Devices and method for detecting body hydration status

Abstract

A device for detecting a hydration status of a user is disclosed. The device includes an electrode patch configured to be positioned on a user. The electrode patch includes a substrate including a first side positioned against the user and a second side, and a first electrode and a second electrode both positioned on the second side. The device further includes an impedance analyzer including a control circuit electrically coupled to the first electrode and the second electrode when the impedance analyzer is engaged with the electrode patch. The control circuit including a processor and a memory, the memory storing instructions executed by the processor to transmit an electrical signal to the first electrode and the second electrode, determine an impedance between the two electrodes, determine a hydration level based on the impedance, compare the hydration level to a threshold range, and transmit a notification based on the hydration level.

Description

DEVICES AND METHOD FOR DETECTING BODY HYDRATION STATUSBACKGROUND

[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 individualwith 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-timemonitoring 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 including an electrode patch configured to be positioned on a user. The electrode patch including a substrate including a first side positioned against the user and a second side opposite the first side. The electrode patch further including a first electrode positioned on the second side of the substrate, and a second electrode positioned on the second side of the substrate. The device further including an impedance analyzer configured to engage with the electrode patch. The impedance analyzer including a control circuit electrically coupled to the first electrode and the second electrode when the impedance analyzer is engaged with the electrode patch. The control circuitincluding a processor and a memory. The memory storing instructions executed by the processor to transmit an electrical signal to the first electrode and the second electrode, determine an impedance between the first electrode and the second electrode while transmitting the electrical signal, and determine a hydration level based on the impedance. The memory storing further instructions executed by the processor to compare the hydration level to a threshold range, and transmit a notification based on the hydration level being less or more than the threshold range.

[0008] In an embodiment, the impedance analyzer is configured to be positioned over the electrode patch to engage with the electrode patch. The impedance analyzer further includes a housing defining two channels. When the impedance analyzer is positioned over the electrode patch, the first electrode and second electrode are positioned within the two channels. The housing encloses the control circuit.

[0009] In an embodiment, the impedance analyzer further includes a display mounted to the housing, wherein the memory stores further instructions executed by the processor to display the notification on the display screen.

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

[0011] In an embodiment, the impedance analyzer further includes a band attached to the housing, wherein the band is configured to maintain the housing against the user.

[0012] In an embodiment, an adhesive is attached to the housing of the impedance analyzer, wherein the adhesive is configured to maintain the housing against the user.

[0013] In an embodiment, the impedance analyzer further includes a band, adhesive, or other means of attachment to attach to the housing, wherein the band, adhesive, or other means ofattachment is configured to maintain the housing against the user.

[0014] In an embodiment, the notification includes an alert and instructions for a user to drink or not drink water and / or other beverages.

[0015] In an embodiment, the control circuit is electrically coupled to the first electrode and the second electrode through the two channels.

[0016] In one aspect, a device for detecting a hydration status of a user is disclosed. The device includes a first impedance electrode positioned against a first section of tissue of the user, a second impedance electrode positioned against a second section of tissue of the user, and a control circuit electrically coupled to the first impedance electrode and the second impedance electrode. The control circuit including a processor and a memory. The memory storing instructions executed by the processor to transmit an electrical signal to the first impedance electrode and the second impedance electrode, determine an impedance between the first impedance electrode and the second impedance electrode while transmitting the electrical signal, and determine a hydration level based on the impedance. The memory storing further instructions executed by the processor to compare the hydration level to a threshold range, and transmit a notification based on the hydration level being less or more than the threshold range.

[0017] In an embodiment, the tissue includes a section of intestinal tissue at a stoma of the user.

[0018] In an embodiment, the first impedance electrode and second impedance electrode are attached to an ostomy ring such that the first impedance electrode and second impedance electrode are in contact with user’s stoma when the ostomy ring is attached to a user.

[0019] In an embodiment, the first impedance electrode and second impedance electrode are attached to an ostomy skin barrier such that the first impedance electrode and second impedance electrode are in contact with user’s stoma when the ostomy skin barrier is attached to a user.

[0020] In an embodiment, the tissue includes a section of urethral tissue of the user.

[0021] In an embodiment, the notification includes an alert and instructions for a user to drink or not drink water and / or other beverages.

[0022] In one aspect, device for detecting a hydration status of a user is disclosed. The device includes a first electrode assembly positioned at a first position on the user. The first electrode assembly includes a first electrode position against the user, and a first base housing the first electrode. The first electrode extends away from the first base to contact the user. The device further includes a second electrode assembly positioned at a second position on the user. The second electrode assembly includes a second electrode position against the user, and a second base housing the second electrode. The second electrode extends away from the second base to contact the user. The device further includes a control circuit electrically coupled to the first electrode and the second electrode. The control circuit including a processor and a memory. The memory storing instructions executed by the processor to transmit a plurality of electrical signals with differing frequencies to the first electrode, receive the plurality of electrical signals from the second electrode after the plurality of electrical signals has passed through the user’s body, and determine an attenuation of a plurality of electrical signals based on the transmitted signal and the received signal. The memory storing further instructions executed by the processor to determine a hydration level of the user based on the attenuation of the plurality of electrical signals based on the frequencies of the signals, compare the hydration level to a threshold range, and transmit a notification based on the hydration level being less or more than the threshold range.

[0023] In an embodiment, the notification includes an alert and instructions for a user to drink or not drink water and / or other beverages.

[0024] In an embodiment, the first electrode assembly is positioned on a first limb of the user, andthe second electrode assembly is positioned on a second limb of the user.

[0025] In an embodiment, the device further includes a third electrode assembly positioned at a third position on the user. The third electrode assembly includes a third electrode position against the user, and a third base housing the third electrode. The third electrode extends away from the third base to contact the user. The device further includes fourth electrode assembly positioned at a fourth position on the user. The fourth electrode assembly includes a fourth electrode position against the user, and a fourth base housing the fourth electrode. The fourth electrode extends away from the fourth base to contact the user. The memory further storing instructions executed by the processor to transmit a plurality of electrical signals with differing frequencies to the first electrode and the third electrode, and receive the plurality of electrical signals from the second electrode and the fourth electrode after the plurality of electrical signals has passed through the user’s body.

[0026] In an embodiment, the first electrode assembly is positioned on a first arm of the user, the third electrode assembly is positioned on a second arm of the user, the second electrode assembly is positioned on a first leg of the user, and the fourth electrode assembly is positioned on a second leg of the user.

[0027] In an embodiment, the third electrode assembly is positioned on a torso of the user, the first electrode assembly is positioned on an arm of the user, the second electrode assembly is positioned on a first leg of the user, and the fourth electrode assembly is positioned on a second leg of the user.

[0028] In an embodiment, the first electrode assembly is positioned on an arm of the user and the second electrode assembly is positioned on a leg of the user.

[0029] In an embodiment, the first electrode assembly is positioned on a torso of the user and the second electrode assembly is positioned on a leg of the user.

[0030] In an embodiment, the first electrode assembly is positioned on a torso of the user and the second electrode assembly is positioned on an arm of the user.

[0031] In an embodiment, the first electrode assembly is positioned at a stoma of the user with the first electrode in contact with intestinal tissue and the second electrode assembly is positioned on a torso of the user.

[0032] In an embodiment, the first electrode is attached to an ostomy ring such that the first electrode is in contact with user’s stoma when the ostomy ring is attached to a user.

[0033] In an embodiment, the first electrode is attached to an ostomy skin barrier such that the first electrode is in contact with user’s stoma when the ostomy skin barrier is attached to a user.

[0034] In an embodiment, the first electrode assembly is positioned on an arm of the user and the second electrode assembly is positioned at a stoma of the user.

[0035] In an embodiment, the first electrode is configured to be in contact with urethral tissue of the user and the second electrode assembly is positioned on a torso of the user.

[0036] In an embodiment, the second electrode is configured to be in contact with urethral tissue of the user and the first electrode assembly is positioned on a torso of the user.BRIEF DESCRIPTION OF THE DRAWINGS

[0037] 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:

[0038] FIG. 1 is a perspective view of an example device for measuring the hydration level of a person, according to an embodiment of the present disclosure;

[0039] FIG. 2 is a perspective view of an electrode patch of the example device of FIG. 1 , according to an embodiment of the present disclosure;

[0040] FIG. 3 is a top view of the electrode patch of FIG. 2, according to an embodiment of the present disclosure;

[0041] FIG. 4 is a side view of the electrode patch of FIG. 2, according to an embodiment of the present disclosure;

[0042] FIG. 5 is a front view of the electrode patch of FIG. 2, according to an embodiment of the present disclosure;

[0043] FIG. 6 is a diagram of the electrode patch of FIG. 2, according to an embodiment of the present disclosure;

[0044] FIG. 7 is a perspective view of an impedance analyzer of the device of FIG. 1, according to an embodiment of the present disclosure;

[0045] FIG. 8 is a top view of the impedance analyzer of FIG. 7, according to an embodiment of the present disclosure;

[0046] FIG. 9 is a side view of the impedance analyzer of FIG. 7, according to an embodiment of the present disclosure;

[0047] FIG. 10 is a front view of the impedance analyzer of FIG. 7, according to an embodiment of the present disclosure;

[0048] FIG. 11 is a side view of the impedance analyzer of FIG. 7 positioned on top of the electrode patch of FIG. 1, according to an embodiment of the present disclosure;

[0049] FIG. 12 is a schematic diagram of the controller of the impedance analyzer of FIG. 7, according to an embodiment of the present disclosure;

[0050] FIG. 13 is an example electrical schematic diagram of an impedance circuit of the impedance analyzer of FIG. 7, according to an embodiment of the present disclosure;

[0051] FIG. 14 is a perspective view of an impedance analyzer, according to an embodiment ofthe present disclosure;

[0052] FIG. 15 is a top view of the impedance analyzer of FIG. 14, according to an embodiment of the present disclosure;

[0053] FIG. 16 is a side view of the impedance analyzer of FIG. 14 positioned on top of the electrode patch of FIG. 2, according to an embodiment of the present disclosure;

[0054]

[0055] FIG. 17 is an example perspective view of an ostomy wafer incorporating impedance electrodes, according to an embodiment of the present disclosure;

[0056] FIG. 18 is a cross-sectional view taken along cross section line 18-18 of FIG. 17, according to an embodiment of the present disclosure;

[0057] FIG. 19 is a top view of the ostomy wafer of FIG. 17, according to an embodiment of the present disclosure;

[0058] FIG. 20 is a top view of an example ostomy ring, according to an embodiment of the present disclosure;

[0059] FIG. 21 is a cross-sectional view taken along cross section line 21-21 of FIG. 20, according to an embodiment of the present disclosure;

[0060] FIG. 22 is a perspective view of an example intermittent catheter, according to an embodiment of the present disclosure;

[0061] FIG. 23 is a cross-sectional view taken along cross section line 23-23 of FIG. 22, according to an embodiment of the present disclosure;

[0062] FIG. 24 is an example device that uses Bioimpedance Spectroscopy (BIS) to determine a hydration level of a person, according to an embodiment of the present disclosure;

[0063] FIG. 25 is an example device that uses BIS to determine a hydration level of a person,according to an embodiment of the present disclosure;

[0064] FIG. 26 is an example device that uses BIS to determine a hydration level of a person, according to an embodiment of the present disclosure;

[0065] FIG. 27 is a schematic diagram of the controller of the device of FIGS. 24-26, according to an embodiment of the present disclosure;

[0066] FIG. 28 is an example electrical schematic diagram of the controller of the device of FIGS. 24-26, according to an embodiment of the present disclosure;

[0067] FIG. 29 is an example perspective view of an ostomy wafer incorporating a BIS electrode, according to an embodiment of the present disclosure;

[0068] FIG. 30 is a cross-sectional view taken along cross section line 30-30 of FIG. 29, according to an embodiment of the present disclosure;

[0069] FIG. 31 is a top view of the ostomy wafer of FIG. 29, according to an embodiment of the present disclosure;

[0070] FIG. 32 is a top view of an example ostomy ring, according to an embodiment of the present disclosure;

[0071] FIG. 33 is a cross-sectional view taken along cross section line 33-33 of FIG. 32, according to an embodiment of the present disclosure;

[0072] FIG. 34 is a perspective view of an example intermittent catheter, according to an embodiment of the present disclosure; and

[0073] FIG. 35 is a cross-sectional view taken along cross section line 35-35 of FIG. 34, according to an embodiment of the present disclosure.DESCRIPTION

[0074] While the present disclosure is susceptible of embodiment in various forms, there is shownin 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.”

[0075] As discussed above, ostomates and intermittent catheter users face unique challenges in maintaining hydration leading to potential imbalances in fluid and electrolyte intake, retention and absorption. Ostomates may have issues maintaining proper hydration due to alterations in their digestive systems and intermittent catheter users may have issues maintaining hydration due to a loss of sensation of bladder filling and emptying. One example solution may be to use an impedance sensor to monitor the hydration level of ostomates and intermittent catheter users. The impedance sensor may be configured to detect subtle changes in impedance in skin and / or intestinal tissue conductance or impedance caused by a user’s hydration. By monitoring tissue impedance levels, impedance sensors can track hydration status in real time. For example, as dehydration progresses, the tissue impedance increases, indicating a need for increased fluid intake. Moreover, incorporating data from impedance sensors into wearable devices may provide ostomates and intermittent catheter users with personalized hydration alerts.

[0076] FIGS. 1-12 illustrate an impedance device 100 for detecting dehydration of a user. In oneembodiment, the impedance device 100 may include an electrode patch 102 and an impedance analyzer 104. The electrode patch 102 may be positioned on the user’s skin and the impedance analyzer 104 may be positioned overtop of the electrode patch 102 for the impedance analyzer 104 to engage with the electrode patch 102. The electrode patch 102 may include two electrodes 106. The impedance analyzer 104 may be configured to determine the impedance between the two electrodes 106 on the electrode patch 102. If the impedance is above or below a threshold range, the impedance analyzer 104 may transmit a notification to the user. The notification may indicate to the user that they need to drink water or some other beverage to hydrate themselves, or stop drinking fluids and / or use a diuretic to prevent overhydration.

[0077] Referring to FIGS. 1-6, the electrode patch 102 may include a bottom substrate 108, a film 110 positioned on top of the bottom substrate, and two electrodes 106 position on top of the film 110. In an embodiment, the bottom substrate 108 may be a cotton substrate. The film 110 may be a thermoplastic polyurethane (TPU) film. The film 110 may be hot pressed onto the bottom substrate 108. In at least one aspect, the film 110 is hot pressed onto the bottom substrate 108 at 110°C.

[0078] Each electrode 106 may include an electrode paste 112 positioned on top of the film 110, an electrode encapsulant 116 positioned on top of at least a portion of the electrode paste 112, and a conductive adhesive 114 positioned on top of at least another portion of the electrode paste 112. The electrode paste 112 may be an aluminum (Ag) paste. The electrode paste 112 may be printed onto the film 1 10 and dried onto the film 110. The electrode encapsulant 116 may be printed onto a first portion of the electrode paste 112. The conductive adhesive 114 may be an Ag based adhesive. The conductive adhesive 114 may be printed on a second portion of the electrode paste 112. The second portion may be adjacent to the first portion. In an alternative aspect, the secondportion may overlap the first portion. In at least one aspect, one end of the electrode paste 112 may be uncovered and the opposite end of the electrode past 112 is covered with the conductive adhesive 114 with the electrode encapsulant 116 positioned between the two ends as shown in FIG. 4. The electrodes 106 may be formed by the layers of electrode paste 112, conductive adhesive 114, and electrode encapsulant 116. In at least one aspect, the electrode 106 may be an impedance electrode.

[0079] The electrode patch 102 may be adhered to the skin of a user so that the bottom substrate 108 is against the user’s skin with the electrodes 106 face away from the user’s skin. For example, the electrode patch 102 may be taped against the user’s skin (e.g., with surgical tape) or an adhesive may be used to attach the electrode patch 102 to the user’s skin. The impedance analyzer 104 may be positioned over the electrode patch 102 to determine the impedance between the two electrodes 106.

[0080] Referring to FIGS. 7-12, the impedance analyzer 104 may include a first band 118, a second band 120, a device housing 122, a display screen 124, a control circuit 130, and user interface button 126. The device housing 122 has a bottom surface 119 defining two channels 128. The first band 118 and the second band 120 may be attached to the housing 122 on opposite sides. The display screen 124 may be positioned on a top surface of the housing 122 and mounted to the housing 122. At least one user interface button 126 may be attached to the housing 122. For example, the user interface button 126 may extend into the housing 122 on a side of the housing 122. The user interface button 126 may allow a user to provide input to the control circuit 130 (FIG. 12) housed or enclosed inside of the housing 122.

[0081] The housing 122 defines the channels 128. The channels 128 are shaped and positioned to fit over the electrodes 106 of the electrode patch 102 when the impedance analyzer 104 ispositioned over the electrode patch 102. The channels 128 may be configured to electrically couple or engaged the electrodes 106 with the control circuit 130. In at least one aspect, the electrode patch 102 may be electrically coupled to the control circuit 130 through the channels 128 to form an impedance sensor.

[0082] As discussed above, the electrode patch 102 may be positioned against the user’s skin (e.g., on a limb of the user) and the impedance analyzer 104 may be positioned over the electrode patch 102. The bands 118, 120 may wrap around a limb of a user to hold the impedance analyzer 104 in position. The bands 118, 120 may be designed to mechanically couple together to position the housing 122 against the electrode patch 102 and a user’s limb. For example, a pin on the band 120 may be positioned within one of a plurality of holes defined in the band 118 to mechanically couple the bands 118, 120 together around a limb of the use.

[0083] Referring to FIG. 12, the control circuit 130 may include at least one processor 132 and at least one memory 134. The processor 132 may be communicably coupled to the memory 134. The memory 134 may be configured to store instructions that are executed by the processor 132 to perform various operations of the device 100. The device 100 may include multiple processors 132 and multiple memories 134 that are all communicably coupled together to perform operations of the impedance analyzer 104.

[0084] The user interfaces 140 may include the user interface button 126 and the display screen 124. For example, the display screen 124 may be a touch display screen that may be configured to receive touch input from the user. Additionally, the control circuit 130 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. Additionally, the control circuit 130 may transmit data to the mobile device to provide the user with a notification.

[0085] The control circuit 130 may be electrically coupled to a battery 138 and powered by the battery 138. The battery 138 may be housed within the housing 122. The battery 138 may be rechargeable. For example, the battery may last for 5 days without being charged. The impedance analyzer 104 may be designed to work for at least 60 days. 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 138. One example battery may be a Lishen sp271620sf lithium ion battery.

[0086] The control circuit 130 may be electrically coupled to the impedance electrodes 106 through the channels 128. The control circuit 130 may measure a skin impedance by delivering a current to the electrodes 106 and measuring the impedance between the electrodes 106. For example, the control circuit 130 may deliver an alternating current (AC) signal with a frequency of 10 Hz. The impedance collected may be within the range from 1 kQ to 10 MQ. Based on the impedance collected, the control circuit 130 may determine a hydration level (e.g., a number ranging from 1-10). Impedance may have an inverse relationship with skin hydration. By sensing when impedance is relatively high, the control circuit 130 may analyze the impedance to effectively determine when hydration levels are low. Alternatively, by sensing low impedance the control circuit 130 may analyze the impedance to determine when hydration levels are high.

[0087] In one aspect, the control circuit 130 may always transmit the hydration level to the display screen 124 as a notification to the user. In an alternative aspect, the hydration level notification may be transmitted to the user only if the control circuit 130 determines that the hydration level is above or below a threshold range. In any case, the control circuit 130 may also transmit the hydration level notification to a mobile device.

[0088] The threshold range may be determined based on patient history and baseline testing beforehand. For example, a physician may inform the patient what hydration levels are acceptableand what hydration levels must be immediately addressed. If the user’s hydration levels remain below the threshold range, then the chance of the user being hospitalized due to dehydration may increase. An alert in this case may provide the user with a notification that they need to drink water or some other beverage to hydrate themselves. Alternatively, if the user’s hydration levels remain above the threshold range, then the chance of hospitalization due to hypoosmotic conditions may increase. An alert in this case may notify the user that they should reduce fluid intake or use a diuretic.

[0089] The control circuit 130 may determine a hydration level for the user periodically through the day. For example, the control circuit may take an impedance measurement at a time interval throughout the day. For example, the time interval may be every 2 hours. The control circuit 130 may go into standby mode between measurements to conserve power in the battery 138. In at least one aspect, pressing the user interface button 126 may cause the control circuit to immediately take an impedance measurement as described above.

[0090] FIG. 13 provides an example electrical schematic diagram of an impedance circuit 142. Power enters the circuitry at the input voltage. In at least one aspect, the input voltage may be supplied through the control circuit 130. The power passes through the circuit 142 and exits at the output voltage nodes. Each output voltage node may be electrically coupled to an electrode 106. The impedance is measured at the skin impedance position of the circuit 142. The measured impedance is indicative of the skin impedance between the electrodes 106.

[0091] The device 100 may be used to measure or approximate water content of the user. For example, as discussed above, 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 the threshold range. The hydration alert may provide the user with an indication to hydrate or cease hydrating themselves.For example, the hydration alert may indicate to the user that they are becoming dehydrated and that they need to drink water or another beverage to hydrate. In another example, the alert may notify of overhydration and indicate a need to reduce or cease fluid intake or use a diuretic.

[0092] 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 138. The device may have a weight that is 21bs or less. The device 100 may collect impedance data through the electrodes 106 and report on hydration of the user at increments that do not allow the user to become dehydrated or overhydrated. For example, the hydration of the user may be determined at least once every 6 hours.

[0093] In another embodiment, an impedance analyzer 105 is similar to impedance analyzer 104 and may attach to the user with an adhesive. Referring to FIGS. 14-16, the impedance analyzer 105 includes the device housing 122, the display screen 124, the control circuit 130, and the user interface button 126. The device housing 122 also has a bottom surface 119 defining two channels 128. The impedance analyzer 105 functions and works the same as impedance analyzer 104 but impedance analyzer 105 does not include the bands 118, 120 of impedance analyzer 104. Without the bands 118, 120, the impedance analyzer 105 may be positioned against the electrode patch 102 and housing 122 may be maintained against the electrode patch 102 through an adhesive or any other means to attach the housing 122 to the electrode patch 102. The adhesive may be positioned between the housing 122 and the film 110 of the electrode patch 102. As such, the housing 122 may be positioned such that the electrodes 106 of the electrode patch 102 are positioned within the channels 128 of the housing 122 and the adhesive may maintain the housing 122 against the electrode patch 102. FIG. 16 illustrates the impedance analyzer 105 positioned against the electrode patch 102. The electrode patch 102 may be positioned on the skin of a user at the user’storso, abdomen, limb, etc. When the electrode patch 102 and impedance analyzer 105 both attach to the user with an adhesive, the device 100 may be attached at any location on the user. As discussed above regarding FIG. 12, the control circuit 130 of device 100 may determine a hydration level for the user periodically through the day.

[0094] In an alternative embodiment, the electrodes 106 and / or electrode patch 102 may be incorporated into an adhesive skin barrier at the interface with the stoma of a user. Referring to FIGS. 17-19, ostomy wafer 200 for an ostomy appliance is shown. The ostomy wafer 200 may include a skin barrier 206, a backing layer 208, a release liner 204, a first electrode 212, a second electrode 214, and an inlet opening 202 for receiving a stoma.

[0095] The skin barrier 206 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 electrode 212 and the second electrode 214 may be positioned within the skin barrier 206 as shown in FIG. 18. The skin barrier 206 may include skin friendly ingredients provided only on a skin contact surface 210 of the skin barrier 206. The skin friendly ingredients may include materials that protect skin, reduce skin irritation, aid healing, and / or promote skin health, such as collagen boosters.

[0096] The ostomy wafer 200 may be configured such that when the release liner 204 is removed prior to use. The skin contact surface 210 of the ostomy wafer 200 may then be attached to a user’s skin with the inlet opening 202 positioned over the user’s stoma. The ostomy wafer 200 may be attached to a pouch for a one piece ostomy pouch at the backing layer 208. Alternatively, the ostomy wafer 200 may be used to make a faceplate including a body-side coupling ring against the backing layer 208. The body-side coupling ring configured to engage a pouch-side coupling ring for a two-piece ostomy pouch system.

[0097] When the ostomy wafer 200 is attached to a user, the first electrode 212 and the second electrode 214 may be in contact with the user’s stoma. The first electrode 212 and the second electrode 214 may also contact the tissue around the user’s stoma. The first electrode 212 may contact a first section of tissue around the stoma and the second electrode 214 may contact a second section of tissue around the stoma. The first electrode 212 and the second electrode 214 may both be the same as electrodes 106 and function the same as the electrode patch 102. In one aspect, both electrodes 212, 214 (similar to electrode 106) may include the electrode paste 112, the electrode encapsulant 116 positioned against of at least a portion of the electrode paste 112, and the conductive adhesive 114 positioned against at least another portion of the electrode paste 112. The electrodes 212, 214 may be positioned in the skin barrier 206 such that the electrode paste 112 may be in contact against the tissue around the user’s stoma when the ostomy wafer 200 is attached. In an alternative aspect, the electrodes 212, 214 may also include the bottom substrate 108 and fdm 110 of the electrode patch 102. For example, both electrodes 212, 214 may include the bottom substrate 108, the film 110 position on the bottom substrate 108, the electrode paste 112 positioned on the film 110, the electrode encapsulant 116 positioned against at least a portion of the electrode paste 112, and the conductive adhesive 114 positioned against at least another portion of the electrode paste 112. The electrodes 212, 214 may be positioned in the skin barrier 206 such that the bottom substrate 108 may be in contact against the tissue around the user’s stoma when the ostomy wafer 200 is attached. The first electrode 212 and the second electrode 214 are similar to electrodes 106 and function the same as electrodes 106.

[0098] The first electrode 212 and the second electrode 214 may be electrically coupled to a control circuit such as control circuit 130. The control circuit may receive data indicative of the impedance of intestinal tissue from the first electrode 212 and the second electrode 214. Thecontrol circuit may process the impedance data to determine the hydration status of the user as discussed previously regarding FIG. 12.

[0099] In yet another alternative embodiment, the electrodes 106 and / or electrode patch 102 may be incorporated into an ostomy ring 220, which may be applied around the base of and in contact with the stoma to improve fit and prevent leakage. Referring to FIGS. 20 and 21, an ostomy ring 220 is shown. The ostomy ring 220 may include a stoma sealing material 222, a first electrode 226, a second electrode 228, skin friendly ingredients 224, and inlet opening 230 for receiving a stoma. The skin friendly ingredients 224 may be provided on outer surfaces of the stoma ring 220.

[0100] The stoma sealing material 222 may be formed from a medical grade sealing material suitable for sealing around a stoma, such as hydrocolloid adhesives and silicone adhesives. The first electrode 212 and the second GR electrode may be positioned within the stoma sealing material 222 as shown in FIG. 13. The stoma sealing material 222 may define an inlet opening 230.

[0101] When the ostomy ring 220 is attached to a user, the first electrode 226 and the second electrode 228 may be in contact with the user’s stoma. The user’s stoma inserting through the inlet opening 230. The first electrode 226 and the second electrode 228 may also contact the tissue around the user’s stoma. The first electrode 226 may contact a first section of tissue around the stoma and the second electrode 228 may contact a second section of tissue around the stoma. The first electrode 226 and the second electrode 228 may both be the same as electrodes 106 and function the same as the electrode patch 102. In one aspect, both electrodes 226, 228 (similar to electrode 106) may include the electrode paste 112, the electrode encapsulant 116 positioned against of at least a portion of the electrode paste 112, and the conductive adhesive 114 positioned against at least another portion of the electrode paste 112. The electrodes 226, 228 may bepositioned in the stoma sealing material 222 such that the electrode paste 112 may be in contact against the tissue around the user’s stoma when the ostomy ring 220 is attached. In an alternative aspect, the electrodes 226, 228 may also include the bottom substrate 108 and film 110 of the electrode patch 102. For example, both electrodes 226, 228 may include the bottom substrate 108, the film 110 position on the bottom substrate 108, the electrode paste 112 positioned on the film 110, the electrode encapsulant 116 positioned against at least a portion of the electrode paste 112, and the conductive adhesive 114 positioned against at least another portion of the electrode paste 112. The electrodes 226, 228 may be positioned in the stoma sealing material 222 such that the bottom substrate 108 may be in contact against the tissue around the user’s stoma when the ostomy ring 220 is attached. The first electrode 226 and the second electrode 228 are similar to electrodes 106 and function the same as electrodes 106.

[0102] The first electrode 226 and the second electrode 228 may be electrically coupled to a control circuit such as control circuit 130. The control circuit may receive data indicative of the impedance of intestinal tissue from the first electrode 226 and the second electrode 228. The control circuit may process the impedance data to determine the hydration status of the user as discussed previously regarding FIG. 12.

[0103] In yet another alternative embodiment, the electrodes 106 and / or electrode patch 102 may be incorporated into an intermittent catheter. Referring to FIGS. 22 and 23, the catheter 240 may include a first section 244 forming an insertable end of the catheter, a second section 246 forming a handle of the catheter 240, a first electrode 250, and a second electrode 252. The first and second sections 244, 246 may have different shapes corresponding to their intended use. The first section 244 may be oblong and define an inlet opening 242 for draining urine from the bladder. The second section 246 may define an outlet opening 248. The draining may occur through aninternal conduit extending through both sections 244, 246 of the catheter 240. The internal conduit may connect the inlet opening 242 with the outlet opening 248. The first section 244 may have a diameter that is smaller than the second section 246.

[0104] The first electrode 250 and the second electrode 252 may both be positioned on an external surface 254 of the first section 244 of the catheter 240. When the catheter 240 is inserted into the user to drain the user’s bladder, the first electrode 250 and the second electrode 252 may contact urethral tissue of the user. The first electrode 250 may contact a first section of urethral tissue and the second electrode 252 may contact a second section of urethral tissue. The first electrode 250 and the second electrode 252 may both be the same as electrodes 106 and function the same as the electrode patch 102. In one aspect, both electrodes 250, 252 (similar to electrode 106) may include the electrode paste 112, the electrode encapsulant 116 positioned against of at least a portion of the electrode paste 112, and the conductive adhesive 114 positioned against at least another portion of the electrode paste 112. The electrodes 250, 252 may be positioned on the external surface 254 such that the electrode paste 112 may be in contact against the urethral tissue when the catheter 240 is inserted. In an alternative aspect, the electrodes 250, 252 may also include the bottom substrate 108 and film 110 of the electrode patch 102. For example, both electrodes 250, 252 may include the bottom substrate 108, the film 110 position on the bottom substrate 108, the electrode paste 112 positioned on the film 110, the electrode encapsulant 116 positioned against at least a portion of the electrode paste 112, and the conductive adhesive 114 positioned against at least another portion of the electrode paste 112. The electrodes 250, 252 may be positioned on the external surface 254 such that the bottom substrate 108 may be in contact against the urethral tissue when the catheter 240 is inserted. The first electrode 226 and the second electrode 228 are similar to electrodes 106 and function the same as electrodes 106.

[0105] The first electrode 250 and the second electrode 252 may be electrically coupled to a control circuit such as control circuit 130. For example, an electrical wire / connection may run the length of the catheter to connect to the control circuit 130. The control circuit may receive data indicative of the impedance of urethral tissue. The control circuit may process the impedance data to determine the hydration status of the user as discussed previously regarding FIG. 12.

[0106] In another embodiment, a device with Bioimpedance Spectroscopy (BIS) may be used to monitor the hydration level of ostomates and intermittent catheter users. BIS is a method of determining body water and fat composition by introducing the body to varying sinusoidal signal frequencies, and reading how the body attenuates the signal due to the natural impedance of the body. A BIS sensor may be configured to detect changes in how the body attenuates varying sinusoidal signal frequencies to determine overall hydration of the user. Incorporating data from BIS sensors into wearable devices may provide ostomates and intermittent catheter users with personalized hydration alerts.

[0107] BIS may rely on two models to determine fat / muscle composition of the body. For example, Cole’s BIS model that provides an electrical representation of the body based on the body having resistive, capacitive, and inductive properties. Hanai’s BIS Model has further developed Cole’s BIS model, stating that there are non-conductive components within the body that Cole’s BIS model lacks. Thus, the Hanai’s BIS Model includes an iteration of Cole’s BIS model, but accounts for these non-conductive components. BIS devices can utilize these two models, and may be used for measuring fat / muscle composition of the body.

[0108] Referring to FIGS. 24-28, a device 154 with BIS may be used to determine a hydration level of a user. For example, BIS may be used to determine the relative loss or gain of water from the body by measuring the change in internal impedance when subjected to sinusoidalsignals ranging from 1-100 kHz. By placing multiple electrodes on the users for example at the wrists, the ankles, the torso and / or the abdomen, signals can be input into the body while also measuring how the internal impedance attenuates certain frequencies due to internal structures and water saturation. For example, the signals may be input into the body at the wrists and those same signals may be read out at the ankles. How the signals attenuate through the body based on the frequency may be compared with a model of hydration based on the BMI and bioimpedance data to determine a hydration level of the user.

[0109] The device 154 may comprise at least two electrode assemblies 146. For example, there may be an electrode assembly 146 on two of the users limbs 144 or there may be an electrode assembly 146 on all four of the users limbs 144. Each electrode assembly 146 may comprise a base 150 and an electrode 148. The electrodes 148 may be titanium electrodes. The base 150 may be configured to house the electrodes 148 and maintain the electrodes 148 against the skin of the user. In some aspects, the base 150 may be a band that is applied to the user by wrapping around the user’s limb 144 and mechanically couple to itself or the band may be elastic and stretch around the user’s limb 144. In some alternative aspects, the base 150 may be a patch with an adhesive that maintains the base 150 against the skin of the user. For example, the adhesive may hold the electrode assembly 146 against the skin of the user with the electrode 148 positioned against the user’s skin. In either case, the base 150 may maintain the electrodes 148 against the skin of the user.

[0110] The device 154 may have different combinations of electrode assemblies 146 with the electrode assemblies 146 positioned at different locations on the user. For example, the electrode assemblies 146 may be positioned on the user’s limbs, toro, abdomen, etc. At least two electrode assemblies 146 are needed but more may be used. FIG. 24 illustrates the device 154having four electrode assembles 146 being used with one positioned on each limb. Each of these assemblies 146 has a base 150 that is a band that wraps around the user’s limb. FIG. 25 illustrates the device 154 having four electrode assembles 146 with one positioned on the user’s torso, one positioned on the user’s wrist, one positioned at the user’s ankle, and the last positioned on the user’s leg. The electrode assembles 146 positioned on the leg and torse have bases 150 that are patches that attach to the user with an adhesive. The electrode assembles 146 positioned on wrist and ankle have bases 150 that are a band that wrap around the user’s limb. FIG. 26 illustrates the device 154 having two electrode assembles 146 with one positioned on the user’s torso and the one positioned on the user’s leg. These electrode assembles 146 may have bases 150 that are patches that attach to the user with an adhesive.

[0111] In any configuration of the device 154, the electrodes 148 may all be electrically coupled to a control circuit 156. In one aspect, the electrodes 148 may be wired to the control circuit 156. For example, referring to FIGS. 24-26, the electrode assemblies 146 may be wired to the control circuit 156 housed within the housing 152. The wires 155 connect the electrodes 148 of the electrode assemblies 146 to the control circuit 156. In an alternative aspect, each electrode assembly 146 may include a control circuit and a battery. Each of these control circuits may be communicable coupled to each other wirelessly (e.g., Bluetooth).

[0112] Referring to FIG. 27, the control circuit 156 may include at least one processor 158 and at least one memory 160. The processor 158 may be communicably coupled to the memory 160. The memory 160 may be configured to store instructions that are executed by the processor 158 to perform various operations of the device 154. The device 154 may include multiple processors 158 and multiple memories 160 that are all communicably coupled together to perform operations of the device 154.

[0113] The control circuit 156 may be electrically coupled to a battery 162 and powered by the battery 162. The battery 162 may be housed within the housing 152. The battery 162 may be rechargeable. For example, the battery may last for 5 days without being charged. The device 154 may be designed to work for at least 60 days. The device 154 may incorporate a sleep mode or standby mode to conserve power when not in active use to minimize recharging of the battery 162.

[0114] The control circuit 156 may measure a user’s hydration by transmitting an electrical signal to the electrodes 148 at one electrode assembly 146 and measuring the signal attenuation of the signals between 1 Hz to 1 MHz through the electrodes 148 of another electrode assembly 146. If there are two electrode assemblies 146 being used, then the signal may be input at a first position on the user (e.g., wrist, ankle, torso, etc.) and read out at a second position on the user (e.g., wrist, ankle, torso, etc.). If there are four electrode assemblies 146 being used, then the signals may be input at two locations on the user (e.g., wrist, ankle, torso, etc.) and read out at two different locations on the user (e.g., wrist, ankle, torso, etc.). This process allows the signals to be read out after they passed through the body. The signal attenuation may be calculated by comparing the signal input to the signal read out at the different location.

[0115] The signal attenuation over frequency may be used to determine an internal hydration of the user. For example, the signal attenuation based on frequency data may be used with a model to determine an internal hydration. The model may be Cole’s BIS model, Hanai’s BIS Model, or another model of hydration based on the BMI and bioimpedance data (e.g., a linear regression model). The internal hydration may be used to determine a hydration level for the user.

[0116] The control circuit 156 may transmit a notification or alert to a user if the hydration level is below a threshold range. The hydration alert may provide the user with an indication tohydrate themselves or decrease or cease hydrating themselves. Ifthe user’s hydration levels remain below the threshold range, then the chance of the user being hospitalized due to dehydration may increase. The alert in this case may provide the user a notification that they need to drink water or some other beverage to hydrate themselves. Alternatively, if the user’s hydration levels remain above the threshold range, then the chance of hospitalization may increase. The alert in this case may provide the user an indication to decrease or cease drinking fluids and / or use a diuretic to decrease hydration levels. The control circuit 156 may transmit the notification to a mobile device of the user. In an alternative aspect, the device 154 may include a display screen and the control circuit 156 may transmit the notification to the display screen.

[0117] The device 154 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 162. The device 154 may collect signal attenuation based on frequency data through the electrodes 148 and report on hydration of the user at increments that do not allow the user to become dehydrated or overhydrated. For example, the hydration of the user may be determined at least once every 6 hours.

[0118] FIG. 28 provides an example electrical schematic diagram 164 for the device 154. In at least one aspect, the input voltages into the diagram 164 may be supplied through the control circuit 156. As shown in the diagram 164, the signals are input into one electrode assembly 146 and read out at another electrode assembly 146. This allows the signals to pass through the user’s body. The signals attenuate as they pass through the body. The attenuation of the signals based on the signal frequency may be used as described above to determine a hydration status of the user.

[0119] In an alternative embodiment, one of the electrodes 148 of the device 154 may be incorporated into an adhesive skin barrier at the interface with the stoma of a user. Referring toFIGS. 29-31, ostomy wafer 300 for an ostomy appliance is shown. The ostomy wafer 300 may include a skin barrier 306, a backing layer 308, a release liner 304, an electrode 312, and an inlet opening 302 for receiving a stoma.

[0120] The skin barrier 306 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 electrode 312 may be positioned within the skin barrier 306 as shown in FIG. 30. The skin barrier 306 may include skin friendly ingredients provided only on a skin contact surface 310 of the skin barrier 306. The skin friendly ingredients may include materials that protect skin, reduce skin irritation, aid healing, and / or promote skin health, such as collagen boosters.

[0121] The ostomy wafer 300 may be configured such that when the release liner 304 is removed prior to use. The skin contact surface 310 of the ostomy wafer 300 may then be attached to a user’s skin with the inlet opening 302 positioned over the user’s stoma. The ostomy wafer 300 may be attached to a pouch for a one piece ostomy pouch at the backing layer 308. Alternatively, the ostomy wafer 300 may be used to make a faceplate including a body-side coupling ring against the backing layer 308. The body-side coupling ring configured to engage a pouch-side coupling ring for a two-piece ostomy pouch system.

[0122] When the ostomy wafer 300 is attached to a user, the electrode 312 may be in contact with the user’s stoma. The electrode 312 may also contact the tissue around the user’s stoma. The electrode 312 may be electrically coupled to control circuit 156. The electrode 312 may be a titanium electrode. The electrode 312 may be used as one of the electrodes 148 of the device 154. For example, the electrode 312 may be used to input the signal from the control circuit 156 or read out the signal and transmit it to the control circuit 156. The electrode 312 may be usedby the control circuit to input the signal at the stoma location or the electrode 312 may be used to read out the signal input at a different location on the user. As discussed above, the signal attenuation over frequency may be used to determine an internal hydration of the user.

[0123] FIG. 31 illustrates the electrode 312 surrounding a portion of the inlet opening 302. In an alternative embodiment, the electrode 312 may fully surround the inlet opening 302.

[0124] In yet another alternative embodiment, one of the electrodes 148 of the device 154 may be incorporated into an ostomy ring 320, which may be applied around the base of and in contact with the stoma to improve fit and prevent leakage. Referring to FIGS. 32 and 33, an ostomy ring 320 is shown. The ostomy ring 320 may include a stoma sealing material 322, an electrode 326, skin friendly ingredients 324, and inlet opening 330 for receiving a stoma. The skin friendly ingredients 324 may be provided on outer surfaces of the stoma ring 320.

[0125] The stoma sealing material 322 may be formed from a medical grade sealing material suitable for sealing around a stoma, such as hydrocolloid adhesives and silicone adhesives. The electrode 312 may be positioned within the stoma sealing material 322 as shown in FIG. 33. The stoma sealing material 322 may define an inlet opening 330.

[0126] When the ostomy ring 320 is attached to a user, the electrode 326 may be in contact with the user’s stoma. The user’s stoma inserting through the inlet opening 230. The electrode 326 may also contact the tissue around the user’s stoma. The electrode 326 may be electrically coupled to control circuit 156. The electrode 326 may be a titanium electrode. The electrode 326 may be used as one of the electrodes 148 of the device 154. For example, the electrode 326 may be used to input the signal from the control circuit 156 or read out the signal and transmit it to the control circuit 156. The electrode 326 may be used by the control circuit to input the signal at the stoma location or the electrode 326 may be used to read out the signal input at a different location on theuser. As discussed above, the signal attenuation over frequency may be used to determine an internal hydration of the user.

[0127] FIG. 32 illustrates the electrode 326 surrounding a portion of the inlet opening 302. In an alternative embodiment, the electrode 326 may fully surround the inlet opening 302.

[0128] In yet another alternative embodiment, one of the electrodes 148 of the device 154 may be incorporated into an intermittent catheter. Referring to FIGS. 34 and 35, the catheter 340 may include a first section 344 forming an insertable end of the catheter, a second section 346 forming a handle of the catheter 340, and an electrode 350. The first and second sections 344, 346 may have different shapes corresponding to their intended use. The first section 344 may be oblong and define an inlet opening 342 for draining urine from the bladder. The second section 346 may define an outlet opening 348. The draining may occur through an internal conduit extending through both sections 344, 346 of the catheter 340. The internal conduit may connect the inlet opening 342 with the outlet opening 348. The first section 344 may have a diameter that is smaller than the second section 346.

[0129] The electrode 350 may be positioned on an external surface 354 of the first section 344 of the catheter 340. When the catheter 340 is inserted into the user to drain the user’s bladder, the first electrode 350 may contact urethral tissue of the user. The electrode 350 may be electrically coupled to control circuit 156. The electrode 350 may be a titanium electrode. The electrode 350 may be used as one of the electrodes 148 of the device 154. For example, the electrode 350 may be used to input the signal from the control circuit 156 or read out the signal and transmit it to the control circuit 156. The electrode 350 may be used by the control circuit to input the signal at the stoma location or the electrode 350 may be used to read out the signal input at a different location on the user. As discussed above, the signal attenuation over frequency may be used to determinean internal hydration of the user.

[0130] 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.

[0131] 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).

[0132] 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

CLAIMSWhat is claimed is:

1. A device for detecting a hydration status of a user, the device comprising: an electrode patch configured to be positioned on a user, the electrode patch comprising: a substrate comprising a first side positioned against the user and a second side opposite the first side; a first electrode positioned on the second side of the substrate; and a second electrode positioned on the second side of the substrate; an impedance analyzer configured to engage with the electrode patch, the impedance analyzer comprising a control circuit electrically coupled to the first electrode and the second electrode when the impedance analyzer is engaged with the electrode patch, the control circuit including a processor and a memory, the memory storing instructions executed by the processor to: transmit an electrical signal to the first electrode and the second electrode; determine an impedance between the first electrode and the second electrode while transmitting the electrical signal; determine a hydration level based on the impedance; compare the hydration level to a threshold range; transmit a notification based on the hydration level being less or more than the threshold range.

2. The device of claim 1, wherein the impedance analyzer is configured to be positioned over the electrode patch to engage with the electrode patch and further comprises:a housing defining two channels, wherein when the impedance analyzer is positioned over the electrode patch, the first electrode and second electrode are positioned within the two channels, and wherein the housing encloses the control circuit.

3. The device of claim 2, wherein the impedance analyzer further comprises a display mounted to the housing, wherein the memory stores further instructions executed by the processor to display the notification on the display screen.

4. The device of any one of claims 2-3, wherein the impedance analyzer further comprises a user interface button mounted to the housing, and wherein the user interface button is configured to allow the user to provide input to the control circuit.

5. The device of any one of claims 2-5, wherein the impedance analyzer further comprises a band attached to the housing, wherein the band is configured to maintain the housing against the user.

6. The device of any one of claims 2-4, wherein an adhesive is attached to the housing of the impedance analyzer, wherein the adhesive is configured to maintain the housing against the user.

7. The device of any one of claims 1-6, wherein the notification includes an alert and instructions for a user to drink or not drink water and / or other beverages.

8. The device of any one of claims 1-7, wherein the control circuit is electrically coupled to the first electrode and the second electrode through the two channels.

9. A device for detecting a hydration status of a user, the device comprising: a first impedance electrode positioned against a first section of tissue of the user; a second impedance electrode positioned against a second section of tissue of the user; a control circuit electrically coupled to the first impedance electrode and the second impedance electrode, the control circuit including a processor and a memory, the memory storing instructions executed by the processor to: transmit an electrical signal to the first impedance electrode and the second impedance electrode; determine an impedance between the first impedance electrode and the second impedance electrode while transmitting the electrical signal; determine a hydration level based on the impedance; compare the hydration level to a threshold range; transmit a notification based on the hydration level being less or more than the threshold range.

10. The device of claim 9, wherein the tissue comprises a section of intestinal tissue at a stoma of the user.

11. The device of claim 10, wherein the first impedance electrode and second impedance electrode are attached to an ostomy ring such that the first impedance electrode and second impedance electrode are in contact with user’s stoma when the ostomy ring is attached to a user.

12. The device of claim 10, wherein the first impedance electrode and second impedance electrode are attached to an ostomy skin barrier such that the first impedance electrode and second impedance electrode are in contact with user’s stoma when the ostomy skin barrier is attached to a user.

13. The device of claims 9, wherein the tissue comprises a section of urethral tissue of the user.

14. The device of any one of claims 9-13, wherein the notification includes an alert and instructions for a user to drink or not drink water and / or other beverages.

15. A device for detecting a hydration status of a user, the device comprising: a first electrode assembly positioned at a first position on the user, the first electrode assembly comprising: a first electrode position against the user; and a first base housing the first electrode, wherein the first electrode extends away from the first base to contact the user; a second electrode assembly positioned at a second position on the user, the second electrode assembly comprising: a second electrode position against the user; and a second base housing the second electrode, wherein the second electrode extends away from the second base to contact the user; anda control circuit electrically coupled to the first electrode and the second electrode, the control circuit including a processor and a memory, the memory storing instructions executed by the processor to: transmit a plurality of electrical signals with differing frequencies to the first electrode; receive the plurality of electrical signals from the second electrode after the plurality of electrical signals has passed through the user’s body; determine an attenuation of a plurality of electrical signals based on the transmitted signal and the received signal; determine a hydration level of the user based on the attenuation of the plurality of electrical signals based on the frequencies of the signals; compare the hydration level to a threshold range; and transmit a notification based on the hydration level being less or more than the threshold range.

16. The device of claim 15, wherein the notification includes an alert and instructions for a user to drink or not drink water and / or other beverages.

17. The device of any one of claims 15 or 16, wherein the first electrode assembly is positioned on a first limb of the user, and wherein the second electrode assembly is positioned on a second limb of the user.

18. The device of any one of claims 15-17, further comprising:a third electrode assembly positioned at a third position on the user, the third electrode assembly comprising: a third electrode position against the user; and a third base housing the third electrode, wherein the third electrode extends away from the third base to contact the user; a fourth electrode assembly positioned at a fourth position on the user, the fourth electrode assembly comprising: a fourth electrode position against the user; and a fourth base housing the fourth electrode, wherein the fourth electrode extends away from the fourth base to contact the user; and wherein the memory further storing instructions executed by the processor to: transmit a plurality of electrical signals with differing frequencies to the first electrode and the third electrode; receive the plurality of electrical signals from the second electrode and the fourth electrode after the plurality of electrical signals has passed through the user’s body.

19. The device of claim 18, wherein the first electrode assembly is positioned on a first arm of the user, wherein the third electrode assembly is positioned on a second arm of the user, wherein the second electrode assembly is positioned on a first leg of the user, and wherein the fourth electrode assembly is positioned on a second leg of the user.

20. The device of claim 18, wherein the third electrode assembly is positioned on a torso of the user, the first electrode assembly is positioned on an arm of the user, the second electrodeassembly is positioned on a first leg of the user, and the fourth electrode assembly is positioned on a second leg of the user.

21. The device of any one of claims 15-20, wherein the first electrode assembly is positioned on an arm of the user and the second electrode assembly is positioned on a leg of the user.

22. The device of any one of claims 15, 16, and 18, wherein the first electrode assembly is positioned on a torso of the user and the second electrode assembly is positioned on a leg of the user.

23. The device of any one of claims 15, 16, and 18, wherein the first electrode assembly is positioned on a torso of the user and the second electrode assembly is positioned on an arm of the user.

24. The device of any one of claims 15, 16, and 18, wherein the first electrode assembly is positioned at a stoma of the user with the first electrode in contact with intestinal tissue and the second electrode assembly is positioned on a torso of the user.

25. The device of claim 24, wherein the first electrode is attached to an ostomy ring such that the first electrode is in contact with user’s stoma when the ostomy ring is attached to a user.

26. The device of claim 24, wherein the first electrode is attached to an ostomy skin barrier such that the first electrode is in contact with user’s stoma when the ostomy skin barrier is attached to a user.

27. The device of any one of claims 15, 16, and 18, wherein the first electrode assembly is positioned on an arm of the user and the second electrode assembly is positioned at a stoma of the user.

28. The device of any one of claims 15, 16, and 18, wherein the first electrode is configured to be in contact with urethral tissue of the user and the second electrode assembly is positioned on a torso of the user.

29. The device of any one of claims 15, 16, and 18, wherein the second electrode is configured to be in contact with urethral tissue of the user and the first electrode assembly is positioned on a torso of the user.

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