Paper microfluidic wearable screen printed biosensor for sweat analysis

Abstract

An apparatus, system, and method for providing a moisture supplementation detection device. The moisture replenishment detection device includes: a flexible substrate having a circuit screen-printed therein, the circuit including a plurality of conductive ink layers and a dielectric ink layer; a sensor on the flexible substrate, wherein the sensor is capable of detecting element data indicative of a characteristic of sweat; an untreated chromatographic paper placed in contact with the skin of the user and capable of wicking sweat from the skin to the sensor along the micro-sized fluid channel; and a Bluetooth antenna on the flexible substrate and in communication with the sensor, and capable of wirelessly communicating the element data to an application capable of indicating to the user the user the suitability of moisture replenishment based on the element data.

Description

Cross Reference to Related Applications

[0001] This application claims priority to U.S. Provisional Patent Application Serial No. 63 / 521,621, filed June 16, 2023, entitled “Paper Microfluidic Wearable Screen Printed Biosensor for Sweat Analysis,” the contents of which are incorporated by reference in their entirety. TECHNICAL FIELD

[0002] The present disclosure relates generally to wearable devices, and more particularly to apparatuses, systems, and methods providing a paper microfluidic wearable screen printed biosensor for sweat analysis. BACKGROUND

[0003] Dehydration is a condition that is highly likely to be successfully treated if detected early. Recently, there has been an increasing interest in analyzing sweat to understand human health, particularly hydration levels.

[0004] Young children suffering from water and sodium imbalance due to nausea, as well as older adults 55 years and above and those who can suffer from comorbidities, are most susceptible to dehydration. Traditional treatments include the use of oral rehydration solutions (ORS), saline, or glucose infusions in severe cases. The most common conditions in which dehydration occurs are heat stroke and electrolyte imbalance.

[0005] The monitoring of electrolyte imbalance is most applicable to the condition of dehydration. Dehydration is a condition caused by the loss of water or salt in the body. It has several potential causes, including illness, the effects of medication, heat exposure, and physical activity. Unless exposed to illness, it is not possible for an adult to become dehydrated for an extended period. Chronic dehydration is more common in the older adult population.

[0006] Dehydration is a condition that can significantly affect the body’s organs depending on the severity. Up to 60% of the human body is composed of water. The brain and heart are composed of 73% water, and the lungs are approximately 83% water. The skin also contains approximately 64% water, while muscles and kidneys are composed of 79% water.

[0007] The primary uses of water by the body are to regulate temperature, maintain overall homeostasis, and normal functioning of organs. For the kidneys, water helps keep blood vessels open for blood transport, which is important for the efficient transfer of nutrients throughout the body. Water is also used by the kidneys to expel waste from the blood. If an individual is dehydrated, the kidneys cannot perform this function, which leads to the accumulation of waste and the formation of kidney stones.

[0008] The heart is also primarily affected by dehydration. Under normal circumstances, blood flow is regular, which helps to keep the heart rate normal. However, if water levels drop, blood circulation is slower and the heart tries to compensate by beating faster.

[0009] Conversely, water also helps exocrine and apocrine glands to expel waste in the form of sweat. Sweat is a mixture of 99% water and 1% chemicals, so water replenishment is critical for the body to be able to produce sweat to excrete toxins.

[0010] Homeostatic mechanisms maintain approximately 66% of the intracellular water content and 33% of the extracellular water content, of which 20% is intravascular. Plasma oncotic processes maintain a stable blood volume in the body, which can easily be disturbed by fluctuations in water, as plasma constitutes 55% of the blood content and itself is composed of approximately 90% water.

[0011] Generally, water homeostasis is regulated by osmoreceptors in the brain. These receptors sense a state of dehydration, which usually stimulates the hypothalamus to produce a sensation of thirst, increasing water intake and correcting the abnormality. If water is not consumed, the hypothalamus can induce the posterior pituitary to release antidiuretic hormone (ADH), prompting the kidneys to reabsorb more water. This process is induced by a drop in blood pressure, which triggers the secretion of renin from the kidneys; renin is converted to angiotensin I, which is then converted to angiotensin II, increasing the release of aldosterone from the adrenal glands, which enhances the kidneys' absorption of sodium and water. Using these methods, the body volume, sodium, and water concentrations are maintained.

[0012] Both fluid replacement deficiency and over-replacement can be problematic. Insufficient perfusion of vital organs and the increased workload of the kidneys to retain fluid can lead to altered mental status, kidney failure, liver shock, lactic acidosis, hypotension, and even death - with organ failure. Conditions related to fluid and electrolyte imbalances can also arise, including: uremia, hyponatremia, hypochloremia, hypokalemia, hyperkalemia, metabolic acidosis, and metabolic alkalosis.

[0013] Electrolyte balance, such as that of sodium and potassium, can easily be disturbed by hyperperfusion or hypoperfusion, leading to seizures and any number of electrical or biochemical abnormalities due to the role these ions play in maintaining the intracellular and extracellular environment. Excessive fluid replacement can lead to peripheral and pulmonary edema, and in the most mismanaged cases of severe hyponatremia, to central pontine myelinolysis (CPM). CPM is a neurological disorder characterized by the demyelination of nerve cells in the pons, leading to many mental and behavioral changes and various movement disorders, such as mutism, Parkinsonism, dystonia, and catatonia.

[0014] Patients who experience dehydration have a higher risk of mortality. Dehydration in elderly patients often causes confusion and aggression, especially if they are also diagnosed with dementia. Severe dehydration cases lead to psychosis, delirium, and unconsciousness.

[0015] Dehydration can also cause sunken eyes, dry mouth, tachycardia, headaches, lethargy, and dizziness. Dehydration is difficult to diagnose due to overlapping symptoms with other conditions, especially in the elderly. Dehydration can be biochemically identified by testing the ratio of plasma urea to creatine or serum osmolarity. Without laboratory testing, dehydration can be identified by skin turgor testing, tachycardia, dry mouth, urine color, and physical tests such as balance testing.

[0016] The most common outcome experienced by patients due to dehydration is health recovery, as the disease can be cured very simply and safely by introducing fluids into the body and restoring the blood's water and electrolyte content. In terms of negative outcomes, acute kidney injury occurs in a small percentage of dehydrated patients. Additionally, mortality rates can be elevated in elderly hospitalized adults.

[0017] Patients who receive a diagnosis of dehydration during a hospital stay are more likely to die in the hospital, independent of any external factors. The accompanying diagnosis of dehydration, combined with a primary diagnosis that spans multiple diseases, is associated with a significantly higher mortality rate within 30 days to one year. Acute kidney injury (AKI) has a 10-12% mortality rate, with dehydration being an important risk factor. In one study, dehydration was found to be the cause of 46% of AKI cases.

[0018] Furthermore, dehydration after a stroke event can lead to venous thromboembolism and systemic thrombosis. Delirium is another possible outcome, as dehydration is found in 66% of delirium patients. Heart failure and other serious diseases, such as kidney failure, are also possible outcomes, although these conditions often involve dehydration, but this is only a secondary factor.

[0019] Dehydration places a significant economic burden not only on patients, but also on the health industry as a whole. While dehydration is one of the most common preventable diagnoses, it remains a root cause of many hospital admittances. The Agency for Healthcare Research and Quality (AHRQ) estimates that dehydration costs approximately $1.6 billion in hospitalization expenses within a one-year time frame.

[0020] Hospitalization expenses are associated with two main expenditures, clinical expenses and hospitalization expenses. Clinical expenses depend largely on the utilization of resources, which can be a significant expense in some cases due to the many clinical conditions that can result from dehydration. This also affects longer hospital stays, which unfortunately increase overall hospitalization expenses due to long-term use of room and board.

[0021] With proper preventative treatment and outpatient care, dehydration- induced hospitalization and readmission can be significantly reduced. According to the AHRQ, nearly one in ten of the approximately 40 million hospitalizations in 2008 could have been avoided. It has also been calculated that by avoiding dehydration through specific preventative measures or post-operative care measures, the health care industry could save up to $1 billion or more. Dehydration, while an easily avoidable ailment, can lead to more catastrophic illnesses and injuries. For example, the National Pressure Ulcer Long-Term Care Study found that "dehydration increased the risk of pressure ulcers in nursing home residents by 42%, and the cost of treating pressure ulcers (also known as bedsores) in the United States (US) is estimated at $1.3 billion annually."

[0022] Therefore, the best approach to treating and managing dehydration is prevention. Many preventative solutions have been introduced to the market, including hydration monitoring devices. For example, sweat patches use a channel within the patch to receive sweat and a colorimetric sensor to monitor the sweat content. Users are typically required to perform strenuous exercise to provide sweat to the channel. However, the patch is typically placed on a body part that produces minimal sweat, so the channel is often not filled with sweat.

[0023] Candy-like jelly drops can contain 95% water and electrolytes to supplement hydration. However, since these jelly drops are often used for elderly patients with mental acuity issues, or for infants, it is the responsibility of the caregiver to provide the jelly drops in a timely manner when necessary to avoid dehydration.

[0024] Prevention can also be as simple as drinking water or electrolyte-rich beverages. However, for the most at-risk populations, this solution still relies on a caregiver to monitor water and electrolyte intake and supplement necessary hydration in a timely manner when necessary.

[0025] Once dehydration has occurred, hydration therapy becomes necessary. For mild dehydration, the primary treatment mechanism is Oral Rehydration Therapy (ORT), where the patient consumes fluids, such as water or broth. Healthcare providers instruct the patient to drink small amounts frequently to avoid vomiting, and a nasogastric tube can be used to control the intake. Therefore, these scenarios typically occur in a medical setting, such as a clinic or hospital, and some medical expertise is required to guide the patient or set up the nasogastric feeding.

[0026] In cases of severe dehydration or hypovolemic shock, typical treatment includes various percutaneous treatments via IV rehydration, ranging from simple saline solutions to specialized solutions (e.g., Lactated Ringer's IV fluid). In cases of dehydration, especially those cases where dehydration is caused by illness, it is critical to balance the patient's fluid intake with the fluid lost by vomiting or diarrhea. Such scenarios require a high degree of medical expertise to safely set up an IV, and often occur in a hospital setting, where the patient is typically closely monitored during the rehydration process.

[0027] While diagnostic solutions do not directly treat dehydration, such solutions play a fundamental role in identifying and guiding the development of optimal treatment plans by providing an assessment of the severity of dehydration. Diagnostic solutions for individuals experiencing dehydration come in several different forms. The most common diagnostic method is through an assessment by a physician, who performs a physical examination, often including a check of blood pressure and heart rate. However, abnormal blood pressure levels and heart rates can be associated with a variety of unrelated illnesses, so it is necessary to assess other aspects of the individual's physical condition, including their level of consciousness, the degree of eye sunkeness, and the secretion of tears and urine. In severe cases, laboratory tests must be performed to identify electrolyte imbalances and determine kidney function.

[0028] These measures are typically determined through the administration of a basic metabolic panel (BMP), a urine analysis, or a blood test to analyze electrolyte concentrations such as sodium and potassium. BMP tests cost approximately $235. Urine analysis tests typically cost in the range of $30 to $250. Electrolyte analysis in a blood test can cost up to $40. These prices are primarily determined by the depth of analysis and the location of sample analysis. For example, if the test is completed in an emergency room, clinic, or laboratory, the price is typically lower than in a hospital.

[0029] Dehydration can also be detected by testing for skin turgor, which involves pinching the skin of an individual and observing whether it returns to its normal state. If the skin does not spring back, it indicates that the individual is dehydrated, as the lack of water causes the skin to lose elasticity.

[0030] An uncommon diagnostic method uses wearable sensors to monitor and detect dehydration. While this type of device monitoring is more beneficial for preventing dehydration, this solution can also be used for dehydration diagnosis.

[0031] Behavioral and lifestyle changes to prevent the onset of dehydration must be implemented by the individual outside of a clinical setting. Drinking an adequate amount of water is the most important preventative measure an individual can take to prevent dehydration. The Mayo Clinic recommends that individuals drink 3.7 liters of water for men and 2.7 liters of water for women. Drinking additional fluids to replace fluids lost due to exercise, vomiting, and diarrhea is another important component of maintaining hydration in daily life.

[0032] For young children who are unable to self-monitor fluid replacement, they should be encouraged to drink water. In the case of illness, the child should be hospitalized for clinical treatment. Nursing staff or nursing home staff should encourage the elderly to take enough fluid, as they are often accompanied by conditions that can lead to dehydration.

[0033] The main gap between the expected results and the results achieved by existing solutions is in preventive measures. The main goal solution is to monitor fluid replacement levels on a large scale in a portable, non-invasive way to prevent dehydration from worsening in adolescents, the elderly, or athletes. Athletes, especially endurance athletes who exercise for long periods of time, can also use a fluid replacement monitor while exercising. Monitoring fluid replacement in this way to prevent dehydration from worsening to the point of requiring IV fluids and hospital intervention will help produce more positive health outcomes and will reduce health care costs.

[0034] However, most of the available monitoring devices are designed for specific targets, such as athletes, adolescents, or the elderly, mainly because these groups are more prone to dehydration. In addition, the main problem that arises with dehydration in adolescents and the elderly is their reduced ability to use monitoring devices and / or self-rehydrate.

[0035] Among all the stakeholders, patients are the group that has the most at stake in clinical outcomes, as it is their health and body that is affected by the condition. Therefore, eliminating the symptoms of dehydration is of immediate interest to patients, as the severe complications of severe dehydration include organ failure, coma, and even death. Patients can seek preventive measures to prevent severe complications due to fear of these outcomes.

[0036] However, if severe complications do develop, the cost to the patient is quite substantial. For example, in cases where dehydration progresses to the point of causing kidney failure, the estimated cost of treatment is $23,700 per person. For some individuals, severe dehydration triggers brain edema, which can place a significant financial burden on the patient due to the resources necessary for surgical treatment in a hospital.

[0037] Doctors and other medical professionals involved in patient care have a direct interest in clinical outcomes, as their primary goal is to cure the patient. Therefore, they will choose the treatment that is most effective for the patient's needs. Of course, this can lead to the choice of a more expensive treatment, which can significantly impact the patient's financial well-being after treatment, even if the physical illness has been cured. For example, in 1996, it was reported that the treatment of elderly patients hospitalized for dehydration and other diseases caused by it cost $1.36 billion.

[0038] In the U.S. healthcare delivery process, insurance companies are often the primary financial stakeholders, but insurance companies have the least direct interest in the clinical outcomes of patients. For patients with federal Medicare or federal-state Medicaid, the insurance stakeholder is the U.S. government. The primary interest of insurance companies in dehydration treatment is to reduce the cost of care. Additionally, insurance companies consider the safety of a treatment - i.e., whether there is a risk of more expensive complications. Insurance companies thus often favor treatment regimens that are just convenient for patients, caregivers, or physicians, simply because they are easy to implement and inexpensive, making them a solution that is agreeable to all parties.

[0039] Insurance companies bear a large economic burden from dehydration, especially in severe cases where dehydration progresses to critical conditions. For these cases, most patients require hospital care, with an average hospitalization cost of approximately $11,700 under federal Medicare, and other insurance can result in bills of up to $12,600.

[0040] When dehydration cases exceed mild levels, subsequent treatment regimens vary depending on the severity of the illness, and also depend on the individual's wait time for an appointment. In some cases, severe and untreated dehydration can lead to more complex problems, such as kidney failure. When the condition extends to this degree, the individual must seek direct treatment by a nephrologist. Individuals with kidney failure can survive for up to several years without dialysis, however, the exact time frame varies depending on the stage of the individual's kidney failure. In most cases, kidney failure is not curable, but symptoms can be alleviated with appropriate treatment. Dialysis can alleviate some symptoms, but only for so many times until a transplant must be performed.

[0041] Another condition that can be caused by untreated dehydration is hypovolemic shock. This is a life-threatening condition that manifests as a severe depletion of blood volume, and the heart reduces the flow of blood through the body. In cases where an individual is in a state of hypovolemic shock, direct medical intervention by a physician is required, who will administer intravenous crystalloid fluids, red blood cell transfusions, platelet transfusions, or plasma transfusions. Emergency treatment continues until the patient is out of shock and stable again.

[0042] Dehydration can also cause and exacerbate existing urinary tract infections (UTIs). If left untreated, UTIs can have serious implications, such as kidney infection. Prevention of dehydration can be a mechanism for treatment of UTIs. Increased fluid intake and increased urination frequency have been shown to prevent UTIs. UTIs are treated using common antibiotics, which can be prescribed by an emergency department, emergency room, or general practitioner. Serious cases of UTIs can require hospitalization and stronger antibiotics. UTIs can be recurrent, but are often a single episode of infection, with the time to cure being the time required to perform an antibiotic course.

[0043] Brain edema is a serious complication of traumatic brain injury (TBI) and can also be induced by rehydrating a dehydrated patient too quickly. Fluid accumulates in the brain and it swells, causing significant mortality rates, especially in TBI patients. The rapid rise in intracranial pressure can affect the brain as well as respiratory and cardiac function. This condition must be treated quickly and direct emergency measures must be taken to suppress the swelling. If the brain injury induces long-term complications, a neurologist can help the patient manage their symptoms.

[0044] Another potential complication of dehydration is seizures. Electrolyte imbalances induced in severe dehydration can cause involuntary muscle contractions and coma, which in turn induce seizures. By treating the patient's dehydration, the seizures induced by dehydration will likely cease. Thus, treatment can simply include rehydrating the patient in a hospital. If the seizures have a lasting impact, a neurologist can be consulted for symptom management.

[0045] In light of the foregoing, it is critical to monitor fluid replacement during the care cycle, rehydrate through the consumption of fluids, and be vigilant of medications that can cause a patient to be prone to dehydration. For healthy individuals, these tasks are relatively easy to perform, unless they are in hot, dry weather for an extended period of time, or engaged in strenuous exercise for an extended period of time.

[0046] The initial treatment regimen prescribed by a physician (e.g., dietary supplements) or reactive treatment regimen (e.g., electrolyte medications that a patient must take daily for an extended period of time) is often based on very sound reasoning: preemptive strategy, long-term management of the condition, and better overall health. However, patients, especially the elderly population, often become frustrated with regimens that require strict daily consumption of supplements and medications.

[0047] Finally, there is a significant conflict of interest between physicians and insurance companies. Physicians are primarily and wholly committed to providing the best, most comprehensive treatment regimen to ensure a high quality of life for the patient. At the same time, insurance companies are often the primary factor that limits the quality or quantity of treatment regimens that physicians can perform, thereby limiting the potential for improvement in the patient's quality of life.

[0048] Accordingly, there are two primary areas in the care cycle for dehydration. The first area is the "home front," which includes the homes of young children, adults, and a significant percentage of the elderly population residing in nursing homes or group care facilities. The second area is "healthcare," which includes the clinic and hospital environments where individuals receive treatment from physicians and medical professionals.

[0049] In the home front line, the stakeholders directly funding the care cycle are the patient, their family, and the caregivers. The form of care paid for by these stakeholders is almost exclusively preventative measures such as adequate water, electrolyte drinks, and supplements, dietary supplements, and lifestyle changes. The cost of ensuring adequate water and lifestyle changes is negligible relative to the other costs associated with the home front line care cycle. With respect to electrolyte drinks and bagged supplements, the cost is borne by the patient and their family. While inexpensive compared to "healthcare" costs, electrolyte drinks and bagged supplements still need to be paid for by the patient and family out of pocket. These costs are at their discretion and depend on how often and how much they wish to take to combat dehydration, especially in the case of athletes, outdoor workers, or those with a higher risk of dehydration due to medication or preexisting conditions. In the case of healthcare, insurance companies or the U.S. government typically bear the majority of the cost for care and prevention. SUMMARY

[0050] The present disclosure is and includes apparatuses, systems, and methods for providing a hydration replenishment detection device. The hydration replenishment detection device includes a flexible substrate having a circuit screen printed therein, the circuit including a plurality of conductive ink layers and dielectric ink layers; a sensor on the flexible substrate, wherein the sensor is capable of detecting element data indicative of sweat properties; untreated chromatography paper placed in contact with a user's skin and capable of wicking sweat from the skin to the sensor along a micro-sized fluidic channel; and a Bluetooth antenna on the flexible substrate and in communication with the sensor and capable of wirelessly transmitting the element data to an application capable of indicating to the user the appropriateness of the user's hydration replenishment based on the element data. BRIEF DESCRIPTION OF DRAWINGS The disclosure is illustrated, by way of example, in the drawings in which one or more embodiments of the disclosure are shown. The drawings can show one or more embodiments of the disclosure alone or in combination. The elements shown in the figures are not necessarily to scale. Reference signs can be repeated in the drawings in order to indicate corresponding or analogous elements.

[0051] Figure 1 Aspects of example embodiments of the invention are illustrated; Figure 2 Aspects of example embodiments of the invention are illustrated; Figure 3 Aspects of example embodiments are illustrated; Figure 4 Aspects of example embodiments are illustrated; Figure 5 Aspects of example embodiments of the invention are illustrated; Figure 6 Aspects of example embodiments of the invention are illustrated; Aspects of example embodiments are illustrated;Figure 7 Aspects of embodiments are illustrated by way of example; Figure 8 Aspects of embodiments are illustrated by way of example; Figure 9 Aspects of example embodiments of the invention are illustrated by way of example; Figure 10 Aspects of example embodiments of the invention are illustrated by way of example; Figure 11 Aspects of embodiments are illustrated by way of example; Figure 12 Aspects of embodiments are illustrated by way of example; and Figure 13 Aspects of example embodiments of the invention are illustrated by way of example; Figure 14 Aspects of example embodiments of the invention are illustrated by way of example; Figure 15 Aspects of example embodiments of the invention are illustrated by way of example; Figure 16 Aspects of example embodiments of the invention are illustrated by way of example; Figure 17 Aspects of example embodiments of the invention are illustrated by way of example; Figure 18 Aspects of example embodiments of the invention are illustrated by way of example; Figure 19 Aspects of example embodiments of the invention are illustrated by way of example; Figure 20 Aspects of example embodiments of the invention are illustrated by way of example; Figure 21 Aspects of example embodiments of the invention are illustrated by way of example; Figure 22 Aspects of example embodiments of the invention are illustrated by way of example; Figure 23 Aspects of example embodiments of the invention are illustrated by way of example; Figure 24 Aspects of example embodiments of the invention are illustrated by way of example; Figure 25 Aspects of example embodiments of the invention are illustrated by way of example; Figure 26 Aspects of example embodiments of the invention are illustrated by way of example; Figure 27 Aspects of example embodiments of the invention are illustrated by way of example; Figure 28 Aspects of example embodiments of the invention are illustrated by way of example; Figure 29 Aspects of example embodiments of the invention are illustrated by way of example; Figure 30Aspects of example embodiments of the present application are illustrated; Figure 31 Aspects of example embodiments of the present application are illustrated; Figure 32 Aspects of example embodiments of the present application are illustrated; Figure 33 Aspects of example embodiments of the present application are illustrated; Figure 34 Aspects of example embodiments of the present application are illustrated; Figure 35 Aspects of example embodiments of the present application are illustrated; Figure 36 Aspects of example embodiments of the present application are illustrated; 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DETAILED DESCRIPTION

[0052] The drawings and description provided herein can have been simplified to illustrate aspects that are relevant to a clear understanding of the devices, systems, and methods described herein, while eliminating, for the purpose of clarity, other aspects that can be found in typical similar devices, systems, and methods. Those of ordinary skill in the art may, therefore, recognize that other elements and / or operations can be desirable and / or necessary to implement the devices, systems, and methods described herein. But because such elements and operations are known in the art, and because they do not facilitate a better understanding of the present disclosure, for the sake of brevity a discussion of such elements and operations can not be provided herein. However, the present disclosure is deemed to still include all such elements, variations, and modifications to the described aspects that would be known to those of ordinary skill in the art.

[0053] Throughout the text, examples are provided so that the present disclosure is fully and thoroughly understood and so that the scope of the disclosed examples is conveyed fully to those skilled in the art. Numerous specific details are set forth, such as examples of specific components, devices, and methods, to provide a thorough understanding of the present disclosure. However, it will be apparent to those skilled in the art that certain specific details can not be required and that the present disclosure can be practiced with different forms of these details. Therefore, the examples should not be construed as limiting the scope of the present disclosure. As described above, in some examples, well-known processes, well-known device structures, and well-known technologies are not described in detail in order to avoid unnecessarily obscuring the present disclosure.

[0054] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting. For example, as used herein, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. The terms "comprises," "comprising," "includes," "including," and the like are inclusive and therefore specify the presence of stated features, integers, steps, operations, elements, and / or components but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof. The steps, processes, and operations described herein are not to be construed as necessarily requiring their performance in the particular order in which they are described, unless specifically identified as a preferred or required order of execution. It is also to be understood that additional or alternative steps can be employed, in place of or in conjunction with the disclosed aspects.

[0055] When an element or layer is referred to as being "on", "engaged to", "connected to" or "coupled to" another element or layer, it can be directly on, engaged, connected or coupled to the other element or layer, or one or more intervening elements or layers can be present. In contrast, when an element is referred to as being "directly on", "directly engaged to", "directly connected to" or "directly coupled to" another element or layer, there are no intervening elements or layers present. Other words used to describe the relationship between elements should be interpreted in a like fashion (e.g., "between" versus "directly between", "adjacent" versus "directly adjacent", etc.). In addition, as used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items.

[0056] In addition, while the terms first, second, third, etc. can be used herein to describe various elements, components, regions, layers and / or sections, these elements, components, regions, layers and / or sections should not be limited by these terms. These terms are only used to distinguish one element, component, region, layer or section from another element, component, region, layer or section. Terms such as "first," "second," and other numerical terms when used herein do not imply a sequence or order unless clearly indicated by the context. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings of the examples.

[0057] Disclosed herein are processor-implemented control modules, systems and methods that can provide access to and conversion of a variety of types of digital content including, but not limited to, video, image, text, audio, metadata, algorithms, identifiers, interactive and document content, and that track, deliver, manipulate, convert, transact and report on the accessed content to control and perform manufacturing processes discussed herein. The described embodiments of these control modules, systems and methods processed by processing systems are intended to be exemplary and not limiting.

[0058] A major problem in preventing dehydration is finding a way for individuals to monitor their water replenishment levels outside of a clinical setting. To remedy this problem, companies have developed affordable patches that monitor water replenishment levels through sweat. These patches not only provide personal water replenishment monitoring, but they also have an economic advantage because they reduce dehydration-related hospitalizations that place a significant economic burden.

[0059] Another existing solution is a gel, which is a hydration snack designed for water replenishment. Although the specific target audience for gels is initially the elderly, they can be taken by people of all ages as a preventative measure or treatment for mild dehydration conditions.

[0060] Electrolyte beverages, such as Gatorade, are another preventative measure and treatment option for mild dehydration. These beverages were originally designed for athletes to ensure water replenishment and enhance on-field performance. Now they are also used by the general population and as a treatment option for mild dehydration conditions.

[0061] Dehydration can worsen when patients do not seek treatment in a timely manner when in a mild dehydration state, which then requires more aggressive measures, such as IV therapy. While this treatment option is effective, the issue that arises with it is the economic burden. These treatment options primarily require hospitalization and administration by medical professionals, which can be costly.

[0062] Therefore, there is a need to create affordable, at-home preventative measures and treatment options.

[0063] The lack of accuracy in the aforementioned monitoring devices is the most significant issue. Many existing devices analyze biomarkers in sweat to correlate sweat levels to total body fluid volume, which quantifies fluid loss. Studies have shown that the correlation between sweat and total body fluid volume is weak. Therefore, some devices monitor water replenishment levels in real-time while also collecting other information such as heart rate, activity tracking, and sleep tracking to generate water replenishment recommendations. However, this device is often very costly.

[0064] Another limitation of sweat analysis devices is the need to collect enough sweat for an accurate reading. Sweat needs to be generated through exercise, which limits the patch to only be used for active individuals, which is problematic because it excludes a large population of people who are more susceptible to dehydration.

[0065] Many existing products are bulky and impractical for everyday use. This is especially a problem for athletes, as bulky devices that are strapped to specific parts of the body can limit range of motion and require constant adjustments.

[0066] Therefore, the need for a monitoring device to prevent dehydration focuses on the accuracy, convenience, and ease of use of the device. This requires providing a quick and easy solution while maintaining the highest accuracy standards of patient care.

[0067] Accordingly, embodiments provide a way to monitor electrolyte imbalance to prevent dehydration and related conditions. Embodiments provide: a biosensor and in-field analysis, such as many information is subsequently transmitted to an app via Bluetooth; a portable and simple to use water replenishment monitor that senses sweat by monitoring only a single analyte; a device that can be screen printed via a mesh screen; a small sized device, e.g., 2 cm x 3 cm; a low cost manufactured (e.g., under $5) device; a device with the ability to run by collecting only a small amount of sweat (e.g., -20 μΐ).

[0068] Further, embodiments can provide in-app baseline setting to determine normal levels customized for each individual user. The device can sense sweat using multiple analytes rather than a single analyte. The device can be reusable (i.e., the device can include disposable components and multi-use circuit components). The device can be aesthetically pleasing and have a comfortable wearable design. Further, the device can include the ability to induce sweat through thermal or electrical means.

[0069] Embodiments can take the form of an adhesive disposable patch with reusable adjacent circuitry. The patch utilizes paper microfluidics to collect microliters of sweat, which is analyzed using a printed OECT (organic electrochemical transistor) biosensor that detects sodium ions. The reusable circuitry can power, process, and transmit data to a mobile app via, e.g., Bluetooth Low Energy (BLE), which will provide information about water replenishment levels. The patch design is suitable for the general population and has great potential in the fitness tracking market related to athletes. "Athletes" refers to individuals who are interested in or participate in sports activities.

[0070] In Figure 1 In the first embodiment shown, the first layer consists of an adhesive strip that allows the patch to be fixed to the skin. Layers 2 and 3 form a paper microfluidic channel, the bottom of which is hydrophilic and consists of an inlet, and the top layer is hydrophobic to direct sweat in a certain direction. The next layer is an insulating layer that protects the PEDOT:PSS layer above from sweat. The PEDOT:PSS layer consists of a source, drain, and gate with wires, e.g., silver wires, leading to the edges of the patch. The sixth layer is a conductive layer that connects the silver wires from the lower layer to the upper circuit layer. This circuit layer is constructed based on a reference circuit design that transmits data from the biosensor to an app via Bluetooth. The last layer is a PDMS encapsulation layer that protects the circuit layer. Exemplary dimensions of the patch are as follows: Figure 2The device functions by collecting sweat in a paper microfluidic, the OECT biosensor analyzes sodium concentration. This information is relayed through a battery-powered BLE circuit and connected to a mobile phone app that provides hydration information. The entire device is disposable.

[0071] Figure 3 A second embodiment is shown. This is a two-part device consisting of a patch and a circuit connected with silver wires. The first layer of the patch is a paper microfluidic, the grey color represents converging hydrophilic inlets and the yellow color represents a hydrophobic barrier. The area under the purple circle is the central reservoir where sweat is collected from each inlet. The second layer is represented by the purple circle, which is PEDOT:PSS. Layer 3 contains carbon ink source, drain, and gate connected with silver wires to the circuit. The last layer is an adhesive / protection layer that encapsulates the biosensor.

[0072] Figure 3 Exemplary dimensions of the design shown in Figure 4 . The device functions by collecting sweat in a paper microfluidic through multiple inlets. The OECT biosensor analyzes sodium concentration. This information is relayed through a connector to a battery-powered BLE circuit and connected to a mobile phone app that provides hydration information. The patch assembly is disposable and the circuit is reusable.

[0073] Figure 5 A further embodiment is shown. Similar to the previous design, this solution has the circuit separated from the biosensor as it simplifies the detachability aspect of making the patch reusable. Layers 1 and 2 form a paper microfluidic channel with inlets, electroactive zone, and outlet. The upper layer is an insulating layer that separates the liquid electrolyte in the paper from the biosensor. Layer 4 is a PEDOT:PSS layer that includes carbon ink source, drain, and gate connected with silver wires. The last layer is an adhesive / protection layer that encapsulates the patch.

[0074] Figure 5 Exemplary dimensions of the design shown in Figure 6 . The device functions by collecting sweat in a paper microfluidic through an inlet. The OECT biosensor analyzes sodium concentration. This information is relayed through a connector to a battery-powered BLE circuit and connected to a mobile phone app that provides hydration information. The patch assembly is disposable and the circuit is reusable.

[0075] Figure 7 Another embodiment shown in includes a combination of the first and third designs. From the first design, the adhesive concept used as the bottom layer is replaced with the encapsulation adhesive layer of the third design. All other aspects of the final design are similar to design 3, with dimensions as shown in Figure 8The device works by collecting sweat through multiple inlets in the paper microfluidic. The OECT biosensor analyzes sodium concentration. This information is relayed through a connector to a battery-powered BLE circuit and connected to a mobile phone app that provides hydration replenishment information. The patch assembly is disposable and the circuit is reusable.

[0076] Table 1 shows relevant standards for the embodiments.

[0077] Table 1

[0078] A number of steps can be used to create the microfluidic portion of the patch. The first step in the manufacturing can be to create the channels; chromatography paper can be selected as the material due to its hydrophilic nature. That is, paper with chromatographic properties provides wicking capability, which will be very effective in wicking sweat from the skin to the sensor. Further, untreated chromatography paper maintains its wicking capability in heavy use. Additionally or alternatively, a stencil from a polyethylene terephthalate (PET) sheet can be used to provide a hydrophobic barrier.

[0079] In Figure 9 , the center portion is the microfluidic channel, and the sheet on which the channel resides is a PET substrate. Note that the square portion of the channel is exposed and will allow fluid to seep up from below and be exposed to the PEDOT:PSS transistor channel of the OECT biosensor.

[0080] The microfluidic portion of the patch can be formed by laying a PET stencil on the chromatography paper and patterning a defined channel on the paper using a spray with hydrophobic properties. The spray with hydrophobic properties can be a water repellent coating containing an organic solvent, such as including acetone, xylene, or liquified petroleum gas. The PET thickness can be between, for example, about 7 microns to 20 microns, and more preferably 10 microns. This is summarized in Figure 10 .

[0081] The two main functions of the embodiments are: wicking liquid through and from the microfluidic channel; and adhesive performance. As described above, the microfluidic can be formed from paper. An adhesive can attach the channel to the PET substrate and the entire patch to the wearer’s skin. Also included are the OECT biosensor, the wireless readout device, and the mobile app platform connected to the device via Bluetooth Low Energy connection. The electroactive region of the channel can be square, diamond, and / or have rounded corners, as such geometries facilitate more efficient collection of fluid for lateral flow.

[0082] Screen printing is a batch production process employed in some embodiments. Biosensors can be manufactured using this method, for example including screen printing flexible hybrid electronics. Screen printing can use custom screens. Wire traces can be formed from silver; carbon can be used on source, drain, and gate; PEDOT:PSS can be used as organic channels; and dielectric / insulation can be used to encapsulate everything but the electroactive region.

[0083] Additionally, the biosensor can be a PCB or connected to a PCB. Female and male connectors can attach and detach the biosensor to and from the PCB. The connection of the disposable patch to the reusable circuitry and microcontroller can be a standard 3-pin connector. The patch including the biosensor and paper microfluidics is designed to be disposable.

[0084] The patch can be adhered to the skin or can simply be attached with Velcro and held by an armband. A simple Velcro armband with a PCB pocket allows for easy removal and replacement of the patch. That is, the Velcro pad can secure the armband.

[0085] Embodiments incorporate the ability to use patterned chromatography paper to wick small amounts of sweat (-15 μΐ^). The functioning OECT biosensor is able to read drain current data in microamperes while running chronoamperometry programs using an interlinked app. A voltage is applied across the gate and a step voltage is provided to produce a clear transfer curve; finally, common ground is placed on the sensor transistor source. The transfer curves resemble the expected trend. The results show changes in drain current at different step gate voltages, which indicates functionality of the sensor. These transfer curves are shown in Figure 11 .

[0086] Ten solutions were provided, ranging from 0 (PBS blank) to 10"8M, prepared from PBS and NaCl crystals. Each solution was wicked in a 20 μΐ^ droplet to the electroactive region of a disposable patch, allowing the app to run chronoamperometry programs and display drain current results on a graphical user interface (GUI).

[0087] This is because there is a linear relationship between the molarity of the solution NaCl and the drain current. As Figure 12 shown, the GUI in this example can indicate "sodium can be low," "sodium can be high," or "no sodium abnormalities." Sensor calibration can be performed as in Figure 13 .

[0088] Thus, the paper microfluidics can be used to correctly produce defined precise channels to wick NaCl solution (i.e. sweat) directly to the electroactive region of the biosensor. The biosensor can be a screen printed OECT, which can produce consistent current output for chronoamperometric analysis at different NaCl concentrations.

[0089] The BLE circuitry runs, reads and transmits the OECT data to a mobile app. The app code is used to analyze the sodium concentration and provide that data and other readings upon request from the user. Thus, embodiments provide a device that measures the statistical differences of micromolar scale NaCl solutions to produce corresponding app outputs.

[0090] Referring now to Figure 14 , a simple NaCl monitoring patch is shown, containing 2 electrodes. It integrates a chip and is attached to the skin via an adhesive layer that extends along the edges of the design.

[0091] Referring now to Figure 15 , a patch is shown that integrates microfluidic channels and has a compartment at the bottom for sweat accumulation. The accumulation of sweat is important for accurate analysis of Na + levels.

[0092] Referring now to Figure 16 , a device is shown that uses four sweat inlets to sense the moisture replenishment level and then the sweat accumulates in the middle torus. This sensor is then encapsulated with a top adhesive layer and is pressed onto the skin to achieve adhesion.

[0093] Referring now to Figure 17 , a patch is shown that integrates 2 electrodes with microfluidic channels. It contains a biosensor to analyze the sweat and read out the moisture replenishment level to an app via Bluetooth for each user accessibility.

[0094] Referring now to Figure 18 , a watch is shown that has an internal compartment for a biosensor and the biosensor is hidden by a detachable face. It has a button that induces sweat by using heat generated from solar energy.

[0095] Referring now to Figure 19 , a patch design is shown. With this patch design, there are eight inlets that allow for sweat absorption, with a compartment in the middle to collect the sweat. This sweat is then used to power the biosensor and the circuitry on it, which eliminates the need for a battery.

[0096] Referring now to Figure 20 , a patch is shown that is specifically designed for the underarm, as the underarm is the area of the body that produces the most sweat. The microchannels have a downward direction so that gravity can help the sweat flow to pass through the patch.

[0097] Referring now to Figure 21 , a patch is shown with a replaceable component that houses an electrolyte solution that can be applied when the water replenishment level is below an acceptable range. Also has a sweat collection compartment that can expel sweat when it becomes full.

[0098] Referring now to Figure 22 , a patch is shown that contains a thermal lining as well as an adsorptive capacity that helps induce sweat. The microfluidic channel has a spiral orientation.

[0099] Referring now to Figure 23 , an armband is shown that can be easily put on before exercise to monitor water replenishment levels. The design also integrates a Bluetooth connection so that data can be accessed via a mobile app.

[0100] Referring now to Figure 24 , a bracelet is shown that is made of silver and integrates a cooling technology that activates when the water replenishment level is low. There is a display that shows the user the real-time water replenishment level.

[0101] Referring now to Figure 25 , a 2-layer patch design using OECTs is shown. It has a thermal layer for inducing sweat and a display that shows the water replenishment level. The bottom layer contains a microfluidic channel.

[0102] Referring now to Figure 26 , a patch is shown that is inspired by Halloween, with two inlets that flow in a vampire tooth-like orientation. The bottom droplet turns red when the water replenishment level is low.

[0103] Referring now to Figure 27 , a device is shown that monitors water replenishment levels as movement begins. It contains a temperature reader because it is a factor that can affect the rate of sweating. Also has a detachable sweat collection compartment.

[0104] Referring now to Figure 28 , a two-piece device is shown that works in tandem to deliver the water replenishment level to the user. The patch collects sweat in a compartment that can be detached and put into a second portable device that analyzes the water replenishment level.

[0105] Referring now to Figure 29 , a flexible patch is shown that is slightly dome-shaped and can be attached to the skin by applying a small adsorptive pressure to induce sweat collection. It also has a flexible display at the top for reading the water replenishment level.

[0106] Referring now to Figure 30, shows a patch designed to collect sweat from the back, which is an area of the body where a large amount of sweat is produced. There are multiple microchannels that direct downward to enhance the gravity of the sweat, so that it collects in the corner area for accurate analysis.

[0107] Reference is now made to Figure 31 , shows a patch that is a full wrap OECT patch with an adhesive backing and a top flexible circuit. In addition to this, the patch is composed of three layers, including a microfluidic channel, an insulating layer, and a PEDOT:PSS layer. The circuit layer is encapsulated by a protective layer in order to be able to withstand various environmental stresses.

[0108] Reference is now made to Figure 32 , shows a two-piece design that allows for easier detachability of the disposable patch. It integrates a regular transistor that then sends a signal to a flexible circuit to process the data and relay the information to an app.

[0109] Reference is now made to Figure 33 , shows a patch that uses organic electrochemical transistors and incorporates a packaging layer to protect the patch and place it onto the skin. The signal is sent to a separate circuit that also powers the transistor layer.

[0110] Reference is now made to Figure 34 , shows a patch design. Sweat is collected through an inlet and flows through a microfluidic channel, removed via an outlet. The adhesive patch also includes a circuit on the back that includes a universal ISE biosensor and a BLE connector to an app.

[0111] Reference is now made to Figure 35 , shows a watch design where sweat is collected via microfluidics and scanned with an optical biosensor. The watch contains a circuit and a BLE connector to an app. The watch is reusable and has a removable microfluidic component.

[0112] Reference is now made to Figure 36 , shows a watch design where sweat is collected via microfluidics and scanned with an optical biosensor. The watch contains a circuit and a BLE connector to an app. The watch is reusable and has a removable microfluidic component. This modification adds an electric field generation function that artificially induces sweat for easier sample collection.

[0113] Reference is now made to Figure 37 , shows a watch design where sweat is analyzed via needle electrodes with an ISE biosensor. The watch contains a circuit and a BLE connector to an app. The watch is reusable, and the needle component must be sterilized after each use.

[0114] Reference is now made to Figure 38, showing a watch design where sweat is collected via microfluidics and scanned with an optical biosensor. The watch contains circuitry and provides an electric field to encourage sweat production. The watch is reusable and has a removable microfluidic component. The device includes a display that directly describes the hydration level, rather than a BLE connection to an app.

[0115] Referring now to Figure 39 , showing a watch design where sweat is collected via self-cleaning microfluidics and scanned by an optical biosensor. When the hydration level is low, a radio connection to a spaceship is relayed, and the spaceship delivers a salt solution through a self-cleaning needle to adjust the hydration level. This concept was born from an "out-there, alien idea" that emerged during a creative workshop aimed at showcasing innovative thinking.

[0116] Referring now to Figure 40 , showing a design that is a basic microfluidic sweat collection ISE biosensor connected to an app device via BLE and packaged in the style of a comfortable armband.

[0117] Referring now to Figure 41 , showing a design in the form of a flexible adhesive tape that moves sweat through a straight, narrow inlet to an outlet. The tape includes fields with positive and negative charges to move the sweat through, as an ISE biosensor to determine sodium concentration. A BLE attached to the tape is powered by the movement of sweat through the fields and transmits information to an app.

[0118] Referring now to Figure 42 , showing a design that uses microfluidics to move through a tape with a basic ISE biosensor and a BLE connection to an app to describe the hydration level.

[0119] Referring now to Figure 43 , showing a design that utilizes tape adhesive, fewer microchannel circuits, and collects sweat in a similar mechanism as previous designs, however it incorporates a colorimetric sensor that can be scanned by an app to display the hydration level.

[0120] Referring now to Figure 44 , showing a design that utilizes tape adhesive, fewer microchannel circuits, and collects sweat in a similar mechanism as previous designs. In contrast to previous designs, it incorporates an overlay to read and process the colorimetric sensor. It contains circuitry and a BLE connection to an app.

[0121] Referring now to Figure 45, showing a design that utilizes the amount of sweat released by the foot. The design takes the form of a "smart insole" that collects and processes sweat. The insole connects to an app via BLE to relay moisture replenishment status.

[0122] Now referring to Figure 46 , showing a design that builds on the previous design, collecting sweat via a "smart insole" and relaying it to an app via BLE. The device includes an additional function that generates an electric field to induce sweat on the foot for analysis.

[0123] Now referring to Figure 47 , showing a design that combines the "smart insole" from ideas 32 and 33 with a reusable component. The insole portion will contain disposable microfluidics, and wires connect it to a clip-on BLE circuit. The sensor transmits data to an app, which gives information about moisture replenishment levels.

[0124] Now referring to Figure 48 , showing a design with an adhesive patch with an adsorptive component that has multiple inlet "holes" for microfluidic collection of sweat. The sweat further flows into the patch, where a biosensor detects sodium concentration. The data is processed using a BLE circuit and output to an app, giving information about moisture replenishment levels.

[0125] Now referring to Figure 49 , showing a design with a curved adhesive patch for adsorption that uses one inlet and paper microfluidics to collect sweat. A biosensor collects information about sodium concentration in the sweat, and a BLE circuit transmits data to an app.

[0126] Now referring to Figure 50 , showing a design that builds on the curved adhesive patch of the previous design, adding a reusable biosensor and BLE circuit that is attached to the top of the disposable patch via a snap-on method.

[0127] Now referring to Figure 51 , showing a design that further builds on the curved adhesive patch by changing the type of connection to the reusable circuit and reducing the size of the circuit to be closer to screen-printing specifications.

[0128] Now referring to Figure 52 , showing a design that integrates multiple inlets into a circular microfluidic adhesive patch. Sweat is drawn to the collector, and an ISE biosensor is located in the center of the patch, with a circuit and BLE connection on the top of the patch. The BLE connects the patch to an app. The entire patch is disposable.

[0129] Now referring to Figure 53, showing a design that builds on previous designs, but makes the adhesive patch cheaper by utilizing a colorimetric sensor above the collection area. The readout can be scanned by a mobile device app to give hydration information for the individual.

[0130] Reference is now made to Figure 54 , showing a design that utilizes microfluidics on the back surface of the housing to optimize sweat collection by funneling the collected sweat into a reservoir. The microfluidic portion of this design is an adhesive patch, so the device is intended for multiple uses by replacing the microfluidics in each case. The device is strapped with an elastic band around the lower bicep area. A small screen on the front of the housing displays the readout from the internal sensing circuitry.

[0131] Reference is now made to Figure 55 , showing a design that takes the form of a simple patch worn on the skin surface that collects sweat at the microfluidic channel entrance at the tip of the horn. The bi-directional nature of this design allows for a differential readout to compare the concentrations sensed in the horn on both sides and produce an averaged, ideally more stable signal. The information is intended to be transmitted to a phone via Bluetooth.

[0132] Reference is now made to Figure 56 , showing a design that mimics a glove that aims to maximize sweat collection by trapping heat and collecting all the sweat produced by the hand in the fingertip reservoirs. Microfluidic channels extending from these reservoirs to the center of the back of the hand transport the sweat to the biosensor built on a flexible hybrid electronic patch embedded in the palm area. This design proves to be practical in winter applications where body sweat can not be obtained in cold temperatures, and it also prevents debris and other contaminants by shielding the sensing area from exposure to the outside.

[0133] Reference is now made to Figure 57 , showing a design that utilizes the flexibility and easy-to-apply nature of K-tape, integrating it into a sensing tape device. The device can be placed anywhere on the body to individualize the sensing process according to the individual's most sweating area. It also serves as an auxiliary tape for athletes, providing a dual function. The microfluidic channels extend longitudinally to obtain maximum collection.

[0134] Reference is now made to Figure 58 , showing a design that is integrated into a cloth headband and is intended to be worn on the forehead. It provides colorimetric sensing via a moisture supplement rod on the front, or the data can be transmitted to a phone via Bluetooth. The cloth collects as much sweat as possible via moisture wicking, and it is machine washable multiple times.

[0135] Reference is now made to Figure 59This illustrates a design that operates via multiple patch-based sensors printed onto fabric using screen printing technology. Accompanying circuitry housed in the center of the chest averages regional measurements from each location to more accurately characterize overall body hydration levels. The design may also include optical activation, where sweat induces color changes in the fabric.

[0136] Now for reference Figure 60 This demonstrates a design specifically for water sports athletes, where biosensors and circuitry are printed onto a polymer substrate to line the inside of a swimming cap. The device collects sweat from the hair and is protected from external contamination.

[0137] Now for reference Figure 61 This demonstrates a design inspired by common contraceptive methods that employs subcutaneous sensing, which provides a more accurate correlation when exudative sweat is diluted by the skin. The design is intended as a long-term solution and is designed for long-term use. Miniature circuitry built into the hollow center of the rod allows for NFC data reading via telephone.

[0138] Now for reference Figure 62 This design, inspired by basketball players who often sweat profusely during games, showcases a system of microfluidic channels that crisscross from the outside of the forearm, wrap around the upper arm, and extend along the entire length of the forearm. The channels converge to a chip embedded in the sleeve. The device is machine washable and designed for multiple uses.

[0139] Now for reference Figure 63 This demonstrates a design that utilizes sensing areas that contact the face along the edges of a mask that tend to be placed close to the skin. Absorbent material around the mask's edges collects sweat, delivering it to biosensors integrated into the fabric, and transmitting access data via Bluetooth.

[0140] Now for reference Figure 64 This paper illustrates a design based on a stacked paper substrate that acts as a sponge to absorb sweat from the skin and deliver it vertically to the sensing area of ​​the device. Hydrophobic patterns on the stacked paper substrate layers allow for 3D microfluidics by controlling vertical flow and limiting lateral diffusion. The electroactive areas are defined by connector boundaries for direct connection to the circuitry. The design includes a reusable upper half and an inexpensive, disposable collection element on the lower half.

[0141] Now for reference Figure 65 This paper illustrates a design based on paper-based microfluidics, where microfluidic channels are defined by hydrophobic regions created by wax printing. The paper substrate is used to collect and sense the desired analyte in a single unit, but the element is inexpensive and disposable, and is connected to a multipurpose circuit via a Crimpflex connector.

[0142] Reference is now made to Figure 66 , showing a design that operates via PDMS casted microfluidic channels to capture sweat in a central reservoir, then squeezes the central reservoir to release the sweat content onto chemically treated chromatographic paper strips to produce a color-based concentration analysis. The distance of the farthest activated area on the strip indicates the user's hydration level.

[0143] Reference is now made to Figure 67 , showing a design that contains microfluidic channels integrated into a screen-printed patch on a flexible substrate, enabling placement at various locations on the body. The circuitry that accompanies this design performs minimal signal processing, otherwise selected to transmit data to a device via Bluetooth. A screen-printed thin film battery as well enables the patch to be implemented as a single use at low cost.

[0144] Reference is now made to Figure 68 , showing a design that uses paper microfluidics, where the substrate is sandwiched between encapsulation layers that define hydrophilic regions. A wax hydrophobic barrier accelerates fluid delivery into the letters for colorimetric concentration analysis. Operation of this design produces a fast and simple detection, albeit with less accurate or meaningful readings.

[0145] Reference is now made to Figure 69 , showing a design that is intended to be worn around the chest, where the band contains microfluidic channels. All sweat that drips from the individual's front and back surfaces is collected and transported by the band channels to a device located in the center of the housing. This design is ultimately inspired by athletes who very frequently wear athletic performance trackers, such as soccer players.

[0146] Reference is now made to Figure 70 , showing a design that is based on a squeegee with a flexible membrane in a recessed area. The intended use involves wiping the arms and legs with the recessed area to collect all surface sweat into a reservoir. Circuitry is located in the handle to analyze the concentration, and the device can be rinsed for reuse.

[0147] Reference is now made to Figure 71 , showing a design that is based on organic electrochemical transistor biosensing technology, which will form the basis of our proposed solution, and it is one of the three proposed solutions outlined in the report.

[0148] Reference is now made to Figure 72 , showing a design that is unique to the other two proposed solutions described in detail in this report, as it employs a circular shape and multiple inlets for the central reservoir. However, it employs the same organic electrochemical transistor biosensing technology.

[0149] Reference is now made to Figure 73 , showing a design as one of the three proposed solutions presented in this report, and which design was ultimately inspirational to the final selected design.

[0150] In the above detailed description, it can be seen that various features are grouped together in one or more embodiments for the purpose of streamlining the disclosure. This approach is not to be interpreted as reflecting an intention that the embodiments require more features than are explicitly recited in each claim. On the contrary, the disclosure covers all variations and modifications of the disclosed embodiments that would be understood by one of ordinary skill in the art in light of the disclosure.

Claims

1. A moisture replenishment detection device, comprising: a flexible substrate having a circuit screen printed therein, the circuit comprising a plurality of conductive ink layers and dielectric ink layers; a sensor on the flexible substrate, wherein the sensor is capable of detecting element data indicative of sweat properties; untreated chromatography paper placed in contact with a user's skin and capable of wicking the sweat from the skin to the sensor along a micro-sized fluidic channel; and a Bluetooth antenna on the flexible substrate and in communication with the sensor, and the Bluetooth antenna is capable of wirelessly transmitting the element data to an application, the application is capable of indicating to the user the appropriateness of the user's moisture replenishment based on the element data.

2. The device of claim 1, wherein the element data is indicative of a concentration of sodium, potassium, chloride, calcium, magnesium, urea, glucose, lactate, and / or pH.

3. The device of claim 1, wherein the element data is indicative of a concentration of sodium, potassium, chloride, calcium, magnesium, urea, glucose, lactate, and / or pH, and the application is capable of indicating to the user the appropriateness of the user's moisture replenishment based on the concentration of sodium, potassium, chloride, calcium, magnesium, urea, glucose, lactate, and / or pH.

4. The device of claim 1, wherein the element data is indicative of a concentration of sodium, potassium, chloride, calcium, magnesium, urea, glucose, lactate, and / or pH, and the application is capable of indicating to the user the appropriateness of the user's moisture replenishment based on the concentration of sodium, potassium, chloride, calcium, magnesium, urea, glucose, lactate, and / or pH.

5. The device of claim 1, wherein the element data is indicative of a concentration of sodium, potassium, chloride, calcium, magnesium, urea, glucose, lactate, and / or pH

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