Sensor systems for monitoring ostomy dejecta and urinary output

Abstract

A body waste collection pouch system includes a pouch and an integrated sensor system for monitoring urine and / or stoma dejecta collected in the pouch. The integrated sensor system includes a sodium sensor and / or a chloride sensor, a gravity filter, and a plurality of volume tracking sensors.

Description

SENSOR SYSTEMS FOR MONITORING OSTOMY DEJECTA AND URINARY OUTPUTBACKGROUND

[0001] The present subject matter relates to sensor systems for monitoring urinary output from catheters and stoma output, which may include urine in the case of urostomy and dejecta in the case of ileostomy or colostomy, to monitor hydration status of patients.

[0002] Acute care, long-term care, intensive care unit (1CU) patients, intermittent and indwelling catheter users, and colostomy, urostomy, and ileostomy patients require hydration monitoring to reduce the risk of delayed discharge, hospitalization, hospital readmission, and complications caused by overhydration or dehydration.

[0003] Urine output (UO) is a fundamental physiological parameter that reflects renal function, fluid balance, and systemic hemodynamics. It is a key component of the Kidney Disease: Improving Global Outcomes (KDIGO) criteria for diagnosing acute kidney injury (AKI), a condition affecting more than 55% of critically ill patients and associated with mortality rates approaching 50%. Accurate and timely UO measurement enables early detection of oliguria and guides 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 ICUs, acute care, and long-term care settings.

[0004] Current practice relies heavily on manual measurement, typically involving hourly visual inspection and charting. This approach introduces significant risk of error and delay; studies indicate 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 demonstrated significant benefits, including real-time data capture, improved detection of oliguria, and reduced incidence of AKI-related complications. However, adoption remains limited, and 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.

[0005] Patients with indwelling urinary catheters — common in long-term care, neurogenic bladder management, and post-surgical recovery — face similar challenges. Current protocols prioritize infection prevention but lack continuous monitoring of urine flow, hydration status, or composition. This gap can contribute to complications such as catheter-associated urinary tract infections (CAUTls), obstruction, bladder overdistension, and renal impairment. CAUTls 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 can fail to detect early signs of retention, dehydration, or infection. Emerging technologies, including smart catheter systems with integrated sensors, have demonstrated feasibility 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.

[0006] Patients with high-output ostomies, ileostomies, and urostomies also have a need for hydration monitoring. These patients often experience substantial fluid and electrolyte losses, placing them at high risk for dehydration, acute kidney injury, and severe electrolyte imbalances. Current management typically relies on intermittent clinical assessment and laboratory testing, which may not capture rapid changes in output or composition. Continuous monitoring of stoma effluent volume and ion concentrations, combined with hydration status sensing, may 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.

[0007] Beyond volumetric assessment, measuring ion concentrations in urine and stoma effluent, such as sodium, potassium, chloride, calcium, and magnesium, can provide insight into patients’ renal function, acid-base balance, and systemic homeostasis. Hydration status, reflected by urine or stoma effluent (also referred to herein as “dejecta” or “stoma dejecta”) osmolality or conductivity, is equally important for guiding fluid therapy and preventing complications like hypovolemia or hypervolemia. Current practice relies on intermittent laboratory testing, whichfails to capture dynamic changes during critical illness or chronic care. Integrating real-time ion and hydration monitoring into output tracking can enable precision fluid and electrolyte therapy, reduce risks of hypernatremia, hypokalemia, metabolic acidosis, and dehydration, and improve outcomes in both ICU and long-term care settings. Uikewise, early detection of UTI markers could prevent progression to severe infection and sepsis, reducing morbidity and healthcare costs.

[0008] Currently known solutions for urine and stoma effluent monitoring focus on volumetric measurements through manual or semi-automated methods. Although some automated systems are available, they remain limited in scope, lacking integration with electronic health records and failing to provide biochemical analysis, hydration assessment, or infection detection. Technologies for ion concentration measurement and UTI detection in urine or stoma effluent are largely restricted to laboratory settings and have not been adapted for continuous, bedside monitoring. Therefore, there is an unmet need for an integrated system capable of real-time tracking of volume, hydration status, ion concentrations, and infection markers across urinary and ostomy applications, with the goal of reducing complications, enhance clinical decision-making, and improve patient outcomes.SUMMARY

[0009] A sensor system and method to assess urine or dejecta composition for ICU patients, intermittent and indwelling catheter users, and recent ileostomy patients to monitor their hydration status for early detection of overhydration or dehydration and to reducing injury, hospitalization, or hospital readmissions are provided according to various embodiments.

[0010] According to one aspect, a body waste collection pouch system may include a sensor system for monitoring urine and / or stoma dejecta collected in a body waste collection pouch. The sensor system may comprise a fdtration system including an ion-selective membrane and a sensor configured to detect an ion. The sensor system may be configured to separate at least one ion from the urine and / or stoma dejecta using the filtration system and measure the collected ion using the sensor.

[0011] In an embodiment, at least one ion may include sodium ion, and the sensor system may be configured to separate and measure sodium ions. The ion-selective membrane may be formed from a polymer-based ion-selective membrane embedded with sodium-specific ionophores. In some embodiments, the ion-selective membrane may be formed from a polymer- based sodium selective ionophore membrane comprising channels configured to allow transport of sodium ions across the ion-selective membrane. In an embodiment, the sensor may include an ion-selective electrode configured to measure sodium ion concentration by detecting electrical potential differences caused by sodium ions.

[0012] In an embodiment, the sensor system may include a housing that has a first chamber and a second chamber, which may be divided by the filtration system. The first chamber may be configured to contain urine and / or stoma dejecta, while the second chamber may be configured to contain a filtered solution of the urine and / or stoma dejecta containing at least one ion. The sensor may be arranged in the second chamber. The sensor system may also include a control board configured to control the sensor and allow data acquisition and support real time monitoring of at least one ion.

[0013] In an embodiment, the sensor system may be arranged in an ostomy pouch.

[0014] In another aspect, a body waste collection pouch system may include a bodyside wall and a distal wall sealed along a peripheral seal to form a chamber for collecting urine and / or stoma dejecta and a port configured to receive a test strip. The port may be provided in the distal wall and configured to allow the test strip to access the urine and / or stoma dejecta collected in the chamber for real time monitoring of the urine or stoma dejecta.

[0015] In an embodiment, the port may include a cap configured to provide a liquid-tight closure of the port. In some embodiments, the test strip may be a chloride test strip configured to react with chloride ions in the urine and / or stoma dejecta and exhibit a color change to indicate a chloride concentration.

[0016] In one aspect, a body waste collection pouch system may include a bodyside wall and a distal wall sealed along a peripheral seal to form a chamber for collecting urine and / or stoma dejecta, a gravity filter, and a sensor system. The gravity filter may be arranged in the chamber and configured to separate a solid content from the urine and / or stoma dejecta. The sensorsystem may be configured to measure ionic compositions from the solid content. Tn an embodiment, the gravity filter may be formed from a polypropylene mesh.

[0017] In another aspect, a body waste collection pouch system may comprise a bodyside wall and a distal wall sealed along a peripheral seal to form a first chamber, an inlet opening formed in the bodyside wall for receiving urine and / or stoma dejecta, a second chamber including an outlet, and a sensor system. The second chamber may be formed within the first chamber between the bodyside wall and the distal wall and arranged to surround the inlet opening. The sensor system may be arranged in the second chamber and configured to measure an ionic and / or osmotic composition of the urine or stoma dejecta. The body waste collection pouch system may be configured to allow real time measurements of the ionic and / or osmotic composition of the urine or stoma dejecta as the urine or stoma dejecta enters the second chamber and egresses through the outlet for collection in the first chamber.

[0018] In an embodiment, the outlet of the second chamber may be provided with a one-way valve configured to allow urine and / or stoma dejecta to flow out from the second chamber and prevent the urine and / or stoma dejecta collected in the first chamber from flowing back into the second chamber.

[0019] In an embodiment, the sensor system may include at least one sodium sensor arranged in a lower portion of the second chamber, such that urine and / or stoma dejecta entering the second chamber may flow over the at least one sodium sensor before egressing out through the outlet. The sensor system may also be configured to monitor user’s hydration status by analyzing sodium concentration levels measured by the sodium sensor.

[0020] In one aspect, a body waste collection pouch system may comprise a bodyside wall and a distal wall sealed along a peripheral seal to form a chamber for collecting urine and / or stoma dejecta and a hydration sensor system including a biofuel cell configured to generate a voltage using the urine and / or stoma dejecta. The hydration sensor may be configured to correlate an amount of the voltage to a user’s hydration state.

[0021] In an embodiment, the biofuel cell may include an anode and a cathode, wherein the anode may be packed with an oxidative biocatalyst. In such an embodiment, the biofuel cell may be configured to catalyze urine and / or stoma dejecta components at the anode to generateelectrons and protons. Tn some embodiments, the hydration sensor system may include a microcontroller, wherein the hydration sensor system may be configured to convert the voltage generated by the biofuel cell into a digital signal for sampling by the microcontroller. The hydration sensor system may also be configured to correlate a change in the voltage to a user’s hydration state.

[0022] In any one of the foregoing aspects and embodiments, the body waste collection pouch system may further include a plurality of volume tracking sensors. The plurality of volume tracking sensors may include a plurality of flexible strain gauges and at least one pressure sensor. In some embodiments, the plurality of flexible strain gauges may be arranged along surfaces of pouch walls, and the at least one pressure sensor may be arranged inside of the pouch in a lower portion. In an embodiment, the plurality of volume tracking sensors may be configured to estimate a volume of urine and / or the stoma dejecta collected in a body waste collection pouch by measuring a geometric distortion of the body waste collection pouch.

[0023] Other aspects and advantages will become apparent upon consideration of the following detailed description and the attached drawing.BRIEF DESCRIPTION OF THE DRAWINGS

[0024] FIG. 1 is a schematic illustration of an ion sensor system including a sodium-selective membrane according to an embodiment;

[0025] FIG. 2 is a perspective view of a body waste collection pouch system including a port for receiving a test strip according to an embodiment;

[0026] FIG. 3 is a partial expanded view of the port of the a body waste collection pouch system of FIG. 2;

[0027] FIG. 4 is an illustration of a test strip according to an embodiment;

[0028] FIG. 5 is a perspective body side view of an ostomy pouch including volume tracking sensors according to an embodiment;

[0029] FIG. 6 is a side view of the ostomy pouch of FIG. 5;

[0030] FIG. 7 is a side view of the ostomy pouch of FIG. 5 filled with urine or stoma effluent;

[0031] FIG. 8 is an illustration of an ostomy pouch including a gravity filter according to an embodiment;

[0032] FIG. 8A is an illustration of the gravity filter of the ostomy pouch of FIG. 8;

[0033] FIG. 9 is an illustration of a body waste collection pouch including a sodium sensor system according to an embodiment;

[0034] FIG. 10 is an illustration of an ostomy pouch including a hydration sensor system according to an embodiment; and

[0035] FIG. 11 is an illustration of a body waste collection pouch system and various applications thereof according to an embodiment.DETAILED DESCRIPTION

[0036] While the present disclosure is susceptible of embodiment in various forms, there is shown in the drawings and will hereinafter be described presently preferred embodiments with the understanding that the present disclosure is to be considered an exemplification and is not intended to limit the disclosure to the specific embodiments illustrated. The words “a” or “an” are to be taken to include both the singular and the plural. Conversely, any reference to plural items shall, where appropriate, include the singular. The words “first,” “second,” “third,” and the like may be used in the present disclosure to describe various information, such information should not be limited to these words. These words are only used to distinguish one category of information from another. The directional words “top,” “bottom,” up,” “down,” front,” “back,” and the like are used for purposes of illustration and as such are not limiting. Depending on the context, the word “if’ as used herein may be interpreted as “when” or “upon” or “in response to determining.”

[0037] The present disclosure discloses body waste collection pouch systems, such as a urine drainage bag or an ostomy pouch, that include an integrated sensor system for monitoring urine and / or stoma dejecta collected therein. The integrated sensor system may include an ion sensor, such as a sodium sensor, a gravity-based filtration system, and volume-tracking sensors. Thesensor system may be configured to monitor ion concentrations and / or osmolarity in urine from catheterized users or stoma effluent (dejecta) from ostomy patients. In some embodiments, the sensor system may be configured to measure specific ion concentrations in urine or stoma effluent within clinically relevant ranges, capturing at least one data point every 30 minutes over a continuous period of at least 168 hours (one week).

[0038] Ion Sensor System with Sodium-Selective Membrane

[0039] Referring to FIG. 1, a schematic illustration of an ion sensor system 10 is provided according to an embodiment. The ion sensor system 10 may be configured to provide a filtration system using an ion-selective permeable membrane 12 to separate and measure sodium ions 14 in urine or stoma dejecta 18.

[0040] In an embodiment, the ion sensor system 10 may include a polymer-based ion- selective membrane 12 embedded with sodium-specific ionophores and an integrated sensor 16 configured for real-time sodium ion detection. The membrane 12 may be a polymer-based sodium selective ionophore membrane which may include channels configured to allow transport of sodium ions 14 across the membrane 12. The sensor 16 may include an ion-selective electrode configured to measure sodium concentration by detecting electrical potential differences caused by the ions.

[0041] In some embodiments, the sensor system 10 may be configured to sample data every 30 minutes by setting the sensor 16 to perform measurements at this interval. The sensor system 10 may also be configured to provide a concentration resolution of 10 mEq / L with a range of 100 - 130 mEq / L, which may be achieved through appropriate tuning of the sensor 16. In an embodiment, the membrane 12 and sensor 16 may be integrated within a filter.

[0042] The sensor system 10 may include a housing 20 configured to contain urine or dejecta 18 and allow the urine or dejecta 18 to flow through the membrane 12 into a sensor chamber 22. The housing 20 may be formed from a polymeric material, such as polyethylene (biocompatible), and configured to encase the membrane 12 and sensor 16. In the embodiment of FIG. 1, the housing 20 may be split into two chambers 21, 22 separated by the membrane 12. A first chamber 21 may be configured to receive and contain the urine or dejecta 18 and a second chamber 22 may be configured to contain sodium ion solution 24. The membrane 12 may bemounted and sealed in the housing 20 to avoid any leakage of urine or dejecta 18 into the second chamber (sensor chamber) 22. The sensor 16 may be integrated into or contained within the second chamber 22 to allow real time measurement of sodium concentration.

[0043] The sensor system 10 may include a control board 26 to electronically control and configure the sensor 16. The control board 26 may be configured to be compatible with the sensor 16 to allow data acquisition and support real time monitoring. Some examples include Arduino or Raspberry Pi.

[0044] In some embodiments, the sensor system 10 may be arranged in a body waste collection pouch, such as an ostomy pouch.

[0045] Body Waste Collection Pouch System with Port for Test Strip

[0046] Referring to FIGS. 2 and 3, a body waste collection pouch system 100 including a port 102 is shown according to an embodiment. In an embodiment, the body waste collection pouch system may be a ostomy pouch system 100 comprising a bodyside wall 104 and a distal wall 106 sealed along a peripheral seal 107 to form a chamber 108 for collecting urine or stoma dejecta. The port 102 may be configured to receive a test strip, such as a chloride test strip 120, and allow the test strip to access urine or stoma dejecta collected in the chamber 108 for realtime reading of the urine or dejecta. For example, the ostomy pouch system 100 may be configured to allow monitoring of a chloride ion concentration in urine or dejecta using chloride test strips, which can be analyzed to assess user’s hydration state.

[0047] In some embodiments, the ostomy pouch system 100 may be configured to monitor ion concentrations in urine or stoma dejecta that can serve as a hydration marker, wherein the port 102 is configured to provide an efficient entry point for a user to access the urine or dejecta collected in the ostomy pouch to measure ion levels, such as chloride, using a test strip. In such embodiments, the port 102 may be configured to have an inner diameter that can accommodate various test strips for measuring various ion concentrations and other components of the urine or dejecta.

[0048] In the embodiment of FIGS. 2 and 3, the port 102 may be a soft tap drain arranged on a distal side of the ostomy pouch 100 covering an opening 110 defined in the distal wall 106 to allow easy insertion of a test strip 120 into the chamber 108. The port 102 may include a cap 112configured to provide a leak-proof closure of the port 102 and prevent pouch contamination. In use, a user may remove the cap 112 to open the port 102 and insert a test strip 120 through the port 102 to reach urine or dejecta collected in the chamber 108. In an embodiment, the test strip 120 may be a chloride test strip configured to react with chloride ions in the urine or dejecta. In such an embodiment, the user may remove the chloride test strip 120 after the chloride test strip 120 contacts and reacts with the urine or dejecta collected in the chamber 108 and compare the resulting color change exhibited on the chloride test strip 120 with a reference chart to determine the chloride concentration.

[0049] Suitable examples for the test strip 120 may include, but are not limited to, the Hach® Chloride QuanTab® test strip, which features a built-in display for indicating the concentration of chloride ions in a target material. It is configured to measure chloride concentrations within a broad range of 300-6000 ppm. This range encompasses the levels typically found in dejecta samples. The data sampling rate using such test strips may not be restricted and may occur at any prescribed intervals. FIG. 4 shows the test strip 120 according to an embodiment.

[0050] Body Waste Collection Pouch with Volume-Tracking Sensors

[0051] Referring to FIGS. 5-7, a body waste collection pouch 200 comprising volume tracking sensors 202 is shown according to an embodiment. In an embodiment, the body waste collection pouch 200 may be an ostomy pouch comprising the volume tracking sensors 202. The volume tracking sensors 202 may comprise a plurality of flexible strain gauges 204 and at least one pressure sensor 206. In the embodiment, of FIGS. 5-7, an array of flexible strain gauges 204 may be arranged along the sides of the ostomy pouch 200 and the several thin film pressure sensors 206 may be arranged inside of the ostomy pouch 200 along the bottom. In some embodiments, the strain gauges 204 and pressure sensors 206 may be attached to walls of the ostomy pouch 200 using an adhesive. In other embodiments, the strain gauges 204 and pressure sensors 206 may be provided by embedding the sensor wires into the walls during manufacture.

[0052] The sensors 202 may be configured to estimate the volume of urine or stoma effluent collected in the ostomy pouch 200 by measuring a geometric distortion of the ostomy pouch 200 and internal pressure. By tracking the volume of the collected urine or stoma effluent and combining with ionic and / or osmotic measurements of the urine or stoma effluent, a more robust system for monitoring user’s hydration level can be achieved.

[0053] In an embodiment, a method of tracking volume using the volume tracking sensors 202 provided in the ostomy pouch 200 may include a calibrated algorithm for determining volume from the sensor measurements. Potential complications may include shifts in ostomy pouch position and deformations of the ostomy pouch caused by the user’s movements. In som embodiments, the algorithm may rely on averaging and a sliding time window to estimate volume. Refinements and error predictions can be achieved using modeling software with fluid dynamic simulation capabilities, such as SolidWorks. In an embodiment, a controller may be provided to process sensor data and execute the algorithm. The volume tracking of urine or stoma effluent collected in the ostomy pouch 200 may assist in analyzing ion and / or osmolarity measurements of the urine or stoma effluent, which can give context for the total activity of the digestive system.

[0054] In an embodiment, the Arduino nano may be used to sample the voltage reading at a rate of up to 10kHz and averaging windows for the volume-measuring algorithms can be made shorter than 30 minutes. The Arduino Nano requires only a 5 V power source and draws approximately 19 mA. As such, when powered by a Li-Polymer battery with a capacity of 1000 mAh, the device’s battery life can exceed 168 hours.

[0055] Body Waste Collection Pouch including Gravity Filter

[0056] Referring to FIGS. 8 and 8A, a body waste collection pouch 300 including a gravity filter 302 is shown according to an embodiment. In an embodiment, the body waste collection pouch may be an ostomy pouch 300. The gravity filter 302 may be arranged in an inner chamber 304 of the ostomy pouch 300 and configured to filter stoma dejecta by gravity to separate solids in the stoma dejecta entering the stoma pouch 300.

[0057] In an embodiment, the gravity filter 302 may be formed from a mesh, such as a polypropylene (PP) mesh. The PP mesh may comprise a plurality of layers configured to separate solids and liquids through sizeable pores measuring 50-500 microns. The pore sizes of the PP mesh may be selected depending on the desired efficiency and composition of the dejecta. (Smaller pores take longer to filter but result in fewer solids remaining in the filtered dejecta.) The PP mesh may be attached to inner surfaces of pouch walls via an adhesive, heat sealing, or any suitable bonding methods.

[0058] The ostomy pouch 300 may be configured to separate and measure certain solid contents in stoma dejecta to determine a range of ionic compositions in the stoma dejecta. The ostomy pouch 300 may be used for more accurate quantification of solids and liquids within a given amount of dejecta.

[0059] Body Waste Collection Pouch including Sodium Sensor System

[0060] Referring to FIG. 9, a body waste collection pouch 400 including a sensor system is shown according to an embodiment. In an embodiment, the body waste collection pouch may be an ostomy pouch 400 including a sensor system configured to analyze ionic and osmotic compositions of stoma dejecta. The ostomy pouch 400 may include a first chamber 402 defined between pouch walls and a second chamber 404 formed within the first chamber 402 and surrounding an inlet opening 406 configured to receive stoma dejecta. In an embodiment, the second chamber 404 may be a U-shaped chamber. In another embodiment, the second chamber 404 may be a funnel-shaped chamber.

[0061] The second chamber 404 may include an outlet 410 and configured to house the sensor system. In some embodiments, the outlet 410 may be provided with a one-way valve configured to allow dejecta to flow out from the second chamber 404 and prevent the dejecta collected in the first chamber 402 from flowing back into the second chamber 404. In an embodiment, the sensor system may comprise at least one sodium sensor 408. In such an embodiment, the ostomy pouch 400 may be configured to allow real time analysis of the sodium ionic composition of stoma dejecta before the stoma dejecta is collected in the first chamber 402. In the embodiment of FIG. 9, the at least one sodium sensor 408 may be arranged in a lower portion of the second chamber 404, such that stoma dejecta entering the second chamber 404 through the inlet opening 406 may flow over the at least one sodium sensor 408 before egressing out through the outlet 410 into the first chamber 402. In some embodiments, the at least one sodium sensor 408 may be configured to measure impedance that correlates with the sodium concentration and user’s overall hydration status. The sensor system may be configured to process sensor data using a small, detachable microcontroller mounted on the exterior of the ostomy pouch 400, which can automatically transmit results to an external monitoring system.

[0062] The sensor system of the ostomy pouch 400 may be configured to continuously monitor user’s hydration status by analyzing the sodium ion concentration of dejecta using the atleast one sodium sensor 408. The sensor system may be configured to process real-time sensor data and wirelessly transmit the processed sensor data, enabling early intervention before severe dehydration occurs. The sensor system may be configured to provide a reliable indicator of user’s hydration status by analyzing sodium levels in user’s stoma dejecta.

[0063] Body Waste Collection Pouch including Hydration Sensor System

[0064] Referring to FIG. 10, a body waste collection pouch 500 including a hydration sensor system 502 is shown according to an embodiment. In an embodiment, the body waste collection pouch may be an ostomy pouch 500 comprising a hydration sensor system 502 that includes a biobattery or biofuel cell (BFC) configured to generate a varying amount of voltage depending on the composition of stoma dejecta collected in a collection chamber 504 of the ostomy pouch 500. The hydration sensor system 502 may be configured to correlate voltage generated by the BFC to the quantity or concentration of selected components in the stoma dejecta. The measured values of these components may then be correlated with user’s hydration state.

[0065] In an embodiment, the hydration sensor system 502 may comprise a BFC including an anode 506 and a cathode 508. The anode 506 and cathode 508 may be packed with biocatalysts 510. In an embodiment, the anode 506 may be packed with an oxidative biocatalyst, and the cathode 508 may be packed with a reductive biocatalyst. The biocatalysts 510 may be selected from microbial or enzymatic biocatalysts depending on the specific dejecta component to be analyzed. The hydration sensor system 502 may be configured to catalyze stoma dejecta components at the anode 506 to generate electrons and protons and transmit the electrons to a microcontroller 512 through an electrode housing 514. The protons may migrate to the cathode 508, where they undergo catalytic reduction. In some embodiment, the biocatalyst on the cathode 508 may be omitted.

[0066] The hydration sensor system 502 may be configured to convert the voltage potential generated by the BFC into a digital signal for sampling by the microcontroller 512. The hydration sensor system 502 may also be configured to correlate variations in the voltage potential with user’s hydration state. The microcontroller 512 may be powered by a lithium battery.

[0067] In an embodiment, the hydration sensor system 502 may be configured to measure ion concentrations in stoma dejecta collected in the ostomy pouch 500. The ion concentration of the stoma dejecta may be measured by monitoring conductivity and microbiota levels in the stoma dejecta. In some embodiments, the hydration sensor system 502 may be configured to measure osmolarity and specific ion concentrations by adjusting the catalysts on the electrodes or by introducing an enzyme into the dejecta.

[0068] In an embodiment, the microcontroller 512 may be configured to sample the voltage reading at a rate of up to 10kHz. In some embodiments, the microcontroller 512 may be the Arduino Nano, which only requires a 5V source and draws only 19 mA. In such embodiments, a Li-Polymer battery with a capacity of lOOOmAh, the battery life of the microcontroller 512 can last well beyond 168 hours.

[0069] The electrode housing 514 may be configured to hold in place the anode 506 and the cathode 508. In an embodiment, the electrode housing 514 may include a silicone closure portion configured to fit in an outlet of ostomy pouch 500 to provide a liquid tight closure.

[0070] In an embodiment, an integrated sensor system may comprise the integrated sodium sensor, gravity filter design, and volume tracking sensor array. The integrated sensor system may take the overall design of the integrated sodium sensor and incorporate the gravity filter within its funnel chamber of the ostomy pouch. The integrated sensor system may further include the stressstrain gauges of the volume tracking design in the reservoir chamber of the ostomy bag.

[0071] Referring to FIG. 11, a body waste collection pouch system 600 including a body waste collection pouch 602 and a body waste monitoring sensor system 604 is shown according to an embodiment. The body waste collection pouch system 600 may be used in various applications, such as ostomy, urostomy, intermittent or indwelling catheter, and ICU and acute care.

[0072] 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 of ordinary skill in the art will recognize that its usefulness is not limited thereto and that the presentdisclosure 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.

[0073] 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.

[0074] 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.

[0075] Numerous modifications to the present disclosure will be apparent to those skilled in the art in view of the foregoing description. It should be understood that the illustrated embodiments are exemplary only and should not be taken as limiting the scope of the disclosure.

Claims

I / WE CLAIM:

1. A body waste collection pouch system including a sensor system for monitoring urine and / or stoma dejecta collected in a body waste collection pouch, the sensor system comprising: a filtration system comprising an ion-selective membrane; and a sensor configured to detect an ion; wherein the sensor system is configured to separate at least one ion from the urine and / or stoma dejecta using the filtration system and measure the at least one ion using the sensor.

2. The body waste collection pouch system of claim 1, wherein the at least one ion includes sodium ion, wherein the sensor system is configured to separate and measure sodium ions.

3. The body waste collection pouch system of claim 1 or 2, wherein the ion-selective membrane is formed from a polymer-based ion-selective membrane embedded with sodiumspecific ionophores.

4. The body waste collection pouch system of claim 1 or 2, wherein the ion-selective membrane is formed from a polymer-based sodium selective ionophore membrane comprising channels configured to allow transport of sodium ions across the ion-selective membrane.

5. The body waste collection pouch system of any one of claims 2-4, wherein the sensor includes an ion-selective electrode configured to measure a sodium ion concentration by detecting electrical potential differences caused by sodium ions.

6. The body waste collection pouch system of any one of claims 1-5, wherein the sensor system includes a housing comprising a first chamber and a second chamber divided from the first chamber by the filtration system, wherein the first chamber is configured to contain urine and / or stoma dejecta and the second chamber is configured to contain a filtered solution of the urine and / or stoma dejecta containing the at least one ion, wherein the sensor is arranged in the second chamber.

7. The body waste collection pouch system of any one of claims 1-6, wherein the sensor system further includes a control board configured to control the sensor, wherein the control board is configured to allow data acquisition and support real time monitoring of the at least one ion.

8. The body waste collection pouch system of any one of claims 1-7, wherein the sensor system is arranged in an ostomy pouch.

9. A body waste collection pouch system, comprising: a bodyside wall and a distal wall sealed along a peripheral seal to form a chamber for collecting urine and / or stoma dejecta; and a port provided in the distal wall and configured to receive a test strip and allow the test strip to access the urine and / or stoma dejecta collected in the chamber for real time monitoring of the urine or stoma dejecta.

10. The body waste collection pouch system of claim 9, wherein the port includes a cap configured to provide a liquid-tight closure of the port.

11. The body waste collection pouch system of claim 9 or 10, wherein the test strip is a chloride test strip configured to react with chloride ions in the urine and / or stoma dejecta and exhibit a color change to indicate a chloride concentration.

12. A body waste collection pouch system, comprising: a bodyside wall and a distal wall sealed along a peripheral seal to form a chamber for collecting urine and / or stoma dejecta; a gravity filter arranged in the chamber and configured to separate a solid content from the urine and / or stoma dejecta; and a sensor system configured to measure ionic compositions from the solid content.

13. The body waste collection pouch system of claim 12, wherein the gravity filter is formed from a polypropylene mesh.

14. A body waste collection pouch system, comprising: a bodyside wall and a distal wall sealed along a peripheral seal to form a first chamber; an inlet opening formed in the bodyside wall for receiving urine and / or stoma dejecta; a second chamber formed within the first chamber between the bodyside wall and the distal wall and arranged to surround the inlet opening, the second chamber including an outlet; and a sensor system arranged in the second chamber and configured to measure an ionic and / or osmotic composition of the urine or stoma dejecta.

15. The body waste collection pouch system of claim 14, wherein the body waste collection pouch system is configured to allow real time measurements of the ionic and / or osmotic composition of the urine or stoma dejecta as the urine or stoma dejecta enters the second chamber and egresses through the outlet for collection in the first chamber.

16. The body waste collection pouch system of claim 14 or 15, wherein the outlet is provided with a one-way valve configured to allow urine and / or stoma dejecta to flow out from the second chamber and prevent the urine and / or stoma dejecta collected in the first chamber from flowing back into the second chamber.

17. The body waste collection pouch system of any one of claims 14-16, wherein the sensor system includes at least one sodium sensor arranged in a lower portion of the second chamber, such that urine and / or stoma dejecta entering the second chamber flows over the at least one sodium sensor before egressing out through the outlet.

18. The body waste collection pouch system of claim 17, wherein the sensor system is configured to monitor user’s hydration status by analyzing sodium concentration levels measured by the sodium sensor.

19. A body waste collection pouch system, comprising: a bodyside wall and a distal wall sealed along a peripheral seal to form a chamber for collecting urine and / or stoma dejecta; anda hydration sensor system comprising a biofuel cell configured to generate a voltage using the urine and / or stoma dejecta, wherein the hydration sensor is configured to correlate an amount of the voltage to a user’s hydration state.

20. The body waste collection pouch system of claim 19, wherein the biofuel cell includes an anode and a cathode, wherein the anode is packed with an oxidative biocatalyst, wherein the biofuel cell is configured to catalyze urine and / or stoma dejecta components at the anode to generate electrons and protons.

21. The body waste collection pouch system of claim 20, wherein the hydration sensor system further includes a microcontroller, wherein the hydration sensor system is configured to convert the voltage generated by the biofuel cell into a digital signal for sampling by the microcontroller, and wherein the hydration sensor system is configured to correlate a change in the voltage to a user’s hydration state.

22. The body waste collection pouch system of any one of claims 9-21, further comprising a plurality of volume tracking sensors.

23. The body waste collection pouch system of claim 22, wherein the plurality of volume tracking sensors includes a plurality of flexible strain gauges and at least one pressure sensor.

24. The body waste collection pouch system of claim 22 or 23, wherein the plurality of volume tracking sensors are configured to estimate a volume of urine and / or the stoma dejecta collected in a body waste collection pouch by measuring a geometric distortion of the body waste collection pouch.

25. The body waste collection pouch system of claim 23 or 24, wherein the plurality of flexible strain gauges are arranged along surfaces of pouch walls, and the at least one pressure sensor is arranged inside of the pouch in a lower portion.

26. A body waste collection pouch system, comprising: a pouch; andan integrated sensor system for monitoring urine or stoma dejecta collected in the pouch, the integrated sensor system comprising: a sodium sensor and / or a chloride sensor; a gravity filter; and a plurality of volume tracking sensors.

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