Body waste containment and sensor systems

Abstract

A body waste collection system includes a body waste collection bag and a wearable device. The body waste collection bag includes: level conductive traces positioned on an internal surface of the collection bag, each conductive trace positioned to correspond to an amount of bodily waste collected; a ground conductive trace positioned at an outlet end of the collection bag; a coupling interface; and insulated traces electrically coupling the level conductive traces and ground conductive trace to the coupling interface. A wearable device configured to mechanically couple to the body waste collection bag. The wearable device includes a controller including a processor and a memory storing instructions executable by the processor to measure a resistance between each level conductive trace and the ground conductive trace, compare each resistance to a resistance threshold, and determine an amount of bodily waste collected in the body waste collection bag based on the comparisons.

Description

BODY WASTE CONTAINMENT AND SENSOR SYSTEMSBACKGROUND

[0001] The present disclosure relates to sensor systems for monitoring a person’s hydration by directly monitoring the person’s hydration, by monitoring the person’s bodily waste to determine their hydration, or a combination of both. Example bodily waste may include urinary output from catheters and stoma output, which may be composed of urine in the case of urostomy or catheterization, and dejecta in the case of ileostomy or colostomy.SUMMARY

[0002] Ileostomy is a connection from the small intestine directly to the outside of the body where digestive output is rerouted to a pouch. Without the large intestine, little water is reabsorbed before excretion which can lead to dehydration in patients. To mitigate this issue, sense devices for detecting overhydration, dehydration and / or stoma output by interfacing with the patient’s body or urine drainage bag or ostomy bag are provided according to various embodiments. The sensor devices may be used to reduce hospital readmissions by alerting the patient when they are at risk. The sensor devices may be non-invasive and user-friendly, integrating seamlessly into the patient’s daily lives. By implementing customizable methods to alert the patient, the severity and frequency of dehydration-related conditions may be reduced, the quality of patient’s life may be improved and may empower the patients with more security over their lives.

[0003] A wearable sensor device for monitoring stoma or urine output that is reliable (high accuracy and durability), automatic, longitudinal (lasting 30-60 days), and easy to acquire information from is provided according to various embodiments. In an embodiment, the sensor device may be configured to measure the bioimpedance of the skin or stoma as a proxy for patient hydration - this may involve a small PCB and four electrodes to take a tetrapolar impedance measurement. In another embodiment, the sensor device may comprise conductive traces, repurposing existing technology to measure ranges of volume of the stoma output. Using a circuit board to communicate with the insulated traces, electric resistance is used to determine volume. In an embodiment, the sensor device may comprise a pressure sensor to gauge dejecta or urine volume or level in the pouch, and thus the total volume output of effluent or urine per day.The pressure sensors may be button-activated to take readings during pouch or drainage bag emptying events in order to reset the system so that the drained volume can be added to the detected volume in order to calculate daily output.

[0004] According to one aspect, an ostomy pouch sensor system or urine drainage bag system may include an ostomy pouch or bag comprising a plurality of conductive traces configured to detect liquid level in the ostomy bag or bag, and a communication device configured to collect data from the plurality of conductive traces and transmit the data.

[0005] In one aspect, a body waste collection system may include a body waste collection bag defining a longitudinal axis and a wearable device. The body waste collection bag may include a plurality of level conductive traces positioned along the longitudinal axis on an internal surface of the collection bag. Each conductive trace may be positioned on the longitudinal axis to correspond to an amount of bodily waste collected in the body waste collection bag. The body waste collection bag may further include a ground conductive trace positioned at an outlet end of the body waste collection bag. The ground conductive trace may be positioned to be the first conductive trace covered in collected bodily waste. The body waste collection bag may further include a coupling interface positioned on an exterior of the body waste collection bag and a plurality of insulated traces electrically coupling the plurality of level conductive traces and ground conductive trace to the coupling interface. An insulated trace may couple one of the plurality of level conductive traces or the ground conductive trace to the coupling interface. The wearable device may be configured to mechanically couple to the body waste collection bag and electrically coupled with the coupling interface. The wearable device may include a user interface engageable by a user and a controller coupled to the user interface and coupling interface. The controller includes a processor and a memory storing instructions executable by the processor to receive an input from the user interface indicative of a measurement being requested; measure, after receiving the measurement request, a resistance between each level conductive trace and the ground conductive trace; compare each resistance to a resistance threshold; and determine an amount of bodily waste collected in the body waste collection bag based on the comparisons.

[0006] In an embodiment of the body waste collection system, the amount of bodily waste collected in the body waste collection bag may be based on the number of resistances below the resistance threshold.

[0007] In an embodiment of the body waste collection system, the resistance between a level conductive trace and the ground conductive trace may be below the resistance threshold when both the level conductive trace and the ground conductive trace are submerged in bodily waste.

[0008] In an embodiment of the body waste collection system, the user interface may be engaged to drain any collected bodily waste from the body waste collection bag. Receiving the input from the user interface indicative of a measurement being requested may correspond to the body waste collection bag being drained of any collected bodily waste. The memory may store further instructions executable by the processor to store the amount of bodily waste collected in the body waste collection bag in the memory.

[0009] In an embodiment of the body waste collection system, the memory may store further instructions executable by the processor to determine an amount of bodily waste collected over the last 24 hours by combining the stored bodily waste measurements for the last 24 hours and transmit an alert to the user when the amount of bodily waste collected over the last 24 hours exceeds a threshold value.

[0010] In an embodiment of the body waste collection system, the wearable device may further include an alert interface. The memory may store further instructions executable by the processor to cause the alert interface to perform a physical function to notify the user of an alert.

[0011] In an embodiment of the body waste collection system, the wearable device may be communicably couplable to a mobile device. The memory may store further instructions executable by the processor to transmit an alert to the mobile device.

[0012] In an embodiment of the body waste collection system, the wearable device may be communicably couplable to a mobile device. The memory may store further instructions executable by the processor to transmit the amount of bodily waste collected in the body waste collection bag to the mobile device.

[0013] In an embodiment of the body waste collection system, each level conductive trace may extend within the body waste collection bag at an angle perpendicular to the longitudinal axis.

[0014] In an embodiment of the body waste collection system, each level conductive trace may extend around the internal surface of the body waste collection bag.

[0015] In an embodiment of the body waste collection system, the user interface may include a button accessible to the user on an exterior surface of the wearable device.

[0016] In an embodiment of the body waste collection system, the wearable device may be moveable from an open position to a closed position to clamp over the coupling interface and electrically couple the wearable device to the coupling interface.

[0017] In an embodiment of the body waste collection system, the body waste collection bag may further include a pressure sensor positioned toward an outlet of the body waste collection bag. The pressure sensor may be configured to measure a hydrostatic pressure of any bodily waste collected in the body waste collection bag. The pressure sensor may be communicably coupled to the wearable device. The memory may store further instructions executable by the processor to receive, after receiving the measurement request, a hydrostatic pressure from the pressure sensor; determine a second value for the amount of bodily waste collected in the body waste collection bag based on the hydrostatic pressure, wherein a first value for the amount of bodily waste collected may be based on the comparisons of the resistances to the resistance threshold; and determine a final value for the amount of bodily waste collected by averaging the first value and the second value.

[0018] In an embodiment of the body waste collection system, the memory may store further instructions executable by the processor to determine a difference between the first value and the second value and transmit an alert to the user when the difference exceeds a threshold value.

[0019] In an embodiment of the body waste collection system, the pressure sensor may be positioned within a reusable pouch to seal the pressure sensor from any collected bodily waste.

[0020] In an embodiment of the body waste collection system, the body waste collection system may further include a bioimpedance sensor communicably coupled to the wearable device. The memory may store further instructions executable by the processor to receive first data indicative of a skin impedance of the user from the bioimpedance sensor, determine a first hydration level of the user based on the first data from the bioimpedance sensor, transmit a first hydration status to the user, and transmit a dehydration status to the user when the first hydration level is below a hydration threshold.

[0021] In an embodiment of the body waste collection system, the memory may store further instructions executable by the processor to receive second data indicative of the skin impedance of the user from the bioimpedance sensor. The second data may be received at a later time than the first data. The memory may store further instructions executable by the processor todetermine a second hydration level of the user based on the second data from the bioimpedance sensor, transmit a second hydration status to the user, transmit the dehydration status to the user when the second hydration level is below the hydration threshold, and transmit a notification to the user. The notification may indicate to the user whether the user’s hydration level has improved, decreased, or stayed the same.

[0022] In an embodiment of the body waste collection system, receive first data indicative of the skin impedance of the user from the bioimpedance sensor may include receiving the first data after receiving the measurement request.

[0023] In an embodiment of the body waste collection system, the bioimpedance sensor may include a plurality of electrodes positioned against the skin of the user to measure an impedance between at least one pair of electrodes of the plurality of electrodes.

[0024] In an embodiment of the body waste collection system, the body waste collection bag may further include an ostomy barrier appliance. The ostomy barrier appliance including an adhesive layer for attachment to the user’s skin. The body waste collection bag may define an opening through the ostomy barrier appliance, the opening configured to receive a user’s stoma and allow bodily waste to enter the body waste collection bag through the user’s stoma. At least one electrode of the plurality of electrodes may be positioned within the ostomy barrier appliance and may be configured to contact the user’s skin when the body waste collection bag is attached to the user.

[0025] In an embodiment of the body waste collection system, a pair of electrodes of the plurality of electrodes may be positioned within the adhesive layer to be positioned against the user’s skin.

[0026] In an embodiment of the body waste collection system, a pair of electrodes of the plurality of electrodes may be positioned within the opening in the ostomy barrier appliance adhesive layer to be positioned against the user’s skin at the user’s stoma.

[0027] In one aspect, the body waste collection system may include a body waste collection bag defining a longitudinal axis and a wearable device. The body waste collection bag may include a pressure sensor positioned within and toward an outlet of the body waste collection bag. The pressure sensor may be configured to measure a hydrostatic pressure of any bodily waste collected in the body waste collection bag. The wearable device may be configured to mechanically couple to the body waste collection bag and communicably couple with thepressure sensor. The wearable device may include a user interface engageable by a user and a controller coupled to the user interface and pressure sensor. The controller may include a processor and a memory storing instructions executable by the processor to receive an input from the user interface indicative of a measurement being requested; receive, after receiving the measurement request, a hydrostatic pressure from the pressure sensor, and determine an amount of bodily waste collected in the body waste collection bag based on the hydrostatic pressure.

[0028] In an embodiment of the body waste collection system, the pressure sensor may be positioned within a reusable pouch to seal the pressure sensor from any collected bodily waste.

[0029] In an embodiment of the body waste collection system, the body waste collection bag may further include a coupling interface position on an exterior of the body waste collection bag. The wearable device may be electrically coupled to the coupling interface when the wearable device is mechanically coupled to the body waste collection bag. The pressure sensor may be electrically coupled to the coupling interface.

[0030] In an embodiment of the body waste collection system, the user interface may be engaged to drain any collected bodily waste from the body waste collection bag. Receiving the input from the user interface indicative of a measurement being requested may correspond to the body waste collection bag being drained of any collected bodily waste. The memory may store further instructions executable by the processor to store the amount of bodily waste collected in the body waste collection bag in the memory.

[0031] In an embodiment of the body waste collection system, the memory may store further instructions executable by the processor to determine an amount of bodily waste collected over the last 24 hours by combining the stored bodily waste measurements for the last 24 hours and transmit an alert to the user when the amount of bodily waste collected over the last 24 hours exceeds a threshold value.

[0032] In an embodiment of the body waste collection system, the wearable device may further include an alert interface. The memory may store further instructions executable by the processor to cause the alert interface to perform a physical function to notify the user of an alert.

[0033] In an embodiment of the body waste collection system, the wearable device may be communicably couplable to a mobile device. The memory may store further instructions executable by the processor to transmit an alert to the mobile device.

[0034] In an embodiment of the body waste collection system, the wearable device is communicably couplable to a mobile device. The memory may store further instructions executable by the processor to transmit the amount of bodily waste collected in the body waste collection bag to the mobile device.

[0035] In an embodiment of the body waste collection system, the user interface may include a button accessible to the user on an exterior surface of the wearable device.

[0036] In an embodiment of the body waste collection system, the wearable device may be moveable from an open position to a closed position to clamp onto the body waste collection bag.

[0037] In an embodiment of the body waste collection system, the body waste collection system may further include a bioimpedance sensor communicably coupled to the wearable device. The memory may store further instructions executable by the processor to receive first data indicative of a skin impedance of the user from the bioimpedance sensor, determine a first hydration level of the user based on the first data from the bioimpedance sensor, transmit a first hydration status to the user, and transmit a dehydration status to the user when the first hydration level is below a hydration threshold.

[0038] In an embodiment of the body waste collection system, the memory may store further instructions executable by the processor to receive second data indicative of the skin impedance of the user from the bioimpedance sensor. The second data may be received at a later time than the first data. The memory may store further instructions executable by the processor to determine a second hydration level of the user based on the second data from the bioimpedance sensor, transmit a second hydration status to the user, transmit the dehydration status to the user when the second hydration level is below the hydration threshold, and transmit a notification to the user. The notification may indicate to the user whether the user’s hydration level has improved, decreased, or stayed the same.

[0039] In an embodiment of the body waste collection system, receive first data indicative of the skin impedance of the user from the bioimpedance sensor may include receiving the first data after receiving the measurement request.

[0040] In an embodiment of the body waste collection system, the bioimpedance sensor may include a plurality of electrodes positioned against the skin of the user to measure an impedance between at least one pair of electrodes of the plurality of electrodes.

[0041] In an embodiment of the body waste collection system, the body waste collection bag may include an ostomy barrier appliance. The ostomy barrier appliance may include an adhesive layer for attachment to the user’s skin. The body waste collection bag may define an opening through the ostomy barrier appliance, the opening configured to receive a user’s stoma and allow bodily waste to enter the body waste collection bag through the user’s stoma. At least one electrode of the plurality of electrodes may be positioned within the ostomy barrier appliance and may be configured to contact the user’s skin when the body waste collection bag is attached to the user.

[0042] In an embodiment of the body waste collection system, a pair of electrodes of the plurality of electrodes may be positioned within the adhesive layer to be positioned against the user’s skin.

[0043] In an embodiment of the body waste collection system, a pair of electrodes of the plurality of electrodes may be positioned within the opening in the ostomy barrier appliance adhesive layer to be positioned against the user’s skin at the user’s stoma.

[0044] In one aspect, a body waste collection system may include a body waste collection bag defining a longitudinal axis and a wearable device. The body waste collection bag may include a bioimpedance sensor comprising a plurality of electrodes positioned against the skin of a user when the body waste collection bag is attached to the user. The bioimpedance sensor may be configured to measure an impedance between at least one pair of electrodes of the plurality of electrodes. The wearable device may be configured to mechanically couple to the body waste collection bag and coupled with the bioimpedance sensor. The wearable device may include a user interface engageable by a user and a controller coupled to the user interface and coupling interface. The controller may include a processor and a memory storing instructions executable by the processor to receive first data indicative of a skin impedance of the user from the bioimpedance sensor, determine a first hydration level of the user based on the first data from the bioimpedance sensor, transmit a first hydration status to the user, and transmit a dehydration status to the user when the first hydration level is below a hydration threshold.

[0045] In an embodiment of the body waste collection system, the memory may store further instructions executable by the processor to receive second data indicative of the skin impedance of the user from the bioimpedance sensor. The second data may be received at a later time thanthe first data. The memory may store further instructions executable by the processor to determine a second hydration level of the user based on the second data from the bioimpedance sensor, transmit a second hydration status to the user, transmit the dehydration status to the user when the second hydration level is below the hydration threshold, and transmit a notification to the user. The notification may indicate to the user whether the user’s hydration level has improved, decreased, or stayed the same.

[0046] In an embodiment of the body waste collection system, wherein receive first data indicative of the skin impedance of the user from the bioimpedance sensor may include receiving the first data after receiving a measurement request.

[0047] In an embodiment of the body waste collection system, the body waste collection bag may include an ostomy barrier appliance. The ostomy barrier appliance may include an adhesive layer for attachment to the user’s skin. The body waste collection bag may define an opening through the ostomy barrier appliance. The opening may be configured to receive a user’s stoma and allow bodily waste to enter the body waste collection bag through the user’s stoma. At least one electrode of the plurality of electrodes may be positioned within the ostomy barrier appliance and are configured to contact the user’s skin when the body waste collection bag is attached to the user.

[0048] In an embodiment of the body waste collection system, a pair of electrodes of the plurality of electrodes are positioned within the adhesive layer to be positioned against the user’s skin.

[0049] In an embodiment of the body waste collection system, a pair of electrodes of the plurality of electrodes may be positioned within the opening in the ostomy barrier appliance adhesive layer to be positioned against the user’s skin at the user’s stoma.

[0050] Other aspects and advantages will become apparent upon consideration of the following detailed description and the attached drawings.BRIEF DESCRIPTION OF THE DRAWINGS

[0051] FIG. 1 is an example of a two-piece ostomy pouch system, according to an embodiment of the present disclosure;

[0052] FIG. 2 is an example of a drainage bag, according to an embodiment of the present disclosure;

[0053] FIG. 3 is a control diagram of an example body waste collection system, according to an embodiment of the present disclosure;

[0054] FIGS. 4A is a diagram of a front view of an example ostomy pouch including conductive traces according to an embodiment of the present disclosure;

[0055] FIG. 4B is a diagram of a side view of the ostomy pouch of FIG. 4A:

[0056] FIG. 5 A is a diagram of the side view of the ostomy pouch of FIG. 4A without the wearable device attached;

[0057] FIGS. 5B is a diagram of the wearable device in an open configuration, according to an embodiment of the present disclosure;

[0058] FIG. 6 is a graphical representation of example resistance measurements from a conductive sensor, according to an embodiment of the present disclosure;

[0059] FIG. 7 illustrates modes of communicating sensor data and alerts, according to an embodiment of the present disclosure;

[0060] FIG. 8 is a diagram of an example ostomy bag with a pressure sensor, according to an embodiment of the present disclosure;

[0061] FIG. 9A illustrates an example pressure sensor, according to an embodiment of the present disclosure;

[0062] FIG. 9B illustrates an example control diagram with the pressure sensor, according to an embodiment of the present disclosure;

[0063] FIG. 10 is a diagram of an ostomy pouch system with a bioimpedance sensor device, according to an embodiment of the present disclosure;

[0064] FIG. 11 is a schematic illustration of a simple three resistor model for bioimpedance, according to an embodiment of the present disclosure; and

[0065] FIG. 12 is an illustration of a bioimpedance measuring device, according to an embodiment of the present disclosure.DETAILED DESCRIPTION

[0066] There is a clinical importance of urine output monitoring. Urine output (UO) is a fundamental physiological parameter reflecting renal function, fluid balance, and systemic hemodynamics. It is integral to the kidney disease. Improving Global Outcomes (KDIGO) criteria for diagnosing acute kidney injury (AKI), which affects over 55% of critically ill patientsand is associated with mortality rates approaching 50%. Accurate and timely UO measurement enables early detection of oliguria, guiding interventions such as fluid resuscitation, diuretic therapy, and renal support. Despite its clinical significance, UO remains one of the few vital signs not routinely captured electronically in most intensive care units (ICUs), acute care, and long-term care settings.

[0067] There are some unmet needs in ICU, Acute Care and Long-term Care. Current practice relies heavily on manual measurement, typically involving hourly visual inspection and charting. This approach introduces substantial error and delay. For example, some studies report that manual monitoring can miss up to 40% of oliguric episodes and often overestimates urine volume by 20 mb or more per hour. These inaccuracies contribute to delayed AKI recognition, inappropriate fluid management, and increased risk of complications such as fluid overload and multi -organ dysfunction. Automated urine monitoring systems have significant benefits, including real-time data capture, improved detection of oliguria, and reduced incidence of AKI- related complications. Existing solutions rarely integrate additional biochemical analysis, hydration state sensing, or infection markers. Hydration status is critical for guiding fluid therapy and preventing both dehydration and fluid overload, while early detection of urinary tract infection (UTI) through markers such as pH, nitrites, or leukocyte indicators could reduce sepsis risk and improve outcomes.

[0068] There are some unmet needs in continence catheter users. Patients with indwelling urinary catheters, common in long-term care, neurogenic bladder, and post-surgical recovery, face similar challenges. Current protocols prioritize infection prevention but lack continuous monitoring of urine flow, hydration state, or composition. This gap contributes to complications such as catheter-associated urinary tract infections (CAUTIs), obstruction, bladder overdistension, and renal impairment. CAUTIs account for up to 40% of healthcare-associated infections and can lead to bacteremia, prolonged hospitalization, and increased mortality. Manual recording of urine volume is labor-intensive and prone to error, while intermittent checks fail to detect early signs of retention, dehydration, or infection. A smart catheter system with integrated sensors may allow for real-time monitoring of volume, hydration markers (e.g., osmolality, conductivity), and infection indicators (e.g., pH, nitrites). Continuous monitoring may enable early intervention, reducing CAUTI incidence, preventing noninfectious complications, and improving hydration and electrolyte management.

[0069] Dehydration may also be an issue for patients using drainage bags (e.g., urine drainage bags) in an ICU, hospital, and / or long-term care. For example, patients with indwelling or intermittent catheters and urine drainage bags which are common in long-term care, post- surgical recovery, or neurogenic bladder management are vulnerable to dehydration. Reduced fluid intake is often mistakenly encouraged to minimize catheter output, increasing the risk of urinary tract infections (UTIs) and bladder irritation. Concentrated urine due to dehydration may lead to crystal formation, catheter blockages, and skin breakdown around insertion sites. As such, dehydration may hurt the quality of life of these patients. Monitoring their hydration can help ensure they are receiving the correct amount of fluids to alleviate these issues.

[0070] Dehydration is also an issue for people with various ostomies (e.g., ileostomy, urostomy, colostomy, etc.). In the United States alone, there are approximately 725,000 to 1 million people with various ostomies. Annually, this population increases by around 100,000, making them a continuously more relevant community. People with ostomies may be referred to as ostomates. They are generally an underserved population, with many ostomates often receiving inadequate care and attention from the medical industry.

[0071] An ileostomy is a surgically created opening in the abdominal wall through which the lumen of the ileum, the distal segment of the small intestine, is brought to the surface to divert the passage of intestinal contents outside the body through a stoma. This procedure is often performed to bypass or remove a dysfunctional or diseased colon and is correlated within conditions such as colorectal cancer, Crohn’s disease, or ulcerative colitis. The effluent from an ileostomy, commonly known as dejecta, ranges from liquid to loose, semi-formed stool, as it bypasses the colon, which is responsible for absorbing water and solidifying fecal material.

[0072] Depending on the clinical scenario, an ileostomy may be temporary, allowing for the reversal of intestinal continuity once healing is complete, or permanent in cases where reattachment is not feasible, such as after complete removal of the colon. There are two main types of ileostomy; an end ileostomy involves the connection of the proximal ileum to the exterior with no downstream bowel continuity, whereas a loop ileostomy involves the exteriorization of a loop of ileum, allowing for proximal stool diversion.

[0073] An urostomy is a surgically created opening in the abdominal wall through which a segment of the urinary tract is brought to the surface to divert urine outside the body through a stoma. This procedure is commonly performed when the bladder is removed or bypassed due toconditions such as bladder cancer, severe trauma, or neurogenic bladder dysfunction. The effluent from an urostomy may consist of urine mixed with bodily waste from the intestinal segment used for diversion, as the conduit originates from bowel tissue rather than the native urinary tract.

[0074] A colostomy is a surgically created opening in the abdominal wall through which the lumen of the colon, a segment of the large intestine, is brought to the surface to divert the passage of fecal material outside the body through a stoma. This procedure is typically performed to bypass or remove a diseased or obstructed portion of the distal bowel and is associated with conditions such as colorectal cancer, diverticulitis, traumatic injury, or congenital anomalies. The effluent from a colostomy varies in consistency depending on the location within the colon, ranging from semi-liquid in ascending colostomies to more formed stool in descending or sigmoid colostomies, as the colon retains its role in water absorption and fecal solidification.

[0075] Ostomy patients (e.g., ileostomy, urostomy, colostomy, etc.) are at a risk for dehydration due to altered fluid absorption and continuous output. Ileostomy patients are at high risk of dehydration because the colon, which normally absorbs water and electrolytes, is bypassed. This leads to high-volume, liquid output and significant fluid loss. Urostomy patients experience continuous urine drainage, including overnight, which can result in unnoticed fluid depletion and electrolyte imbalances. If not monitored, the continuous urine drain may lead to dehydration. Colostomy patients generally retain more of the colon’s absorptive function, but dehydration risk still exists during illness or diarrhea. Symptoms of dehydration in ostomy patients include fatigue, muscle cramps, dizziness, and reduced urine output, and may escalate to kidney damage or hospital readmission if not addressed promptly.

[0076] Although ostomates are effective in managing many of the adverse conditions, they are associated with several complications that can significantly impact patient quality of life. Without proper aftercare, ostomates are at a significantly greater risk of readmission postoperation compared to the average non-ostomate patient. These numbers are roughly around 15% of readmission for non-ostomates but drastically increases to a range of 43% to as high as 49% for ostomates. Such high risks of readmission impact the quality of life for these patients and emphasizes the importance of multidisciplinary care for optimal outcomes. Additionally, their quality of life may be impacted by medical complications from dehydration ranging fromurinary tract infections to kidney failure or neurological symptoms that can lead to dizziness and falls and downstream consequences.

[0077] Some ostomates have a high-output stoma (HOS) characterized by output exceeding 1200-1500 ml / day, leading to dehydration and electrolyte imbalances. Comparatively, the normal range of output is around 600 to 1,200 ml / day. Treatment includes fluid resuscitation, restricted hypotonic fluid intake, and use of antimotility drugs. Prevention requires early detection and patient education on fluid management. Patients are instructed to record their daily intake and output of fluid to determine whether they have high-output stoma and contact their doctor if they suspect they do. However, these instructions are rarely followed for a variety of reasons, hence the high readmission rates for HOS.

[0078] Ostomates with a HOS present a significant need for hydration monitoring. These patients often experience large fluid and electrolyte losses, placing them at high risk for dehydration, acute kidney injury, and severe electrolyte imbalances. Current management relies on self-assessment, intermittent clinical assessment, and laboratory testing, which cannot capture rapid changes in output or composition. Continuous monitoring of stoma effluent volume and ion concentrations, combined with hydration state sensing, would enable timely intervention with oral or intravenous fluid replacement and electrolyte correction. This approach may prevent complications such as hypovolemia, metabolic acidosis, and hospital readmissions, improving patient safety and quality of life.

[0079] There is a clinical relevance for ion concentration and hydration monitoring. Beyond volumetric assessment, urine and stoma effluent ion concentrations, such as sodium, potassium, chloride, calcium, and magnesium, are essential indicators of renal function, acid-base balance, and systemic homeostasis. Hydration state, reflected in urine or effluent (dejecta) osmolality or conductivity, is equally important for guiding fluid therapy and preventing complications such as hypovolemia or hypervolemia. Current practice relies on intermittent laboratory testing, which cannot capture dynamic changes during critical illness or chronic care. Incorporating real-time ion and hydration monitoring into output tracking would enable precision fluid and electrolyte therapy, reduce risks of hypernatremia, hypokalemia, metabolic acidosis, and dehydration, and improve outcomes in both ICU and chronic care settings. Similarly, early detection of UTI markers could prevent progression to severe infection and sepsis, reducing morbidity and healthcare costs.

[0080] Existing solutions for urine and effluent monitoring primarily address volumetric measurement through manual or semi-automated methods. While some automated systems exist, they are limited in scope, often lacking integration with electronic health records and failing to provide biochemical analysis, hydration sensing, or infection detection. Technologies for ion concentration measurement and UTI detection in urine or stoma effluent are largely confined to laboratory settings and have not been adapted for continuous monitoring. Therefore, there is a clear unmet need for an integrated system capable of real-time volume, hydration state, ion concentration, and infection marker tracking across urinary and ostomy applications, with potential to reduce complications, improve clinical decision-making, and enhance patient outcomes.

[0081] Patients with a body waste collection bag (e.g., ostomy patient with an ostomy pouch or patients with a catheter and drainage bag) need a quick, reliable, and convenient way to detect when they are at risk of dehydration. For ostomy patients, postoperative dehydration due to high- output stoma is a common complication within the first 30-60 days. Additionally, in patients with fecal collection devices, dehydration may worsen constipation or diarrhea, both of which complicate device management and skin integrity. For patients with a catheter, it may be subjective, labor intensive, and prone to error to track urine output to be able to detect dehydration. All of these patients have a risk for dehydration that could be mitigated by urine and or fecal volume tracking. Thus, it is desirable to provide a sensor system that may provide information regarding the patient’s hydration status or amount of output without disrupting daily routines and alert patients when dehydration risks arise.

[0082] There are some known technologies that may be used to measure bioimpedance, ostomy-related impedance, pressure, and stoma output. Bioimpedance is a frequently used way to measure hydration, and there have been many technologies that intend to measure hydration by measuring the impedance of someone’s skin. The principle behind bioimpedance is that body fluids containing dissolved ions that conduct electricity well. Pure water is not conductive, but physiological fluids are highly conductive because of their electrolyte content (Na , K+, Cl", etc.). Therefore, higher fluid volume and higher ionic concentration decrease the electrical impedance of tissues, whereas lower fluid volume or lower ionic content increase impedance. In the past few years, there have been a large number of approaches that leverage bioimpedance to measure hydration and any number of a large selection of possible metrics including heart rate,blood pressure, tissue turgor, or EMG. These range from relatively large but still wearable devices to “tattoos”, extremely thin devices that can be barely noticeable on the user. One constant between these devices is that they use some kind of calibration to link between bioimpedance and hydration level, and many papers calibrate using a Comeometer, a device that measures the capacitance of the stratum comeum as a proxy for skin hydration. Some studies also use an LCR (impedance, capacitance, resistance) meter to measure whole-body impedance, which could be used to calibrate bioimpedance measurements.

[0083] Many extant bioimpedance measures use very advanced contacts that resemble tattoos in that they stretch well and adhere to the skin. Unfortunately, these devices universally require calibration to find the relationship between bioimpedance and hydration for each individual. It seems that there may be a linear relationship between percent body weight loss from dehydration and bioimpedance. Notably, there are no commercial wearable products to track bioimpedance. This is most likely due to the calibration requirement.

[0084] Some technologies currently exist using printed, conductible traces as a means to detect fluid leaking from a stoma to the skin. The traces are integrated into ostomy skin barriers, with the traces masked from view from the outside. Each trace may be printed into a ring formation that is individually insulated, ensuring that they run separately towards the tail to the sensing device measuring resistance against a base, grounded electrode. Initially, the measured resistance between a certain ground electrode (denoted as G) and the measuring / sensor electrodes (denoted as L) is greater than the processor can detect (> 2 MQ). As fluid leaks out from the stoma at the center of the apparatus and comes into contact with the ground and measuring electrodes, the measured resistance between the two rapidly drops to a level around 1 k£l. This measurement may occur between any of the ground electrodes and a sensor, such as LI to Gl, G1 to L2, L2 to G2, etc. As long as there is a continuous presence of fluid between the electrodes, the output resistance will be significantly lower than the baseline, indicating leakage.

[0085] These traces may be printed into an ostomy appliance similar to how a printable circuit board (PCB) is created, using a screen printer with chosen conductible material for the traces, and non-conductible for the substrate. The skin barrier with the traces may be disposed and reused when necessary, while the durable, attachable sensor may be reusable, interfacing with the tail end of the barrier apparatus. The attachable device may be able to clip on to the end of the barrier portion, electrodes contacting the ends of the conductible traces to individuallymeasure the resistance at each level. It contains an embedded circuit board and battery, allowing for the device to process the measured resistances and provide an alert if leakage is detected.

[0086] When ostomy patients are discharged from the hospital, they are instructed to record their intake and output of fluids. Keeping track of the net amount of fluid in their body is necessary to detect if they have a high-output stoma and maintain hydration levels. To keep track of this, they are instructed to record this information in a journal. Every cup of water should be logged, and the volume of stoma output should be as well. Some ostomates may drain their ostomy pouch multiple times a day and each time, they must empty the contents into a graduated cylinder, check the volume, and note it. This process can be overwhelming for patients having a surgery or an ostomy for the first time, and many find it difficult to keep up. They may simply forget to record all measurements, or decide not to do so, due to the involved process of taking measurements or aversion to handling the contents of the pouch.

[0087] The present disclosure discloses a body waste collection system that includes at least one sensor system for tracking a person’s hydration. The body waste collection system may include a wearable device with a controller that is coupled to the at least one sensor system to track the output of bodily fluid from the person and / or track a measurement of hydration directly. For example, the body waste collection system may include a body waste collection bag that has a conductive sensor made from conductive traces and coupled to controller. The controller may be configured to use the conductive sensor to measure the amount of bodily fluid in the body waste collection bag before draining the bodily waste from the bag. This measurement may be used to help track the person’s hydration level to help them maintain a healthy hydration level. As another example, the body waste collection bag may include a pressure sensor coupled to the controller. The pressure sensor may be configured to measure a hydrostatic pressure in the body waste collection bag. The controller may be configured to measure the hydrostatic pressure in the body waste collection bag before draining bodily fluid from the body waste collection bag. The hydrostatic pressure may be used to calculate how much bodily waste is in the body waste collection bag. As yet another example, the body waste collection system may include a bioimpedance sensor comprising a plurality of electrodes. The electrodes may be positioned against the person’s skin and / or tissue. The controller may be configured to use the bioimpedance sensor to measure the person’s hydration status. The body waste collection system may include one or any combination of the example sensor systems or help track a person’shydration through either a direct measurement and / or measurement of bodily fluid output. The body waste collection system may also include an alert system to inform the user of their hydration status (e.g., if they are dehydrated). The body waste collection system may provide a plurality of advantageous features including automatic operation, longitudinal tracking, easy data acquisition, wearable device, and reliability.

[0088] The operation of the body waste collection system may be considered automatic. As such, the patient, user, or clinician does not need to do anything or only needs to perform minimal tasks for the device to record information. For example, the device may be configured to record information automatically right before the process of draining a body waste collection bag. This eliminates the concern for low patient cooperation for recording their stoma output, clinician resources, and / or ease of use. Successful automatic data acquisition may be the device autonomously taking measurements.

[0089] The device may allow for easy longitudinal tracking. The patient, user, or clinician is able to see changes in their hydration over the entire course of their use of the device (1 day to 2 months). Being able to see trends is very important in monitoring patient health, and the ability to see whether a patient’s hydration is trending up or down will be important information to determine whether or not the ostomate, intermittent catheter user, or patient may need to be treated for high-output stoma, dehydration, or overhydration. A successful longitudinal device may show the hydration status of the patient over the past week, storing data before the past week somewhere easily accessible.

[0090] The data from the device may be easily accessible. For example, it may be convenient to access and view past and present data from the device. Outside of initial setup, the sensor device may be configured to take less than a minute to receive additional data from the device, so the ostomate, intermittent catheter user, or clinician (e.g., ICU, acute, or long-term care clinician) may view their most recent data if desired. Convenient data access can improve quality of life for both the patient and their caretakers. It may be more difficult for everyone involved if, for example, a nurse had to manually jot down an analog reading from the device every ten minutes. A successful device for easy data access may wirelessly transmit past and present hydration information to a phone or laptop.

[0091] The device may be wearable. The sensor device may be sufficiently light and low profile for an ostomate or other person to not be inconvenienced by the sensor device beingattached to their body, ostomy bag, drainable bag, wheelchair, or bed. For example, the sensor device may be about 1” by 1” by 8 mm, and up to 15 grams. The overall profile and weight is important because we very frequently need to know data that can only be obtained by interfacing with the user’s body or bodily fluids. If the device is not wearable, then a person will probably not use it. For example, a successful wearable device may attach directly to the bottom of a typical ostomy bag or drainage bag, which may be around 12 inches in length. In this case, little to no additional work is needed by the person to use the device beyond the normal ostomy bag or drainage bag application. The sensor device may also be unobtrusive, not being noticeable or bothersome to the ostomate or patient.

[0092] The device needs to be reliable. For example, the device may break or otherwise stop working properly less than 1% of the time over the course of two months. It also may provide accurate data. For impedance data, accurate is defined as a correlation coefficient greater than 0.8 between our measurements and the Comeometer, which is the industry standard for tracking hydration levels. The Corneometer being a commercial product. In general, an accuracy within 2% per measurement is preferred because the error may compound over the duration of 24 hours if multiple measurements are taken. Both patients and clinicians need to be able to rely on the device to be functional and accurate. The sensor device may be configured to interface with moisture, and thus, be water-resistant or waterproof. If there are detectable software or hardware errors, the sensor device may raise an error instead of failing silently.

[0093] The users of the sensor device may include intermittent catheter patients, ICU patients, acute care patients, long-term care patients, or ostomy patients (e.g., ileostomy, urostomy, colostomy, etc.). Especially new ostomy patients who are at risk of dehydration due to the common complication of a high output stoma. The sensor device may serve as a secondary line of communication between the patient and their body by communicating to the patient when they may be dehydrated via an alert system. The alert system may be configured for the patient to mitigate the risk of dehydration by serving as a reminder to drink water. The sensor device may be used in various environments of ostomates, patient’s, or user’s daily routine. For example, the ostomate or other patient may remain in the hospital after a procedure (e.g., for an ostomate they may remain in the hospital for up to a week or so after surgery) and may begin using the sensor device upon their return home. For ostomates, they are instructed to get back to their normal routine as soon as they feel ready. As such, some people may immediately go backto exercising and some will wait the 6-8 weeks it typically takes to feel completely normal again. As such, the sensor device needs to be as non-inhibitory as possible. For example, the sensor device may be built into an ostomy apparatus. In any case, the sensor device may be configured to work in wet or aqueous environments.

[0094] FIG. 1 illustrates an example standard two-piece ostomy pouch system 100. According to example embodiments shown in FIG. 1, the ostomy pouch system 100 includes an ostomy barrier appliance 102 and an ostomy bag 104 (also refer to herein as “ostomy pouch”). The ostomy bag 104 may include a body-side wall and a distal-side wall joined by a heat-sealed peripheral edge to form a cavity to collect bodily waste. The body-side wall may define an inlet opening 106 configure to receive a user’s stoma through which bodily waste can enter the cavity within the ostomy bag 104. The ostomy bag 104 includes a tail section 112 ending in an outlet 114. Collected bodily waste may be drained out of the cavity through the outlet 114. The outlet 114 may be sealed by folding the tail section 112 upward toward the pouch body (e.g., folding the tail section 112 two or three times) to seal the outlet 114 and then secure the fold in place with a clamp or another method for securing the fold in position.

[0095] In two-piece ostomy pouch systems 100, the body-side wall may include a pouch coupling member 108 to attach the ostomy bag 104 to an ostomy barrier appliance 102. The ostomy barrier appliance 102 may include a barrier coupling member 110 configured to engage with the pouch coupling member 108. In one-piece ostomy pouch systems, an ostomy barrier appliance may be permanently attached to the ostomy pouch around the inlet opening 106. In either two-piece ostomy pouch systems or one-piece ostomy pouch systems, the ostomy barrier appliance may include an adhesive skin barrier layer for attaching the ostomy barrier appliance 102 to a user, wherein the user’s stoma may be received through an inlet opening of the ostomy barrier appliance 102.

[0096] FIG. 2 illustrates a catheter drainage bag 120. A catheter drainage bag 120 is a medical device designed to collect urine directly from the bladder via a catheter 122. The system consists of a catheter (e.g., a flexible tube) inserted into the bladder to allow urine to flow continuously into a collection bag 126. The collection bag 126 itself may be made of medicalgrade plastic and features an inlet 132 securely connected to the catheter to prevent leaks. Inside the collection bag 126, urine accumulates in a sealed cavity (e.g., formed by joining two layers of material along the edges). To prevent backflow and maintain hygiene, the collection bag 126may include a one-way valve 124 at the inlet 132. The collection bag may be equipped with graduated volume markings so users or clinicians can monitor the user’s urine output easily. For patient comfort and mobility, the collection bag 126 may be designed with straps or holders to attach it to the patient’s leg (for ambulatory use) or hang from a bedside frame (for patients confined to bed). A drainage outlet 130 is positioned at the bottom of the bag, fitted with a valve 128 or secured cap, allowing for emptying any urine from the collection bag 126. This outlet is designed to minimize the risk of contamination during urine disposal.

[0097] FIG. 3 illustrates a control diagram of an example body waste collection system 140. The body waste collection system may include a wearable device 142 and a sensor system 156. The wearable device 142 may include a controller 144, battery 150, user interface 138, and an alert interface 152. The controller 144 may be coupled to the battery 150, the user interface 138, and the alert interface 152. The controller 144 and other components of the body waste collection system 140 may be powered by the battery 150.

[0098] The controller 144 may receive input from the user through the user interface 138. For example, the user interface 138 may be a button positioned on an exterior surface of the wearable device 142 that may be engageable (e.g., pressed) by the user. When the user interface 138 is engaged, the controller 144 may receive an input indicative of the user interface being engaged by the user. In some aspects, the controller 144 may be configured to take measurements of the amount of bodily waste collected in a body waste collection bag 162 when the user interface 138 is engaged. As such, engaging the user interface 138 may be indicative of a measurement of the amount of bodily waste collected being requested.

[0099] The alert interface 152 may allow the controller 144 to inform the user of any detected statuses or issues. For example, the controller may transmit a notification or alert to the user through the alert interface 152 through a physical function (e.g., lights or vibrations) of the alert interface. The alert interface 152 may include a vibration device. Transmitting a notification may have the controller 144 cause the vibration device to vibrate which vibrates the wearable device 142 notifying the user. The alert interface 152 may also include one or more LED lights. Transmitting a notification may have the controller 144 cause the one or more LED lights to light up or flash to notify the user. In any case, the controller 144 may interact with the alert interface 152 to provide input to the user on a status of the wearable device or a status of the user (e.g., a dehydration status).

[0100] The controller 144 may include a memory 148 coupled to a processor 146. The memory 148 storing instructions that are executable by the processor to perform the various operations of the wearable device 142. Although the memory 148 is illustrated as one in FIG. 3, the memory may be one or more memories 148 and similarly the processor 146 may be one or more processors 146 all coupled together to perform the various operations of the wearable device 142. Instructions used to program logic to perform various disclosed aspects can be stored within the memory 148 in the system such as dynamic random access memory (DRAM), cash, flash memory, or other storage. Furthermore, the instructions can be distributed via network or by way of other computer readable media. Thus a machine- readable medium may include any mechanism for storing or transmitting information in a form readable by a machine (e.g., a computer), but is not limited to, floppy diskettes, optical disks, compact disc, read-only memory (CD-ROMS), and magneto-optical disks, read-only memory (ROMS), random access memory (RAM), erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), magnetic or optical cards, flash memory, or a tangible, machine-readable storage used in the transmission of information over the internet via electrical, optical, acoustical, or other forms of propagated signals (e.g., carrier waves, infrared signals, digital signals, etc.). Accordingly, the non-transitory computer-readable medium includes any type of tangible machine-readable medium suitable for storing or transmitting electronic instructions or information in a form readable by a machine (e.g., a computer).

[0101] As used in any aspect herein, the term “controller”, “control circuit”, or “control system” may refer to, for example, hardwired circuitry, programmable circuitry (e.g., a computer processor including one or more individual instruction processing cores, processing unit, processor, microcontroller, microcontroller unit, controller, digital signal processor (DSP), programmable logic device (PLD), programmable logic array (PLA), or field programmable gate array (FPGA)), state machine circuitry, firmware that stores instructions executed by programmable circuitry, and any combination thereof. The control circuit may, collectively or individually, be embodied as circuitry that forms part of a larger system, for example, an integrated circuit (IC), an application-specific integrated circuit (ASIC), a system on-chip (SoC), desktop computers, laptop computers, tablet computers, servers, smart phones, etc. Accordingly, as used herein “control circuit” includes, but is not limited to, electrical circuitry having at least one discrete electrical circuit, electrical circuitry having at least one integrated circuit, electricalcircuitry having at least one application specific integrated circuit, electrical circuitry having forming a general purpose computing device configured by a computer program (e.g., a general purpose computer configured by a computer program which at least partially carries out processes and / or devices described herein, or a microprocessor configured by a computer program which at least partially carries out processes and / or devices described herein), electrical circuitry forming a memory device (e.g., forms of random access memory), and / or electrical circuitry forming a communications device (e.g., a modem, communications switch, or optical- electrical equipment). Those having skill in the art will recognize that the subject matter described herein may be implemented in an analog or digital fashion or some combination thereof.

[0102] The wearable device 142 may be coupled to the sensor system 156 and receive data from the sensor system 156. The controller 144 may receive input indicative of the user’s hydration and / or amount of collected bodily waste collected from the sensor system 156. The sensor system 156 may include a bioimpedance sensor 160 positioned on the user’s skin, a bioimpedance sensor 164 built into a body waste collection bag 162, a conductive sensor 166 built into the body waste collection bag 162, a pressure sensor 168 built into the body waste collection bag 162, or any combination thereof. The body waste collection bag 162 may be an ostomy bag (e.g., ostomy bag 104), a drainage bag (e.g., catheter drainage bag 120), or any other bag or device for collecting bodily waste from a person. The wearable device 142 may attach to the body waste collection bag 162. For example, the wearable device 142 may be movable from an open configuration to a closed configuration, where the wearable device 142 may clamp onto the body waste collection bag 162 in the closed configuration.

[0103] In some aspects, the wearable device 142 may be coupled with a coupling interface 196 (FIG. 5 A) positioned on an exterior surface of the body waste collection bag 162, when the wearable device 142 is attached to the body waste collection bag 162. For example, the wearable device 142 may move from the open configuration to the closed configuration to clamp onto the coupling interface 196 to electrically couple the wearable device 142 to the coupling interface 196. The coupling interface may communicably and electrically couple the controller 144 to one or more of the sensors 160, 164, 166, 168 of the sensor system 156. In this aspect, the sensors 160 may be powered by the battery 150. In some aspects, the controller 144 may becommuni cably coupled to one or more of the sensors 160, 164, 166, 168 of the sensor system 156 wirelessly (e.g., through any standard wireless communication protocols).

[0104] The wearable device 142 may be attached to the body waste collection bag 162 such that a user may need to remove the wearable device 142 before emptying the body waste collection bag 162. Removing the wearable device 142 may require the user to engage the user interface 138 (e.g., press a button on an exterior surface of the wearable device 142). The user may need to remove the wearable device 142 to empty the body waste bag 162 and as such may need to engage the user interface 138. By engaging the user interface 138, the controller 144 may receive an input from the user interface 138 indicative of a measurement being requested before the user empties the body waste collection bag 162. The input from the user interface 138 may correspond to the body waste collection bag 162 being drained of any collected bodily waste. In this way, the controller 144 may be configured to take a measurement of the amount of bodily waste collected in the body waste collection bag 162 upon receiving the input from the user through the user interface 138. As such, the controller 144 may receive data from the sensor system 156 indicative of an amount of bodily waste in the body waste collection bag. The controller 144 may then determine an amount of bodily waste collected in the body waste collection bag based on the received data. This process allows the controller 144 to record how much bodily waste was collected before the body waste collection bag 162 is emptied.

[0105] The controller 144 may be configured to store the amount of bodily waste collected in the memory 148 along with a timestamp. The controller 144 may be configured to determine how much bodily waste was collected over the last 24 hours. The amount collected over 24 hours may be compared to a threshold value and if the threshold is exceeded then the user may be at risk of being dehydrated. For an ostomate, the threshold value may be selected to determine if the ostomy patient has a high output stoma. For others, the threshold value may indicate an above normal output of bodily fluid from the patient. In either case, the threshold value may be used to determine if the patient is at risk of dehydration based on a large amount of bodily waste being output over 24 hours. If the threshold is exceeded, the controller 144 may transmit an alert to the user. The alert or notification may be transmitted to the alert interface 152 to cause the alert interface 152 to cause a physical function (e.g., as described previously) to notify the user. The alert of notification may also be transmitted to a mobile device 154.

[0106] The controller 144 may be communicably coupled to the mobile device 154. The controller 144 may transmit the measurements of collected bodily waste to the mobile device 154. The mobile device 154 may store the amount of bodily waste collected for the user or a clinician to view later. The controller 144 may also transmit alerts and notifications to the mobile device 154. The mobile device 154 may be a personal device that is owned by the user.

[0107] FIGS. 4A-5B are illustrations of an example body waste collection system 140 with conductive sensors 166 to measure an amount of bodily waste collected in the body waste collection bag 162. The body waste collection bag 162 is illustrated as an ostomy bag 104 with an ostomy barrier appliance 102. The same approach may be used to apply conductive sensors 166 to any body waste collection bag 162 (e.g., a drainage bag as shown in FIG. 2). The ostomy bag 104 may be part of a two-piece system as shown in FIG. 1 or a one-piece system with the ostomy barrier appliance 102 integrated into the ostomy bag 104.

[0108] As discussed regarding FIG. 3, the sensory system 158 may include conductive trace sensors 166 configured to detect an amount of bodily waste collected in the body waste collection bag 162. The conductive sensors 166 may include conductive traces configured to detect liquid level in the ostomy bag 104. The conductive traces may be viewed as level conductive traces 170, a ground conductive trace 172, and insulated traces 174. As shown in FIG. 4A, the body waste collection system 140 may include an ostomy pouch 104 or urine drainage bag 120 that includes level conductive traces 170, with each level conductive trace 170 individually printed into the bag 104 to designate a certain level of volume. The level conductive traces 170 may be printed at varying heights to customize the resolution of measurement. Each ostomy bag 104 may have these traces printed inside them, and the attachable wearable device 142 may clamp at the bottom of the ostomy bag 104 and may be reused each time to take and record measurements.

[0109] The first conductive trace at the base of the bag 162 may be considered a ground conductive trace 172 and the conductive traces above may be level conductive traces 170. The ground conductive trace 172 may be positioned at an outlet 114 of the body waste collection bag 162. The body waste collection bag 162 may define a longitudinal axis 116. The level conductive traces 170 may be positioned along the longitudinal axis 116 to measure increments of bodily waste collected (e.g., 25mL, 50 mb, or 100 m , etc.). The ground conductive trace 172 and each level conductive trace 170 may be positioned within the body waste collection bag 162 at anangle perpendicular to the longitudinal axis 116. Positioning the ground conductive trace 172 and level conductive traces 170 in this way allows accurate measuring when the body waste collection bag 162 is held vertically and a measurement of bodily waste collected is taken. The ground conductive trace 172 may be positioned such that as bodily waste is being collected, ground conductive trace 172 is the first conductive trace to be covered in collected bodily waste when the bag 162 is held in the upright position. The level conductive traces 170 and the ground conductive trace 172 may extend around the internal surface of the body waste collection bag 162.

[0110] Referring to FIGS. 4B and 5A, the level conductive traces 170 and the ground conductive trace 172 may each connect to an insulated trace 174. The level conductive traces 170 and the ground conductive trace 172 may extend around the internal surface of the body waste collection bag 162 except where the insulated traces 174 run along the length of the bag 162. The insulated trace 174 may extend from a level conductive trace 170 or the ground conductive trace 172 to the coupling interface 196. As such, the plurality of insulated traces 174 may electrically coupling the level conductive traces 170 and the ground conductive trace 172 to the coupling interface 196. The coupling interface 196 may be positioned on an exterior surface of the body waste collection bag 162. In some aspects, the coupling interface 196 may be positioned on the tail section 112 of an ostomy bag 104.

[0111] Referring to FIG. 5B, the wearable device 142 may include a first jaw 192 and a second jaw 194 that have a hinged connection between them allowing the first and second jaws 192, 194 to move toward one another. The wearable device 142 may be moveable from an open configuration shown to a closed configuration by clamping the jaws 192, 194 together. In the jaws 192, 194 may have a lock feature (e.g., a snap) that maintains the jaws 192, 194 in the closed configuration. The open configuration shown in FIG. 5B and the closed configuration shown in FIGS. 4A and 4B. The wearable device 142 may be clamped (i.e., positioned in the closed configuration) over the bottom or outlet area of the body waste collection bag 162 such that the coupling interface 196 is positioned within the wearable device 142. In this way, the wearable device 142 may be mechanically coupled to the body waste collection bag 162. In the closed configuration, the wearable device 142 may couple with the coupling interface 196. For example, pins positioned within the wearable device 142 may couple with the coupling interface 196 to electrically coupled with the coupling interface 196 with the controller 144. As such, thecontroller 144 may be coupled with the conductive sensors 166 and receive measurements of the collected bodily waste through the conductive sensors 166.

[0112] As stated previously, the wearable device 142 may include a battery-powered circuit board (e.g., the controller 144) that has data storage capability (e.g., the memory 148), along with wireless communication capability. To ensure that only the interior circuitry of the wearable device 142 interacts with the conductive traces 170, 172, 174 running through the bag 162, the wearable device 142 may be constructed from a non-conductive substrate, such as plastic. Similarly, the body waste collection bag 162 itself may be designed from a non-conductive material, while the traces 170, 172 themselves are conductive (Cu, Carbon Black, AgCl, etc.).

[0113] To record an accurate measurement of the bodily waste collected in the body waste collection bag 162, the body waste collection bag 162 may need held in an upright position for the measurement. The user may be required to engage a button 178 of the user interface 138 to take a recording of the body waste collected. The button 178 being positioned on an exterior surface of the wearable device 142. As discussed previously regarding FIG. 3, the controller 144 may be coupled to the user interface 138 as well as the coupling interface 196.

[0114] The controller 144 may be configured to perform a method to measure an amount of bodily fluid collected in the body waste collection bag 162. The method may include the controller 144 receiving an input from the user interface 138 indicative of a measurement being requested. For example, the user may press the button 178 requesting a measurement to be taken. The measurement may be taken by the user before draining the body waste collection bag 162. The method may further include the controller 144 measuring, after receiving the measurement request, a resistance between each level conductive trace 170 and the ground conductive trace 172. The method may further include the controller 144 comparing each resistance to a resistance threshold, where the resistance threshold is selected to determine if bodily waste is covering the ground conductive trace 172 and the level conductive trace 170. For example, the resistance may be different if the level conductive trace 170 and ground conductive trace 172 are covered in bodily waste compared to them not being covered in bodily waste. The method may further include the controller 144 determining an amount of bodily waste collected in the body waste collection bag 162 based on the comparisons. For example, the resistance between a level conductive trace 170 and the ground conductive trace 172 may be below the resistance thresholdwhen both the level conductive trace 170 and the ground conductive trace 172 are submerged in bodily waste.

[0115] The controller 144 may determine an amount of bodily fluid in the body waste collection bag 162 by knowing which level conductive traces are submerged in bodily fluid based on the resistances. As such, if the third level conductive trace 170 from the ground conductive trace 172 is submerged and the fourth level conductive trace 170 is not submerged, then the amount of collected bodily waste is between 150mL and 200M1 with a 50mL increase for each level conductive trace 170. In an alternative aspect, the controller 144 may determine the amount of bodily waste collected in the body waste collection bag 162 based on the number of resistances below the resistance threshold. For example, if each level conductive trace 170 represents an increase of 50mL, then the amount of bodily fluid collected is between the value of the number of resistances below the resistance threshold multiplied by 50mL and the value of the number of resistances below the resistance threshold plus one and multiplied by 50mL. As such, if the number of resistances below the resistance threshold is 3, then following the math the amount of bodily fluid collected is between 150mL (3*50mL) and 200 mb (4*50mL).

[0116] When there is no bodily waste present in the bag 162, the resistance between the ground conductive trace 172 and any of the level conductive traces 170 above measures as effectively infinite (e.g., in reality a magnitude of 1013) given the lack of ions present in air. However, as bodily waste begins to collect in the bag 162 (e g., effluent exits the stoma or urine enters the bag and flows into the bag), the ground conductive trace 172 comes into contact with the bodily waste and the bag fills to a certain threshold. Each level conductive trace 170 that comes into contact with a continuous presence of fluid from the base of the bag 162 will show a sharp, significant decrease in the measured resistance due to the ionic composition of the effluent.

[0117] FIG. 6 illustrates a graphical representation 184 of example resistance measurements between a level conductive trace 170 and the ground conductive trace 172 as they are both submerged in bodily waste. The resistance between the level conductive trace 170 and the ground conductive trace 172 are shown as resistance line 186. At approximately the time noted by exposure line 188, the level conductive trace 170 and the ground conductive trace 172 are both being submerged in bodily waste. As shown in FIG. 6, there is a sharp decrease in the resistance line 186 before being submerged in bodily waste and after being submerged in bodilywaste. The resistance threshold may be shown as resistance threshold line 190. The resistance threshold may be selected to detect when the level conductive trace 170 and the ground conductive trace 172 are both submerged. As such, when the resistance between the level conductive trace 170 and the ground conductive trace 172 is above the resistance threshold line 190 the level conductive trace 170 and the ground conductive trace 172 are not submerged in bodily waste. When the resistance between the level conductive trace 170 and the ground conductive trace 172 is below the resistance threshold line 190 the level conductive trace 170 and the ground conductive trace 172 are submerged in bodily waste.

[0118] If 125 mL were to be output or collected in the body waste collection bag 162, then the volume would fill between the second and third level conductive traces 170, which represent lOOmL and 150mL, respectively. When individually measuring the resistance at these traces 170, the third trace 170 may output a relatively low resistance, while fourth trace 170 may output the undetectable infinite resistance. This tells us that the overall output (e g., output of the stoma or urinary catheter) was greater than 100 mL, but less than 150 mL. By following this procedure for any volume of output, we are able to measure the resistance of the traces 172, 170 and determine at what point the volume is at, depending on the intervals of volume we design.

[0119] As the user empties their bag 162 throughout the day and the wearable device 142 may take measurements, these may be collected in a running total, with a warning threshold (e.g., the warning threshold may be 1000 mL). The threshold may be set to be well before the range of a HOS, which is around 1200 mL / day. This is to allow for any low resolution from discrete measurements and / or compounding errors, the leeway between the warning threshold and actual HOS volume may ensure that the measurements are still effective and not to a user that they may have a HOS. As such, the notification may not for the user that they are at risk of being dehydrated. For ostomates, not only will the measurements provide valuable information for the ostomates, but the measured resistance can also be used to estimate the ionic levels within the effluent of the user, providing useful information to further characterize the stoma’s output. For any user, the warning threshold being exceeded may cause the controller to transmit a notification to the user through the alert interface 152 or to a mobile device 154. The notification may inform the user of the large quantity of bodily waste collected to note that they may be at risk of being dehydrated.

[0120] To rectify the wearable device’s 142 requirement that the body waste collection bag 162 (e.g., the ostomy bag 104 or urine drainage bag 126) is in an upright position, every time the user takes off their bag 162 to empty it, they may be required to press the button 178 to unclip the wearable device 142 and empty the contents. For example, the user may be required to press the button 178 to move the wearable device 142 from the closed configuration to the open configuration. This may ensure two things. First, every time a measurement is made, the bag 162 is in a vertical position, and free from external pressure and deformation, which will allow for the most accurate measurements. Second, this aims to tackle the issue of patient compliance, essentially strong-arming them into taking a measurement without having to manually measure with a graduated cylinder. Due to the memory storage capability of the device, the measured volumes may be stored longitudinally, keeping a running total over a 24 hour period (e.g., to monitor the risk level for HOS if the user is an ostomate).

[0121] The data acquisition may be simple, requiring one press of the button 178 to record the resistances and determine the volume within the bag as discussed above and then the volume may be stored in the memory 148. Both the reusable and disposable parts of the device are wearable. For example, the ostomy bag 104 may be a single time use or a set number of uses making the conductive traces disposable as they are integrated into the ostomate’ s daily appliances. The wearable device 142 may be a reusable good designed to clip or clamp on to the bottom of the bag 162. The wearable device 142 device may be reliable, providing accurate enough measurements within the chosen resolution to give a clear warning of risk when bodily waste output exceeds standard ranges.

[0122] As discussed previously, the body waste collection system 140 may include the clip- on wearable device 142 that includes a circuit board (e.g., controller 144) with wireless communication capabilities. In an embodiment, the wearable device 142 may include an alert interface 152 that includes lights (e.g., LEDs 180, 182), have the capability of vibrating, or producing a sound. Due to potential disruption of a patient’s day-to-day routine by audible noise, incorporating that feature may be less preferred. Due to the location of the wearable device 142, lights may not be noticeable if someone is wearing a hoodie or tucking in their body waste collection bag 162. As such, the alert interface 152 may include a vibrator that may cause the wearable device 142 to vibrate or buzz, which the patient may feel on their torso or upper thigh, depending on their position. The duration of buzzing and the intensity may be varied. Veryintense buzzing may cause unwanted noise, but subtle buzzing may not be enough to notice. There must be a careful balance between the two.

[0123] A secondary mode of communication may be using bluetooth to transport data from the wearable device 142 to a mobile device 154 (e.g., a smartphone). In this case, the mobile device 154 may alert the patient in their preferred mode (buzzing, flashing light, noise). The data may then be processed and stored in a memory of the mobile device 154. An app that the patient can access to view the recorded information and be able to track trends in volume changes over time may be provided. In an embodiment, the wearable device 142 may be customizable for the patient based on their preferences. Every person responds differently to different stimuli and making data communication customizable allows the patient to have greater ease and control over their post operative experience.

[0124] FIG. 7 illustrates some example communication modes of the wearable device 142. For example, the alert interface 152 of the wearable device 142 may include LED lights 180, 182. The LED lights 180, 182 may be colored and light and / or flash to provide a notification to the user. The alert interface 152 may include a speaker allowing the wearable device 142 to produce a noise to notify the user. The alert interface 152 may include a vibrating device that allows the wearable device 142 to vibrate to notify the user. The controller 144 may control the alert interface 152 to cause any of the described physical functions to notify the user. The controller 144 may also be communicably coupled to a mobile device 154 and the notifications may be transmitted to the mobile device 154.

[0125] FIG. 8 is a diagram of an example body waste collection system 140 with a pressure sensor 168 to measure an amount of bodily waste collected in the body waste collection bag 162. The body waste collection bag 162 is illustrated as an ostomy bag 104 with an ostomy barrier appliance 102. The same approach may be used to apply a pressure sensor 168 to any body waste collection bag 162 (e.g., a drainage bag as shown in FIG. 2). The ostomy bag 104 may be part of a two-piece system as shown in FIG. 1 or a one-piece system with the ostomy barrier appliance 102 integrated into the ostomy bag 104.

[0126] As discussed regarding FIG. 3, the sensory system 158 may include a pressure sensor 168 configured to detect hydrostatic pressure which may be related to an amount of bodily waste collected in the body waste collection bag 162. For ostomates, the sensory system 158 may be used to monitor a high-output stoma by measuring effluent volume by using one or moresubmersible pressure sensors 168. Submersible pressure sensors may offer a reliable method for measuring liquid levels and volumes. These sensors operate on the principle of hydrostatic pressure, where the pressure at the bottom of a liquid column is proportional to its height. This technology can be used with the wearable device 142 to accurately measure the volume of bodily waste collected in a body waste collection bag 162.

[0127] To accurately measure and interpret the pressure sensor output, proper signal conditioning and data acquisition are crucial. For example, Texas Instruments offers solutions for interfacing with pressure sensors: Wheatstone bridge configuration for sensor connection, Instrumentation amplifier for signal amplification, and Analog-to-digital converter (ADC) for digitizing the signal. This setup allows for precise measurement of small pressure changes, which is essential for accurately determining effluent volume. This setup may be built into or mimicked by the controller 144 to configure the signals from the pressure sensor 168 to take measurements. To convert pressure readings into volume measurements, the following equation p may be employed: V = — A, where, V is volume, P is measured pressure, p is density, g isacceleration coefficient for gravity, and A is cross-sectional area of bag 162.

[0128] In an embodiment, the sensor system may include a pressure sensor 168 (e g., the pressure sensor NPC-1210) configured to measure a hydrostatic pressure at the base of the bag 162. The wearable device 142 may measure the volume of bodily waste collected in the body waste collection bag 162 based on the hydrostatic pressure at the base of the bag 162. As such, the pressure sensor 168 may be positioned within the body waste collection bag 162 at the bottom of the bag 162 toward the outlet of the body waste collection bag 162. The pressure sensor 168 may be housed in a protective, reusable pouch 198 located at the flat bottom of the body waste collection bag 162. The reusable pouch 198 may shield the pressure sensor 168 from direct contact with the bodily waste. The body waste collection bag 162 being more rigid than the reusable pouch 198 ensures consistent readings of the hydrostatic pressure. Additionally, this placement allows the pressure sensor 168 to be reused when the bag 162 is discarded, reducing costs and environmental waste. The body waste collection system includes the controller 144 (e.g., an Arduino microcontroller) connected to the pressure sensor 168, and programmed to record the pressure readings, activate alerts, and log the cumulative daily bodily waste volume collected.

[0129] Another example of the pressure sensor 168 may be ultra-miniature pressure sensors, which are small in size and have high sensitivity. Suitable options include MP-1-20 UltraMiniature Pressure Sensor (Diameter: 1.2 mm; Pressure range: 0-1 bar (0-14.5 psi); Accuracy: ±0.5% FSO (Full Scale Output)2) and MP- 1-25 Ultra-Miniature Flat Pressure Sensor (Dimensions: 2.5 x 2.5 x 0.8 mm; Pressure range: 0-1 bar (0-14.5 psi); Accuracy: ±0.5% FSO3). These sensors’ small form factors make them ideal for integration into a compact, wearable device for stoma output monitoring. In any case, the pressure sensor 168 may be any pressure sensor suitable to measure the hydrostatic pressure in the body waste collection bag 162.

[0130] The user may activate the pressure sensor 168 by pressing the button 178 integrated into the wearable device 142. This button 178 may serve two purposes: it engages the pressure sensor 168 for measurement and enables effluent drainage. By requiring the user to stand while pressing the button 178, the wearable device 142 may ensure accurate readings based on consistent posture, mitigating the variability caused by changes in bag orientation, such as lying down. This setup enhances reliability by measuring bodily waste volume only when conditions are optimal for accurate pressure sensing. The pressure sensor 168 may operate by converting the hydrostatic pressure into a voltage output, with a sensitivity of 50 mV per 10 inches of liquid height. This allows the sensor to detect depth changes as small as 1 inch, providing high accuracy for volume calculations. Calibration may be performed by measuring the sensor’s output for known liquid volumes, establishing a linear relationship between pressure and depth. Using this calibration, the depth readings may be converted into volume measurements based on the cross-sectional area of the bag. The bag itself may be constructed from medical -grade polymers for durability and rigidity, with the sensor pouch 198 being made from waterproof, non-corrosive materials like silicone or Teflon. The overall system is compact, with the sensor 168 and pouch occupying minimal space. The system is cost-effective and practical for widespread use. The high sensitivity and specificity of the pressure sensor ensure reliable data, while the modular design allows for easy assembly and maintenance.

[0131] The fabrication process may involve manufacturing the rigid, flat-bottomed body waste collection bag 162 and waterproof sensor pouches 198, installing the pressure sensor into the pouch, and connecting it to the controller 144. The controller 144 may be programmed to activate the sensor 168, process data, and manage alerts.

[0132] The pressure sensor 168 may be wired into the side wall of the body waste collection bag 162 and connect to a coupling interface 196 as described regarding FIG. 5 A. As such, wires 200 or conductive material may couple the pressure sensor 168 to the coupling interface 196. The wearable device 142 may be coupled with the coupling interface 196 as described regarding FIGS. 4A-5B. In an alternative aspect, the pressure sensor 168 may have a pressure sensor controller that wirelessly couples to the controller 144. For example, the pressure sensor 168 may be a stand-alone unit that has its own controller that communicably couples with the controller 144. In this way, the controller of the pressure senor may transmit a hydrostatic pressure from the pressure sensor 168 to the controller 144 when the pressure sensor controller receives a request for a measurement. In any case, the pressure sensor 168 is coupled to the controller 144 to provide a hydrostatic pressure measurement to the controller 144 when desired.

[0133] FIG. 9A illustrates an example pressure sensor 168. FIG. 9B illustrates the pressure sensor 168 being coupled to the controller 144, where FIG. 9B illustrates a subsection of FIG. 3 showing only the pressure sensor 168, alert interface 152, and controller 144 of FIG. 3. The other sections of FIG. 3 are not shown but may still be there and coupled to the controller 144.

[0134] The wearable device 142 may clamp on the body waste collection bag 162 as described regarding FIGS. 4A-5B. The wearable device 142 may be used to take and record measurements of the volume of bodily waste collected. The controller 144 of the wearable device 142 may be configured to perform a method to measure an amount of bodily fluid collected in the body waste collection bag 162.

[0135] The method may include the controller 144 receiving an input from the user interface 138 indicative of a measurement being requested. For example, the user may press the button 178 requesting a measurement to be taken. The measurement may be taken by the user before draining the body waste collection bag 162. The method may further include the controller 144 receiving, after receiving the measurement request, a hydrostatic pressure from the pressure sensor 168. The method may further include the controller 144 determining an amount of bodily waste collected in the body waste collection bag 162 based on the hydrostatic pressure. For example, the hydrostatic pressure may correspond to a volume of bodily waste collected. The volume of bodily waste collected may be a predetermined function of hydrostatic pressure. The function may have been determined by measuring the pressure sensor’s output for known liquid volumes, establishing a relationship between pressure and depth. As discussed previouslyregarding FIGS. 4A-7, the controller 144 may store the amount of bodily waste collected and transmit the amount to a mobile device 154. Additionally, the controller 144 may track the amount of bodily fluid collected over 24 hours and alert the user if a threshold is exceeded as discussed previously. The controller 144 may interact with the alert interface 152 in the same manner as previously described.

[0136] As discussed regarding FIG. 3, the sensor system 156 may include both the conductive sensors 166 described in FIGS. 4A-5B and the pressure sensor 168 as described in FIG. 8. In this aspect, the controller 144 may combine the methods described to determine an amount of bodily waste collected. The controller 144 may receive a first value for the amount of bodily waste collected from the conductive sensors 166 through the method described regarding the conductive sensors 166. The controller 144 may receive a second value for the amount of bodily waste collected from the pressure sensor 168 through the method described regarding the pressure sensor 168. The method may further include the controller 144 determining a final value for the amount of bodily waste collected by averaging the first value and the second value. In this way, the controller 144 may combine the value for the amount of bodily waste determined based on the conductive sensors 166 and the value for the amount of bodily waste determined based on the pressure sensor 168.

[0137] By having two measurements for the volume of bodily waste collected, the body waste collection system 140 may be more accurate. The controller 144 may also be able to detect an issue with one of the measurement values. The method may further include the controller 144 determining a difference between the first value and the second value (e.g., by subtracting the first and second values). The method may further include the controller 144 transmitting an alert to the user when the difference exceeds a threshold value. The threshold value may be set to determine that there is an issue with one of the two values. The controller 144 may provide the alert to the user through the alert interface 152 and / or through the mobile device 154 as described previously. The alert may inform the user that there is an issue with the measurement for the amount of bodily waste collected and that the measurement needs retaken.

[0138] Measuring the amount of bodily waste output by a user may be considered an indirect method to measure the user’s hydration. Measuring the user’s hydration directly may also provide some benefits. Bioimpedance is a frequently used method in the literature to measure hydration in a wearable form factor, and it has emerged as one of our leading methods tomeasure hydration as well. Generally, the main cause of readmission for patients with high- output stoma (HOS) is dehydration 21, and 25% of patients with ileostomies develop chronic kidney disease within 2 years of the operation, most likely due to chronic dehydration. Bioimpedance also makes a compelling metric for research, as ostomate hydration over time is potentially useful to evaluate treatment strategies. For these reasons, we find hydration a compelling characteristic to measure directly, and bioimpedance the most successful, well- implemented, and feasible metric to do so.

[0139] FIG. 10 is a diagram of an example body waste collection system 140 with a bioimpedance sensor 164 built into the body waste collection system 140. The body waste collection system 140 may include a wearable device 142 as a durable electronic component attached to one or more sensors 164 as disposable component(s). Even if the contacts do not end up disposable, it will be useful to switch between durable components in case the battery gets low or a part of the contacts break. The bioimpedance sensor 164 may be placed at or around the stoma, as existing adhesives and the ostomy bag form a convenient point of attachment. The wearable device 142 may be attached to the ostomy bag 104, as slight movement of the durable good is not a concern, and which can avoid the hassle of giving the ostomate another adhesive site that may get irritated. Possible attachment locations for the contacts may include the stoma itself or the skin around the stoma. If the user is an ostomate or is not an ostomate, the bioimpedance sensor 160 may be a standalone device coupled to the wearable device 142. FIG. 12 illustrates an example stand-alone bioimpedance sensor 160.

[0140] FIG. 10 illustrates the body waste collection bag 162 as an ostomy bag 104. The ostomy bag 104 may have an ostomy barrier appliance 102. The bioimpedance sensor 164 includes a plurality of electrodes positioned against the skin of a user when the body waste collection bag 162 is attached to the user. The bioimpedance sensor 164 is configured to measure an impedance between at least one pair of electrodes of the plurality of electrodes. The bioimpedance sensor 164 may include skin electrodes 210 positioned against the skin slightly away from and surrounding the stoma 202 and stoma electrodes 204 positioned against the user’s tissue directly at the stoma 202. These electrodes 204, 210 may positioned in a “ring barrier” of the ostomy pouch system 100. The ring barrier is a soft ring of material placed between the stoma 202 and the adhesive attaching the ostomy bag 104 to the skin. The ring barrier may be part of the ostomy barrier appliance 102. The electrodes 204, 210 may be positioned within anadhesive layer of the ostomy barrier appliance 102 to be positioned against the user’s skin and / or tissue when the ostomy barrier appliance 102 is attached. The adhesive layer is positioned around the stoma 202 and against the user’s skin to hold the ostomy barrier appliance 102 and ostomy bag 104 to the user. For example, the skin electrodes 210 may be positioned around the stoma 202 in the adhesive layer and the stoma electrodes 204 may be positioned in the opening in the adhesive layer for the stoma 202. The opening may be configured to receive a user’s stoma 202 and allow bodily waste to enter the cavity in the body waste collection bag through the user’s stoma 202. In one aspect, at least one pair of skin electrodes 210 may be positioned around the stoma. In an alternative or additional aspect, at least one pair of stoma electrodes 204 may be positioned in the opening in the adhesive layer for the stoma 202. Studies have shown that the stoma itself may be a good place to measure bioimpedance. This is because it lacks the stratum comeum, an insulating layer of skin present in the epidermis.

[0141] Referring to the diagram 208 of FIG. 11, we can very crudely model the bioimpedance measurement as measuring the total resistance of three resistors in series. Ri and R3 represent the insulating layer of the skin, which we may assume changes resistance much less with hydration thanks to lower water content. The middle resistor R2 represents everything inside the skin, including blood vessels and fat tissue. At full hydration, let us say that Ri = R3 = 2R2 when measuring through the stratum corneum but Ri = R3 = R2 when measuring at the stoma 202. These exact numbers may be different, but it is true that the stratum corneum has a higher resistance than the surface of the stoma. Imagine that our patient has lost 5% of their body weight in water, a significant indicator of dehydration, so R2 increases by 30% (this exact resistance changes varies by patient, but this is a reasonable increase) but Ri and R3 remain the same. In the skin measurement case, the overall resistance increases by 6%, whereas in the stoma measurement case, the overall resistance increases by 10%. This is a large difference in the sensitivity of the measurement, which indicates the stoma’s lack of a stratum corneum is a good reason to attempt measuring stoma bioimpedance.

[0142] There are a number of benefits to the bioimpedance design. To start, a device measuring bioimpedance is electronic, and thus, it may take automatic measurements frequently once it is attached. Optimal data storage and communication systems can be added to the device at a very low additional cost. The bioimpedance measurements may be implemented with a wearable technology, so easy wearable adaptability is a strong benefit of this design. ExistingPCBs from the literature fit our specific size requirement to be wearable. It is also relatively easy to measure impedance using a small chip. Bioimpedance measuring systems can be very reliable in terms of low failure rate, in fact one of the tattoo references describe their device as usable for up to six months. These devices also have a high agreement with industry-standard methods for measuring hydration, so bioimpedance measurements can be relevant to sensing dehydration.

[0143] The bioimpedance sensor 164 may be coupled to the wearable device 142, where the controller 144 is electrically coupled to the bioimpedance sensor 164. For example, the electrodes 204, 210 may be electrically coupled to the controller 144 through a wire or electrically conductive material extending along the body waste collection bag 162. For example, the electrodes 204, 210 may be electrically coupled to a coupling interface 196 (FIG. 5 A). In this aspect, the controller 144 may control the electrodes 204, 210 to perform a measurement of skin impedance, which is a bioimpedance measurement used to determine a hydration status. The controller may measure an impedance between at least one pair of electrodes 204, 210 of the plurality of electrodes.

[0144] The bioimpedance sensor may also be a stand-alone device that communicably couples to the wearable device 142. Referring to FIG. 12, the bioimpedance sensor 160 may include a controller 206 coupled to a plurality of electrodes 204. The controller 206 may include a processor and a memory and may have wireless communication capabilities that allow the controller 206 to communicably couple to the controller 144. The controller 206 may measure the user’s skin impedance and transmit them to the controller 144 when requested by the controller 144. The controller 206 may also periodically take measurements of skin impedance at various times and store them as well as transmit them to the controller 144. The skin impedance may be measured between at least one pair of electrodes 204 of the plurality of electrodes.

[0145] In any case the bioimpedance sensor 160 or the bioimpedance sensor 164 may be used by the controller 144 to receive a measurement of skin impedance to calculate a hydration level for a user. The controller 144 of the wearable device 142 may be configured to perform a method to measure a hydration status or level of the user. The method may include the controller 144 receiving first data indicative of a skin impedance of the user from the bioimpedance sensor 160, 164. The controller 144 may receive the first data after receiving an input from the user interface 138 indicative of a measurement being requested. For example, the user may press the button 178 requesting a measurement to be taken and the controller 144 may then request a skinimpedance measurement or take the skin impedance measurement. The measurement may be taken by the user before draining the body waste collection bag 162. Alternatively, the controller 144 may periodically receive the data indicative of a skin impedance of the user from the bioimpedance sensor 160, 164.

[0146] The method may further include the controller 144 determining a first hydration status of the user based on the first data from the bioimpedance sensor 160, 164. For example, the controller 144 may compare the first data to previously recorded values to determine a general hydration status for the user. The method may further include the controller 144 transmitting the first hydration status to the user. For example, the controller 144 may use the alert interface 152 as discussed previously to inform the user of the first hydration status. For example, the alert interface 152 may make a particular noise or light / flash LED lights to indicate the hydration status to the user. The controller 144 may also transmit the first hydration status to the mobile device 154 to inform the user of the first hydration status. The first hydration status may be stored in the memory 148 and timestamped to track the hydration status of the user over time. The method may further include the controller 144 transmitting a dehydration status to the user when the first hydration level is below a hydration threshold. As such, the controller 144 may compare the first hydration level to the hydration threshold. The hydration threshold may be based on previously recorded data to set the value at a point where most people are dehydrated. The hydration threshold may also be calibrated to the user to be set to a value of when they begin to become dehydrated. The controller 144 may control the alert interface 152 and / or transmit to the mobile device 154 to inform the user of the dehydration status. The dehydration status may be to inform the user to drink liquids to increase their hydration.

[0147] The method may further include the controller 144 receiving second data indicative of the skin impedance of the user from the bioimpedance sensor. The second data may be received at a later time than the first data. The method may further include the controller 144 determining a second hydration status of the user based on the second data from the bioimpedance sensor 160, 164. The second hydration status may be determined in the same manner as the first hydration status while using the second data. The method may further include the controller 144 transmitting the second hydration status to the user. For example, the controller 144 may use the alert interface 152 as discussed previously and / or transmit to the mobile device 154 to inform the user of the second hydration status. The method may further include the controller 144transmitting the dehydration status to the user when the second hydration level is below the hydration threshold. The controller 144 may control the alert interface 152 and / or transmit to the mobile device 154 to inform the user of the dehydration status. The dehydration status may be to inform the user to drink liquids to increase their hydration. The method may further include the controller 144 comparing the first hydration status with the second hydration status. The method may further include the controller 144 transmitting a notification to the user. The notification indicating to the user whether the user’s hydration status has improved, decreased, or stayed the same. The controller 144 may control the alert interface 152 and / or transmit to the mobile device 154 to inform the user of the notification.

[0148] As discussed regarding FIG. 3, the sensor system 156 may include a bioimpedance sensor 160, 164, the conductive sensors 166 described in FIGS. 4A-5B, and the pressure sensor 168 as described in FIG. 8. Alternatively, the sensor system 156 may include a bioimpedance sensor 160, 164 and the conductive sensors 166 without the pressure sensor 168. As yet another alternative, the sensor system 156 may include a bioimpedance sensor 160, 164 and the pressure sensor 168 without the conductive sensors 166. In any of these cases, the method described above regarding both the pressure sensor 168 and the conductive sensors 166, the method described above regarding only the pressure sensor 168, and the method described above regarding only the conductive sensors 166 may be combined with the method regarding the bioimpedance sensor 160, 164. In any of these combinations of methods, the controller 144 would determine both a hydration status for the user and an amount of bodily waste collected. This information may be provided to the user as discussed previously. These combinations provide the user with information regarding the amount of bodily waste they are outputting and an indication of their current hydration status. The user may use this information to prevent themselves from becoming dehydrated. As well as receiving notifications if they become dehydrated or are at risk of becoming dehydrated. As such, this may improve the user’s quality of life.

[0149] While particular embodiments of the present invention have been illustrated and described, it would be apparent to those skilled in the art that various other changes and modifications can be made and are intended to fall within the spirit and scope of the present disclosure. Furthermore, although the present disclosure has been described herein in the context of a particular implementation in a particular environment for a particular purpose, those ofordinary skill in the art will recognize that its usefulness is not limited thereto and that the present disclosure may be beneficially implemented in any number of environments for any number of purposes. Accordingly, the claims set forth below should be construed in view of the full breadth and spirit of the present disclosure as described herein.

[0150] All references, including publications, patent applications, and patents, cited herein are hereby incorporated by reference to the same extent as if each reference were individually and specifically indicated to be incorporated by reference and were set forth in its entirety herein.

[0151] The use of the terms “a” and “an” and “the” and similar references in the context of describing the embodiments disclosed herein (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. Recitation of ranges of values herein are merely intended to serve as a shorthand method of referring individually to each separate value falling within the range, unless otherwise indicated herein, and each separate value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., “such as”) provided herein, is intended merely to better illuminate the disclosure, and does not pose a limitation on the scope of the disclosure unless otherwise claimed. No language in the specification should be construed as indicating any non-claimed element as essential to the practice of the disclosure.

Claims

CLAIMSWhat is claimed is:

1. A body waste collection system, comprising: a body waste collection bag defining a longitudinal axis, the body waste collection bag comprising: a plurality of level conductive traces positioned along the longitudinal axis on an internal surface of the collection bag, wherein each conductive trace is positioned on the longitudinal axis to correspond to an amount of bodily waste collected in the body waste collection bag; a ground conductive trace positioned at an outlet end of the body waste collection bag, wherein the ground conductive trace is positioned to be the first conductive trace covered in collected bodily waste; a coupling interface positioned on an exterior of the body waste collection bag; and a plurality of insulated traces electrically coupling the plurality of level conductive traces and ground conductive trace to the coupling interface, wherein an insulated trace couples one of the plurality of level conductive traces or the ground conductive trace to the coupling interface; and a wearable device configured to mechanically couple to the body waste collection bag and electrically coupled with the coupling interface, the wearable device comprising: a user interface engageable by a user; and a controller coupled to the user interface and coupling interface, the controller comprising a processor and a memory storing instructions executable by the processor to: receive an input from the user interface indicative of a measurement being requested; measure, after receiving the measurement request, a resistance between each level conductive trace and the ground conductive trace; compare each resistance to a resistance threshold; and determine an amount of bodily waste collected in the body waste collection bag based on the comparisons.

2. The body waste collection system of claim 1 , wherein the amount of bodily waste collected in the body waste collection bag is based on the number of resistances below the resistance threshold.

3. The body waste collection system of claims 1 or 2, wherein the resistance between a level conductive trace and the ground conductive trace is below the resistance threshold when both the level conductive trace and the ground conductive trace are submerged in bodily waste.

4. The body waste collection system of any one of claims 1-3, wherein the user interface is engaged before draining any collected bodily waste from the body waste collection bag, wherein receiving the input from the user interface indicative of a measurement being requested corresponds to the body waste collection bag being drained of any collected bodily waste, and wherein the memory stores further instructions executable by the processor to store the amount of bodily waste collected in the body waste collection bag in the memory.

5. The body waste collection system of claim 4, wherein the memory stores further instructions executable by the processor to: determine an amount of bodily waste collected over the last 24 hours by combining the stored bodily waste measurements for the last 24 hours; and transmit an alert to the user when the amount of bodily waste collected over the last 24 hours exceeds a threshold value.

6. The body waste collection system of any one of claims 1-5, wherein the wearable device further comprises an alert interface, and wherein the memory stores further instructions executable by the processor to cause the alert interface to perform a physical function to notify the user of an alert.

7. The body waste collection system of any one of claims 1-6, wherein the wearable device is communicably couplable to a mobile device, wherein the memory stores further instructions executable by the processor to transmit an alert to the mobile device.

8. The body waste collection system of any one of claims 1 -6, wherein the wearable device is communicably couplable to a mobile device, and wherein the memory stores further instructions executable by the processor to transmit the amount of bodily waste collected in the body waste collection bag to the mobile device.

9. The body waste collection system of any one of claims 1-8, wherein each level conductive trace extends within the body waste collection bag at an angle perpendicular to the longitudinal axis.

10. The body waste collection system of any one of claims 1-9, wherein each level conductive trace extends around the internal surface of the body waste collection bag.

11. The body waste collection system of any one of claims 1-10, wherein the user interface comprises a button accessible to the user on an exterior surface of the wearable device.

12. The body waste collection system of any one of claims 1-11, wherein the wearable device is moveable from an open position to a closed position to clamp over the coupling interface and electrically couple the wearable device to the coupling interface.

13. The body waste collection system of any one of claims 1-12, wherein the body waste collection bag further comprises a pressure sensor positioned toward an outlet of the body waste collection bag, wherein the pressure sensor is configured to measure a hydrostatic pressure of any bodily waste collected in the body waste collection bag, wherein the pressure sensor is communicably coupled to the wearable device, and wherein the memory stores further instructions executable by the processor to: receive, after receiving the measurement request, a hydrostatic pressure from the pressure sensor; determine a second value for the amount of bodily waste collected in the body waste collection bag based on the hydrostatic pressure, wherein a first value for the amount of bodily waste collected is based on the comparisons of the resistances to the resistance threshold; anddetermine a final value for the amount of bodily waste collected by averaging the first value and the second value.

14. The body waste collection system of claim 13, wherein the memory stores further instructions executable by the processor to: determine a difference between the first value and the second value; and transmit an alert to the user when the difference exceeds a threshold value.

15. The body waste collection system of claims 13 or 14, wherein the pressure sensor is positioned within a reusable pouch to seal the pressure sensor from any collected bodily waste.

16. The body waste collection system of any one of claims 1-15, further comprising a bioimpedance sensor communicably coupled to the wearable device, wherein the memory stores further instructions executable by the processor to: receive first data indicative of a skin impedance of the user from the bioimpedance sensor; determine a first hydration level of the user based on the first data from the bioimpedance sensor; transmit a first hydration status to the user; and transmit a dehydration status to the user when the first hydration level is below a hydration threshold.

17. The body waste collection system of claim 16, wherein the memory stores further instructions executable by the processor to: receive second data indicative of the skin impedance of the user from the bioimpedance sensor, wherein the second data is received at a later time than the first data; determine a second hydration level of the user based on the second data from the bioimpedance sensor; transmit a second hydration status to the user; transmit the dehydration status to the user when the second hydration level is below the hydration threshold; andtransmit a notification to the user, wherein the notification indicates to the user whether the hydration level has improved, decreased, or stayed the same.

18. The body waste collection system of claims 16 or 17, wherein receive first data indicative of the skin impedance of the user from the bioimpedance sensor comprises receiving the first data after receiving the measurement request.

19. The body waste collection system of any one of claims 16-18, wherein the bioimpedance sensor comprises a plurality of electrodes positioned against the skin of the user to measure an impedance between at least one pair of electrodes of the plurality of electrodes.

20. The body waste collection system of claim 19, wherein the body waste collection bag comprises an ostomy barrier appliance, the ostomy barrier appliance comprising an adhesive layer for attachment to the user’s skin, the body waste collection bag defines an opening through the ostomy barrier appliance, the opening configured to receive a user’s stoma and allow bodily waste to enter the body waste collection bag through the user’s stoma, wherein at least one electrode of the plurality of electrodes are positioned within the ostomy barrier appliance and are configured to contact the user’s skin when the body waste collection bag is attached to the user.

21. The body waste collection system of claim 20, wherein a pair of electrodes of the plurality of electrodes are positioned within the adhesive layer to be positioned against the user’s skin.

22. The body waste collection system of claims 20 or 21, wherein a pair of electrodes of the plurality of electrodes are positioned within the opening in the ostomy barrier appliance adhesive layer to be positioned against the user’s skin at the user’s stoma.

23. A body waste collection system, comprising: a body waste collection bag defining a longitudinal axis, the body waste collection bag comprising:a pressure sensor positioned within and toward an outlet of the body waste collection bag, wherein the pressure sensor is configured to measure a hydrostatic pressure of any bodily waste collected in the body waste collection bag; and a wearable device configured to mechanically couple to the body waste collection bag and communicably couple with the pressure sensor, the wearable device comprising: a user interface engageable by a user; and a controller coupled to the user interface and pressure sensor, the controller comprising a processor and a memory storing instructions executable by the processor to: receive an input from the user interface indicative of a measurement being requested; receive, after receiving the measurement request, a hydrostatic pressure from the pressure sensor; and determine an amount of bodily waste collected in the body waste collection bag based on the hydrostatic pressure.

24. The body waste collection system of claim 23, wherein the pressure sensor is positioned within a reusable pouch to seal the pressure sensor from any collected bodily waste.

25. The body waste collection system of claims 23 or 24, wherein the body waste collection bag further comprises a coupling interface position on an exterior of the body waste collection bag, wherein the wearable device is electrically coupled to the coupling interface when the wearable device is mechanically coupled to the body waste collection bag, and wherein the pressure sensor is electrically coupled to the coupling interface.

26. The body waste collection system of any one of claims 23-25, wherein the user interface is engaged before draining any collected bodily waste from the body waste collection bag, wherein receiving the input from the user interface indicative of a measurement being requested corresponds to the body waste collection bag being drained of any collected bodily waste, and wherein the memory stores further instructions executable by the processor to store the amount of bodily waste collected in the body waste collection bag in the memory.

27. The body waste collection system of claim 26, wherein the memory stores further instructions executable by the processor to: determine an amount of bodily waste collected over the last 24 hours by combining the stored bodily waste measurements for the last 24 hours; and transmit an alert to the user when the amount of bodily waste collected over the last 24 hours exceeds a threshold value.

28. The body waste collection system of any one of claims 23-27, wherein the wearable device further comprises an alert interface, and wherein the memory stores further instructions executable by the processor to cause the alert interface to perform a physical function to notify the user of an alert.

29. The body waste collection system of any one of claims 23-28, wherein the wearable device is communicably couplable to a mobile device, wherein the memory stores further instructions executable by the processor to transmit an alert to the mobile device.

30. The body waste collection system of any one of claims 23-28, wherein the wearable device is communicably couplable to a mobile device, and wherein the memory stores further instructions executable by the processor to transmit the amount of bodily waste collected in the body waste collection bag to the mobile device.

31. The body waste collection system of any one of claims 23-30, wherein the user interface comprises a button accessible to the user on an exterior surface of the wearable device.

32. The body waste collection system of any one of claims 23-31, wherein the wearable device is moveable from an open position to a closed position to clamp onto the body waste collection bag.

33. The body waste collection system of any one of claims 23-32, further comprising a bioimpedance sensor communicably coupled to the wearable device, wherein the memory stores further instructions executable by the processor to:receive first data indicative of a skin impedance of the user from the bioimpedance sensor; determine a first hydration level of the user based on the first data from the bioimpedance sensor; transmit a first hydration status to the user; and transmit a dehydration status to the user when the first hydration level is below a hydration threshold.

34. The body waste collection system of claim 33, wherein the memory stores further instructions executable by the processor to: receive second data indicative of the skin impedance of the user from the bioimpedance sensor, wherein the second data is received at a later time than the first data; determine a second hydration level of the user based on the second data from the bioimpedance sensor; transmit a second hydration status to the user; transmit the dehydration status to the user when the second hydration level is below the hydration threshold; and transmit a notification to the user, wherein the notification indicates to the user whether the hydration level has improved, decreased, or stayed the same.

35. The body waste collection system of claims 33 or 34, wherein receive first data indicative of the skin impedance of the user from the bioimpedance sensor comprises receiving the first data after receiving the measurement request.

36. The body waste collection system of any one of claims 33-35, wherein the bioimpedance sensor comprises a plurality of electrodes positioned against the skin of the user to measure an impedance between at least one pair of electrodes of the plurality of electrodes.

37. The body waste collection system of claim 36, wherein the body waste collection bag comprises an ostomy barrier appliance, the ostomy barrier appliance comprising an adhesive layer for attachment to the user’s skin, the body waste collection bag defines an opening through the ostomy barrier appliance, the opening configured to receive a user’s stoma and allow bodily wasteto enter the body waste collection bag through the user’s stoma, wherein at least one electrode of the plurality of electrodes are positioned within the ostomy barrier appliance and are configured to contact the user’s skin when the body waste collection bag is attached to the user.

38. The body waste collection system of claim 37, wherein a pair of electrodes of the plurality of electrodes are positioned within the adhesive layer to be positioned against the user’s skin.

39. The body waste collection system of claims 37 or 38, wherein a pair of electrodes of the plurality of electrodes are positioned within the opening in the ostomy barrier appliance adhesive layer to be positioned against the user’s skin at the user’s stoma.

40. A body waste collection system, comprising: a body waste collection bag defining a longitudinal axis, the body waste collection bag comprising: a bioimpedance sensor comprising a plurality of electrodes positioned against the skin of a user when the body waste collection bag is attached to the user, the bioimpedance sensor configured to measure an impedance between at least one pair of electrodes of the plurality of electrodes; and a wearable device configured to mechanically couple to the body waste collection bag and coupled with the bioimpedance sensor, the wearable device comprising: a user interface engageable by a user; and a controller coupled to the user interface and coupling interface, the controller comprising a processor and a memory storing instructions executable by the processor to: receive first data indicative of a skin impedance of the user from the bioimpedance sensor; determine a first hydration level of the user based on the first data from the bioimpedance sensor; transmit a first hydration status to the user; and transmit a dehydration status to the user when the first hydration level is below a hydration threshold.

41. The body waste collection system of claim 40, wherein the memory stores further instructions executable by the processor to: receive second data indicative of the skin impedance of the user from the bioimpedance sensor, wherein the second data is received at a later time than the first data; determine a second hydration level of the user based on the second data from the bioimpedance sensor; transmit a second hydration status to the user; transmit the dehydration status to the user when the second hydration level is below the hydration threshold; and transmit a notification to the user, wherein the notification indicates to the user whether the hydration level has improved, decreased, or stayed the same.

42. The body waste collection system of claims 40 or 41, wherein receive first data indicative of the skin impedance of the user from the bioimpedance sensor comprises receiving the first data after receiving a measurement request.

43. The body waste collection system of claim 40, wherein the body waste collection bag comprises an ostomy barrier appliance, the ostomy barrier appliance comprising an adhesive layer for attachment to the user’s skin, the body waste collection bag defines an opening through the ostomy barrier appliance, the opening configured to receive a user’s stoma and allow bodily waste to enter the body waste collection bag through the user’s stoma, wherein at least one electrode of the plurality of electrodes are positioned within the ostomy barrier appliance and are configured to contact the user’s skin when the body waste collection bag is attached to the user.

44. The body waste collection system of claim 43, wherein a pair of electrodes of the plurality of electrodes are positioned within the adhesive layer to be positioned against the user’s skin.

45. The body waste collection system of claims 43 or 44, wherein a pair of electrodes of the plurality of electrodes are positioned within the opening in the ostomy barrier appliance adhesive layer to be positioned against the user’s skin at the user’s stoma.

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