WO2019169327A1

WO2019169327A1 - System and method for detecting ostomy bag fill

Info

Publication number: WO2019169327A1
Application number: PCT/US2019/020397
Authority: WO
Inventors: Irina DOROFEEVA; Tianbin Zhao
Original assignee: 11 Health and Technologies Inc.
Priority date: 2018-03-02
Filing date: 2019-03-01
Publication date: 2019-09-06

Abstract

A method of detecting a fill level of an ostomy bag of a draining device can be based on resistance readings from a resistance sensor mounted on the ostomy bag and/or a user input that the ostomy bag has been drained. Smoothing algorithms can be implemented to identify drain data points by filtering out noises in a fill volume signal obtained based on the resistance readings.

Description

SYSTEM AND METHOD FOR DETECTING OSTOMY BAG FILL

INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

[0001] This application claims the priority benefit of U.S. Provisional Application No. 62/637,531, filed March 2, 2018, the entirety of which is incorporated herein by reference.

BACKGROUND

[0002] A stoma is an artificial opening in the abdomen, which connects a portion of the body cavity to the outside environment. A removable bag, called an ostomy bag, is adhered to the outside of the abdomen wall to collect waste leaving the body through the stoma. Example types of stoma include an ileostomy, which is an opening from the small intestine, to allow faeces to leave the body without passing through the large intestine; a colostomy, which is an opening from the large intestine, to allow faeces to leave the body without passing through the anus; and a urostomy, which is an opening from the ureters, to allow urine to leave the body without passing through the bladder. An ostomy bag can collect body waste diverted from the ileum, colon or urinary tract.

SUMMARY

[0003] A problem experienced by many stoma (or ostomy) bag users is that they lack reliable ways of knowing the extent to which the bag has been filled, and consequently when it needs to be emptied or changed. If the user does not monitor the bag periodically and empty it in due time, the bag can overfill, leak, burst, and/or detach itself from the user.

[0004] A sensor having an electrical resistance element can be used to detect a filling level in the bag by monitoring changes in an electrical resistance of the resistance element. The resistance change can depend on the degree of stretching of the resistance element as the bag becomes filled and/or emptied.

[0005] The present disclosure provides methods of detecting a fill level or content level of an ostomy bag using a resistance sensor applied across a width of the ostomy bag and attached to opposing sides of the bag or other types of resistance sensors. Although the fill level detection using a resistance sensor is described in this disclosure using an ostomy bag as an example, the fill level detection system and methods using a resistance sensor can be applied to any flexible bag system.

[0006] In some configurations, a fluid and/or semi-solid collection system capable of automatically detecting a fill level of a flexible bag of the system can include: the flexible bag; a resistance sensor coupled with the bag; a hardware processor in electronic communication with the resistance sensor and configured to: at a first time, obtain a first resistance value from the resistance sensor; convert the first resistance value to a first volume value; at a second time after the first time, obtain a second resistance value from the resistance sensor; convert the second resistance value to a second volume value; determine that the second volume value may be lower than the first volume value; and in response to said determining, replace the second volume value with the first volume value.

[0007] In some configurations, the resistance value of the resistance sensor can correspond to a degree of bending of the resistance sensor, the degree of bending varying according to the fill level of the flexible bag.

[0008] In some configurations, the resistance sensor can be attached across a width of the flexible bag.

[0009] In some configurations, the hardware processor can be configured to receive calibration information for converting the first and second resistance values to the first and second volume values.

[0010] In some configurations, the calibration information may be determined by measuring calibration resistance data at different simulated bends of the resistance sensor.

[0011] In some configurations, the calibration information can include a calibration fit based on the calibration resistance data.

[0012] In some configurations, the calibration information may vary based on a flexible bag orientation.

[0013] In some configurations, the flexible bag orientation may include a horizontal or vertical orientation.

[0014] In some configurations, the flexible bag orientation may be determined by at least one of: a user input or an inertial measurement sensor. [0015] In some configurations, the hardware processor can be configured to reset the fill level of the flexible bag to zero in response to any of: the hardware processor outputting that a drain of the flexible bag has occurred; the hardware processor receiving a user input that the flexible bag has been drained; and/or the hardware processor detecting a resistance sensor disconnection from the flexible bag.

[0016] In some configurations, the hardware processor may be configured to output that a drain of the flexible bag has occurred in response to determining that a difference between a current volume value and a previous volume value may be negative and exceeds a threshold drain volume.

[0017] In some configurations, the user input can include a tapping of a drain button on a user interface of a user device in electronic communication with the hardware processor.

[0018] In some configurations, the hardware processor may only reset the fill level in response to receiving the user input that the flexible bag has been drained.

[0019] In some configurations, the hardware processor can be configured to output an alarm when the hardware processor has outputted that a drain of the flexible bag has occurred but does not receive the user input that the flexible bag has been drained.

[0020] In some configurations, the hardware processor can be configured to keep a previous volume value as the fill level of the flexible bag in response to any of: a current volume value exceeding a maximum capacity of the flexible bag; the current volume being a negative volume; and/or the current volume value being less than the previous volume value by an amount less than a threshold drain volume.

[0021] In some configurations, a draining device capable of automatically detecting a fill level of an ostomy bag of the draining device can include: the ostomy bag; a resistance sensor coupled with the ostomy bag; a hardware processor in electronic communication with the resistance sensor and configured to: at a first time, obtain a first resistance value from the resistance sensor; convert the first resistance value to a first volume value; at a second time after the first time, obtain a second resistance value from the resistance sensor; convert the second resistance value to a second volume value; determine that the second volume value may be lower than the first volume value; and in response to said determining, replace the second volume value with the first volume value. [0022] In some configurations, the resistance value of the resistance sensor can correspond to a degree of bending of the resistance sensor, the degree of bending varying according to the fill level of the ostomy bag.

[0023] In some configurations, the resistance sensor can be attached across a width of the ostomy bag.

[0024] In some configurations, the hardware processor can be configured to receive calibration information for converting the first and second resistance values to the first and second volume values.

[0025] In some configurations, the calibration information can be determined by measuring calibration resistance data at different simulated bends of the resistance sensor.

[0026] In some configurations, the calibration information can include a calibration fit based on the calibration resistance data.

[0027] In some configurations, the calibration information may vary based on an ostomy bag orientation.

[0028] In some configurations, the ostomy bag orientation can include a supine or vertical orientation.

[0029] In some configurations, the ostomy bag orientation can be determined by at least one of: a user input or an inertial measurement sensor.

[0030] In some configurations, the hardware processor can be configured to reset the fill level of the ostomy bag to zero in response to any of: the hardware processor outputting that a drain of the ostomy bag has occurred; the hardware processor receiving a user input that the ostomy bag has been drained; and/or the hardware processor detecting a patient and/or resistance sensor disconnection from the ostomy bag.

[0031] In some configurations, the hardware processor can be configured to output that a drain of the ostomy bag has occurred in response to determining that a difference between a current volume value and a previous volume value may be negative and exceeds a threshold drain volume.

[0032] In some configurations, the user input can include a tapping of a drain button on a user interface of a user device in electronic communication with the hardware processor. [0033] In some configurations, the hardware processor may only reset the fill level in response to receiving the user input that the ostomy bag has been drained.

[0034] In some configurations, the hardware processor can be configured to output an alarm when the hardware processor has outputted that a drain of the ostomy bag has occurred but does not receive the user input that the ostomy bag has been drained.

[0035] In some configurations, the hardware processor can be configured to keep a previous volume value as the fill level of the ostomy bag in response to any of: a current volume value exceeding a maximum capacity of the ostomy bag; the current volume being a negative volume; the current volume value being less than the previous volume value by an amount less than a threshold drain volume; the hardware processor being inconclusive whether a patient may be connected to the ostomy bag.

[0036] In some configurations, a draining device capable of automatically detecting a draining point of an ostomy bag of the draining device can include: the ostomy bag; a resistance sensor coupled with the ostomy bag; a hardware processor in electronic communication with the resistance sensor and configured to: at a first time, obtain a first resistance value from the resistance sensor; convert the resistance value to a first volume value; determine that the first volume value exceeds a minimum threshold value; at a second time after the first time, obtain a second resistance value from the resistance sensor; convert the second resistance value to a second volume value; determine that the second volume value exceeds a negative volume threshold; and in response to said determining that the first volume value exceeds a minimum threshold value and that the first second volume value exceeds the negative volume threshold, output that a drain of the ostomy bag has occurred.

[0037] In some configurations, the resistance value of the resistance sensor may correspond to a degree of bending of the resistance sensor, the degree of bending varying according to the fill level of the ostomy bag.

[0038] In some configurations, a polarity of the resistance value may vary according to a direction of bending of the ostomy bag, a positive resistance value resulting from filling of the ostomy bag and a negative resistance value not resulting from filling of the ostomy bag.

[0039] In some configurations, the resistance sensor may be attached across a width of the ostomy bag. [0040] In some configurations, the minimum threshold value may be about 100 mL.

[0041] In some configurations, the hardware processor may be configured to receive calibration information for converting the first and second resistance values to the first and second volume values.

[0042] In some configurations, the calibration information may be determined by measuring calibration resistance data at different simulated bends of the resistance sensor.

[0043] In some configurations, the calibration information can include a calibration fit based on the calibration resistance data.

[0044] In some configurations, the calibration information may vary based on an ostomy bag orientation.

[0045] In some configurations, the ostomy bag orientation can include a supine or vertical orientation.

[0046] In some configurations, the ostomy bag orientation may be determined by at least one of: a user input or an inertial measurement sensor.

[0047] In some configurations, the hardware processor may be configured to reset a fill level of the ostomy bag to zero in response to any of: the hardware processor outputting that a drain of the ostomy bag has occurred; the hardware processor receiving a user input that the ostomy bag has been drained; and/or the hardware processor detecting a patient and/or resistance sensor disconnection from the ostomy bag.

[0048] In some configurations, the user input can include a tapping of a drain button on a user interface of a user device in electronic communication with the hardware processor.

[0049] In some configurations, the hardware processor may only reset the fill level in response to receiving the user input that the ostomy bag has been drained.

[0050] In some configurations, the hardware processor may be configured to output an alarm when the hardware processor has outputted that a drain of the ostomy bag has occurred but does not receive the user input that the ostomy bag has been drained.

[0051] In some configurations, the hardware processor may be configured to keep a previous volume value as the fill level of the ostomy bag in response to any of: a current volume value exceeding a maximum capacity of the ostomy bag; the current volume being a negative volume; the current volume value being less than the previous volume value by an amount less than a threshold drain volume; the hardware processor being inconclusive whether a patient is connected to the ostomy bag.

[0052] In some configurations, the hardware processor may be further configured to output that a drain of the ostomy bag has occurred in response to determining that the second time may be a predetermined duration after the first time.

[0053] In some configurations, the predetermined duration may be at least about 30 minutes.

[0054] In some configurations, the predetermined duration may be at least about

1 hour.

[0055] In some configurations, the predetermined duration may be at least about

2 hours.

[0056] In some configurations, the predetermined duration may be at least about

3 hours.

[0057] In some configurations, a draining device capable of automatically detecting a draining point of an ostomy bag of the draining device, the bag comprising: the ostomy bag; a resistance sensor coupled with the ostomy bag; a hardware processor in electronic communication with the resistance sensor and configured to: at a first time, obtain a first resistance value from the resistance sensor; convert the resistance value to a first volume value; determine that the first volume value may be a positive value; at a second time after the first time, obtain a second resistance value from the resistance sensor; convert the second resistance value to a second volume value; determine that the second volume value may be a negative value and that the second time may be a predetermined duration after the first time; in response to said determining that the first volume value may be a positive value, that the second volume value may be a negative value, and that the second time may be the predetermined duration after the first time, output that a drain of the ostomy bag has occurred.

[0058] In some configurations, the predetermined duration may be at least about 30 minutes.

[0059] In some configurations, the predetermined duration may be at least about

1 hour. [0060] In some configurations, the predetermined duration may be at least about

2 hours.

[0061] In some configurations, the predetermined duration may be at least about

3 hours.

[0062] In some configurations, a resistance value of the resistance sensor may correspond to a degree of bending of the resistance sensor, the degree of bending varying according to the fill level of the ostomy bag.

[0063] In some configurations, a polarity of the resistance value may vary according to a direction of bending of the ostomy bag, a positive resistance value resulting from filling of the ostomy bag and a negative resistance value not resulting from filling of the ostomy bag.

[0064] In some configurations, the resistance sensor may be attached across a width of the ostomy bag.

[0065] In some configurations, the hardware processor may be configured to receive calibration information for converting the first and second resistance values to the first and second volume values.

[0066] In some configurations, the calibration information may be determined by measuring calibration resistance data at different simulated bends of the resistance sensor.

[0067] In some configurations, the calibration information can include a calibration fit based on the calibration resistance data.

[0068] In some configurations, the calibration information may vary based on an ostomy bag orientation.

[0069] In some configurations, the ostomy bag orientation can include a supine or vertical orientation.

[0070] In some configurations, the ostomy bag orientation may be determined by at least one of: a user input or an inertial measurement sensor.

[0071] In some configurations, the hardware processor may be configured to reset a fill level of the ostomy bag to zero in response to any of: the hardware processor outputting that a drain of the ostomy bag has occurred; the hardware processor receiving a user input that the ostomy bag has been drained; and/or the hardware processor detecting a patient and/or resistance sensor disconnection from the ostomy bag. [0072] In some configurations, the user input can include a tapping of a drain button on a user interface of a user device in electronic communication with the hardware processor.

[0073] In some configurations, the hardware processor may only reset the fill level in response to receiving the user input that the ostomy bag has been drained.

[0074] In some configurations, the hardware processor may be configured to output an alarm when the hardware processor has outputted that a drain of the ostomy bag has occurred but does not receive the user input that the ostomy bag has been drained.

[0075] In some configurations, the hardware processor may be configured to keep a previous volume value as the fill level of the ostomy bag in response to any of: a current volume value exceeding a maximum capacity of the ostomy bag; the current volume being a negative volume; the current volume value being less than the previous volume value by an amount less than a threshold drain volume; whether a patient may be connected to the ostomy bag being inconclusive.

[0076] In some configurations, the hardware processor may be further configured to output that a drain of the ostomy bag has occurred in response to determining that a volume value from a time before the second volume value may be above a minimum threshold value.

[0077] In some configurations, the minimum threshold value may be about 100 mL.

[0078] In some configurations, a method of detecting a draining level of an ostomy bag of a draining device can include: under control of a hardware processor, at a first time, obtaining a first resistance value from a resistance sensor coupled with the ostomy bag; converting the resistance value to a first volume value; determining that the first volume value may be a positive value; at a second time after the first time, obtaining a second resistance value from the resistance sensor; converting the second resistance value to a second volume value; determining that a difference between the first and second volume values exceeds a negative volume threshold, and that the second time may be a predetermined duration after the first time; and in response to said determining that the first volume value may be a positive value, that difference between the first and second volume values exceeds the negative threshold value, and that the second time may be the predetermined duration after the first time, outputting that a drain of the ostomy bag has occurred.

[0079] In some configurations, the predetermined duration may be at least about 30 minutes.

[0080] In some configurations, the predetermined duration may be at least about

1 hour.

[0081] In some configurations, the predetermined duration may be at least about

2 hours.

[0082] In some configurations, the predetermined duration may be at least about

3 hours.

[0083] In some configurations, a resistance value of the resistance sensor may correspond to a degree of bending of the resistance sensor, the degree of bending varying according to the fill level of the ostomy bag.

[0084] In some configurations, a polarity of the resistance value may vary according to a direction of bending of the ostomy bag, a positive resistance value resulting from filling of the ostomy bag and a negative resistance value not resulting from filling of the ostomy bag.

[0085] In some configurations, the resistance sensor may be attached across a width of the ostomy bag.

[0086] In some configurations, the method may include receiving calibration information for converting the first and second resistance values to the first and second volume values.

[0087] In some configurations, the calibration information may be determined by measuring calibration resistance data at different simulated bends of the resistance sensor.

[0088] In some configurations, the calibration information can include a calibration fit based on the calibration resistance data.

[0089] In some configurations, the calibration information may vary based on an ostomy bag orientation.

[0090] In some configurations, the ostomy bag orientation can include a supine or vertical orientation. [0091] In some configurations, the ostomy bag orientation may be determined by at least one of: a user input or an inertial measurement sensor.

[0092] In some configurations, the method may include resetting a fill level of the ostomy bag to zero in response to any of: the hardware processor outputting that a drain of the ostomy bag has occurred; the hardware processor receiving a user input that the ostomy bag has been drained; and/or the hardware processor detecting a patient and/or resistance sensor disconnection from the ostomy bag.

[0093] In some configurations, the user input can include a tapping of a drain button on a user interface of a user device in electronic communication with the hardware processor.

[0094] In some configurations, the method may include only resetting the fill level in response to receiving the user input that the ostomy bag has been drained.

[0095] In some configurations, the method may include generating an alarm when outputting that a drain of the ostomy bag has occurred but the user input that the ostomy bag has been drained has been received.

[0096] In some configurations, the method may include keeping a previous volume value as the fill level of the ostomy bag in response to any of: a current volume value exceeding a maximum capacity of the ostomy bag; the current volume being a negative volume; the current volume value being less than the previous volume value by an amount less than a threshold drain volume; whether a patient may be connected to the ostomy bag being inconclusive.

[0097] In some configurations, the method may include outputting that a drain of the ostomy bag has occurred in response to determining that a volume value from a time before the second volume value may be above a minimum threshold value.

[0098] In some configurations, the minimum threshold value may be about 100 mL.

[0099] In some configurations, a method of detecting a fill level of an ostomy bag of a draining device can include: under control of a hardware processor, at a first time, obtaining a first resistance value from a resistance sensor coupled with an ostomy bag; converting the first resistance value to a first volume value; at a second time after the first time, obtaining a second resistance value from the resistance sensor; converting the second resistance value to a second volume value; determining that the second volume value may be lower than the first volume value; and in response to said determining, replacing the second volume value with the first volume value.

[0100] In some configurations, a resistance value of the resistance sensor may correspond to a degree of bending of the resistance sensor, the degree of bending varying according to the fill level of the ostomy bag.

[0101] In some configurations, the resistance sensor may be attached across a width of the ostomy bag.

[0102] In some configurations, the method may include receiving calibration information for converting the first and second resistance values to the first and second volume values.

[0103] In some configurations, the calibration information may be determined by measuring calibration resistance data at different simulated bends of the resistance sensor.

[0104] In some configurations, the calibration information can include a calibration fit based on the calibration resistance data.

[0105] In some configurations, the calibration information may vary based on an ostomy bag orientation.

[0106] In some configurations, the ostomy bag orientation can include a supine or vertical orientation.

[0107] In some configurations, the ostomy bag orientation may be determined by at least one of: a user input or an inertial measurement sensor.

[0108] In some configurations, the method may include comprising resetting the fill level of the ostomy bag to zero in response to any of: outputting that a drain of the ostomy bag has occurred; receiving a user input that the ostomy bag has been drained; and/or detecting a patient and/or resistance sensor disconnection from the ostomy bag.

[0109] In some configurations, the method may include comprising outputting that a drain of the ostomy bag has occurred in response to determining that a difference between a current volume value and a previous volume value may be negative and exceeds a threshold drain volume. [0110] In some configurations, the user input can include a tapping of a drain button on a user interface of a user device in electronic communication with the hardware processor.

[0111] In some configurations, the method may include only resetting the fill level in response to receiving the user input that the ostomy bag has been drained.

[0112] In some configurations, the method may include generating an alarm when outputting that a drain of the ostomy bag has occurred but the user input that the ostomy bag has been drained has not been received.

[0113] In some configurations, the method may include keeping a previous volume value as the fill level of the ostomy bag in response to any of: a current volume value exceeding a maximum capacity of the ostomy bag; the current volume being a negative volume; the current volume value being less than the previous volume value by an amount less than a threshold drain volume; the hardware processor being inconclusive whether a patient may be connected to the ostomy bag.

[0114] In some configurations, a method of detecting a fill level of an ostomy bag of a draining device, the method comprising: under control of a hardware processor, at a first time, obtaining a first resistance value from a resistance sensor coupled with an ostomy bag; converting the resistance value to a first volume value; determining that the first volume value exceeds a minimum threshold value; at a second time after the first time; obtaining a second resistance value from the resistance sensor; converting the second resistance value to a second volume value; determining that the second volume value exceeds a negative volume threshold; and in response to said determining that the first volume value exceeds a minimum threshold value and that the second volume value exceeds a negative volume threshold, outputting that a drain of the ostomy bag has occurred.

[0115] In some configurations, a resistance value of the resistance sensor may correspond to a degree of bending of the resistance sensor, the degree of bending varying according to the fill level of the ostomy bag.

[0116] In some configurations, a polarity of the resistance value may vary according to a direction of bending of the ostomy bag, a positive resistance value resulting from filling of the ostomy bag and a negative resistance value not resulting from filling of the ostomy bag. [0117] In some configurations, a resistance sensor may be attached across a width of the ostomy bag.

[0118] In some configurations, the minimum threshold value may be about 100 mL.

[0119] In some configurations, the method may include receiving calibration information for converting the first and second resistance values to the first and second volume values.

[0120] In some configurations, the calibration information may be determined by measuring calibration resistance data at different simulated bends of the resistance sensor.

[0121] In some configurations, the calibration information can include a calibration fit based on the calibration resistance data.

[0122] In some configurations, the calibration information may vary based on an ostomy bag orientation.

[0123] In some configurations, the ostomy bag orientation can include a supine or vertical orientation.

[0124] In some configurations, the ostomy bag orientation may be determined by at least one of: a user input or an inertial measurement sensor.

[0125] In some configurations, the method may include resetting a fill level of the ostomy bag to zero in response to any of: outputting that a drain of the ostomy bag has occurred; receiving a user input that the ostomy bag has been drained; and/or detecting a patient and/or resistance sensor disconnection from the ostomy bag.

[0126] In some configurations, the user input can include a tapping of a drain button on a user interface of a user device in electronic communication with the hardware processor.

[0127] In some configurations, the method may include only resetting the fill level in response to receiving the user input that the ostomy bag has been drained.

[0128] In some configurations, the method may include generating an alarm when outputting that a drain of the ostomy bag has occurred but the user input that the ostomy bag has been drained has not been received.

[0129] In some configurations, the method may include keeping a previous volume value as the fill level of the ostomy bag in response to any of: a current volume value exceeding a maximum capacity of the ostomy bag; the current volume being a negative volume; the current volume value being less than the previous volume value by an amount less than a threshold drain volume; whether a patient may be connected to the ostomy bag being inconclusive.

[0130] In some configurations, the method may include outputting that a drain of the ostomy bag has occurred in response to determining that the second time may be a predetermined duration after the first time.

[0131] In some configurations, the predetermined duration may be at least about 30 minutes.

[0132] In some configurations, the predetermined duration may be at least about

1 hour.

[0133] In some configurations, the predetermined duration may be at least about

2 hours.

[0134] In some configurations, the predetermined duration may be at least about

3 hours.

BRIEF DESCRIPTION OF THE DRAWINGS

[0135] Various examples are depicted in the accompanying drawings for illustrative purposes, and should in no way be interpreted as limiting the scope of the disclosure. Furthermore, various features of different disclosed examples can be combined to form additional examples, which are part of this disclosure.

[0136] Figure 1 A illustrates a perspective view of an example ostomy bag having an example resistance sensor.

[0137] Figure 1B illustrates an enlarged view of example attaching mechanisms for attaching the resistance sensor of Figure 1 A to an outside surface of the ostomy bag.

[0138] Figure 1C illustrates a perspective view of another example attaching mechanism for attaching the resistance sensor of Figure 1A to an outside surface of the ostomy bag.

[0139] Figure 1D illustrates schematically how electronic components of the resistance sensor of Figure 1 A interact with one another. [0140] Figure 1E illustrates an example screenshot of an application paired with a resistance sensor attached to an ostomy bag.

[0141] Figure 2A illustrates an example theoretical drainage curve of an ostomy bag.

[0142] Figure 2B illustrates an example volume signal over time based on resistance readings of a resistance sensor attached to an ostomy bag.

[0143] Figure 2C illustrates an example user interface of an application paired with a resistance sensor attached to an ostomy bag.

[0144] Figure 2D illustrates an example polynomial regression curve for calibrating a raw fill volume of an ostomy bag based on resistance readings of a resistance sensor attached to an ostomy bag.

[0145] Figure 3 A illustrates an example flow chart of a volume signal smoothing algorithm.

[0146] Figure 3B illustrates another example flow chart of a volume signal smoothing algorithm.

[0147] Figure 4 illustrates an example flow chart of resetting an algorithmic volume to zero.

[0148] Figure 5 illustrates an example flow chart of keeping an algorithmic volume at a previous value.

[0149] Figure 6 illustrates example graphs of raw volume, algorithmic volume, predicted drain time points, and user-set drain time points using the algorithms of Figures 3B-5.

[0150] Figures 7A illustrates an example shape of an ostomy bag with a positive raw volume reading.

[0151] Figure 7B illustrates an example shape of an ostomy bag with a negative raw volume reading.

[0152] Figure 8A illustrates an example flow chart of a drain point prediction algorithm.

[0153] Figure 8B illustrates application of the algorithm of Figure 8A on the example volume signal over time of Figure 2B. [0154] Figure 9 illustrates a schematic overview of an example ostomy monitoring environment incorporating a resistance sensor and other sensors.

DETAILED DESCRIPTION

[0155] Aspects of the disclosure are provided with respect to the figures and various examples. Other examples and configurations of the devices and methods disclosed herein can still fall within the scope of this disclosure even if not described in the same detail as some other examples. Aspects of various examples discussed do not limit scope of the disclosure herein, which is instead defined by the claims following this description.

Introduction

[0156] An ostomy bag can be a medical bag that collects human waste (either stools, urine, or both) from patients who cannot excrete waste naturally due to medical issues, which include, among others, cancer, trauma, inflammatory bowel disease (IBD), bowel obstruction, infection and fecal incontinence. In such cases, a surgical procedure is performed whereby a waste passage is created. This waste passage can be the ureter (called an urostomy), the small bowel or ileum (called an ileostomy, part of the small intestine) or the large bowl or colon (called a colostomy, part of the large intestine), which may be diverted to an artificial opening in the abdominal wall, thus resulting in part of the specific internal anatomy, to lie partially outside the body wall. This procedure can be referred to as an ostomy, and the part of the waste passage which is seen on the outside of the body can be referred to as a stoma.

[0157] A problem facing ostomy patients is leakage at the ostomy site, for example, due to overfilling of the ostomy bag. It can be difficult for some users to detect when an ostomy bag is full. This is particularly the case because an ostomy bag typically reaches its designed capacity before it appears full to a user. The designed capacity of an ostomy bag may be less than its apparent capacity to avoid leakage back into the stoma. In addition, a user may forget to check the ostomy bag and thus may accidentally permit the bag to overflow. Leakage can be uncomfortable, embarrassing, and damaging to clothing and skin, and/or can create skin irritation and inflammation. [0158] This disclosure describes examples of systems and methods for automatically detecting volume and/or drainage of an ostomy bag. The systems and methods can be used in the context of an ostomy monitoring system, such as disclosed herein, for colostomies, ileostomies, urostomies, and the like. One example system can include a resistance sensor attached to an ostomy bag to measure drain volume data, which can provide users, such as ostomy patients and healthcare professionals with useful trend data relating to the draining of fluids and/or solids in patients who are wearing the bags.

[0159] The ostomy system can include an ostomy wafer used together with an ostomy bag. The ostomy wafer may also be integrated together with the ostomy bag. The bag and/or wafer can include one or more sensors, such as a resistance sensor, capacitive sensors, thermistors, or otherwise. Further, an example system may also include one or more wireless transmitters that transmit data from the ostomy wafer and/or ostomy bag to another device, such as an electronics hub, a user device, a clinician device, and/or a back-end system. For example, the ostomy wafer and/or the ostomy bag can wirelessly transmit data to a hub coupled to the ostomy bag, and the hub can transmit the received data to a back-end system (such as cloud servers). A user device (for example, a smartphone or tablet) can download the data and other information from the remote server.

[0160] Figures 1A-1C illustrates an example volume or ostomy bag level sensor, which can include a flexible resistor element 10. The resistor element 10 can extend substantially across an entire width of an ostomy bag 11. A clip or any other suitable attaching mechanism can be provided at each end of the resistor element 10 to clamp the flexible resistor element 10 to the surface of the ostomy bag 11. As shown in Figure 1A, the resistor element 10 can be attached to the ostomy bag 11 by clips 12 and 13.

[0161] The flexible resistor element 10 may be a commercially available resistor such as the“Flex Sensor” from Spectra Symbol, which has a flat resistance of 10K Ohms and a bend resistance range of from 60K to 11 OK Ohms. The relationship between the electrical resistance and the degree of flexing in the resistor element 10 can remain consistent or substantially consistent over multiple lifecycles (for example, at least 10 cycles, at least 100 cycles, at least 1,000 cycles, or any ranges between those values) of the flexible resistor element 10. [0162] The resistor element 10 can include an active portion having an electrical resistance that changes in dependence upon its degree of flexing. The resistor element 10 can include a resilient casing to facilitate“spring back” of the element after it has been flexed. The resistor element 10 can also include a plurality of, such as two, conductor wires. The conductor wires can be connected to the active portion such that the active portion is connected in series between the wires. The wires can be arranged such that the free end of each wire extends out of the same end of the resilient casing and terminates within one of the clips 12, 13.

[0163] As shown in Figures 1B and 1C, the clips 12, 13 can have a top portion 22, 23 and a clamp portion 32, 33. Figures 1B and 1C illustrate different example configurations of the top portion 22, 23, and the clamp portion 32, 33. Other configurations are also possible. The top portion 22, 23 can be connected to the clamp portion 32, 33 by a hinge 15, which allows the top portion 22, 23 to rotate relative to the clamp portion 32, 33, and thereby rise as the flexible ostomy bag fills. As shown in Figure 1B, a plurality of inwardly directed teeth 14 can optionally be formed on inwardly facing surfaces of the clips 12, 13 to grip the outside surface of the bag 11 and/or the resistor element 10. The teeth 14 can help in reducing and/or preventing movement of the resistor element 10 with respect to the outside surface of the bag 11.

[0164] A schematic diagram of the electronic function of the resistor element 10 is shown in Figure 1D. The flexible resistor element 10 can be connected to the microprocessor 17, which can be located on the resistor element 10, on the clips 12, 13, or on the ostomy bag 11 (such as on the bag itself or on an electronic hub inserted into the bag). The microprocessor 17 can be located on the resistance sensor and be in electrical communication with a microprocessor on the ostomy bag 11 (such as on the bag itself or on an electronic hub inserted into the bag). The microprocessor 17 can periodically or continuously read the electrical resistance of the resistor element 10 and convert the detected resistance to a digital signal by an on-board Analogue to Digital Converter (ADC). The digital signal corresponding to the electrical resistance can be outputted periodically (for example, every 1, 2 or 5 minutes), or continuously, to a Bluetooth module 18, which is programmed to transmit the signal to a receiver via Bluetooth. The Bluetooth module 18 can also be located on the ostomy bag 11 (such as on the bag itself or on an electronic hub inserted into the bag). The Bluetooth module can be replaced by any other suitable wireless communication modules.

[0165] The microprocessor 17 and Bluetooth module 18 can be powered by a small battery 19 via a switching regulator 20. Both the microprocessor 17 and the Bluetooth module 18 can be connected to a debug connector 21 to facilitate programming by any methods. The microprocessor 17, Bluetooth module 18, battery 19, switching regulator 20 and the debug connector 21 can be all housed within one of the clips 12, 13. The microprocessor 17 can be switched on or off by a button 16, which can located on the top portion 22, 23 of the clip 12, 13, such as shown in Figures 1B and 1C.

[0166] In use, the flexible resistor element 10 can be fastened to the flexible bag 11 by the clips 12 and 13, and the flexible bag 11 can be attached to a stoma. The conductor wires of the resistor element 10 can be connected (for example, by a connector) to the microprocessor 17, which reads the value of the flexible resistor element 10 through the Analogue to Digital Converter (ADC). The microprocessor 17 can subsequently generate a digital signal corresponding to the electrical resistance of the resistor element 10 and communicate this signal to the Bluetooth module 18.

[0167] In use, the Bluetooth module 18 can be paired to a wireless receiver of a portable device, such as a mobile phone, which runs an application, such as an android application.

[0168] An example screen shot of an Android application is shown in Figure 1E. The screen shows“home” and“back” buttons 25, and three tabs 26, labelled“Status”, “alarms” and“devices”, which can provide navigation throughout the application.

[0169] The“status” display (such as shown in Figure 1E) can be set up to advise the user of the current connection status 27 of the wireless receiver and to provide the user with a visual representation of the current content level of the bag 28 (which in Figure 1E is shown as a percentage of fullness and can be shown in other forms of visual representation). The“status” display can also allow the user to switch the application into“sleep mode” 29, when the user is about to adopt a sitting or prone position.

[0170] In the“sleep mode” the application can optionally use a set of stored reference data (correlating the value of electrical resistance of the resistor element 10 to the actual content level of the bag 11 when the user is lying down) to interpret the signal received from the Bluetooth module and adjust the“apparent” content level of the bag 11 accordingly. This allows the resistance sensor disclosed herein to more accurately detect the progressive filling of the ostomy bag 11 even when the user adopts a sitting or prone position (as compared to standing).

[0171] The resistor element 10, the clips 12, 13, and/or the ostomy bag 11 can include an accelerometer. The user interface of the application can be configured to allow the user to calibrate the accelerometer with respect to an upright position of the bag, and thereby to generate a value corresponding to a degree of deviation from the upright position. The accelerometer can be calibrated in a number of orientations, including, for example, when the user is standing upright, lying down, and lying sideways.

[0172] On receiving a digital signal corresponding to the orientation of the bag 11 the application can use a set of stored reference data (correlating the value of electrical resistance of the resistor element 10 to the actual content level of the bag 11 when the bag 11 is so orientated) to interpret the signal and adjust the“apparent” content level of the bag 11 accordingly. For example, if the accelerometer signals that the bag 11 is orientated such that it is 20% upright and 80% lying down (such as when the user is reclined), the application can calculate the actual content level of bag 11 by correlating the value of electrical resistance of the resistor element 10 to the actual content level of the bag 11 when the user is (i) standing upright and (ii) lying down, and adding together 20% of value (i) and 80% of value (ii). This allows the resistance sensor to more accurately detect the progressive filling of the flexible bag 11 even when the bag is orientated at one or more degrees of deviation from the upright position.

[0173] Figure 2A illustrates an example ideal or theoretical signal from a resistance sensor configured to measure a fill level of a flexible bag, such as an ostomy bag. As shown in Figure 2A, resistance readings from the resistance sensor are expected to result in volume measurements that gradually increase as the bag collects more fluid and/or solid. The curve can terminate at a spike 202 and immediately drop 204 when a user drains the bag. The ideal volume curve can repeat cycles of gradual increase and an immediate drop.

[0174] However, the resistance sensor can collect noises due to various reasons. The reasons can include, for example, the bag being not stable (such as wrinkling and/or bending), the patient being in a supine position and/or having a laptop, tablet, book, or other object, on the patient’s belly, or the patient moving around while wearing the draining device. Figure 2B illustrates example volume data points calculated based on the resistance sensor readings. The ideal volume over time curve can be masked by the noises, such as noise spikes which can resemble the spike at the actual drain time point. It can be difficult to filter out the noises without eliminating the spikes due to draining.

[0175] As describe above, accelerometer or any other motion sensor can be worn on the patient, such as by being positioned on the ostomy bag, a processing hub of the device, or elsewhere. Motion signals from the motion sensor can be processed to provide information related to the patient’s posture and/or movements, but the posture and/or movement data may not be sufficient to remove the noise data points without also removing the drain data points. Accordingly, calibrating the resistance sensor based on reading of the optional accelerometer alone may not be effective in reducing the noise in the signal.

[0176] Another difficulty in accurately monitoring the volume and drainage of an ostomy bag will now be described with reference to Figure 2C, which illustrates a user-end mobile application or web application that can allow a user, such as a patient wearing the draining device, to manually reset the value of the bag fill volume to zero. The application user interface can include a“Drain” button 106. When a user empties or drains the bag, the user can press the“Drain” button 106 to reset the volume value to zero. The user-input draining point can be used to confirm a drainage detected by the resistance sensor.

[0177] However, users do not always remember to press the“Drain” button when the user drains the bag. For example, the user’s device (such as a smartphone, laptop, tablet, etc.), which runs the application, can be in a different room from where the user drains the bag (such as in a bathroom). The user may forget to press the button after the user returns to the room in which the smartphone is located.

[0178] The“Drain” button can also be located on the ostomy bag or sensor instead of in the mobile application. A user may be less likely to forget to press the“Drain” button on the bag as the user empties the bag. However, it can be expensive to design or redesign the bag to incorporate hardware for a“Drain” button.

[0179] Accordingly, it can be desirable to be able both predict whether the user has drained the bag based on the resistance sensor readings using prediction algorithms and receive input from users via the“Drain” button on the mobile application. To improve user compliance in using the“Drain” button on the mobile application, the application can incorporate an activity tracker that can allow patients, healthcare professionals, and/or other interested parties to monitor the draining history. To improve prediction of a drain point with readings from the resistance sensor, various data smoothing algorithms can be implemented on the application and/or on a remote server.

[0180] The application shown in Figure 2C can also include a user interface displaying the status of a connected ostomy bag, such as shown in Figure 1E, and/or incorporate any of features of the user interface in Figure 1E and its application as described above.

[0181] The application shown in Figure 2C can also include a user interface which allows the user to set one or more alarms in order to alert the user when the content level of the bag exceeds a predetermined threshold level. The user interface can also allow the user to edit the settings of the alarm, including, for example, its melody, volume, and/or duration, and can also allow for an alarm to be removed or cancelled.

[0182] In addition to showing the user the current Bluetooth module (or any other wireless communication module) which is paired to the mobile phone (if any), the application also can allow the user to scan for other modules, and pair them with the mobile phone. The application also allows the user to un-pair the mobile phone from a paired Bluetooth module.

[0183] The application can also be configured to produce an output graph, which can plot the volume of fluid and/or solid collected by the bag over a time period selected by the user. In addition, the application can store the user's details, such as name, patient number, their physician's email address, and/or the like and can be programmed to send these output graphs to the user's physician and/or other interested parties (such as device manufacturer, insurance company, or otherwise).

Calibration

[0184] Before applying the smoothing algorithms disclosed herein, the resistance sensor readings can be converted to raw volume readings. Regression analysis software, using a polynomial regression algorithm, can be used for this calculation. [0185] Calibration may be performed prior to shipping a sensor to a patient to develop coefficients for the linear regression equation for a particular sensor. In this calibration, initial measurements of an ostomy bag with different amount of bends due to different fill levels can be made. The initial measurements can be used to create a testing jig that can simulate the curve of the bag at different fill levels in supine and/or vertical positions. Each resistance sensor can be calibrated using the testing jig before leaving the manufacturing facility. It can be desirable to calibrate each resistance sensor because resistance sensors can drift. It can be challenging in manufacturing to replicate the flex or bend of every sensor to the same extent so as to get the same resistance value for the same amount of flex in every sensor. The resistance values of a certain amount of flex can vary among different sensors by about 20% or more.

[0186] In an example calibration process, a sensor’s resistance measurement at simulated bends of 0 mL, 50 mL, 100 mL, 150 mL, 200 mL, 250 mL, 300 mL, and/or any other fill volume can be obtained using the testing jig. The measurements can be fed into a polynomial regression algorithm. As illustrated in Figure 2D, an example calibration equation can be a quadratic equation, V = C3r^A2 + C2r + Cl, with Cl, C2, and C3 being coefficients of the equation and r representing resistance. The polynomial regression algorithm can determine the coefficient Cl, C2, and C3 for each sensor based on the measurements fed into the program. Other orders of equations can be used in any linear regression program to fit the calibration measurements.

[0187] The coefficients for each sensor can be store in the cloud, such as on a remote server. When a user receives the sensor, the user can download the coefficients for the particular sensor using the mobile application described above by pairing the application to the sensor. For example, the user can scan a bar code or a QR code of the sensor, using the mobile application, which can in turn obtain the coefficients from the remote server automatically. The user can also enter the device serial number or any other identifying information, for example, on the manufacturer’s website, so as to search for and download the coefficients for the sensor from the remote server. Alternatively, the sensor can have a memory device to store the coefficients for the sensor that is programmed with the coefficients at the manufacturing facility. [0188] Prior to using the resistance sensor to detect a fill level of the ostomy bag, the user can further calibrate the resistance sensor by pressing a“Calibrate” button on the user interface of the application (see, for example,“Calibrate” button 106 in Figure 2C). Pressing the“Calibrate” button can send an initial resistance reading of the resistance sensor to the application. The initial resistance reading can be a reading when the bag is empty and/or flat. The application can optionally provide instructions to the user to make sure the bag is empty and/or to wear the empty bag before pressing the“Calibrate” button. The initial resistance read can be a calibration or“flat” value of the sensor. The resistance value r of the calibration equation can be obtained by subtracting the“flat” value from the raw sensor resistance reading. The“flat” value can cause the calibration curve to be shifted up or down along the volume axis. The“flat” value can also be user-specific, for example, depending on a body shape and/or position of the user when the user presses the“Calibrate” button.

Combination of Smoothing Algorithms & User Input

[0189] After the sensor calibration value and the coefficients (for example, Cl, C2, and C3) have been retrieved onto the applications, the processing hub of the ostomy device can send raw resistance readings of the sensor to the application as the bag undergoes cycles of collecting waste from a patient’s body and being drained. The application can calculate a raw volume value based on the raw resistance reading, the calibration value, and the coefficients.

[0190] However, the calibration process still may not remove the noise signals described above. Accordingly, the raw volume values can include a large number of noise readings so that it can be difficult to distinguish the actual drain data points from the noise.

[0191] The present disclosure provides example smoothing algorithms that can make corrections to the raw volume data points. The smoothing algorithms can filter out or attenuate noise or data points that do not fall on the volume curve of the resistance sensor, such as the curve shown in Figure 2A. The smoothing algorithms can also interpret the raw volume data points to determine whether a data point represents a drain, a minor expulsion from the patient’s body, an abundance of air, or whether a data point is an actual volume data point on the volume curve of the resistance sensor. The smoothing algorithms can also classify the data points accordingly. The algorithms described herein and the raw volume data points can be stored in a memory device accessed by the application (for example, a memory of the user device). The algorithms described herein and the raw volume data points can also be stored on the remote server. Some or all the data and software can be optionally stored on the remote server and/or in the user device.

[0192] Figure 3A illustrates an example smoothing algorithm. At decision block 300, the server can determine whether the sensor is attached to the bag. When the sensor is detached form the bag, the device may send junk data to the application, which is connected to the remote server. The server can instruct the application to reset the volume measurement to zero at block 302. The application can also reset the volume measurement to zero without instructions from the server.

[0193] At block 304, the application can receive resistance sensor readings from the processing hub of the device. At block 306, the application can calculate the raw volume measurement based on the incoming resistance reading using the calibration equation described above.

[0194] At decision block 308, the application can determine whether the raw volume measurement, V, is lower than the previous raw volume measurement by more than a threshold drain volume. As the maximum filling capacity of an ostomy bag may be known (or inputted into the mobile application by the user), the threshold drain volume can be determined accordingly. For example, the threshold drain volume can be about 120 mL for when the user is in a vertical position. The threshold drain volume for a supine position can be lower than the threshold drain volume for a vertical position. For example, the maximum filling capacity of the ostomy bag when the user is in a supine position can be about half of the maximum filling capacity when the user is in a vertical position.

[0195] If the decrease in the raw volume measurement has not exceeded the threshold drain volume, the application can return to block 300 to repeat the algorithm. The application can also optionally update the smoothed volume reading to V at block 322 before returning to block 300. If the decrease in the raw volume measurement has exceeded the threshold drain volume, the application can classify the data point as a drain point at block 310. The application can also reset the volume measurement to zero before returning to block 300. [0196] The smoothing algorithm in Figure 3 A may not capture every drain point and can mistake one of the actual drain points as noise. Missing any drain point can result in inaccurate cumulative volume calculations. A cumulative drain volume can be calculated by summing up all the increases, or positive changes, in volume measurements over time.

[0197] Figure 3B illustrates another example smoothing algorithm that can also improve accuracy in identifying the drain points. At decision block 300, the server can determine whether the sensor is attached to the bag. When the sensor is detached form the bag, the device can send junk data to the application, which is connected to the remote server. The server can instruct the application to reset the volume measurement to zero at block 302. The application can also reset the volume measurement to zero without instructions from the server.

[0198] At decision block 303, the application can determine whether the patient is attached to the bag, for example, by analyzing a motion signal from the motion sensor (such as the accelerometer described above). If the motion sensor indicates that the patient is disconnected from the ostomy bag, the application can set a smoothed volume to 0 mL at block 302.

[0199] If the motion sensor indicates that the user is neither stationary nor moving, the raw volume data point can be classified as inconclusive and may be ignored. The application can move to block 314 to keep the previous smoothed volume measurement.

[0200] If the motion sensor indicates that the user is connected to the ostomy bag, at block 304, the application can receive resistance sensor readings from the processing hub of the device. At block 306, the application can calculate the raw volume measurement based on the incoming resistance reading using the calibration equation described above.

[0201] At decision block 312, the application can determine whether the raw volume measurement, V, is higher than the maximum filling capacity of the bag, or a negative value. If the raw volume measurement, V, is higher than the maximum filling capacity of the bag, or a negative value, it is likely the raw volume measurement is noise. The bag cannot be filled to beyond its maximum capacity. Nor can the bag have a negative fill volume. The application can ignore this raw volume data point and keep the previous smoothed volume measurement at block 314. Negative fill volume readings may be generated when the sensor bends inward, toward the user (for example, if the user puts a book or other object on the sensor).

[0202] If the raw volume measurement, V, is positive and lower than the maximum filling capacity of the bag, at decision block 316, the application can determine whether the raw volume measurement, V, has decreased from the previous volume measurement. The previous volume measurement can be a previous smoothed or algorithmic volume measurement. The previous volume measurement can also be a previous raw volume measurement. The filling level in the bag would not be expected to decrease except when the bag is drained. Therefore, if the volume measurement has decreased from the previous volume measurement (such as the smoothed volume measurement), the application can determine at block 308 whether the raw volume measurement, is lower than the previous volume measurement (such as the smoothed volume measurement) by more than a threshold drain volume as described above.

[0203] If the decrease in the volume measurement has not exceeded the threshold drain volume, the application can treat the raw volume data point as sensor drift, which can be ignored, and move to block 314 to keep the previous smoothed volume measurement.

[0204] If the decrease in the volume measurement has exceeded the threshold drain volume, the application can classify the incoming data point as a drain point at block 310. The application can also reset the volume measurement to zero before returning to block 300.

[0205] If the raw volume measurement V is greater than the previous smoothed volume measurement, the application can classify the data point as expulsion, or discharge from the user’s body, at step 320. Although the data point can also be caused by noise or a large amount of air, it can be unlikely for the resistance sensor to pick up noise of such a large magnitude. The application can then update the smoothed volume measurement to V, the incoming raw volume measurement, at block 322. The application can return to block 300 to repeat the algorithm.

[0206] As described above, the smoothing algorithms can be combined with user inputs to improve accuracy in determining the drain points and also in calculating the cumulative drain volume. As shown in Figure 4, the application can reset the smoothed or algorithmic volume measurement to zero when there has been a drain point and/or the user is disconnected from the device, and/or when the sensor is detached from the device. In addition, the application can also reset the smoothed or algorithmic volume measurement to zero when the user presses the“Drain” button. Pressing the“Drain” button can cause the application to send a data point, such as the“flat” value, to reset the smoothed or algorithmic volume measurement.

[0207] As shown in Figure 5, the smoothing algorithm of Figure 3B can ignore the incoming raw volume measurement and keep the previous smoothed volume measurement under various conditions. The conditions can include: when the incoming raw measurement exceeds the maximum filling capacity, is negative, is lower than the previous smoothed volume measurement but not exceeding the threshold drain volume, and/or when it is indeterminate whether the user is connected to the device. These conditions can improve accuracy in filtering out noises without eliminating the drain data points.

[0208] Figure 6 illustrates example graphs of raw volume measurements calculated from the resistance sensor readings, and algorithmic volumes by implementing the algorithms of Figures 3B-5. As shown in Figure 6, although the raw volume measurements fluctuated between Time 12-19-13 and Time 12-19-19, the smoothed or algorithmic volume measurements increased gradually in the same time period. For example, the raw volume measurement calculated from the resistance sensor reading showed a small spike 602 of about 200 mL at about Time 12-19-17. However, the raw measurement was still lower than the previous smoothed or algorithmic volume 604 of around 280 mL since around Time 12- 19-15. Accordingly, the application still held the smoothed volume measurement at the previous algorithmic volume since around Time 12-19-15.

[0209] As further illustrated in Figure 6, the smoothing algorithm of Figure 3B-5 classified a drain point 606 at around Time 12-19-19, indicated by a square diamond. The user also pressed the“Drain” button shortly after Time 12-19-19 as indicated by an elongate diamond 608. Figure 6 also illustrates that the algorithm-determined drain points (square diamonds 610, 614) at Time 12-19-21 and Time 12-19-23 also coincided substantially with the user-determined drain points (elongate diamonds 612, 616). Accordingly, the algorithms of Figures 3B-5 can improve accuracy in identifying the actual drain points despite the noises in the raw volume measurements. [0210] Further, the application can optionally set the bag status to having been drained, that is, to zero, only after a user has pressed the“Drain” button, regardless of the algorithm-determined drain points. If a user has drained the bag but has not pressed the “Drain” button, the application can show that the bag is still full. The user can be reminded to press the button when the user views the bag status on the application. The application can also send notifications to the user to remind or prompt the user to press the“Drain” button.

[0211] In addition, if the application indicates that the bag is still full when the bag has been emptied because the user has not pressed the“Drain” button, the smoothing algorithm described above with reference to Figures 3B-5 can output high smoothed volume measurements for an extended period of time. This can be due to the smoothing algorithm ignoring any decrease in the volume measurement that is not classified as a drain, resulting in the smoothed volume measurement being held at the highest pre-drain value. The application can optionally send a notification to the user to prompt the user to press the“Drain” button after having received a predetermined number (for example, 10, 25, 50, or more) of high smoothed volume values, such as a value exceeding 250 mL or otherwise. The application can also optionally send a notification to the user to prompt the user to press the“Drain” button when the difference between a lower incoming raw value and a higher smoothed value exceed a predetermined limit (such as 250 mL or otherwise). The application can also optionally send a notification to the user to prompt the user to press the“Drain” button when the cumulative drain volume exceeds a daily drain limit (such as 2 L or otherwise).

Additional Example Smoothing Algorithm

[0212] In some application of the draining device disclosed herein, the user may not always have access to an application for pressing the“Drain” button or otherwise inform the remote server or a hospital application that the bag has been emptied. For example, hospitals using the device on the hospitalized users may not have the mobile application described herein. It can be desirable to have an algorithm for reliably determining the drain points using the resistance sensor readings without requiring confirmation from the user that the bag has been emptied.

[0213] Figure 8A illustrates an example algorithm for determining drain points based on the resistance sensor readings that need not require confirmation from the users. The algorithm makes use of the negative volume measurements, which are typically disregarded as noise. As shown in Figures 7A and 7B, when the ostomy bag lies flat and is filled with fluid and/or solids, the bag can bulge outward and cause the resistance sensor attached to a surface 702 of the bag to bend with the bag. The resistance sensor can output a positive resistance reading, which can be converted to a positive raw volume measurement. However, as shown in Figure 7B, the surface on which the resistance sensor is mounted 704 can also deform in a different direction such that the resistance sensor outputs a negative reading, which can be converted to a negative raw volume measurement.

[0214] The bag can be more prone to deformation, such as bending and/or wrinkling, when the bag is relatively empty (such as when the bag fill is below about 100 mL). As the bag becomes fuller, it can be more difficult to the bend the surface of the bag on which the sensor is mounted so as to result in a negative resistance reading.

[0215] As shown in Figure 8A, at decision block 800, the server can determine whether the sensor is attached to the bag. When the sensor is detached from the bag, the device can send junk data to the application, which is connected to the remote server. The server can instruct the application to reset the volume measurement to zero at block 802. The application can also reset the volume measurement to zero without instructions from the server.

[0216] At decision block 803, the application can determine whether the patient is attached to the bag, for example, by analyzing a motion signal from the motion sensor described above. If the motion sensor indicates that the patient is disconnected from the ostomy bag, the application can set a smoothed volume to 0 mL at block 802.

[0217] If the motion sensor indicates that the user is neither stationary nor moving, the raw volume data point can be classified as inconclusive and be ignored. The application can move to block 814 to keep the previous smoothed volume measurement.

[0218] If the motion sensor indicates that the user is connected to the ostomy bag, at block 804, the application can receive resistance measurements of the sensor from the device. At block 806, the application can calculate the raw volume measurement based on the incoming resistance reading using the calibration equation described above.

[0219] At decision block 812, the application can determine whether the raw volume measurement, V, is a negative value. If the raw volume measurement, V, is a positive value, the application can return to block 800. The application can update the smoothed volume measurement to V at decision block 822 before returning to block 800. The application can also apply any of the conditions in Figure 5 to keep the previous volume measurement, such as when V exceeds the maximum fill capacity of the bag, when there is sensor drift, or when it is indeterminate whether the patient is connected to the device.

[0220] If the raw volume measurement, V, is a negative value, at decision block 824, the application can determine whether the decrease in volume measurement is greater than a drop threshold. The drop threshold can be between about 350 mL and about 450 mL, or between about 350 mL and about 400 mL, or any other value based on the maximum filling capacity of the ostomy bag.

[0221] If the volume decrease does not exceed the drop threshold, the application can ignore the incoming raw volume data point and keep the previous smoothed volume measurement at block 814. If the volume decrease exceeds the drop threshold, the application can determine at decision block 826 whether a predetermined amount of time has lapsed since the last negative reading was obtained, or whether the volume is greater than a predetermined volume amount. The predetermined amount of time can depend on the application of the ostomy bag and/or the maximum filling capacity of the bag, and can be about 30 minutes, 1 hour, 2 hour, 3 hour, or otherwise. The predetermined volume amount can be 100 mL for some bags but other values for others. As mentioned above, negative readings can be more frequent when the bag is relatively empty because the bag is more deformable, such as when the bag is under about 100 mL.

[0222] As it is less likely for the bag to bend in a direction that results in negative readings when the bag has been filled to a certain level (such as greater than about 100 mL or otherwise), a negative reading that is different from the previous volume measurement by more than the drop threshold after a certain time gap can likely be due to a drain of the bag. If the predetermined time gap has not lapsed since the last negative reading was obtain, the application can ignore the incoming raw volume data point and keep the previous smoothed volume measurement at block 814.

[0223] If the predetermined time gap has lapsed since the last negative reading was obtain, the application can classify the incoming raw data point as a drain point and reset the volume to 0 mL at block 818. The application can return to block 800 to restart the algorithm.

[0224] Figure 8B illustrates an example implementation of the algorithm of Figure 8 A on the raw volume signal shown in Figure 1B. As shown in Figure 8B, data point 850 can be a drain point. The data point 850 has a negative raw volume measurement. The decrease from the previous volume measurement 852 and the volume measurement of the data point 850, AV, is greater than a drop threshold. A time gap between the data point 850 and the last negative volume data point 854 is greater than a predetermined time gap.

[0225] The drop threshold and the time gap can be optimized as more data is collected using the combination of the smoothing algorithms and user input described above. The algorithm illustrated in Figures 8A and 8B can also be combined with user input by pressing the“Drain” button as described above.

[0226] More generally, if the volume of the bag is above a first threshold amount (such as 100 mL or another amount), a negative drop about a second threshold amount can be considered a drain event, and the algorithm may set the volume back to 0 mL.

Example Ostomy Monitoring System

[0227] In Figure 9, a schematic overview of an ostomy monitoring environment 100 is provided in which an ostomy device 102— as well as optionally a patient (not shown) using that device 102— may be monitored. The ostomy device 102 may be the ostomy bag 11 described above. In this environment 100, a hub 122 of the ostomy device 102 is shown in communication with a user device 130, which can transmit data from the hub 122 and/or the wafer 104 to a backend system 170 (such as a remote server or cloud server) over a network 140, or directly with the backend system 170 over the network 140. The user device 130 (such as the mobile phone described above), the backend system 170, and other devices can be in communication over the network 140. In some cases, such as shown in Figure 9, the user device 130 can download processed data from the backend system 170 after the hub 122 transmits the data to the backend system 170 for further processing. These other devices can include, in the example shown, a clinician device(s) 160, and third party systems 150. The ostomy monitoring environment 100 depicts an example environment, and more or fewer devices may communicate with the ostomy device 102 in other systems or devices. The ostomy monitoring environment 100 can enable a user and others (such as clinicians) to monitor various aspects related to the user’s ostomy device 102, such as ostomy bag fill, leaks, and skin irritation.

[0228] The ostomy device 102 can be a one-piece or two-piece device including an ostomy wafer 104 and an ostomy bag 120.

[0229] The ostomy wafer 104 can include a patient-facing side that has an adhesive pad, flange, or the like that attaches to a patient’s skin around a stoma 110 and a bag-facing side that is opposite the patient-facing side. The stoma 110 can include any stoma disclosed herein, for example, an aperture or hole in a patient’s abdomen (or other location) resulting from a colostomy, ileostomy, urostomy, or other similar medical procedure. The ostomy bag 120 can removably attach to the bag-facing side of the ostomy wafer 104 (such as via adhesives or a Tupperware click mechanism) and receive and store output (for example, effluent) from the stoma 110. The ostomy bag 120 can be flexible so that the bag 120 can be substantially flat when empty and can expand as effluent enters the bag 120. Once the ostomy bag 120 has reached its designed capacity, the patient (or caregiver) may remove the ostomy bag 120 from the ostomy wafer 104, discard and/or empty it, and attach a new ostomy bag 120 (or clean and reattach the old ostomy bag 120). Accordingly, the patient (or caregiver) may remove the resistance sensor from the ostomy bag and attached the sensor to a new ostomy bag, or re-attach the resistance sensor after the ostomy bag has been emptied (which may require recalibration of the sensor using the application as described above). In another example, the ostomy bag 120 is provided or sold together with the ostomy wafer 104 as a single device, with the ostomy wafer 104 integrally formed with the ostomy bag 120. The ostomy bag 120 can be made of non-porous sterile plastic materials such as, but not limited to, polyvinyl chloride, polyethylene, ethylene vinyl acetate, polypropylene, and copolyester ether.

[0230] The ostomy bag 120 can include one or more sensors 124 and the hub 120, which can be located on a side facing away from the wafer 104. The sensors 124 can include the resistance sensor described above, a plurality of temperature sensors, capacitive sensors, a camera (infrared or visible light), a gas sensor, a magnetic sensor such as an AMR sensor, and/or microfluidic sensor(s), among others. The bag 120 can include multiple layers. One or more sensor layers may be provided in which at least some of the sensors are embedded or otherwise attached. [0231] The ostomy bag 120 can include a measurement sheet. The side of the ostomy bag 120 facing away from the wafer 104 can include the measurement sheet. The measurement sheet can include a plurality of layers (such as layers made of polyimide, polyurethane, or the like). Four or two layers can be used. Other numbers of layers can be used. A layer of temperature sensors and/or a layer of capacitive sensors, for instance, may be provided that detects temperature and/or capacitance changes as effluent enters the bag 120 and disperses about an interior of the bag 120. The temperature and/or capacitive sensors may each be arranged in a matrix or matrix-like arrangement. A processor, whether in the hub 122, the user device 130, or the backend system 170, can process the sensor data, such as the resistance data from the resistor element, and/or temperature and/or capacitance data obtained from the temperature and/or capacitive sensors, to detect bag fill, drainage, leakage, and/or skin irritation metrics, such as an increase in temperature and/or bag fill. Electronics in communication with the sensors can also be provided on one or more of the layers.

[0232] The ostomy wafer 104 can be a flexible sheet with one or more layers, and optionally, multiple layers including one or more sensor layers. The layers can be made of the same or similar materials as the layers of the bag 120 described above. One or more of the layers of the ostomy wafer 104 may include one or more of the following sensors: temperature sensors (such as thermistors, temperature sense integrated circuits (ICs), thermocouples, infrared (IR) temperature sensors, etc.), capacitive sensors, flex sensors, odor sensors, microfluidic sensors, leak sensors, combinations of the same, or the like.

[0233] The sensors (such as temperature sensors and/or other types of sensors disclosed herein) of the ostomy wafer 104 can be disposed in a sensor layer (described in detail below). The sensor layer can have a similar or the same shape outline as the ostomy wafer 104. For example, if the ostomy wafer 104 is shaped like a donut or annulus, the sensor layer may include a generally annular shape. The sensor layer can also have a shape that differs from the general shape of the wafer 10, such as a partially annular or partial ring shape. Optionally, the ostomy bag 122 can include a carbon filter port to allow gas to escape. An optional gas sensor placed on or near the port can detect a characteristic about the gas, such as the pungency of the gas to determine the status of the user’ s gut.

[0234] The ostomy wafer 104 can be any size. The size of the ostomy wafer 104 can depend on the type of stoma that the wafer 104 is used with. For example, a colostomy stoma can be larger than a urostomy stoma. Thus, the ostomy wafer 104 can be sized larger for some colostomy stomas than for some urostomy stomas. The ostomy wafer 104 may be a “one-size fits all” wafer that has punch-out sections in the center for adapting to various different stoma sizes. The ostomy wafer 104 can also come in different versions, which have stoma holes 110 of different sizes to accommodate different stoma sizes.

[0235] The ostomy wafer 104 can also be in any of a variety of different shapes. For example, the ostomy wafer 104 can have a generally annular, ovular, or circular shape, such as a ring, donut, or the like. The ostomy wafer 104 can also have a more rectangular, oblong, or square shape (optionally with rounded corners).

[0236] As described above, the ostomy wafer 104 can be layered in structure to encapsulate the sensors. Encapsulation can improve fixation of the temperature sensors in position in the flexible sheet and/or reduce corrosion of the sensors by the external environment. As an alternative to encapsulation, the temperature sensors may be protected from corrosion by a coating, such as a conformal coating. Some example wafers (and bags, discussed below) can have at least one temperature sensor in a second region of the flexible sheet that is protected by a conformal coating.

[0237] As described above, the patient-facing side of the ostomy wafer 104 can have an adhesive side that adheres to skin around a stoma 110 and/or directly to the stoma 110. The adhesive can be a double-sided adhesive. The adhesive may be a hydrocolloid adhesive.

[0238] The sensors of the ostomy wafer 104 and/or the bag 120 can detect information based on the output of the stoma 110. The sensors can sense the constituents of the effluent or output of the stoma 110. Temperature sensors can be used to determine whether there is likelihood of inflammation at the site of the stoma and/or a leak. Temperature sensors may also be used to detect the phasing of the constituents, which can be used to determine, for example, how much gas and/or solid is in the bag. A capacitive sensor in the wafer 104 (and/or in the bag 120) may serve as a fallback, provide redundancy to, and/or supplement a temperature sensor to determine if there is a leak. For example, the temperature sensors on the wafer 104 can detect a leak due to the effluent not entering the bag for various reasons as described above in addition to overfill of the bag 120 (such as when the bag 120 is relatively empty but the adhesives on the wafer become loose). As another example, the temperature and/or capacitive sensors on the bag 120 can detect bag fill and output an indication of an imminent overfill or leak, before an actual occurrence of a leak. In another example, capacitive sensors can be used instead of temperature sensors to detect leaks or skin irritation.

[0239] If microfluidic sensors are used on the wafer 104 and/or the bag 120, the sensors can be used to detect electrolyte or inflammation markers within the constituents. This data can be used to show the user what he or she could intake or do to obtain a healthier balance of electrolytes and other chemical compositions in the user’s body. An odor sensor can be incorporated into the bag 120 and/or the wafer 104 to determine whether there is bacterial growth in the digestive tracts. An inertial measurement unit (“IMU”) sensor, a form of positional indicator, can also be integrated into the bag 120 and/or the wafer 104. An optical sensor, such as a camera, may also be integrated into the bag 120 and/or the wafer 104 where the sensor looks down over the stoma and/or into bag in order to detect a degrading stoma, blood in stool, or etc. An audio sensor, such as a microphone, can be included in the bag and/or the wafer to detect gas output and/or bowel movement sounds. pH sensors may also be integrated into the bag 120 and/or the wafer 104 to determine the acidity of the constituents of the bag.

[0240] The ostomy wafer 104 and the ostomy bag sensor(s) 124 can collect patient data related to the stomal output and can transmit the data wirelessly or with wires to the hub 122. The hub 122 can include electronics that can facilitate one or both of (1) processing sensor data and (2) transmitting sensor data. For instance, the hub 122 can include a hardware processor, memory, and a wireless transmitter. The hub 122 can also optionally have a display for outputting data related to the sensors (such as an indication of a leak, bag fill, or the like). The hub 122 can also optionally include a speaker that outputs an audible warning indicative of a leak, bag fill, or the like.

[0241] The optional wireless transmitter of the hub 122 can send data received from sensors (wafer or bag) to a user device 130. The data can then be sent to a network 140, third-party systems 150, a clinician device 160, a backend system 170, or to a patient data storage device 180 (each of which is discussed in greater detail below). In order to preserve battery life, the wireless transmitter may be switchable to an active mode and idle mode. The wafer 104 and/or the bag 120 can send data periodically, for example, over Bluetooth. The data transmitted by the hub 122 can include unprocessed, or conditioned (such as filtered, demodulated, and so on) signal data. The backend system 170 can process the received signal data to calculate the metrics disclosed herein, such as temperature and/or capacitance values, bag fill volumes, and/or leakage detection. The user device 130 and/or other devices can download the calculated metrics from the backend system 170. Performing the calculation on the backend system 170 can reduce the need for processing power in the hub 122, which can in turn reduce battery consumption and/or frequency in changing or recharging a battery in the hub 122.

[0242] The optional wireless transmitter of the hub 122 may include a near-field communication (NFC) reader and/or writer, a Bluetooth transmitter, a radio transmitter, or a Wi-Fi (802.1 lx) transmitter. The NFC reader and/or writer can be coupled to NFC antennas on the hub for communicating with NFC antennas on the bag 120 and/or the wafer 104 to receive sensor data from the sensors on the bag 120 and/or the wafer 104. The NFC reader and/or writer can have sufficient power or current (for example, with an output current up to about 250 mA) to receive data transmitted by the NFC antennas on the wafer 104 (and/or the antennas on the bag) when the bag 120 is filled to its apparent capacity and/or when the wafer 104 is separated from the hub 122 by a certain (for example, maximum) distance. The NFC reader and/or writer can serve as the main wireless communication tool with the sensors on the bag 120 and/or the wafer 104, and Bluetooth communication can optionally serve as a backup tool. Different wireless communication protocols can also optionally be used for transmitting data among the hub, the ostomy bag, and/or the wafer. The Bluetooth transmitter may include a Bluetooth module and/or a Bluetooth low energy (BLE) module. A Bluetooth module may be, but is not limited to, a Bluetooth version 2.0 + EDR (Enhanced Data Rates) module, or any other Bluetooth module. A Bluetooth low energy module may be a Bluetooth module such as, but not limited to, a Bluetooth version 4.0 (Bluetooth smart), a Bluetooth version 4.1, a Bluetooth version 4.2 or a Bluetooth version 5. The Bluetooth sensor module may include a Bluetooth module using IPv6 Internet Protocol Support Profile (IPSP) or any other protocols.

[0243] The hub 122 can be in various positions on the device 102. The hub 122 can be placed in many areas on the ostomy bag 120. The hub 122 can be placed in the front, the back, next to a gas filter, or the like. The hub 122 can also be placed in a pocket on the ostomy bag 120 or the hub 122 could be a replaceable feature on the ostomy bag 120. The hub 122 can also come in different forms. When the hub is removed from an ostomy bag 120 it can use previous collected data and carry over that data to the next subsequent ostomy bag 120 that it is placed upon. Hub removability can save money for the user.

[0244] The hub 122 can include a plurality of electronics, including but not limited to the wireless transmitters and/or receivers, motion sensor (such as a three-axis accelerometer), temperature sensors (such as far infrared (FIR) temperature sensors, ambient temperature sensor, and/or the like), camera module, lighting for the camera (such as LED lighting), a microphone (such as a microelectromechanical (MEMS) microphone), battery charging circuitry, and/or other electronics. The ambient temperature sensor, which can be any type of temperature sensor, can be mounted on a side of the hub 122 facing away from the bag and the patient. Temperature measurements from the ambient temperature sensor can approximate a room or ambient temperature, and/or serve as reference for the temperature sensors on the bag 120 and/or the wafer 104. The microphone can record audio information related to the stomal output and/or monitor the metrics related to the stomal output (for example, gas output, bowel movement, or others).

[0245] The user device 130 can be any device with a processor and a wireless receiver that can communicate with the hub 122. For example, the user device 130 can be a phone, smart phone, tablet, laptop, desktop, audio assistant or smart speaker (such as an Amazon Echo™, Google Home™, Apple HomePod™, or the like), television, or the like, that may pair automatically to the wireless transmitter and may include a mechanism that advises the user of the existence of a wireless link between the wireless receiver and the wireless transmitter. The user device 130 may have software and algorithms to process the data to show the user the status of the fill of the bag, the nearest restroom, nearest sources of electrolytes, nearest source of food, patterns and contents of discharge, hydration levels, and recommendations to improve the user’s condition. The user device 130 may also transmit the data wirelessly to a network 140. The network 140 can be a local area network (LAN), a wide area network (WAN), the Internet, an Intranet, combinations of the same, or the like.

[0246] The third-party systems 150 can be a data processing tool/feature; backend servers for audio assistants; or fitness trackers, personal health monitors, or any third party systems that can use or manipulate the data collected by the device 102. These third-party systems 150 may also include algorithms and software to calculate and process the data.

[0247] Third party systems 150 and audio assistants can fetch data from the ostomy device 102 to announce reminders or alerts for the user such as to empty the bag, change the bag, change the hub, intake or stop in-taking certain types of food, intake water, and/or providing periodic check-ins. Other third party systems may use data collected from other users to create a better feedback system or to identify patterns within a demographic of ostomy patients and/or bag users.

[0248] The clinician device 160 can be a data processing tool or monitoring program used by a clinician. These clinician devices 160 may receive data from the device 102 to provide a remote clinician to diagnosis the user, recommend actions to the user, or function as an augmented reality system for the clinician. These clinician devices 160 may also include algorithms and software to calculate and process the data.

[0249] The backend system 170 (such as cloud servers) can also use algorithms and software to perform data processing. For instance, the backend system 170 can process any data received from the sensors on the wafer and/or bag and return information based on that processing to the user device 130 or other devices. Another optional feature is an inclusion of a patient data storage system 180. From here the backing system can send the data to the patient data storage wirelessly or the patient data storage can access the data from the network 140.

[0250] Algorithms and software can show when the user should replace the bag, alert the user when the bag is nearly full or when there is a leak in the wafer or bag. Software features include, but are not limited to, identifying the nearest restrooms within the user’s radius, the volume of the user’s bag, alarms for different fill levels, a hydration and electrolyte tracker which calculates the user’s recommended daily hydration goal with an algorithm. The hydration and electrolyte software can notify the user based on their effluent output or constituents what his or her dietary needs may be throughout the day.

Flexible Bag with Resistance Sensor

[0251] The fill level detection systems and methods described herein can be applied to any flexible bag system configured to receive fluid and/or semi-solid contents. For example, the bag can have opposing surfaces, with one surface having the resistance sensor attached as disclosed herein. The opposing surface can be in contact with another surface, such as a patient’s body, a table surface, or otherwise, which may move and/or have different orientations that may result in noises in a volume signal derived from the resistance readings of the resistance sensor. Any features of the smoothing algorithms disclosed herein can be applied to reduce the noises in the volume signal to obtain a more accurate algorithmic volume measurement of the content in the flexible bag.

Terminology

[0252] Many other variations than those described herein will be apparent from this disclosure. For example, depending on the embodiment, certain acts, events, or functions of any of the algorithms described herein can be performed in a different sequence, can be added, merged, or left out altogether (e.g., not all described acts or events are necessary for the practice of the algorithms). Moreover, in certain embodiments, acts or events can be performed concurrently, e.g., through multi-threaded processing, interrupt processing, or multiple processors or processor cores or on other parallel architectures, rather than sequentially. In addition, different tasks or processes can be performed by different machines and/or computing systems that can function together.

[0253] The various illustrative logical blocks, modules, and algorithm steps described in connection with the embodiments disclosed herein can be implemented as electronic hardware, computer software, or combinations of both. To clearly illustrate this interchangeability of hardware and software, various illustrative components, blocks, modules, and steps have been described above generally in terms of their functionality. Whether such functionality is implemented as hardware or software depends upon the particular application and design constraints imposed on the overall system. The described functionality can be implemented in varying ways for each particular application, but such implementation decisions should not be interpreted as causing a departure from the scope of the disclosure.

[0254] The various illustrative logical blocks and modules described in connection with the embodiments disclosed herein can be implemented or performed by a machine, such as a hardware processor comprising 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 designed to perform the functions described herein. A general purpose processor can be a microprocessor, but in the alternative, the processor can be a controller, microcontroller, or state machine, combinations of the same, or the like. A processor can include electrical circuitry configured to process computer-executable instructions. In another embodiment, a processor includes an FPGA or other programmable device that performs logic operations without processing computer-executable instructions. A processor can also be implemented as a combination of computing devices, e.g., a combination of a DSP and a microprocessor, a plurality of microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration. A computing environment can include any type of computer system, including, but not limited to, a computer system based on a microprocessor, a mainframe computer, a digital signal processor, a portable computing device, a device controller, or a computational engine within an appliance, to name a few.

[0255] The steps of a method, process, or algorithm described in connection with the embodiments disclosed herein can be embodied directly in hardware, in a software module stored in one or more memory devices and executed by one or more processors, or in a combination of the two. A software module can reside in RAM memory, flash memory, ROM memory, EPROM memory, EEPROM memory, registers, hard disk, a removable disk, a CD-ROM, or any other form of non-transitory computer-readable storage medium, media, or physical computer storage known in the art. An example storage medium can be coupled to the processor such that the processor can read information from, and write information to, the storage medium. In the alternative, the storage medium can be integral to the processor. The storage medium can be volatile or nonvolatile. The processor and the storage medium can reside in an ASIC.

[0256] Conditional language used herein, such as, among others, "can," "might," "may,"“e.g.,” and the like, unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements and/or states. Thus, such conditional language is not generally intended to imply that features, elements and/or states are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without author input or prompting, whether these features, elements and/or states are included or are to be performed in any particular embodiment. The terms“comprising,”“including,”“having,” and the like are synonymous and are used inclusively, in an open-ended fashion, and do not exclude additional elements, features, acts, operations, and so forth. Also, the term“or” is used in its inclusive sense (and not in its exclusive sense) so that when used, for example, to connect a list of elements, the term“or” means one, some, or all of the elements in the list. Further, the term“each,” as used herein, in addition to having its ordinary meaning, can mean any subset of a set of elements to which the term“each” is applied.

[0257] Disjunctive language such as the phrase“at least one of X, Y and Z,” unless specifically stated otherwise, is to be understood with the context as used in general to convey that an item, term, etc. may be either X, Y, or Z, or a combination thereof. Thus, such conjunctive language is not generally intended to imply that certain embodiments require at least one of X, at least one of Y and at least one of Z to each be present.

[0258] Unless otherwise explicitly stated, articles such as“a” or“an” should generally be interpreted to include one or more described items. Accordingly, phrases such as“a device configured to” are intended to include one or more recited devices. Such one or more recited devices can also be collectively configured to carry out the stated recitations. For example,“a processor configured to carry out recitations A, B and C” can include a first processor configured to carry out recitation A working in conjunction with a second processor configured to carry out recitations B and C.

[0259] While the above detailed description has shown, described, and pointed out novel features as applied to various embodiments, it will be understood that various omissions, substitutions, and changes in the form and details of the devices or algorithms illustrated can be made without departing from the spirit of the disclosure. As will be recognized, certain embodiments of the inventions described herein can be embodied within a form that does not provide all of the features and benefits set forth herein, as some features can be used or practiced separately from others.

Claims

WHAT IS CLAIMED IS:

1. A fluid and/or semi-solid collection system capable of automatically detecting a fill level of a flexible bag of the system, the system comprising:

the flexible bag;

a resistance sensor coupled with the bag;

a hardware processor in electronic communication with the resistance sensor and configured to:

at a first time, obtain a first resistance value from the resistance sensor; convert the first resistance value to a first volume value;

at a second time after the first time, obtain a second resistance value from the resistance sensor;

convert the second resistance value to a second volume value;

determine that the second volume value is lower than the first volume value; and

in response to said determining, replace the second volume value with the first volume value.

2. The device of Claim 1, wherein a resistance value of the resistance sensor corresponds to a degree of bending of the resistance sensor, the degree of bending varying according to the fill level of the flexible bag.

3. The device of Claim 1 or 2, wherein the resistance sensor is attached across a width of the flexible bag.

4. The device of any of Claims 1-3, wherein the hardware processor is configured to receive calibration information for converting the first and second resistance values to the first and second volume values.

5. The device of Claim 4, wherein the calibration information is determined by measuring calibration resistance data at different simulated bends of the resistance sensor.

6. The device of Claim 5, wherein the calibration information comprises a calibration fit based on the calibration resistance data.

7. The device of any of Claim 4-6, wherein the calibration information varies based on a flexible bag orientation.

8. The device of Claim 7, wherein the flexible bag orientation comprises a horizontal or vertical orientation.

9. The device of Claim 7 or 8, wherein the flexible bag orientation is determined by at least one of: a user input or an inertial measurement sensor.

10. The device of any of Claims 1-9, wherein the hardware processor is configured to reset the fill level of the flexible bag to zero in response to any of: the hardware processor outputting that a drain of the flexible bag has occurred; the hardware processor receiving a user input that the flexible bag has been drained; and/or the hardware processor detecting a resistance sensor disconnection from the flexible bag.

11. The device of Claim 10, wherein the hardware processor is configured to output that a drain of the flexible bag has occurred in response to determining that a difference between a current volume value and a previous volume value is negative and exceeds a threshold drain volume.

12. The device of Claim 10 or 11, wherein the user input comprises a tapping of a drain button on a user interface of a user device in electronic communication with the hardware processor.

13. The device of any of Claims 10-12, wherein the hardware processor may only reset the fill level in response to receiving the user input that the flexible bag has been drained.

14. The device of Claim 13, wherein the hardware processor is configured to output an alarm when the hardware processor has outputted that a drain of the flexible bag has occurred but does not receive the user input that the flexible bag has been drained.

15. The device of any of Claims 1-14, wherein the hardware processor is configured to keep a previous volume value as the fill level of the flexible bag in response to any of: a current volume value exceeding a maximum capacity of the flexible bag; the current volume being a negative volume; and/or the current volume value being less than the previous volume value by an amount less than a threshold drain volume.

16. A draining device capable of automatically detecting a fill level of an ostomy bag of the draining device, the device comprising:

the ostomy bag;

a resistance sensor coupled with the ostomy bag; a hardware processor in electronic communication with the resistance sensor and configured to:

convert the second resistance value to a second volume value;

17. The device of Claim 16, wherein a resistance value of the resistance sensor corresponds to a degree of bending of the resistance sensor, the degree of bending varying according to the fill level of the ostomy bag.

18. The device of Claim 16 or 17, wherein the resistance sensor is attached across a width of the ostomy bag.

19. The device of any of Claims 16-18, wherein the hardware processor is configured to receive calibration information for converting the first and second resistance values to the first and second volume values.

20. The device of Claim 19, wherein the calibration information is determined by measuring calibration resistance data at different simulated bends of the resistance sensor.

21. The device of Claim 20, wherein the calibration information comprises a calibration fit based on the calibration resistance data.

22. The device of any of Claim 19-21, wherein the calibration information varies based on an ostomy bag orientation.

23. The device of Claim 22, wherein the ostomy bag orientation comprises a supine or vertical orientation.

24. The device of Claim 22 or 23, wherein the ostomy bag orientation is determined by at least one of: a user input or an inertial measurement sensor.

25. The device of any of Claims 16-24, wherein the hardware processor is configured to reset the fill level of the ostomy bag to zero in response to any of: the hardware processor outputting that a drain of the ostomy bag has occurred; the hardware processor receiving a user input that the ostomy bag has been drained; and/or the hardware processor detecting a patient and/or resistance sensor disconnection from the ostomy bag.

26. The device of Claim 25, wherein the hardware processor is configured to output that a drain of the ostomy bag has occurred in response to determining that a difference between a current volume value and a previous volume value is negative and exceeds a threshold drain volume.

27. The device of Claim 25 or 26, wherein the user input comprises a tapping of a drain button on a user interface of a user device in electronic communication with the hardware processor.

28. The device of any of Claims 25-27, wherein the hardware processor may only reset the fill level in response to receiving the user input that the ostomy bag has been drained.

29. The device of Claim 28, wherein the hardware processor is configured to output an alarm when the hardware processor has outputted that a drain of the ostomy bag has occurred but does not receive the user input that the ostomy bag has been drained.

30. The device of any of Claims 16-29, wherein the hardware processor is configured to keep a previous volume value as the fill level of the ostomy bag in response to any of: a current volume value exceeding a maximum capacity of the ostomy bag; the current volume being a negative volume; the current volume value being less than the previous volume value by an amount less than a threshold drain volume; the hardware processor being inconclusive whether a patient is connected to the ostomy bag.

31. A draining device capable of automatically detecting a draining point of an ostomy bag of the draining device, the bag comprising:

the ostomy bag;

a resistance sensor coupled with the ostomy bag;

at a first time, obtain a first resistance value from the resistance sensor; convert the resistance value to a first volume value; determine that the first volume value exceeds a minimum threshold value;

convert the second resistance value to a second volume value;

determine that the second volume value exceeds a negative volume threshold; and

in response to said determining that the first volume value exceeds a minimum threshold value and that the first second volume value exceeds the negative volume threshold, output that a drain of the ostomy bag has occurred.

32. The device of Claim 31, wherein a resistance value of the resistance sensor corresponds to a degree of bending of the resistance sensor, the degree of bending varying according to the fill level of the ostomy bag.

33. The device of Claim 32, wherein a polarity of the resistance value varies according to a direction of bending of the ostomy bag, a positive resistance value resulting from filling of the ostomy bag and a negative resistance value not resulting from filling of the ostomy bag.

34. The device of any of Claims 31-33, wherein the resistance sensor is attached across a width of the ostomy bag.

35. The device of any of Claims 31-34, wherein the minimum threshold value is about 100 mL.

36. The device of any of Claims 31-35, wherein the hardware processor is configured to receive calibration information for converting the first and second resistance values to the first and second volume values.

37. The device of Claim 36, wherein the calibration information is determined by measuring calibration resistance data at different simulated bends of the resistance sensor.

38. The device of Claim 37, wherein the calibration information comprises a calibration fit based on the calibration resistance data.

39. The device of any of Claim 36-38, wherein the calibration information varies based on an ostomy bag orientation.

40. The device of Claim 39, wherein the ostomy bag orientation comprises a supine or vertical orientation.

41. The device of Claim 38 or 39, wherein the ostomy bag orientation is determined by at least one of: a user input or an inertial measurement sensor.

42. The device of any of Claims 31-41, wherein the hardware processor is configured to reset a fill level of the ostomy bag to zero in response to any of: the hardware processor outputting that a drain of the ostomy bag has occurred; the hardware processor receiving a user input that the ostomy bag has been drained; and/or the hardware processor detecting a patient and/or resistance sensor disconnection from the ostomy bag.

43. The device of Claim 42, wherein the user input comprises a tapping of a drain button on a user interface of a user device in electronic communication with the hardware processor.

44. The device of Claim 42 or 43, wherein the hardware processor may only reset the fill level in response to receiving the user input that the ostomy bag has been drained.

45. The device of Claim 44, wherein the hardware processor is configured to output an alarm when the hardware processor has outputted that a drain of the ostomy bag has occurred but does not receive the user input that the ostomy bag has been drained.

46. The device of any of Claims 31-45, wherein the hardware processor is configured to keep a previous volume value as the fill level of the ostomy bag in response to any of: a current volume value exceeding a maximum capacity of the ostomy bag; the current volume being a negative volume; the current volume value being less than the previous volume value by an amount less than a threshold drain volume; the hardware processor being inconclusive whether a patient is connected to the ostomy bag.

47. The device of any of Claims 31-46, wherein the hardware processor is further configured to output that a drain of the ostomy bag has occurred in response to determining that the second time is a predetermined duration after the first time.

48. The device of Claim 47, wherein the predetermined duration is at least about 30 minutes.

49. The device of Claim 47, wherein the predetermined duration is at least about 1 hour.

50. The device of Claim 47, wherein the predetermined duration is at least about 2 hours.

51. The device of Claim 47, wherein the predetermined duration is at least about 3 hours.

52. A draining device capable of automatically detecting a draining point of an ostomy bag of the draining device, the bag comprising:

the ostomy bag;

a resistance sensor coupled with the ostomy bag;

at a first time, obtain a first resistance value from the resistance sensor; convert the resistance value to a first volume value;

determine that the first volume value is a positive value;

convert the second resistance value to a second volume value;

determine that the second volume value is a negative value and that the second time is a predetermined duration after the first time;

in response to said determining that the first volume value is a positive value, that the second volume value is a negative value, and that the second time is the predetermined duration after the first time, output that a drain of the ostomy bag has occurred.

53. The device of Claim 52, wherein the predetermined duration is at least about 30 minutes.

54. The device of Claim 52, wherein the predetermined duration is at least about 1 hour.

55. The device of Claim 52, wherein the predetermined duration is at least about 2 hours.

56. The device of Claim 52, wherein the predetermined duration is at least about 3 hours.

57. The device of any of Claims 52-56, wherein a resistance value of the resistance sensor corresponds to a degree of bending of the resistance sensor, the degree of bending varying according to the fill level of the ostomy bag.

58. The device of Claim 57, wherein a polarity of the resistance value varies according to a direction of bending of the ostomy bag, a positive resistance value resulting from filling of the ostomy bag and a negative resistance value not resulting from filling of the ostomy bag.

59. The device of any of Claims 52-58, wherein the resistance sensor is attached across a width of the ostomy bag.

60. The device of any of Claims 52-59, wherein the hardware processor is configured to receive calibration information for converting the first and second resistance values to the first and second volume values.

61. The device of Claim 60, wherein the calibration information is determined by measuring calibration resistance data at different simulated bends of the resistance sensor.

62. The device of Claim 61, wherein the calibration information comprises a calibration fit based on the calibration resistance data.

63. The device of any of Claim 60-62, wherein the calibration information varies based on an ostomy bag orientation.

64. The device of Claim 63, wherein the ostomy bag orientation comprises a supine or vertical orientation.

65. The device of Claim 63 or 64, wherein the ostomy bag orientation is determined by at least one of: a user input or an inertial measurement sensor.

66. The device of any of Claims 52-65, wherein the hardware processor is configured to reset a fill level of the ostomy bag to zero in response to any of: the hardware processor outputting that a drain of the ostomy bag has occurred; the hardware processor receiving a user input that the ostomy bag has been drained; and/or the hardware processor detecting a patient and/or resistance sensor disconnection from the ostomy bag.

67. The device of Claim 66, wherein the user input comprises a tapping of a drain button on a user interface of a user device in electronic communication with the hardware processor.

68. The device of Claim 66 or 67, wherein the hardware processor may only reset the fill level in response to receiving the user input that the ostomy bag has been drained.

69. The device of Claim 68, wherein the hardware processor is configured to output an alarm when the hardware processor has outputted that a drain of the ostomy bag has occurred but does not receive the user input that the ostomy bag has been drained.

70. The device of any of Claims 52-69, wherein the hardware processor is configured to keep a previous volume value as the fill level of the ostomy bag in response to any of: a current volume value exceeding a maximum capacity of the ostomy bag; the current volume being a negative volume; the current volume value being less than the previous volume value by an amount less than a threshold drain volume; whether a patient is connected to the ostomy bag being inconclusive.

71. The device of any of Claims 52-70, wherein the hardware processor is further configured to output that a drain of the ostomy bag has occurred in response to determining that a volume value from a time before the second volume value is above a minimum threshold value.

72. The device of Claim 71, wherein the minimum threshold value is about 100 mL.

73. A method of detecting a draining level of an ostomy bag of a draining device, the method comprising:

under control of a hardware processor,

at a first time, obtaining a first resistance value from a resistance sensor coupled with the ostomy bag;

converting the resistance value to a first volume value;

determining that the first volume value is a positive value;

at a second time after the first time, obtaining a second resistance value from the resistance sensor;

converting the second resistance value to a second volume value; determining that a difference between the first and second volume values exceeds a negative volume threshold, and that the second time is a predetermined duration after the first time; and in response to said determining that the first volume value is a positive value, that difference between the first and second volume values exceeds the negative threshold value, and that the second time is the predetermined duration after the first time, outputting that a drain of the ostomy bag has occurred.

74. The method of Claim 73, wherein the predetermined duration is at least about

30 minutes.

75. The method of Claim 73, wherein the predetermined duration is at least about

1 hour.

76. The method of Claim 73, wherein the predetermined duration is at least about

2 hours.

77. The method of Claim 73, wherein the predetermined duration is at least about 3 hours.

78. The method of any of Claims 73-77, wherein a resistance value of the resistance sensor corresponds to a degree of bending of the resistance sensor, the degree of bending varying according to the fill level of the ostomy bag.

79. The method of Claim 78, wherein a polarity of the resistance value varies according to a direction of bending of the ostomy bag, a positive resistance value resulting from filling of the ostomy bag and a negative resistance value not resulting from filling of the ostomy bag.

80. The method of any of Claims 73-79, wherein the resistance sensor is attached across a width of the ostomy bag.

81. The method of any of Claims 73-80, comprising receive calibration information for converting the first and second resistance values to the first and second volume values.

82. The method of Claim 81, wherein the calibration information is determined by measuring calibration resistance data at different simulated bends of the resistance sensor.

83. The method of Claim 82, wherein the calibration information comprises a calibration fit based on the calibration resistance data.

84. The method of any of Claim 81-83, wherein the calibration information varies based on an ostomy bag orientation.

85. The method of Claim 84, wherein the ostomy bag orientation comprises a supine or vertical orientation.

86. The method of Claim 84 or 85, wherein the ostomy bag orientation is determined by at least one of: a user input or an inertial measurement sensor.

87. The method of any of Claims 73-86, comprising resetting a fill level of the ostomy bag to zero in response to any of: the hardware processor outputting that a drain of the ostomy bag has occurred; the hardware processor receiving a user input that the ostomy bag has been drained; and/or the hardware processor detecting a patient and/or resistance sensor disconnection from the ostomy bag.

88. The method of Claim 87, wherein the user input comprises a tapping of a drain button on a user interface of a user device in electronic communication with the hardware processor.

89. The method of Claim 87 or 88, comprising only resetting the fill level in response to receiving the user input that the ostomy bag has been drained.

90. The method of Claim 89, comprising generating an alarm when outputting that a drain of the ostomy bag has occurred but the user input that the ostomy bag has been drained has been received.

91. The method of any of Claims 73-90, comprising keeping a previous volume value as the fill level of the ostomy bag in response to any of: a current volume value exceeding a maximum capacity of the ostomy bag; the current volume being a negative volume; the current volume value being less than the previous volume value by an amount less than a threshold drain volume; whether a patient is connected to the ostomy bag being inconclusive.

92. The method of any of Claims 73-91, comprising outputting that a drain of the ostomy bag has occurred in response to determining that a volume value from a time before the second volume value is above a minimum threshold value.

93. The method of Claim 92, wherein the minimum threshold value is about 100 mL.

94. A method of detecting a fill level of an ostomy bag of a draining device, the method comprising:

under control of a hardware processor, at a first time, obtaining a first resistance value from a resistance sensor coupled with an ostomy bag;

converting the first resistance value to a first volume value;

converting the second resistance value to a second volume value; determining that the second volume value is lower than the first volume value; and

in response to said determining, replacing the second volume value with the first volume value.

95. The method of Claim 94, wherein a resistance value of the resistance sensor corresponds to a degree of bending of the resistance sensor, the degree of bending varying according to the fill level of the ostomy bag.

96. The method of Claim 94 or 95, wherein the resistance sensor is attached across a width of the ostomy bag.

97. The method of any of Claims 94-96, comprising receiving calibration information for converting the first and second resistance values to the first and second volume values.

98. The method of Claim 97, wherein the calibration information is determined by measuring calibration resistance data at different simulated bends of the resistance sensor.

99. The method of Claim 98, wherein the calibration information comprises a calibration fit based on the calibration resistance data.

100. The method of any of Claim 97-99, wherein the calibration information varies based on an ostomy bag orientation.

101. The method of Claim 100, wherein the ostomy bag orientation comprises a supine or vertical orientation.

102. The method of Claim 100 or 101, wherein the ostomy bag orientation is determined by at least one of: a user input or an inertial measurement sensor.

103. The method of any of Claims 94-102, comprising resetting the fill level of the ostomy bag to zero in response to any of: outputting that a drain of the ostomy bag has occurred; receiving a user input that the ostomy bag has been drained; and/or detecting a patient and/or resistance sensor disconnection from the ostomy bag.

104. The method of Claim 103, comprising outputting that a drain of the ostomy bag has occurred in response to determining that a difference between a current volume value and a previous volume value is negative and exceeds a threshold drain volume.

105. The method of Claim 103 or 104, wherein the user input comprises a tapping of a drain button on a user interface of a user device in electronic communication with the hardware processor.

106. The method of any of Claims 103-105, comprising only resetting the fill level in response to receiving the user input that the ostomy bag has been drained.

107. The method of Claim 106, comprising generating an alarm when outputting that a drain of the ostomy bag has occurred but the user input that the ostomy bag has been drained has not been received.

108. The method of any of Claims 94-107, comprising keeping a previous volume value as the fill level of the ostomy bag in response to any of: a current volume value exceeding a maximum capacity of the ostomy bag; the current volume being a negative volume; the current volume value being less than the previous volume value by an amount less than a threshold drain volume; the hardware processor being inconclusive whether a patient is connected to the ostomy bag.

109. A method of detecting a fill level of an ostomy bag of a draining device, the method comprising:

under control of a hardware processor,

at a first time, obtaining a first resistance value from a resistance sensor coupled with an ostomy bag;

converting the resistance value to a first volume value;

determining that the first volume value exceeds a minimum threshold value;

converting the second resistance value to a second volume value; determining that the second volume value exceeds a negative volume threshold; and

in response to said determining that the first volume value exceeds a minimum threshold value and that the second volume value exceeds a negative volume threshold, outputting that a drain of the ostomy bag has occurred.

110. The method of Claim 109, wherein a resistance value of the resistance sensor corresponds to a degree of bending of the resistance sensor, the degree of bending varying according to the fill level of the ostomy bag.

111. The method of Claim 110, wherein a polarity of the resistance value varies according to a direction of bending of the ostomy bag, a positive resistance value resulting from filling of the ostomy bag and a negative resistance value not resulting from filling of the ostomy bag.

112. The method of any of Claims 109-111, wherein the resistance sensor is attached across a width of the ostomy bag.

113. The method of any of Claims 109-112, wherein the minimum threshold value is about 100 mL.

114. The method of any of Claims 109-113, comprising receiving calibration information for converting the first and second resistance values to the first and second volume values.

115. The method of Claim 114, wherein the calibration information is determined by measuring calibration resistance data at different simulated bends of the resistance sensor.

116. The method of Claim 115, wherein the calibration information comprises a calibration fit based on the calibration resistance data.

117. The method of any of Claim 114-116, wherein the calibration information varies based on an ostomy bag orientation.

118. The method of Claim 117, wherein the ostomy bag orientation comprises a supine or vertical orientation.

119. The method of Claim 117 or 118, wherein the ostomy bag orientation is determined by at least one of: a user input or an inertial measurement sensor.

120. The method of any of Claims 109-119, comprising resetting a fill level of the ostomy bag to zero in response to any of: outputting that a drain of the ostomy bag has occurred; receiving a user input that the ostomy bag has been drained; and/or detecting a patient and/or resistance sensor disconnection from the ostomy bag.

121. The method of Claim 120, wherein the user input comprises a tapping of a drain button on a user interface of a user device in electronic communication with the hardware processor.

122. The method of Claim 120 or 121, comprising only resetting the fill level in response to receiving the user input that the ostomy bag has been drained.

123. The method of Claim 122, comprising generating an alarm when outputting that a drain of the ostomy bag has occurred but the user input that the ostomy bag has been drained has not been received.

124. The method of any of Claims 109-123, comprising keeping a previous volume value as the fill level of the ostomy bag in response to any of: a current volume value exceeding a maximum capacity of the ostomy bag; the current volume being a negative volume; the current volume value being less than the previous volume value by an amount less than a threshold drain volume; whether a patient is connected to the ostomy bag being inconclusive.

125. The method of any of Claims 109-124, comprising outputting that a drain of the ostomy bag has occurred in response to determining that the second time is a predetermined duration after the first time.

126. The method of Claim 125, wherein the predetermined duration is at least about 30 minutes.

127. The method of Claim 125, wherein the predetermined duration is at least about 1 hour.

128. The method of Claim 125, wherein the predetermined duration is at least about 2 hours.

129. The method of Claim 125, wherein the predetermined duration is at least about 3 hours.