region of the flexible sheet for measuring the temperature in the second region of the flexible sheet, the second region being remote from the first region; measuring the temperatures in the first and second regions of the flexible sheet; and comparing the temperature in the first region of the flexible sheet with the temperature in the second region of the flexible sheet to detect the presence of skin inflammation in the skin area in contact with the first region of the flexible sheet.

[0558] In some configurations, the stoma bag may include: two walls joined together along a seam surrounding at least a portion of the edge of the stoma bag, a first wall configured to face the user's skin and a second wall configured to face away from the user when the first wall faces the user's skin; an opening in the first wall configured to be arranged around the user's stoma and to receive effluent from the stoma; and a plurality of temperature sensors and a plurality of capacitance sensors, wherein the plurality of temperature sensors measure temperature changes due to effluent entering the bag, and wherein the plurality of capacitance sensors measure capacitance changes due to effluent entering the bag, the sensor layer further including one or more wireless communication antennas, wherein, in use, the one or more antennas are in electrical communication with one or more antennas on a stoma chip configured to connect the first wall of the stoma bag to the user's skin, and / or with one or more antennas on a hub of the stoma bag configured to connect on the second wall of the stoma bag.

[0559] In some configurations, multiple temperature sensors and multiple capacitance sensors are located on a sensor layer situated in, above, or between one of the two walls of the stoma bag.

[0560] In some configurations, multiple temperature sensors and multiple capacitance sensors are printed on one or both of the two walls of the stoma bag.

[0561] In some configurations, the capacitive sensors are arranged in a pattern of lines that are not at a 90-degree angle to each other.

[0562] In some configurations, the capacitive sensor is configured to detect the fill level of the outflow in the bag when the bag is in an upright position and tilted.

[0563] In some configurations, the stoma bag may include: two walls joined together along a seam surrounding at least a portion of the edge of the stoma bag; a first wall configured to face the user's skin; a second wall configured to face away from the user when the first wall faces the user's skin; an opening in the first wall configured to be arranged around the user's stoma and to receive effluent from the stoma; and a sensor layer disposed among, above, or between one of the two walls of the stoma bag, the sensor layer including a plurality of temperature sensors and a plurality of capacitance sensors, wherein the plurality of temperature sensors measure temperature changes due to effluent entering the bag, and wherein the plurality of capacitance sensors measure capacitance changes due to effluent entering the bag, the sensor layer also including one or more wireless communication antennas, wherein, in use, the one or more antennas are in electrical communication with one or more antennas on a stoma chip and / or one or more antennas on a hub, the stoma chip being configured to connect the first wall of the stoma bag to the user's skin, and the hub being configured to connect to the stoma bag on the second wall of the stoma bag.

[0564] In some configurations, capacitive sensors can be arranged in a pattern of lines, with the lines positioned at non-90-degree angles to each other.

[0565] In some configurations, the stoma bag may include: two walls joined together along a seam surrounding at least a portion of the edge of the stoma bag, a first wall configured to face the user's skin and a second wall configured to face away from the user when the first wall faces the user's skin; an opening in the first wall configured to be arranged around the user's stoma and to receive outflow from the stoma; and a sensor layer disposed in one of the two walls of the stoma bag, the sensor layer including a temperature sensor configured to measure the temperature of the outflow.

[0566] In some configurations, methods for detecting skin irritation around the stoma may include, under the control of a hardware processor, sensing temperature readings from multiple temperature sensors disposed in a ring around the stoma wafer; detecting slow temperature changes from one or more temperature sensors, where such slow changes occur for a period exceeding a threshold time; and outputting an indication that irritation has occurred at the location in the stoma wafer corresponding to one or more temperature sensors.

[0567] In some configurations, this method can be implemented using any feature of the ostomy device disclosed herein.

[0568] In some configurations, a method for detecting the filling of a stoma bag may include: sensing temperature using readings from multiple temperature sensors disposed in the stoma bag under the control of a hardware processor; detecting temperature changes from the multiple temperature sensors as flow; and outputting an indication that the bag filling volume has increased in response to the detected temperature change.

[0569] In some configurations, multiple temperature sensors are arranged in a matrix within the stoma bag.

[0570] In some configurations, the hardware processor can be configured to detect temperature changes as temperature variations occurring from a first temperature sensor located at the top of the stoma bag to a second temperature sensor located at the bottom of the stoma bag.

[0571] In some configurations, the hardware processor is also configured to detect the phase of the effluent based on the rate of temperature change.

[0572] In some configurations, the hardware processor is also configured to consider temperature changes corresponding to the effluent, but reject a second temperature change that does not correspond to the temperature change flowing from the first temperature sensor to the second temperature sensor.

[0573] In some configurations, the hardware processor is also configured to reject second temperature changes below a threshold rate.

[0574] In some configurations, the hardware processor is also configured to perform calibration based on detected body temperature before the effluent flows.

[0575] In some configurations, the hardware processor is also configured to ignore temperature changes caused by the gas.

[0576] In some configurations, the hardware processor is also configured to subtract the volume of effluent due to gas from the volume calculation based on fill detection.

[0577] In some configurations, the hardware processor is further configured to detect gas based on the output from a gas sensor placed in the ostomy bag.

[0578] In some configurations, the method may include displaying the volume of the bag filling on a user device that is in electrical communication with the bag.

[0579] In some configurations, the method may include displaying the distance to a nearby restroom on a user device that is in communication with the bag.

[0580] In some configurations, the method may include displaying the hydration tracker on a user device that is in communication with the bag.

[0581] In some configurations, this method can be implemented using any feature of the ostomy device disclosed herein.

[0582] In some configurations, a method for detecting the phase of effluent in a stoma bag may include, under the control of a hardware processor, sensing temperature values ​​from a plurality of temperature sensors disposed in the stoma bag, the plurality of temperature sensors being in contact with the effluent; and determining the phase of the effluent in part based on the temperature values.

[0583] In some configurations, the detection is based in part on the rate of change of temperature values ​​from multiple temperature sensors in contact with the effluent.

[0584] In some configurations, the detection is based in part on the flow rate determined from temperature values ​​from multiple temperature sensors.

[0585] In some configurations, temperature values ​​are presented as heatmaps.

[0586] In some configurations, heavier thermal prints on the heatmap indicate a stickier effluent.

[0587] In some configurations, computations are performed using machine learning.

[0588] In some configurations, computations are performed using a trained neural network model.

[0589] In some configurations, the trained neural network model is configured to identify the boundaries between effluents of different phases on a heatmap.

[0590] In some configurations, a system for monitoring stoma patients may include a wireless device configured to receive sensor signals from a stoma device, including temperature-related signals; a memory device storing processor-executable instructions; a hardware processor configured to execute the processor-executable instructions to perform any feature of the stoma device disclosed herein, or optionally to provide sensor signals to a back-end server performing any feature of the stoma device disclosed herein; and a display configured to output the results of the execution of the processor-executable instructions, including one or more of the following: leakage indication, skin irritation indication, and volume indication of effluent in the stoma device.

[0591] In some configurations, the hardware processor may be further configured to output one or more of the following: a user interface for allowing a user to specify hydration and / or food inputs; a user interface configured to output information related to the specified hydration and / or food inputs; a user interface configured to warn the user that more hydration and / or food inputs are needed; a user interface configured to indicate the location of a nearby restroom; and a user interface configured to indicate that hydration and / or food inputs are available at a restroom location.

[0592] the term

[0593] Based on this disclosure, many other variations besides those described herein will be apparent. For example, according to embodiments, certain actions, events, or functions of any algorithm described herein may be performed in a different order, may be added, combined, or omitted entirely (e.g., not all described actions or events are necessary for implementing the algorithm). Furthermore, in some embodiments, actions or events may be performed, for example, through multithreaded processing, interrupt handling, or multiple processors or processor cores, or concurrently on other parallel architectures, rather than sequentially. Additionally, different tasks or processes may be performed by different machines and / or computing systems that can work together.

[0594] The various exemplary logic blocks, modules, and algorithm steps described in conjunction with the embodiments disclosed herein can be implemented as electronic hardware, computer software, or a combination of both. To clearly illustrate this interchangeability between hardware and software, various exemplary components, blocks, modules, and steps have been generally described above in terms of their functionality. Whether this functionality is implemented as hardware or software depends on the specific application and the design constraints imposed on the system as a whole. The described functionality can be implemented in various ways for each specific application, but such implementation decisions should not be construed as departing from the scope of this disclosure.

[0595] The various exemplary logic blocks and modules described in conjunction with the embodiments disclosed herein can be implemented or executed by a machine designed to perform the functions described herein, such as a hardware processor including digital logic circuitry, a general-purpose processor, a digital signal processor (DSP), an application-specific integrated circuit (ASIC), a field-programmable gate array (FPGA) or other programmable logic device, discrete gate or transistor logic, discrete hardware components, or any combination thereof. A general-purpose processor may be a microprocessor, but alternatively, the processor may be a controller, a microcontroller, or a state machine, a combination thereof, etc. The processor may include circuitry configured to process computer-executable instructions. In another embodiment, the processor includes an FPGA or other programmable device that performs logical operations without processing computer-executable instructions. The processor may also be implemented as a combination of computing devices, such as a combination of a DSP and a microprocessor, multiple microprocessors, one or more microprocessors combined with a DSP core, or any other such construction. The computing environment may include any type of computer system, including but not limited to computer systems based on computing engines within microprocessors, mainframe computers, digital signal processors, portable computing devices, device controllers, or appliances, to name just a few.

[0596] The steps of the methods, processes, or algorithms described in conjunction with the embodiments disclosed herein can be implemented directly in hardware, stored in one or more storage devices and executed by one or more processors, or a combination of both. The software module can reside in RAM memory, flash memory, ROM memory, EPROM memory, EEPROM memory, registers, hard disk, removable disk, CD-ROM, or any other form of non-transitory computer-readable storage medium or physical computer memory known in the art. An exemplary storage medium can be coupled to a processor such that the processor can read information from and write information to the storage medium. Alternatively, the storage medium can be integrated with the processor. The storage medium can be volatile or non-volatile. The processor and storage medium can reside in an ASIC.

[0597] Unless otherwise specifically stated or otherwise understood in the context in which it is used, conditional language used herein, such as “may,” “possibly,” “can,” “e.g.,” etc., is generally intended to convey that certain embodiments include certain features, elements, and / or states while certain embodiments do not. Therefore, such conditional language is not generally intended to imply that features, elements, and / or states are necessary in any way for one or more embodiments, or that one or more embodiments necessarily include logic for determining whether there is author input or prompting, whether such features, elements, and / or states are included in any particular embodiment, or whether any particular embodiment is performed. The terms “comprising,” “including,” “having,” etc., are synonyms, included in an open-ended manner, and do not exclude other elements, features, actions, operations, etc. Similarly, the term “or” is used in its inclusive sense (rather than in its exclusive sense), so that, for example, when used to connect lists of elements, the term “or” means one, some, or all of the elements in the list. Furthermore, the term “each” as used herein, in addition to having its ordinary meaning, can also refer to any subset of the set of elements to which the term “each” is applied.

[0598] Unless otherwise explicitly stated, disjunctive language such as the phrase “at least one of X, Y, and Z” should be understood in conjunction with the context in which items, terms, etc., are typically used to convey information, and may be X, Y, or Z or combinations thereof. Therefore, such union language is not generally intended to imply that certain embodiments require the presence of at least one of X, at least one of Y, and at least one of Z.

[0599] Unless otherwise explicitly stated, articles such as “a” or “one” should generally be interpreted as including one or more described items. Therefore, phrases such as “device configured to…” are intended to include one or more described devices. Such one or more described devices may also be configured collectively to execute the stated records. For example, “processors configured to execute records A, B, and C” could include a first processor configured to execute record A working in conjunction with a second processor configured to execute records B and C.

[0600] While the above detailed description has shown, described, and pointed out novel features applicable to various embodiments, it will be understood that various omissions, substitutions, and changes may be made in the form of the illustrated devices or algorithms without departing from the spirit of this disclosure. It will be appreciated that certain embodiments of the invention described herein may be practiced in a form that does not provide all the features and advantages set forth herein, as some features may be used or implemented separately from other features.

Claims

1. An ostomy pouch comprising: two walls joined together along a seam around at least a portion of an edge of the ostomy pouch, a first of the walls configured to be placed facing a user's skin, a second of the walls configured to face away from the user when the first wall faces the user's skin; an opening in the first wall configured to be disposed around a stoma of the user and to receive effluent from the stoma, wherein the opening is located proximate to a portion of the seam and further from a portion of the two walls defining a drain opening that is unsealed; and a sensor layer disposed in, on, or between one of the two walls of the ostomy pouch, the sensor layer having a first portion located closer to the opening and a second portion located further from the opening and closer to the drain opening, the sensor layer comprising a plurality of temperature sensors and a plurality of capacitive sensors, wherein the plurality of temperature sensors are distributed across the first portion and the second portion, and wherein the plurality of capacitive sensors are distributed across the second portion; the sensor layer further comprising one or more wireless communication antennas, wherein, in use, the one or more wireless communication antennas are in electrical communication with one or more antennas on an ostomy wafer and / or one or more processors on a user device, the ostomy wafer configured to couple the first wall of the ostomy pouch to the user's skin; wherein the drain opening is closed by a Velcro connector; wherein at least one of the plurality of capacitive sensors is located on a surface of the sensor layer opposite the rest of the temperature and capacitive sensors, the at least one of the plurality of capacitive sensors facing away from the user; wherein a first portion of the Velcro connector comprises a metal strip, the at least one of the plurality of capacitive sensors configured to detect a change in capacitance when the first portion of the Velcro connector is disengaged from a second portion of the Velcro connector to detect a drain event.

2. The ostomy pouch of claim 1, wherein, the sensor layer is generally rectangular.

3. The ostomy pouch of claim 1 or 2, wherein, the sensor layer is smaller than the two walls.

4. The ostomy pouch of claim 1, wherein, the capacitive sensors are arranged in a pattern of lines, at least some of the lines being at a non-90 degree angle relative to each other.

5. The ostomy pouch of claim 1, wherein, the temperature sensors are arranged in a matrix circuit.

6. The ostomy pouch of claim 1, wherein, the plurality of capacitive sensors comprises 24 capacitive sensors.

7. The ostomy pouch of claim 1, wherein, the plurality of temperature sensors comprises 48 temperature sensors.

8. The ostomy pouch of claim 1, wherein, the pouch comprises a plurality of layers, a layer located between the metal strip and the at least one of the plurality of capacitive sensors facing away from the user when the first portion of the Velcro connector is attached to the second portion comprises one or more openings to allow direct contact between the metal strip and the at least one of the plurality of capacitive sensors facing away from the user.

9. The ostomy pouch of claim 1 or 8, wherein, the direct or indirect contact between the metal strip and the at least one of the plurality of capacitive sensors facing away from the user is configured to electronically activate the pouch.

10. The ostomy pouch of claim 1, further comprising an accelerometer.

11. The ostomy pouch of claim 1, further comprising a Bluetooth module.

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