WO2025207720A1

WO2025207720A1 - Devices and method for detecting body hydration status

Info

Publication number: WO2025207720A1
Application number: PCT/US2025/021465
Authority: WO
Inventors: Reem ALLAM; Aarushi Arora; Jerwyn CASTILLO; Jacob DEVADAS; Citlally SANTACRUZ; Mark W. Jockel; Abram D. Janis
Original assignee: Hollister Inc
Current assignee: Hollister Inc
Priority date: 2024-03-26
Filing date: 2025-03-26
Publication date: 2025-10-02
Anticipated expiration: 2026-09-26
Also published as: WO2025207722A1; WO2025207723A1

Abstract

A device for detecting a hydration status of a user is disclosed. The device includes a galvanic response sensor positioned against a section of the user's tissue and a control circuit communicable coupled to the galvanic response sensor. The control circuit including a processor and a memory, the memory storing instructions executed by the processor to receive first data from the galvanic response sensor indicative of a resistance of the tissue at the galvanic response sensor, and determine an approximate fluid loss or gain of the user based on at least the first data. The memory storing further instructions executed by the processor to determine an overall hydration level based on the fluid loss or gain and a user's body mass index, compare the overall hydration level to a threshold range, and transmit a notification based on the overall hydration level being less than or greater than the threshold range.

Description

DEVICES AND METHOD FOR DETECTING BODY HYDRATION STATUS BACKGROUND

[0001] Ostomy surgery involves creating a surgical opening in the abdomen (such as the colon, ileum, or bladder) to reroute bodily waste, or dejecta, allowing it to pass through a stoma and be collected in an external ostomy pouch. It's commonly performed for individuals with conditions like colorectal cancer, Crohn's disease, ulcerative colitis, bladder cancer, or trauma resulting in the rerouting of the digestive or urinary system. Ostomates rely on external ostomy pouches or bags to collect waste, which can lead to various challenges, including skin irritation, leaks, and concerns related to hydration state.

[0002] Intermittent catheterization is necessary forthose with spinal cord injury (SCI), paraplegia, or tetraplegia with residual hand function or neurogenic bladders, caused by multiple sclerosis, Parkinson’s disease, stroke, diabetes, spinal bifida, spinal tumors, cerebral palsy, multiple system atrophy, spinal cord injury, and motor neuron disease. The preservation of bladder and kidney health is dependent on properly timed catheterization for bladder drainage and hydration status.

[0003] A prevalent issue among ostomates and intermittent catheter users is overhydration and dehydration. If the user has a stoma, then the stoma, being a direct passage for waste, can often result in increased fluid loss and electrolyte imbalance. This phenomenon may occur due to the stoma’s location in the digestive, or urinary tract, disrupting the body's natural absorption of fluids and nutrients. For example, a jejunostomy is particularly impactful on dehydration risk, as this anatomy tends to lead to a high-output ostomy, due to loss of water and electrolyte absorbing intestinal tissue. Intermittent catheter users may lack the sensation related to bladder filling and must rely on other indicators to time bladder emptying. In urostomy, the urine is continuously draining into the pouch, and therefore excretion may be more difficult to track than in an individual with a bladder and discrete micturition events. As such, ostomates and intermittent catheter users may experience higher levels of water loss, making them more susceptible to dehydration if not managed effectively. Oral rehydration can also impact hydration state, with the timing, volume, or the ingestion of hypertonic, isotonic, and hypotonic fluids potentially impacting the hydration state, without the sensory cues and/or homeostatic physiologic responses in those without an ostomy or neurogenic bladder. In some cases, this can cause acute kidney damage and/or failure. Thus, hydration monitoring is a critical aspect of healthcare, especially for ostomates and intermittent catheter users. Managing a stoma and ostomy pouch also involves monitoring skin health around the stoma site, detecting leakage, and preventing complications like infections and skin irritation. Managing the use of an intermittent catheter also carries the risk of urethral trauma and urinary tract infection (UTI) with each catheterization event.

[0004] Maintaining proper hydration levels is essential for overall health and well-being of a person. For ostomates and intermittent catheter users, imbalances in hydration can lead to complications such as hypovolemic shock, electrolyte imbalances, seizures, and/or kidney failure. Dehydration in intermittent catheter users may lead to infection, insufficient bladder emptying, and/or kidney damage. The need for accurate and continuous hydration monitoring in these populations is evident due to the 7-20% hospital readmission of ostomy patients within 30 days of having surgery.

[0005] Currently, hydration monitoring primarily relies on subjective assessments by healthcare providers, ostomates, or intermittent catheter users themselves, using methods like measuring body mass, tracking fluid intake, measuring stoma dejecta or urine output volume, or monitoring urine color and frequency, or monitoring urinalysis parameters. However, these methods are often cumbersome to the ostomate or intermittent catheter user and lack precision and real-time monitoring capabilities. Wearable sensors and devices for hydration monitoring have emerged in recent years but are not specifically tailored for ostomates or intermittent catheter users. Existing solutions often face challenges related to accuracy, comfort, and usability for these specific user groups.

[0006] Commercially available hydration monitoring devices often focus on general population needs rather than catering to the unique requirements of ostomates and intermittent catheter users. For example, the Nix hydration biosensor is a device mainly used for users who work in outdoor environments or athletes to test their fluid and electrolyte loss through their sweat. It also contains an app which tracks the user’s activity and recommends a certain amount of water the user should drink from the data collected at that moment. However, this type of device may not work well for an ostomate or an intermittent catheter user because these populations are generally dry individuals (e.g., there are many older individuals) who are not subject to much physical activity. Additionally, a sensor that only provides data in the presence of sweat would likely not be sufficient for the needs of these users, who would benefit from more frequent and/or continuous monitoring.

BRIEF SUMMARY

[0007] In one aspect, a device for detecting a hydration status of a user is disclosed. The device includes a galvanic response sensor positioned against a section of tissue of the user, and a control circuit communicable coupled to the galvanic response sensor. The control circuit including a processor and a memory, the memory storing instructions executed by the processor to receive first data from the galvanic response sensor indicative of a resistance of the tissue at the galvanic response sensor, and determine an approximate fluid loss or gain of the user based on at least the first data. The memory storing further instructions executed by the processor to determine an overall hydration level based on the fluid loss or gain, and a user’s body mass index (BMI), compare the overall hydration level to a threshold range, and transmit a notification based on the overall hydration level being less or more than the threshold range.

[0008] In an embodiment, the device further includes a housing enclosing the control circuit, and a display mounted to the housing. The memory stores further instructions executed by the processor to display the notification on the display screen.

[0009] In an embodiment, the notification includes an alert and instructions for a user to drink water and/or other beverages, or decrease the intake of water or other beverages.

[0010] In an embodiment, the device further includes a user interface button mounted to the housing, and the user interface button is to allow the user to provide input to the control circuit.

[0011] In an embodiment, the device further includes a band attached to the housing, wherein the band is to maintain the housing against the tissue of the user.

[0012] In an embodiment, the galvanic response sensor includes at least two galvanic response electrodes. The at least two galvanic response electrodes are arranged and configured to measure an electrical resistance of the section of tissue between the at least two galvanic response electrodes.

[0013] In an embodiment, the device further includes a heart rate sensor attached to the housing. The memory stores further instructions executed by the processor to receive second data from the heart rate sensor indicative of a heart rate of the user, and determine the approximate fluid loss or gain of the user based on at least the first data and the second data.

[0014] In an embodiment, the device further includes a temperature sensor attached to the housing. The memory stores further instructions executed by the processor to receive third data from the temperature sensor indicative of a temperature of the user, and determine the approximate fluid loss or gain of the user based on at least the first data and the third data.

[0015] In an embodiment, the device further includes a heart rate sensor attached to the housing and a temperature sensor attached to the housing. The memory stores further instructions executed by the processor to receive second data from the heart rate sensor indicative of a heart rate of the user, receive third data from the temperature sensor indicative of a temperature of the user, and determine the approximate fluid loss or gain of the user based on at least the first data, the second data, and the third data.

[0016] In an embodiment, the heart rate sensor includes an infrared light source, a phototransistor, and a signal condition circuitry. The infrared light source is positioned against user’s skin. The phototransistor is configured to detect a light from the infrared light source off of the user’s skin. A signal from the phototransistor is processed in the signal condition circuitry to generate the second data, and the second data is transmitted to the control circuit.

[0017] In an embodiment, the tissue includes a section of skin of the user.

[0018] In an embodiment, the galvanic response sensor is mounted to the housing.

[0019] In an embodiment, the tissue includes a section of intestinal tissue at a stoma of the user.

[0020] In an embodiment, the galvanic sensor is attached to an ostomy ring such that the galvanic sensor is in contact with user’s stoma when the ostomy ring is attached to a user.

[0021] In an embodiment, the galvanic sensor is attached to an ostomy skin barrier such that the galvanic sensor is in contact with user’s stoma when the ostomy skin barrier is attached to a user. [0022] In an embodiment, the tissue includes a section of urethral tissue of the user.

[0023] In an embodiment, the galvanic sensor includes at least two galvanic electrodes. The at least two galvanic electrodes are arranged on an external surface of a catheter and configured to be in contact with the urethral tissue when the catheter is inserted into the user.

BRIEF DESCRIPTION OF THE DRAWINGS

[0024] The benefits and advantages of the present embodiments will become more readily apparent to those of ordinary skill in the relevant art after reviewing the following detailed description and accompanying drawings, wherein:

[0025] FIG. l is a perspective view of an example device for measuring the hydration level of a person, according to an embodiment of the present disclosure;

[0026] FIG. 2 is a side view of the device of FIG. 1, according to an embodiment of the present disclosure;

[0027] FIG. 3 is a top view of the device of FIG. 1, according to an embodiment of the present disclosure;

[0028] FIG. 4 is a front view of the device of FIG. 1, according to an embodiment of the present disclosure;

[0029] FIG. 5 is a diagram of the control system of the device of FIG. 1, according to an embodiment of the present disclosure;

[0030] FIG. 6 is an example electrical schematic diagram of a galvanic skin response sensor, according to an embodiment of the present disclosure;

[0031] FIG. 7 is an example electrical schematic diagram of a heart rate sensor, according to an embodiment of the present disclosure;

[0032] FIG. 8 is an example electrical schematic diagram of a temperature sensor, according to an embodiment of the present disclosure;

[0033] FIG. 9 is an example perspective view of an ostomy wafer incorporating a galvanic response sensor, according to an embodiment of the present disclosure;

[0034] FIG. 10 is a cross-sectional view taken along cross section line 10-10 of FIG. 9, according to an embodiment of the present disclosure;

[0035] FIG. 11 is a top view of the ostomy wafer of FIG. 9, according to an embodiment of the present disclosure;

[0036] FIG. 12 is a top view of an example ostomy ring, according to an embodiment of the present disclosure;

[0037] FIG. 13 is a cross-sectional view taken along cross section line 13-13 of FIG. 12, according to an embodiment of the present disclosure;

[0038] FIG. 14 is a perspective view of an example intermittent catheter, according to an embodiment of the present disclosure; and

[0039] FIG. 15 is a cross-sectional view taken along cross section line 15-15 of FIG. 14, according to an embodiment of the present disclosure.

DESCRIPTION

[0040] 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.”

[0041] The following disclosure is directed to methods and devices for detecting total body hydration for ostomates and those using intermittent catheters, and can detect total body hydration through skin, stoma, and/or urethral tissue. It is to be appreciated that reference to any should be inferred as applying to all.

[0042] As discussed above, ostomates and intermittent catheter users face unique challenges in maintaining hydration leading to potential imbalances in fluid intake and absorption. Ostomates may have issues maintaining hydration due to alterations in their digestive systems and intermittent catheter users face may have issues maintaining hydration due to a loss of sensation of bladder fdling and emptying. One example solution may be to use Galvanic Response (GR) sensors to monitor the hydration level of ostomates and intermittent catheter users. GR sensors may be configured to detect subtle changes in skin and/or intestinal tissue conductance caused by dehydration. In an embodiment, GR sensors may be configured to detect subtle changes in skin, exteriorized intestinal tissue (e g., stoma), and/or urethral tissue (accessed via a catheter) conductance caused by dehydration. In such an embodiment, the tissue may function as a conductor and may be influenced by tissue moisture content. Dehydration can lead to a reduction in tissue moisture content, and overhydration can lead to an increase in tissue moisture content, altering its conductive property. GR sensors may include electrodes which may be placed on the skin, stoma, and/or urethral surface to measure conductance changes by analyzing the tissue’s electrical characteristics. By continuously monitoring tissue conductance levels, GR sensors can track hydration status in real time. As dehydration progresses, the tissue conductance decreases, indicating a need for increased fluid intake. Moreover, incorporating data from GR sensors into wearable devices may provide ostomates and intermittent catheter users with personalized hydration alerts.

[0043] Additional measurements of the user may be collected to determine a more accurate hydration level of the user. For example, intact skin may be a challenging substrate, due to its dehydration limiting features such as hydrophobic lipids; and by adding additional measurements, the hydration status of the user may be determined more accurately. Examples of the additional measurements may include user’s heart rate, which may be measured using a photoplethysmography (PPG) method and user’s skin temperature that may be collected along with the GR sensor data. With all three measurements, the percentage of fluid loss or gain of the user may be approximated and compared to their body mass index (BMI) to determine if the patient is dehydrated. All of these components and data may be combined together via a control circuit so that all the components may be analyzed together simultaneously to determine the hydration status of the user. These additional measurements may be collected using the GR sensors (e.g., skin, intestinal tissue, and/or urethral tissue) and used to improve the hydration status approximation.

[0044] In an embodiment, the GR sensors may include galvanic skin response (GSR) sensors that are positioned against user’s skin. For example, Seed galvanic skin response sensors may be used to measure resistance properties of the skin to determine hydration status of the underlying tissue. The GSR sensors may be configured for monitoring various physiological conditions, including dehydration, by assessing changes in skin conductance. When applied to ostomates, these sensors may offer a non-invasive and continuous means of evaluating hydration levels. The skin acts as a conductor and it is influenced by moisture content. Dehydration leads to a reduction in skin moisture, altering its conductive properties. GSR sensors comprising electrodes for placement on the skin's surface may be configured to measure these conductance changes by analyzing the skin's electrical characteristics. For ostomates or intermittent catheter users, these sensors may be placed on areas of the skin less affected by ostomy and intermittent catheter components, such as the forearm or near the ostomy site or groin, ensuring reliable readings.

[0045] For ostomates, the presence of a stoma offers unique challenges and opportunities to assess hydration state via the exteriorized intestinal tissue. Measuring characteristics of the exteriorized intestinal tissue, such as a stoma, can improve accuracy of determining user’s hydration status when compared measuring the skin since the skin is a barrier to vapor and fluid loss. For example, intact skin may present some challenges for the sensing of hydration state that may be alleviated by measuring the exteriorized intestinal tissue. The GR sensors may be configured for placement on the stoma through incorporation into existing ostomy appliances. In one example, the tissue contacting GR electrodes of the sensor may be integrated into an ostomy ring, which may be applied around the base of and in contact with the stoma to improve fit and prevent leakage (see FIGS. 12 and 13). In another example, the GR electrodes may be incorporated into an adhesive skin barrier at the interface with the stoma (see FIGS. 9-11). In another example, the GR electrodes may be incorporated into and extend to the stoma from the faceplate at the interface with the ostomy pouch. By continuously monitoring intestinal tissue of the stoma’s conductance levels, GR sensors may track hydration status in real time. As dehydration progresses, the intestinal tissue’s conductance decreases, indicating a need for increased fluid intake. Moreover, incorporating data from GR sensors into wearable devices can provide ostomates with personalized hydration alerts. [0046] For intermittent catheter users, the use of an intermittent catheter can offers a novel and unique means to assess hydration state via the surrounding urethral tissue. Measuring characteristics of the surrounding urethral tissue can improve accuracy of determining user’s hydration status when compared to measuring characteristics of the skin since the skin is a barrier to vapor and fluid loss. For example, intact skin can present some challenges for the sensing of hydration state that may be alleviated by measuring the urethral tissue surrounding the intermittent catheter. GR sensors may be integrated into the outer wall of an intermittent catheter with the tissue contacting electrodes placed on the tissue contacting surface of the external catheter (See FIGS. 14 and 15). By continuously monitoring the urethra’s conductance levels, GR sensors may track hydration status in real time. As dehydration progresses, the urethra’s conductance decreases, indicating a need for increased fluid intake. Moreover, incorporating data from GR sensors into wearable devices may provide intermittent catheter users with personalized hydration alerts.

[0047] Any of the GR sensors (e g., placed on skin, stoma, or catheter) may be used to determine hydration of a user. The GR sensor(s) may also be combined with a heart rate sensor and skin temperature sensor to improve the hydration approximation of the user. In at least one aspect, these sensors may be combined into a device configured to measure total body hydration levels. By allowing a user to easily measure their hydration level and providing hydration alerts, the device may be used to improve the rate of rehospitalizations due to dehydration.

[0048] FIGS. 1-5 illustrate an example device 100 for determining the hydration status of a user. The device 100 may include a first band 102, a second band 112, a device housing 104, a display screen 106, user interface buttons 110, a charging port 108, and a bottom sensor area 114. The first band 102 and the second band 112 may be attached to the housing 104 on opposite sides. The display screen 106 may be positioned on a top surface of the housing 104 and mounted to the housing 104. A plurality of user interface buttons 110 may be attached to the housing 104. For example, the user interface buttons 110 may extend into the housing 104 on two sides. The user interface buttons 110 may allow a user to provide input to a control circuit 116 (FIG. 5) housed or enclosed inside of the housing 104. The charging port 108 may allow a user to charge a battery 130 of the device 100. The battery 130 may then supply power to the components of the device 100.

[0049] The bottom sensor area 114 may be positioned on a bottom surface of the housing 104.

The bands 102, 112 may be positioned around an arm of a user. The bands 102, 112 may be designed to mechanically couple together to position the housing 104 against the user’s skin such that the bottom sensor area 114 is positioned against the user’s skin. As such, the bottom sensor area 114 may be positioned against a section of tissue of the user. The bottom sensor area 114 may include a GSR sensor 122, a temperature sensor 124, and a heart rate sensor 126. Each of the sensors 122, 124, and 126 may contact the user’s skin at the bottom sensor area 114. In an alternative aspect, the device 100 may not include the bands 102, 112 and the housing 104 may be attached to the user with an adhesive. The adhesive may be placed on the bottom sensor area 114 to attach the bottom sensor area 114 to the user. The adhesive may be placed to not blocking the GSR sensor 122, temperature sensor 124, or heart rate sensor 126 allowing the device 100 to function properly.

[0050] The GSR sensor 122 may include two GSR electrodes. The GSR sensor 122 may be used to measure the resistance of the skin between the electrodes. For example, the two GSR electrodes contact the user’s skin in two different positions and the resistance of the skin between the electrodes may be measured using the GSR sensor 122. The two GSR electrodes may be arranged on the bottom sensor area 114 and configured to contact user’s skin. As such, the GSR electrodes may be mounted to the housing 104. The GSR sensor 122 may transmit the skin resistance data to the control circuit 116, where the control circuit 116 may process the skin resistance data to determine the hydration status of the user.

[0051] The temperature sensor 124 may include a temperature electrode configured to measure temperature of user’s skin. The temperature electrode may be arranged on the bottom sensor area 114 and configured to contact user’s skin. The temperature sensor 124 measures a temperature of the user’s skin via the temperature electrode. The temperature data may be transmitted to the control circuit 116, where the control circuit 116 may process the temperature data with the skin resistance data to determine the hydration status of the user.

[0052] The heart rate sensor 126 may include an infrared light source, phototransistor, and signal condition circuitry. In an embodiment, the heart rate sensor 126 may comprise a photoplethysmography system. The device 100 may be configured such that the infrared light source is positioned against the user’s skin at the bottom sensor area 114. The phototransistor may detect the light from the infrared light source off of the user’s skin and the signal from the phototransistor may go through signal condition circuitry before being transmitted to the control circuit 116. The heart rate sensor 126 may transmit data indicative of the user’s heart rate to the control circuit 116 and the control circuit 116 may process the heart rate data with the skin resistance data and/or the temperature data to determine the hydration status of the user.

[0053] Referring to FIG. 5, the control circuit 116 may include at least one processor 118 and at least one memory 120. The processor 118 may be communicably coupled to the memory 120. The memory 120 may be configured to store instructions that are executed by the processor 118 to perform various operations of the device 100. The device 100 may include multiple processors 118 and multiple memories 120 that are all communicably coupled together to perform operations of the device 100.

[0054] The user interfaces 128 may include the user interface buttons 110 and the display screen 106. For example, the display screen 106 may be a touch display screen that may be configured to receive touch input from the user. Additionally, the control circuit 116 may be communicable coupled to a mobile device (i .e., cell phone, tablet, etc.) of the user and receive information from the user via the mobile device. For example, the user may be able to enter their BMI into the user interface and the control circuit 116 may store their BMI in the memory 120. Additionally, the control circuit 116 may transmit data to the mobile device to provide the user with a notification. [0055] The control circuit 116 may be communicably coupled to the GSR sensor 122, the temperature sensor 124, the heart rate sensor 126, the display screen 106, and the user interfaces 128. The control circuit 116 may be powered by the battery 130. The control circuit 116 may be configured to receive data from each of the sensors 122, 124, 126 as discussed above. The control circuit 116 may be configured to process and analyze the data received from the GSR sensor 122, the temperature sensor 124 and the heart rate sensor 126 to determine an approximate fluid loss or gain of the user. Equation 1 below is one example equation to determine an approximation for fluid loss or gain of the user. The equation 1 may be stored in the memory 120.

Fluid Gain/Loss

= -1.95403 ^Eq' ¹

+ (0.008418

[0056] Fluid Gain/Loss is the approximate amount of fluid gained or fluid lost by the user. The “BMI” is the body mass index of the user. The user may enter their BMI prior to the device 100 collecting any data with the sensors 122, 124, 126. For example, the user’s BMI may be received through the user interfaces 128 and stored in the memory 120. In at least one aspect, data may be collected by the sensors 122, 124, 126 at least once every 6 hours. “Temp” is the data from the temperature sensor 124 received by the control circuit 116 indicative of the temperature of the user’s skin. “HR” is the data from the heart rate sensor 126 received by the control circuit 116 indicative of the heart rate of the user. “GSR” is the data from the GSR sensor 122 received by the control circuit 116 indicative of the skin resistance between the two GSR electrodes.

[0057] The control circuit 116 may receive the data from the sensors 122, 124, 126 and calculate an approximate fluid loss or gain based on the data from the sensors. Once the fluid loss or gain is determined, then the control circuit 116 may compare the fluid loss or gain with the user’s body mass index to approximate a hydration status for the user. For example, the control circuit 116 may determine the user’s overall hydration level based on the fluid loss or gain, and BMI. The hydration level may then be compared to a threshold range to determine the user’s hydration status. If the hydration level is below or above the threshold range (e.g., below the lower end of the threshold range or above the upper end of the threshold range), then the control circuit 116 may transmit the alert or notification to the user. For example, the control circuit 116 may transmit the alert to a mobile device of the user. The control circuit 116 may also transmit the alert to the display screen 106 for the alert or notification to be displayed on the display screen 106. If the user’s hydration levels remain below the threshold range, then the chance of the user being hospitalized due to dehydration may increase. Alternatively, if the user’s hydration levels remain above the threshold range, then the chance of hospitalization due to hypoosmotic conditions may increase. The alert may provide the user a notification that they need to drink water or some other beverage to hydrate themselves, or inform the user that they are over hydrated and need to refrain from drinking water or other beverages. In some aspects, the alert may instruct the user to use a diuretic. [0058] FIG. 6 provides an example electrical schematic diagram 132 of the GSR sensor 122. The input 134 represents the first and second GSR electrodes in the diagram 132. The circuitry receives power through the V+ and V. nodes. The output of the circuitry goes to the control circuit 116 providing a signal indicative of the skin resistance between the first and second GSR electrodes. [0059] FIG. 7 provides an example electrical schematic diagram 136 of the heart rate sensor 126. Power enters the circuitry at V_ec nodes. The ZRLED represents the infrared light source being powered. The PTransistor represents the phototransistor. The diagram shows the signal from the phototransistor going through the circuitry and out to the control circuit 116. In at least one aspect, the circuitry may be signal condition circuitry. The signal received by the control circuit 116 is indicative of the heart rate of the user. In at least one aspect, the signal received by the control circuit 116 may pass through signal condition circuitry prior to being received by the control circuit

116.

[0060] FIG. 8 provides an example electrical schematic diagram 138 of the temperature sensor 124. The diagram 138 shows the temperature sensor 124 as a micro-chip 140. Power enters the circuitry at V_ce nodes. The signal output of the micro-chip 140 is received by the control circuit 116. The signal received by the control circuit 116 is indicative of the temperature of the user’s skin.

[0061] The device 100 may be used to measure or approximate water content of the user. For example, the device 100 may determine the user’s water level and transmit a hydration alert to the user if the user’s water level is below or above a threshold range. The hydration alert may provide the user with an indication to hydrate themselves or provide an indication to refrain from drinking if they are overly hydrated. For example, the hydration alert may indicate to the user that they are becoming dehydrated due to having a hydration level below the threshold range and that they need to drink water or another beverage to hydrate. The hydration alert may provide the user with an indication to they are overly hydrated due to having a hydration level above the threshold range. For example, the hydration alert may indicate to the user that they need to refrain from drinking water or another beverages for a time period to move to a healthy hydration level.

[0062] The device 100 may be configured to be a low maintenance device such that it may not require servicing by the user aside from occasionally charging the battery 130. The battery 130 may be a rechargeable battery with a minimum of 64 watt-hours capacity. The device 100 may incorporate a sleep mode or standby mode to conserve power when not in active use to minimize recharging of the battery 130. The device may have a weight that is 21bs or less. The device 100 may collect data from sensors 122, 124, 126 and report on hydration of the user at increments that do not allow the user to become dehydrated. For example, the hydration of the user may be determined at least once every 6 hours.

[0063] In an alternative embodiment, the GR sensors may be incorporated into an adhesive skin barrier at the interface with the stoma. Referring to FIGS. 9-11, ostomy wafer 142 for an ostomy appliance is shown. The ostomy wafer 142 may include a skin barrier 148, a backing layer 150, a release liner 146, a first GR electrode 152, a second GR electrode 154, and inlet opening 144 for receiving a stoma.

[0064] The skin barrier 148 may be formed from a suitable medical grade adhesive, such as various hydrocolloid adhesives comprising water absorbing hydrocolloid particles dispersed in skin friendly adhesive compositions. The first GR electrode 152 and the second GR electrode 154 may be positioned within the skin barrier 148 as shown in FIG. 10. The skin barrier 148 may include skin friendly ingredients provided only on a skin contact surface 145 of the skin barrier 148. The skin friendly ingredients may include materials that protect skin, reduce skin irritation, aid healing, and/or promote skin health, such as collagen boosters.

[0065] The ostomy wafer 142 may be configured such that when the release liner 146 is removed prior to use. The skin contact surface 145 of the ostomy wafer 142 may then be attached to a user’s skin with the inlet opening 144 positioned over the user’s stoma. The ostomy wafer 142 may be attached to a pouch for a one piece ostomy pouch at the backing layer 150. Alternatively, the ostomy wafer 142 may be used to make a faceplate including a body-side coupling ring against the backing layer 150. The body-side coupling ring configured to engage a pouch-side coupling ring for a two-piece ostomy pouch system.

[0066] When the ostomy wafer 142 is attached to a user, the first GR electrode 152 and the second GR electrode may be in contact with the user’s stoma. The first GR electrode 152 and the second GR electrode may also contact the tissue around the user’s stoma. The first GR electrode 152 and the second GR electrode 154 may be part of a GR sensor similar to GSR sensor 122 and function the same as GSR sensor 122. As such, the first GR electrode 152 and the second GR electrode 154 may be electrically coupled to a control circuit such as control circuit 116. The control circuit may receive data indicative of the resistance of intestinal tissue from the first GR electrode 152 and the second GR electrode 154. The control circuit may process the resistance data to determine the hydration status of the user as discussed previously.

[0067] In yet another alternative embodiment, the GR sensors may be incorporated into an ostomy ring 156, which may be applied around the base of and in contact with the stoma to improve fit and prevent leakage. Referring to FIGS. 12 and 13, an ostomy ring 156 is shown. The ostomy ring 156 may include a stoma sealing material 158, a first GR electrode 162, a second GR electrode 164, skin friendly ingredients 160, and inlet opening 144 for receiving a stoma. The skin friendly ingredients 160 may be provided on outer surfaces of the stoma ring 156.

[0068] The stoma sealing material 158 may be formed from a medical grade sealing material suitable for sealing around a stoma, such as hydrocolloid adhesives and silicone adhesives. The first GR electrode 152 and the second GR electrode may be positioned within the stoma sealing material 158 as shown in FIG. 13. The stoma sealing material 158 may define an inlet opening 166.

[0069] When the ostomy ring 156 is attached to a user, the first GR electrode 162 and the second GR electrode 164 may be in contact with the user’s stoma. The user’s stoma inserting through the inlet opening 166. The first GR electrode 162 and the second GR electrode 164 may also contact the tissue around the user’s stoma. The first GR electrode 162 and the second GR electrode 164 may be part of a GR sensor similar to GSR sensor 122 and function the same as GSR sensor 122. As such, the first GR electrode 162 and the second GR electrode 164 may be electrically coupled to a control circuit such as control circuit 116. The control circuit may receive data indicative of the resistance of intestinal tissue from the first GR electrode 162 and the second GR electrode 164.

The control circuit may process the resistance data to determine the hydration status of the user as discussed previously.

[0070] In yet another alternative embodiment, the GR sensors may be incorporated into an intermittent catheter. Referring to FIGS. 14 and 15, the catheter 168 may include a first section 172 forming an insertable end of the catheter, a second section 174 forming a handle of the catheter 168, a first GR electrode 178, and a second GR electrode 180. The first and second sections 172, 174 may have different shapes corresponding to their intended use. The first section 172 may be oblong and define an inlet opening 170 for draining urine from the bladder. The second section 174 may define an outlet opening 176. The draining may occur through an internal conduit extending through both sections 172, 174 of the catheter 168. The internal conduit may connect the inlet opening 170 with the outlet opening 176. The first section 172 may have a diameter that is smaller than the second section 174.

[0071] The first GR electrode 178 and the second GR electrode 180 may both be positioned on an external surface 182 of the first section 172 of the catheter 168. When the catheter 168 is inserted into the user to drain the user’s bladder, the first GR electrode 178 and the second GR electrode 180 may contact urethral tissue of the user. The first GR electrode 178 and the second GR electrode 180 may be part of a GR sensor similar to GSR sensor 122 and function the same as GSR sensor 122. As such, the first GR electrode 178 and the second GR electrode 180 may be electrically coupled to a control circuit such as control circuit 116. For example, an electrical wire/connection may run the length of the catheter to connect to the control circuit 116. The control circuit may receive data indicative of the resistance of urethral tissue. The control circuit may process the resistance data to determine the hydration status of the user as discussed previously.

[0072] From the foregoing it will be observed that numerous modifications and variations can be effectuated without departing from the true spirit and scope of the novel concepts of the present disclosure. It is to be understood that no limitation with respect to the specific embodiments illustrated is intended or should be inferred. The disclosure is intended to cover by the appended claims all such modifications as fall within the scope of the claims.

[0073] Instructions used to program logic to perform various disclosed aspects can be stored within a memory 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).

[0074] As used in any aspect herein, the term “control circuit” 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, electrical circuitry 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.

Claims

CLAIMS What is claimed is:

1. A device for detecting a hydration status of a user, the device comprising: a galvanic response sensor positioned against a section of tissue of the user; and a control circuit communicable coupled to the galvanic response sensor, the control circuit including a processor and a memory, the memory storing instructions executed by the processor to: receive first data from the galvanic response sensor indicative of a resistance of the tissue at the galvanic response sensor; determine an approximate fluid loss or gain of the user based on at least the first data; determine an overall hydration level based on the fluid loss or gain, and a user’s body mass index (BMI); compare the overall hydration level to a threshold range; transmit a notification based on the overall hydration level being less or more than the threshold range.

2. The device of claim 1, wherein the device further comprises: a housing enclosing the control circuit; and a display mounted to the housing, and wherein the memory stores further instructions executed by the processor to display the notification on the display screen.

3. The device of any one of claims 1-2, wherein the notification includes an alert and instructions for a user to drink water and/or other beverages, or decrease the intake of water or other beverages.

4. The device of any one of claims 1-3, wherein the device further comprises a user interface button mounted to the housing, and wherein the user interface button is to allow the user to provide input to the control circuit.

5. The device of claim 2 or 3, wherein the device further comprises a band attached to the housing, wherein the band is to maintain the housing against the tissue of the user.

6. The device of any one of claims 1-4, wherein the galvanic response sensor includes at least two galvanic response electrodes, wherein the at least two galvanic response electrodes are arranged and configured to measure an electrical resistance of the section of tissue between the at least two galvanic response electrodes.

7. The device of any one of claims 2-5, further comprising a heart rate sensor attached to the housing, wherein the memory stores further instructions executed by the processor to: receive second data from the heart rate sensor indicative of a heart rate of the user; and determine the approximate fluid loss or gain of the user based on at least the first data and the second data.

8. The device of any one of claims 2-4, further comprising a temperature sensor attached to the housing, wherein the memory stores further instructions executed by the processor to: receive third data from the temperature sensor indicative of a temperature of the user; and determine the approximate fluid loss or gain of the user based on at least the first data and the third data.

9. The device of any one of claims 2-4, further comprising a heart rate sensor attached to the housing and a temperature sensor attached to the housing, wherein the memory stores further instructions executed by the processor to: receive second data from the heart rate sensor indicative of a heart rate of the user; receive third data from the temperature sensor indicative of a temperature of the user; and determine the approximate fluid loss or gain of the user based on at least the first data, the second data, and the third data.

10. The device of claim 7 or 9, wherein the heart rate sensor includes an infrared light source, a phototransistor, and a signal condition circuitry, wherein the infrared light source is positioned against user’s skin, wherein the phototransistor is configured to detect a light from the infrared light source off of the user’s skin, wherein a signal from the phototransistor is processed in the signal condition circuitry to generate the second data, wherein the second data is transmitted to the control circuit.

11 . The device of any one of claims 1-10, wherein the tissue comprises a section of skin of the user.

12. The device of any one of claims 1-11, wherein the galvanic response sensor is mounted to the housing.

13. The device of any one of claims 1-10, wherein the tissue comprises a section of intestinal tissue at a stoma of the user.

14. The device of claim 13, wherein the galvanic sensor is attached to an ostomy ring such that the galvanic sensor is in contact with user’s stoma when the ostomy ring is attached to a user.

15. The device of claim 13, wherein the galvanic sensor is attached to an ostomy skin barrier such that the galvanic sensor is in contact with user’s stoma when the ostomy skin barrier is attached to a user.

16. The device of any one of claims 1-10, wherein the tissue comprises a section of urethral tissue of the user.

17. The device of claim 16, wherein the galvanic sensor includes at least two galvanic electrodes, wherein the at least two galvanic electrodes are arranged on an external surface of a catheter and configured to be in contact with the urethral tissue when the catheter is inserted into the user.