Wearable systems, devices and methods for measuring and analyzing body fluids

Abstract

Systems, devices, and methods are described herein for various embodiments of a sample analysis system worn by a user, which is configured to collect samples of bodily fluids and measure and analyze the bodily fluids to determine characteristics and / or health parameters of the user's bodily fluids (e.g., level of hydration, electrolyte loss, sweat rate, etc.).

Description

[0001] Cross references to related applications

[0002] This application claims priority to and the benefit of U.S. Provisional Application No. 62 / 760,202, filed on November 13, 2018, entitled “Wearable systems, devices, and methods for measure and analysis of body fluids,” the entire contents of which are expressly incorporated by reference for all purposes. Technical Field

[0003] Embodiments described herein relate to systems, devices, and methods for near instantaneous measurement and analysis of bodily fluids and potential analytes contained therein. Embodiments described herein also relate to implementations of real-time hydration detection systems and hydration strategy development systems for use during activity. Summary of the invention

[0004] Systems, devices, and methods are described herein for various embodiments of a sample analysis system worn by a user, which is configured to collect samples of body fluids and measure and analyze the body fluids to determine characteristics of the body fluids and / or health parameters of the user (e.g., hydration level, electrolyte loss, sweat rate, etc.). BRIEF DESCRIPTION OF THE DRAWINGS

[0005] Figure 1 is a schematic diagram of an example use of a sample handling device on a user's skin surface according to an embodiment.

[0006] Figure 2A and 2B is a schematic diagram of a sample handling device according to an embodiment. The sample handling device may be used with a sample analysis system ("SA system").

[0007] Figure 3 According to an embodiment, Figure 2A , 2B Schematic diagram of an example sample analysis system (“SA system”) of a sample handling device.

[0008] Figure 4 is a schematic diagram of structural components of a sample handling device according to one embodiment.

[0009] Figure 5A is a schematic diagram of a perspective view of an example sample handling device according to an embodiment.

[0010] Figure 5B yes Figure 3 A is a schematic diagram of a top view of an example sample handling device.

[0011] Figure 6yes Figure 5A A schematic diagram of an exploded view of an example sample handling device illustrating the component layers of the sample handling device.

[0012] Figures 7A-7C Schematically illustrates Figure 5A , 5B and 6 component layers of a sample processing device.

[0013] Figure 8 yes Figure 5A , 5B 6 are schematic diagrams of a portion of the electrode and channel layers of a sample processing device.

[0014] Fig. 9 yes Figure 8 Schematic diagram of the collection of electrodes in the interfacial layer.

[0015] Fig.10 is a schematic diagram of a perspective view of an example sample processing device of an SA system, according to an embodiment.

[0016] Figures 11A-11C is a schematic diagram of top, bottom, and perspective views of an example sample processing device of an SA system according to an embodiment.

[0017] Fig.12 It is taken along line 12-12 Fig.11A Schematic diagram of a cross section of a sample processing device.

[0018] Fig.13 It is taken along line 13-13 Fig.11A Schematic diagram of a cross-sectional perspective view of a sample processing device.

[0019] Fig.14 It is taken along line 14-14 Fig. 11C Schematic diagram of a cross-sectional perspective view of a sample processing device.

[0020] Fig.15 is a schematic diagram of a top view of a sample handling device that may be used with an example SA system, according to an embodiment.

[0021] Fig.16 yes Fig.15 Schematic diagram of an exploded view of a sample handling device showing the component layers of the sample handling device.

[0022] Fig.17 According to the embodiment Figure 15-16 Schematic diagram of the electrode and channel layers for sample handling.

[0023] Fig.18 A schematic flow chart of an example method for measuring and analyzing a user's hydration level using the SA system according to an embodiment is illustrated.

[0024] Fig.19 is a schematic diagram of a perspective view of an example SA system integrated with an example wearable device, according to an embodiment.

[0025] Fig. 20 is with Fig.19 Examples of wearable device integration Fig.19 Schematic diagram of a perspective view of the rear of the SA system.

[0026] Fig.21 is a schematic diagram of a top view of a sample handling device that may be used with an example SA system, according to an embodiment.

[0027] Fig. 22 According to the implementation method Fig.21 Top view image of a sample handling device.

[0028] Fig.23A According to the implementation method Fig.21 Schematic diagram of a perspective exploded view of a sample handling device illustrating the component layers of the sample handling device.

[0029] Fig. 23B According to the implementation method Fig.21 Schematic diagram of an exploded view of a sample handling device illustrating the component layers of the sample handling device.

[0030] Fig.24A According to the implementation method Fig.21 Schematic diagram of a perspective side view of a sample handling device.

[0031] Fig. 24B yes Fig.24A Magnified view of the boxed area.

[0032] Fig.24C According to the implementation method Fig.21 Schematic diagram of a top view of a portion of a sample handling device, where layers are rendered transparent to show overlap.

[0033] Fig.25A According to the implementation method Fig.21 Schematic diagram of the bottom view of the electrode and channel layers of the sample handling device.

[0034] Figures 25B-25D According to the implementation mode Fig.21 Schematic diagram of top view, side view and bottom view of electrode layers of a sample handling device.

[0035] Fig.25E It is shown that according to the embodiment Figures 25B-25D Schematic diagram of an enlarged view of a portion of an electrode layer, indicating the top and bottom of the electrode layer.

[0036] Fig.26A is a schematic diagram of a top view of a sample handling device that may be used with an example SA system, according to an embodiment.

[0037] Fig.26B According to the implementation method Fig.26A Bottom view image of the sample handling device after removing the interface layer.

[0038] Fig.26C is installed on the clamping ring interface according to the embodiment Fig.26A Top view image of the sample.

[0039] Fig.27A yes Fig.26A Schematic diagram of a perspective side view of a sample handling device.

[0040] Fig.27B According to the implementation method Fig.26A Schematic diagram of an exploded view of a sample handling device illustrating the component layers of the sample handling device.

[0041] Fig.28 According to the implementation method Fig.26A Schematic diagram of an exploded view of a sample handling device illustrating the component layers of the sample handling device.

[0042] Fig.29A According to the implementation method Fig.26A Schematic diagram of a perspective top view of a sample handling device where layers are rendered transparent to show overlapping features.

[0043] Figures 29B-29E According to the implementation method Fig.26A Schematic diagram of a sample handling device including a top view of an electrode layer with a channel layer removed, a top view of the channel layer, a side view of the channel layer, and a bottom view including a spacer portion of the electrode layer.

[0044] Fig.30 According to the implementation method Fig.26A Schematic diagram of an exploded view of a sample handling device coupled to an assembly fixture.

[0045] Fig.31 is a schematic diagram of a top view of a sample handling device that may be used with an example SA system, according to an embodiment.

[0046] Fig.32 According to the embodiment Fig.31 Schematic diagram of a top view of a sample handling device mounted on a retaining ring interface for use with an example SA system.

[0047] Fig.33A and 33B According to the implementation method Fig.31 A schematic diagram of a perspective top view and a top view of a sample handling device, including a cushioning layer for packaging.

[0048] Fig.34 According to the implementation method Fig.31 Schematic diagram of an exploded view of a sample handling device coupled to a mounting interface.

[0049] Fig.35A and 35B According to the implementation mode Fig.31 Schematic diagram of the top and bottom views of the sample handling device.

[0050] Figures 36A-36C According to the implementation method Fig.31 Schematic diagram of a top view of an electrode layer, a side view of the electrode layer, and a bottom view including a spacer portion of the electrode layer of a sample handling device.

[0051] Fig.37 is installed on the clamping ring interface according to the embodiment Fig.35A and 35B Schematic diagram of a perspective side exploded view of a sample handling device illustrating the component layers of the sample handling device.

[0052] Fig.38 is installed on the clamping ring interface according to the embodiment Fig.35A and 35B Schematic diagram of a perspective exploded side view of a sample handling device illustrating the component layers of the sample handling device.

[0053] Fig.39 According to the implementation method Fig.31 Schematic diagram of an exploded view of a sample handling device coupled to a mounting interface.

[0054] Figures 40A-40D is a schematic diagram of a bottom view, a top view, a side view, and a perspective view of a sample handling device according to an embodiment.

[0055] Fig.41 According to the implementation method Figures 40A-40D Schematic diagram of an exploded view of a sample handling device.

[0056] Fig.42 According to the implementation method Fig.41 Schematic diagram of a top view of a sample handling device, layers are rendered transparent to show underlying features in intermediate layers. DETAILED DESCRIPTION

[0057] The disclosed embodiments generally relate to systems, devices and methods for near instantaneous measurement and analysis of bodily fluids and potential analytes contained therein. The embodiments described herein also relate to implementations of real-time hydration detection systems and hydration strategy development systems for use during activity.

[0058] In one embodiment, a method is disclosed, including collecting a sample of body fluid from a source of body fluid in a sample collection area of ​​a wearable device, and directing a portion of the sample of body fluid from the sample collection area to a set of electrodes. The set of electrodes may include an excitation electrode and a sensing electrode. The method includes applying an excitation signal through the portion of the sample of body fluid, and sensing a response signal in response to the excitation signal. The method also includes measuring an impedance associated with the portion of the sample of body fluid based on the response signal, and determining a characteristic of the source of body fluid based on the impedance.

[0059] In one embodiment, a wearable device is disclosed, which includes a sample collection area having an inlet and configured to receive an initial volume of body fluid via the inlet. The wearable device includes an entry port in fluid communication with the sample collection area, and a flow channel in fluid communication with the entry port. The flow channel is configured to direct a portion of the initial volume of body fluid to a collection of electrodes. The collection of electrodes includes an excitation electrode and a sensing electrode. The excitation electrode is configured to apply an excitation signal to the portion of the initial volume of body fluid, and the sensing electrode is configured to receive a response signal from the portion of the initial volume of body fluid in response to the excitation signal. The sensing electrode is configured to transmit the response signal to a processor to calculate an impedance associated with the portion of the initial volume of body fluid.

[0060] In one embodiment, a system is disclosed that includes a memory storing an instruction set, a processor coupled to the memory and configured to execute the instructions stored in the memory, and a wearable device. The wearable device includes a sample collection area configured to receive an initial volume of body fluid, an entry port in fluid communication with the sample collection area, and a flow channel in fluid communication with the entry port. The flow channel is configured to direct a portion of the initial volume of body fluid to a set of electrodes, including an excitation electrode and a sensing electrode. The excitation electrode is configured to apply an excitation signal to the portion of the initial volume of body fluid, and the sensing electrode is configured to receive a response signal from the portion of the initial volume of body fluid and in response to the excitation signal.

[0061] In one embodiment, a device for measuring biophysical properties of a sample of body fluid is disclosed, which includes an interface layer, an adhesive layer, an entry port layer, a channel layer, and an electrode layer. The interface layer includes a pad configured to be released to fix the device on the user's body. The adhesive layer has a predefined thickness, includes an adhesive proximal surface to be fixed to the user's body, and includes an adhesive distal surface to be fixed to the entry port layer. The adhesive layer defines an opening, through which a sample of body fluid is received. The entry port layer includes a proximal surface configured to be fixed to the distal surface of the adhesive layer, an adhesive layer and an entry port layer that jointly define a sample collection area, and a distal surface. The entry port layer defines an entry port to promote the flow of body fluid from the sample collection area. The channel layer defines a flow channel, which is configured to guide the flow of body fluid from the sample collection area. The flow channel includes a test area, which is configured to test the body fluid properties of a portion of the sample of body fluid. The electrode layer is configured to define a collection of electrodes and interface with the flow channel at the test area. The set of electrodes includes (i) an excitation electrode configured to apply an excitation signal to a portion of a body fluid sample at a test area, and (ii) a sensing electrode configured to receive a response signal from the portion of the body fluid in response to applying the excitation signal at the test area. The set of electrodes also includes terminal connections to provide electrical communication between the set of electrodes and a processor to which the response signal is sent for processing.

[0062] Embodiments described herein relate to systems, devices, and methods for measuring and analyzing body fluids using a wearable system for measurement and analysis. The sample analysis system may be configured to collect samples of body fluids, and measure and analyze body fluids to determine characteristics of body fluids (e.g., osmotic pressure) and / or health parameters of users (e.g., hydration level, electrolyte loss, sweat rate, etc.). For example, systems and devices as described herein may collect samples of body fluids (e.g., sweat) and measure the impedance of body fluids. Impedance measurements may then be used to determine and / or predict characteristics of sweat (e.g., osmotic pressure). Without wishing to be bound by any particular theory, it is believed that the electrolyte content of sweat is the main contributor to sweat osmotic pressure; therefore, the determined osmotic pressure may be used to estimate the electrolyte content of sweat. Sweat data may then be used to determine or predict health parameters of users (e.g., hydration level, electrolyte loss, sweat rate, etc.).

[0063] Although the above system is described as being used to determine the electrolyte content of sweat based on impedance measurements, the system can also be used to determine the osmotic pressure of other body fluids and / or secretions, including, for example, saliva, tears, urine, breast milk, etc., which can provide insights into the hydration or other health parameters of the user. In addition, without wishing to be bound by any particular theory, some scientific evidence suggests that the osmotic pressure of breast milk can be used to determine the nutritional content of breast milk. Therefore, similar to the above analysis, the system can be used to measure the impedance of breast milk, which can be correlated with the osmotic pressure of breast milk to provide insights into its nutritional content.

[0064] As described herein, using appropriate indicators of health status, individuals such as athletes, military personnel, laborers, children, the elderly, intensive care patients, and the general population can benefit from timely monitoring of their health and well-being, and timely intervention or correction based on the monitoring. Some example secondary indicators of health and well-being include hydration level, signs of body water loss, and electrolyte loss, which can be indicators of electrolyte balance / imbalance.

[0065] Research shows that up to 87% of endurance athletes suffer from dehydration during their workouts and competitions, despite having ample fluids available. Dehydration causes lowered blood pressure, increased heart rate, increased respiratory rate, and decreased blood flow to the extremities. These physiological changes lead to cardiopulmonary stress, impaired thermoregulation, and fatigue—all of which can have a significant impact on a patient's health or athletic performance. Because the symptoms of mild dehydration are subtle—often imperceptible—individuals suffer the consequences without realizing it.

[0066] Dehydration causes athletic performance to deteriorate after only a 1% weight loss, and deteriorates exponentially with each 1% weight loss. Athletes experience significant loss of athletic ability and functional impairment when they lose approximately 5% of their body water (by weight). In addition to physical damage, dehydration can also lead to cognitive impairment. Studies have shown that dehydration also increases the risk of other injuries, such as soft tissue injuries and traumatic brain injuries. If an athlete's dehydration reaches a critical level, medical intervention is required to prevent permanent side effects or shutdown of major body systems. In extreme cases, death can even occur. Because athletes have no way to effectively monitor their hydration status during exercise, they often misunderstand how easily and quickly it can occur. The effects of dehydration on children, the elderly, and patients in intensive care can be more severe and / or devastating.

[0067] Managing hydration is complicated by the high variability of sweat rates. Each individual can sweat at a different rate based on personal factors such as gender, weight, and fitness level. For any individual athlete, there are many additional variables that can affect sweat rate from weather conditions, intensity of workout, amount and type of clothing or equipment worn, etc. The same athlete performing the same activity on any given day can have different sweat rates.

[0068] One method used to measure an athlete's hydration level is to record naked body mass before and after an activity. The difference between the before and after measurements is converted into a percentage of body mass loss. Because this method of measuring dehydration can only be performed before and after an activity, athletes currently have no way of determining their hydration status during the activity.

[0069] Other methods for measuring hydration status include collecting blood samples periodically during activity and measuring the osmolality of the plasma with an osmometer. This method has some of the same problems as the naked mass measurement method because current blood sample collection methods cannot be performed during activity. It provides information about hydration status before or after activity, but not during activity. Similar to collecting blood for plasma osmolality measurements, other body fluid collection methods for osmolality measurements have also been used as a method to determine hydration status, but with less success. Other fluids collected include saliva, urine, sweat, and tears. Each of these fluids presents challenges for collection and osmolality measurement.

[0070] Some devices collect sweat with patches that are attached to the skin. The sweat can be collected either in an absorbent patch or in a reservoir. The patch is then removed from the athlete and the conductance of the sweat in the patch is measured using a desktop device. This method requires a large amount of sweat; the athlete must sweat profusely for 15 to 20 minutes to collect this minimum amount. This method does not provide live, instant hydration monitoring for the athlete. In addition, these patches need to be replaced every 15 to 20 minutes in order to be able to collect accurate hydration status throughout the activity being studied. Therefore, there is a need for systems, devices, and methods for near-instantaneous measurement and analysis of body fluids.

[0071] Sample analysis system

[0072] Embodiments described herein relate to systems, devices, and methods for near instantaneous measurement and analysis of body fluids, such as sweat and potential analytes contained therein. The disclosed embodiments of the systems and devices are lightweight in nature and can therefore be worn by an individual during any form of activity. The disclosed systems, devices, and methods allow for near instantaneous measurement and analysis of body fluids through their independent, real-time sample collection and analysis properties. Embodiments of the disclosed systems and methods also support repeated instantaneous measurements of samples of body fluids, which are performed for a period of time while the individual is engaged in an activity.

[0073] As used herein, the terms "analyte" and / or "target analyte" refer to any ion, molecule, or compound to be detected and / or that can be bound to a binding substance (e.g., a detection molecule or reagent), as described herein. Suitable analytes may include, but are not limited to, metal and non-metal ions (e.g., Na + , Cl - , Ca 2+ , K + or Mg 2+ ions), nitrogen-containing compounds (such as amino acids and urea), metabolites (e.g., lactate and pyruvate), xenobiotics (such as drug molecule enzymes, metabolic byproducts, disease-related biomarkers), small chemical molecules (such as, for example, environmental molecules, clinical molecules, chemicals, pollutants and / or biomolecules). More specifically, such chemical molecules can include, but are not limited to, pesticides, insecticides, toxins, therapeutic and / or abuse drugs, hormones, antibiotics, antibodies, organic materials, proteins (e.g., enzymes, immunoglobulins and / or glycoproteins), nucleic acids (e.g., DNA and / or RNA), lipids, lectins, carbohydrates, whole cells (e.g., prokaryotic cells (such as pathogenic bacteria) and / or eukaryotic cells (such as mammalian tumor cells)), viruses, spores, polysaccharides, glycoproteins, metabolites, cofactors, nucleotides, polynucleotides, transition state analogs, inhibitors, nutrients, electrolytes, growth factors and other biological molecules and / or non-biological molecules, as well as fragments and combinations thereof. Some of the analytes described herein can be proteins, such as enzymes, drugs, cells, antibodies, antigens, cell membrane antigens and / or receptors or their ligands (e.g., neural receptors or their ligands, hormone receptors or their ligands, nutrient receptors or their ligands, and / or cell surface receptors or their ligands).

[0074] As used herein, the term "sample" refers to a composition comprising one or more analytes to be detected. The sample can be heterogeneous, comprising multiple components (e.g., different proteins), or homogeneous, comprising one component. In some cases, the sample can be a naturally occurring biological material, and / or an artificial material. In addition, the sample can be in a natural or denatured form. In some cases, the sample can be processed before detecting the analyte. For example, the sample can undergo a lysis step, a denaturation step, a heating step, a purification step, a precipitation step, an immunoprecipitation step, a column chromatography step, centrifugation, etc. In some cases, the separation and / or fixation of the sample (via electrophoresis) can be performed on a natural substrate and / or an analyte of interest (e.g., protein). In other cases, the sample can undergo denaturation to expose its internal hydrophobic groups to be fixed in a fluid path.

[0075] As used in this specification and claims, the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, the term "member" is intended to mean a single member or a combination of members, and "material" is intended to mean one or more materials, or a combination thereof.

[0076] As used in this specification, the term "and / or" used in this disclosure means "and" or "or" unless otherwise stated.

[0077] As used herein, "body fluid" may include any fluid obtained from the body of an individual (e.g., an athlete, a patient, etc.). For example, "body fluid" includes, but is not limited to, sweat, tears, blood, urine, breast milk, saliva, sebum, mucus, vitreous fluid, etc., or any combination thereof.

[0078] As used in this application, the terms "about" and "approximately" are used as equivalents. Any number used in this application with or without about / approximately is intended to cover any normal fluctuations recognized by a person of ordinary skill in the relevant art. In certain embodiments, unless otherwise specified or obvious from the context, the term "approximately" or "approximately" refers to a range of values ​​that falls within 10% or less in either direction (greater than or less than) of the reference value (unless such a number would exceed 100% of the possible value or be less than 0% of the possible value).

[0079] As used herein, the term "rigidity" relates to the resistance of an object to deflection, deformation and / or displacement caused by an applied force, and is generally understood to be the opposite of the "flexibility" of an object. For example, a wall with greater rigidity is more resistant to deflection, deformation and / or displacement when subjected to a force than a wall with lower rigidity. Similarly, an object with higher rigidity can be characterized as being more rigid than an object with lower rigidity. Rigidity can be characterized based on the amount of force applied to the object and the resulting distance that a first portion of the object deflects, deforms and / or displaces relative to a second portion of the object. When characterizing the rigidity of an object, the deflection distance can be measured as the deflection of a portion of the object that is different from the portion of the object to which the force is directly applied. In other words, in some objects, the point of deflection is different from the point at which the force is applied.

[0080] As used herein, the words "proximal" and "distal" refer to directions closer to and farther from a user who will place the device or system against their body, respectively. Thus, for example, the end of the device that first contacts the user's body would be the proximal end, while the other end of the device (e.g., the end of the device that is away from the user's body) would be the distal end of the device.

[0081] As described in further detail herein, any of the systems, devices, and methods may be used to collect and analyze bodily fluid samples in a repeated manner, for example by collecting a first sample or first volume of bodily fluid, testing a first volume or sample of bodily fluid, draining a first volume or sample of bodily fluid, and collecting a subsequent volume or sample of bodily fluid after a given duration. Each of the terms "first," "subsequent," and / or "initial" may be used interchangeably to describe and / or refer to an amount, portion, or volume of bodily fluid that is collected, conveyed, transferred, directed, and / or drained during use of the sample analysis systems described herein. In some embodiments, the terms "first," "subsequent," and / or "initial" may refer to a predetermined, defined, desired, or given volume, portion, or amount of bodily fluid, which may depend on a number of parameters, including device configuration, user needs, etc.

[0082] The embodiments described herein and / or portions thereof can be formed or constructed from one or more biocompatible materials. In some embodiments, the biocompatible material can be selected based on one or more properties of the constituent materials (such as, for example, rigidity, toughness, hardness, bioreactivity, etc.). Examples of suitable biocompatible materials include metals, glass, ceramics, or polymers. Examples of suitable metals include medical grade stainless steel, gold, titanium, nickel, iron, platinum, tin, chromium, copper, and / or their alloys.

[0083] The embodiments described herein and / or portions thereof may include components formed by one or more parts, features, structures, etc. When referring to such components, it should be understood that the components may be formed by a single part having any number of sections, layers, regions, parts, and / or features, or may be formed by multiple parts or features. For example, when referring to a structure such as a wall or a chamber, the structure may be considered to be a single structure having multiple parts or multiple different substructures, etc., which are coupled to form the structure. Therefore, the overall structure may include, for example, a collection of substructures. This collection of substructures may include multiple parts that are either continuous or discontinuous with each other. The collection of substructures may also be made of multiple items or components that are produced separately and then joined together (e.g., via welding, adhesives, or any suitable method).

[0084] According to some embodiments, a sample analysis system (also referred to herein as a "SA system") includes a disposable sample disposal device and a durable sample disposal device connected to the sample disposal device. In some embodiments, according to some embodiments, the sample analysis system may include a disposable sample disposal device and a disposable sample processing device connected to the sample disposal device. The sample disposal device is configured to collect a sample of a body fluid, guide the sample to a test and measurement interface, and allow the sample to be tested with a test stimulus and measure a response signal from the sample in response to the test stimulus. After the collected sample is tested, the sample disposal device is configured to guide the sample to be discharged. The response signal can then be analyzed to determine quantitative properties of the sample, such as solute concentration, solvent content, analyte concentration, etc.

[0085] Sample handling equipment

[0086] Figure 1 A schematic diagram of a segment of a user's skin is shown, and an example sample handling device positioned on the user's skin is illustrated. The schematic diagram of the skin segment shows the density of secretory glands (e.g., sweat glands) that result in holes that release body fluids (e.g., sweat). The sample handling device (also referred to herein as an "SH device") is represented by a disk and is shown as being positioned on the surface of the user's skin. As shown, the disk covers a subset of holes that release body fluids and is configured to collect sample body fluids (e.g., sweat) that can be measured and analyzed from the user when the user participates in an activity (i.e., in near real time). Although the sample handling device is shown as being used to collect and analyze sweat on the user's skin, it should be understood that the sample analysis system described herein including the sample handling device can be used without being attached to the user and can be used to analyze any number of other body fluids.

[0087] Figure 2A and 2Bis a schematic diagram of an example sample handling device 110 indicating some of the components included in the sample handling device 110 according to an embodiment. Figure 2B The schematic diagram in includes an illustration of an example configuration of various components of the sample handling device 110, and a flow path defined for the flow of a sample of bodily fluid indicated by dashed arrows. In some embodiments, the sample handling device 110 can be constructed as a whole. In some other embodiments, the sample handling device 110 can be constructed by assembly of a collection of parts or layers, as described in further detail herein. Figure 2A and 2B As shown in , the sample handling device 110 includes a sample collection area 112 , an entry port 114 , a flow channel 116 , a testing area(s) 118 , a set of electrodes 120 , and optionally a temperature sensor 140 .

[0088] The sample collection area 112 is a portion of the sample handling device 110 that is configured to receive and collect a body fluid sample, such as sweat, from the user's body when the user wears the sample handling device 110. The sample collection area 112 includes an opening 122, such as Figure 2B As indicated in , the opening allows access to a source of bodily fluid when the user wears the sample handling device 110. The sample collection area 112 also defines a space or volume that is configured to be fluidically coupled to the opening 122 and configured to hold or collect a sample of bodily fluid when the user wears the sample handling device 110. Although Figure 2A and 2B 10. Although not shown, the sample handling device 110 may include one or more interface structures between the user's body and the sample collection area 112 of the sample handling device 110. Such interface structures may be configured for ease of use or increased comfort when using the sample handling device 110. For example, one or more pads may be used to provide a better interface with the user's body and increase comfort during use of the sample handling device 110. In addition, the interface structure may be used to provide a seal between the sample handling device 110 and the user's body so that pressure generated by the sweat glands forces sweat to pass through the flow channel 116.

[0089] In some embodiments, the sample collection area 112 can be defined by one or more parts of the sample handling device 110. For example, in some embodiments, the sample collection area 112 can be formed by assembling two or more parts or layers of the structure to include an opening 122 for collecting body fluids, and define a specific volume to temporarily hold a sample of the collected body fluid. Two or more parts or layers can be selected or made so that once assembled, the sample collection area 112 includes a suitable opening 122, and the body of the assembled parts of the sample handling device 110 defines a volume in the sample collection area 112, which can hold an appropriate amount of collected body fluid. For example, the thickness of the two or more parts can be selected to determine the volume or fluid capacity of the sample collection area 112. The two or more parts can be assembled using any suitable method, such as friction fit, gluing using an adhesive material (e.g., transfer adhesive), using fasteners, etc. In some other embodiments, the sample collection area 112 can be integrally formed by a single integral part or structure to include an opening 122, which is appropriately configured to collect body fluid samples and defines a volume for accommodating the collected body fluid samples.

[0090] The portion forming the sample disposal device 110 and / or the sample collection area 112 may have suitable flexibility to provide convenience for the user to wear, and provide convenience for access to a source of bodily fluids. For example, in some embodiments, the portion or layer forming the sample disposal device 110 and / or the sample collection area 112 may have a flexible property so that the sample disposal device 110 can be worn on the surface of the user's skin, and the proximal portion of the sample collection area 112 can optimally dock with the user's skin and conform to the contour of the user's body, even when the user is involved in an activity. In some embodiments, the sample disposal device 110 and / or the sample collection area 112 may have a relatively rigid construction so that the rigidity allows for better docking with the surface of the user's body and prevents the sample disposal device 110 from being misplaced or falling off the user during intense activity. In some embodiments, one or more portions or components of the sample disposal device 110 may be made rigid to achieve a locally rigid construction. The portion of the locally rigid construction may be designed to avoid deformation of the sample analysis and / or test area 118. For example, the locally rigid portion can be configured so that the testing area 118 deforms no more than a few percent (e.g., 0-10%) under a load of approximately 1-10 Newtons. In some embodiments, the sample handling device 110 can be configured so that portions other than the locally rigid portion of the device and / or the sample collection area 112 are generally flexible and conform to the skin and / or body of the user.

[0091] exist Figure 2BThe opening 122 defined in the sample collection area 112 shown in the figure can make a source of a bodily fluid sample (e.g., skin containing sweat pores) accessible and fluidly connected to a sample configured to temporarily contain the bodily fluid collected from the source. The sample collection area 112 can be formed such that the volume and the opening 122 are defined in the body of the sample handling device 110 or a portion of the body of the sample handling device 110. In some embodiments, for example, the sample collection area 112 can be configured such that, when the sample handling device 110 is positioned on the user's body, the sample collection area 112 is located proximal to the user's skin surface and covers a suitable skin area to collect a suitable volume of bodily fluid (such as sweat) over a suitable period of time. For example, as Figure 1 As shown in the schematic diagram in , a section of a user's human skin can have a specific density of sweat pores that release sweat, with each pore separated from the other pores by a specific distance. The sample collection area 112 can be configured so that when the opening 122 is placed on the user's skin, it can cover a specific skin area containing a specific minimum number of sweat pores. Such positioning can allow an initial amount of sweat released from those pores to be collected within a desired period of time. In other words, the opening 122 can be large enough to collect sweat from enough sweat glands to substantially fill the sample collection area 112 in a relatively short period of time, so that the sweat can be analyzed shortly after the user begins to sweat.

[0092] In some embodiments, the SA system may require a minimum amount of body fluid for accurate testing and analysis. The volume of the opening 122 and / or the sample collection area 112 may be configured to determine the volume of body fluid collected in the initial sample and ensure that the collected initial sample meets the minimum amount of body fluid required for accurate testing and analysis. In some embodiments, the sample collection area 112 may include one or more structures ( Figure 2A and 2B ), which is constructed to occupy and / or occupy the volume in the sample collection area 112 so that the volume of the initial sample of body fluid to be collected and guided via the entry port 114 can be smaller than the total volume defined by the sample collection area 112.

[0093] The space-occupying structure(s) may be defined in the sample collection area 112 in any suitable manner. In some embodiments, the space-occupying structure(s) may be solidly formed, for example, assembled and / or deposited as a material, such as a spacer ink (e.g., ink cured by UV light), etc., using one or more spacer portions of a spacer film on the surface of the sample collection area 112. For example, the space-occupying structure may include (e.g., deposited) on a layer or portion used to form a wall of the sample collection area 112. In some embodiments, the space-occupying structure may be implemented by assembling one or more spacer layers or portions with one or more other portions to form the sample collection area 112. In some embodiments, the space-occupying structure(s) may include an outer covering that defines a hollow portion within the outer covering and / or encapsulates a volume defined within the outer covering. In some embodiments, the outer covering of the space-occupying structure may be molded and / or contoured to define a space that may be excluded or isolated from the volume defined by the sample collection area 112.

[0094] In some embodiments, the volume of the initial sample may also determine the ease of collection, the direction and discharge of the fluid flow to be tested, and thus the rate at which the sample can be collected and tested or analyzed. In other words, in some embodiments of the sample handling device 110, an initial sample of body fluid (e.g., sweat) may be collected, the volume of the initial sample being determined by the volume of the sample collection area 112. The collected initial sample may be directed into the flow channel 116 through the entry port 114 for testing and discharged in a continuous stream of body fluids, thereby leaving room for continuous collection of body fluids subsequently secreted by the user during use. The process of sample collection, sample testing, and sample discharge may be performed in a continuous manner, with the collected body sample continuously flowing through the collection area 112, the entry port 114, the flow channel 116, and (one or more) testing areas 118 at a suitable rate. In such embodiments, the volume of the sample collection area 112 and the size of the opening 122 defined in the sample collection area 112 may determine the rate at which the initial amount of the sample is collected. The volume of sample collection area 112 and the size of opening 122 may determine in part the linear flow rate (i.e., the volumetric flow rate divided by the cross-sectional area of ​​flow channel 116) at which sample is directed through entry port 114, flow channel 116, and testing area(s) 118 before being expelled.

[0095] In some embodiments, by way of example, the sample collection area 112 may have a volume and / or fluid capacity between about 0.01 milliliters (mL) and about 5.0 mL. In some embodiments, the sample collection area 112 may have a fluid capacity between about 0.02 mL and about 1 mL, between about 0.03 mL and about 0.5 mL, between about 0.04 mL and about 0.3 mL, between about 0.06 mL and about 0.1 mL, including all ranges or sub-ranges therebetween. In some embodiments, the sample collection area 112 may have a volume sufficient to accommodate as little as microliters or less of body fluid (e.g., as little as 20 drops of body fluid, 10 drops of body fluid, 5 drops of body fluid, 1 drop of body fluid, or any suitable volume therebetween). In other embodiments, the sample collection area 112 may have a volume of up to, for example, about 5.0 mL, 10.0 mL, 15 mL, or more. In some embodiments, the sample collection area 112 may have a fluid capacity based on a volume defined by one or more space-occupying structures and / or based on a volume isolated and / or removed by a space-occupying structure, as previously described.

[0096] like Figure 2A and 2B As shown in , the entry port 114 of the sample handling device 110 is fluidically coupled to the sample collection area 112. The entry port 114 can be an opening, a through hole, a conduit, a fluid flow path, etc., defined in the body of the sample handling device 110 to fluidly connect the sample collection area 112 to the flow channel 116, which is further described in detail below. In some embodiments, the sample collection area 112 can be formed by assembling two or more parts or structures, as described herein. In some embodiments, one of the parts can be configured to include and / or define the opening 122, while another part can be configured to include and / or define the entry port 114. One or more of the assembled parts can be configured to form one or more walls of the sample collection area 112 when assembled. In embodiments where the sample collection area 112 is defined as a unitary structure, the entry port 114 can be an orifice, a conduit, and / or a flow path defined in the body of the sample handling device 110 to fluidically couple the sample collection area 112 with the flow channel 116.

[0097] The access port 114 can be located at any suitable position relative to the sample collection area 112 to mediate the fluid connection between the sample collection area 112 and the flow channel 116. For example, in some embodiments, the access port 112 can be an orifice defined on the inner surface of the sample collection area 112. In some embodiments, the access port 114 can be defined on a distal portion of the sample collection area 112 (i.e., away from the user's body when the sample handling device 110 is used). In some embodiments, for example, the access port 114 can be defined at a central portion relative to the opening 122 and / or a volume defined by one or more walls of the sample collection area 112 to accommodate the collected body fluid. In some other embodiments, for example, the access port 114 can be defined at an eccentric position relative to the opening 122 and / or a volume defined by the walls of the sample collection area 112 to hold the collected body fluid. In some embodiments, the access port 114 can be located at any suitable position relative to the sample collection area 112, the opening 122, and / or the flow channel 116 to prevent and / or flush the formation of bubbles in the sample of the collected body fluid. In some embodiments, the access port 114 may be located such that the sample collection region 112 is adapted to direct fluid flow toward the access port 114, such as via one or more structural narrowings, conduits, contours, etc.

[0098] The entry port 114 can be of any suitable size to allow the collected bodily fluid sample to be transported from the sample collection area 112 to other portions of the sample handling device 110 (e.g., (one or more) testing areas 118, etc.). In embodiments, the size of the entry port 114 can range from a few hundred microns to a few millimeters. For example, the entry port 114 can have an internal cross-sectional diameter between about 0.05 millimeters (mm) and about 5.0 millimeters (mm). In some embodiments, the entry port 114 can have a cross-sectional area sufficient to allow the collected bodily fluid sample to flow continuously to the flow channel 116.

[0099] In some embodiments, the inlet port 114 can be configured to allow continuous flow of the collected bodily fluid sample once the initial sample of bodily fluid reaches a minimum volume. In some embodiments, the inlet port 114 can be configured to allow continuous flow of the collected bodily fluid sample after the sample collection area 112 reaches a minimum amount of positive pressure from collecting a large or minimum volume of bodily fluid (e.g., as small as 20 drops of bodily fluid, 10 drops of bodily fluid, 5 drops of bodily fluid, 1 drop of bodily fluid, 20 μL, 15 μL, 10 μL, 5 μL, or any suitable volume therebetween).

[0100] The entry port 114 can use the SA system with the sample handling device 110 to determine the flow rate of the collected body fluid to be tested. In some embodiments, the entry port 114 can have a wicking property to draw the collected fluid sample from the sample collection area 112 into the flow channel 116. In some embodiments, the sample collected in the sample collection area 112 can be guided into the entry port 114 and beyond by a pressure differential. For example, the lower pressure in the entry port 114 and the flow channel 116 compared to the sample collection area 112 can extract the collected body fluid sample through the entry port 114 and the flow channel 116. Similarly, as the sample collection area 112 is increasingly filled with the collected body fluid, the increase in pressure in the sample collection area 112 (i.e., generated by the sweat glands) can push the collected body fluid sample through the entry port 114 into the flow channel 116. In other words, the seal between the sample handling device 110 and the user's body is sufficiently impermeable to the fluid so that the pressure generated by the sweat glands prompts sweat to pass through the flow channel 116. In some other embodiments, the access port 114 may be configured such that fluid in the sample collection area 112 is drawn out by capillary action.

[0101] The flow channel 116 can have any suitable width, height, diameter or cross-sectional area to receive the collected body fluid sample from the sample collection area 112 through the entry port 114 and appropriately transport the body fluid sample to other parts of the sample handling device 110, such as (one or more) test areas 118. For example, the flow channel 116 can have a circular cross-section with a suitable diameter, or a rectangular cross-section of the flow channel 116 with a suitable width and height. The width, height or diameter of the flow channel 116 can range from hundreds of microns to several millimeters. For example, the width, height and / or diameter of one or more parts of the flow channel 116 can be between about 0.05 millimeters (mm) and about 5.0 mm. The flow channel 116 can extend any suitable length, from a few millimeters to a few centimeters, and is configured to present any suitable shape along the length. For example, the flow channel 116 can extend over a length between 5 millimeters (mm) and about 15.0 centimeters (cm). The flow channel 116 can be configured to follow any suitable path, such as a linear, straight, curved or serpentine path.

[0102] In some embodiments, the flow channel 116 may be defined within an integrally constructed, monolithic structure such that the diameter of the flow channel 116 is determined, at least in part, by the thickness of the monolithic structure defining the flow channel 116. In some other embodiments, the flow channel 116 may be constructed by assembling two or more portions or layers of a structure that together define the flow channel 116. In some embodiments, the flow channel 116 may be formed from several layers or portions assembled together to direct the flow of a fluid through one or more channels, through-holes, apertures, etc. The flow channel 116 may be configured such that external influences during use (such as forces generated by gravity, movement of a user's body, etc.) do not interfere with the flow of fluid within the flow channel 116 and / or do not significantly change the physical shape or size of the flow channel 116 while in use.

[0103] In some embodiments, the flow channel 116 may include various parts that are appropriately configured to guide the flow of body fluids at a suitable flow rate or flow rate. For example, in some embodiments, the flow channel 116 may include parts configured with different cross-sectional shapes and / or sizes. For example, some parts of the flow channel 116 may be circular or rectangular, while other parts are not. Similarly, some parts of the flow channel 116 may have a narrower or wider cross-sectional area compared to other parts of the flow channel 116. In some embodiments, the flow channel 116 may include an inflow portion and an outflow portion. The inflow portion of the flow channel 116 may be configured to transport the body fluids collected in the sample collection area 112 to the test area 118 described below via the entry port 114. The outflow portion of the flow channel 116 may be configured to remove the body fluid sample after testing at the test area 118 to discharge it from the sample handling device 110, such as into the environment. For example, in some embodiments, the flow path 116 can be configured to be linear at some portions defined by the one or more testing areas 118 and the outflow portion of the flow channel 116 can include a tortuous exhaust path to reduce and / or avoid air ingress. In some embodiments, the tortuous path can be configured to reduce and / or avoid undesirable fluid / air flow due to gravity, acceleration, user motion, etc.

[0104] The inflow and outflow portions of the flow channel 116 can be appropriately shaped to allow optimal flow of the bodily fluid sample, optimal access to the bodily fluid sample for testing, and optimal discharge of the sample after testing. In some embodiments, portions of the flow channel 116 can also include structural and / or functional adjustments to overcome or allow for physical forces (such as stresses and / or strains that may be encountered when the sample handling device 110 is used when the user is engaged in intense activities). For example, in some embodiments, the flow channel 116 can be constructed to include suitable linear, angular and / or curved portions or serpentine portions to better withstand different types of physical forces, including stresses and / or strains encountered when the sample handling device 110 is worn by the user in high-intensity or contact sports activities. In some embodiments, the flow channel 116 can be constructed to include one or more curved portions or serpentine portions to act as a localized trap to prevent air from outside the sample handling device 110 from entering the flow channel 116.

[0105] like Figure 2B , the flow channel 116 may include an outlet 124 to discharge the collected and tested bodily fluid sample. In some embodiments, the bodily fluid sample may be directed through the outflow portion of the flow channel 116 and through the outlet 124 by a series of pressure differentials. In some other embodiments, after testing at the (one or more) testing areas 118, the bodily fluid sample may be directed toward the outlet 124 by one or more suitable physical forces. For example, the bodily fluid sample may be discharged through the outlet 124 by gravity, capillary action, motion of the user, etc.

[0106] like Figure 2A and 2B As shown in , the sample handling device 110 includes (one or more) test areas 118. (One or more) test areas 118 may include any suitable number of test areas defined along the flow channel 116. For example, in some embodiments, the sample handling device 110 may include two, three or more test areas defined at a specified portion of the flow channel 116, so that the body fluid collected at the sample collection area 112 can be guided via the entry port 114 and passed through one or more test areas for sequential or parallel processing, as described herein. In some embodiments, (one or more) test areas 118 can be separated from the flow channel 116 but fluidly coupled. In some embodiments, (one or more) test areas 118 can be defined as a portion of the flow channel 116. For example, the flow channel 116 can include an inflow portion and an outflow portion separated by (one or more) test areas 118 as a third portion. (One or more) test areas 118 can be configured to intersect with the body fluid flow in the flow channel 116. In some embodiments, (one or more) test areas 118 can be configured to define a volume sufficient to accommodate a portion of the body fluid sample when tested.

[0107] The (one or more) test areas 118 of the sample handling device 110 may include a collection of sample ends of a collection of electrodes 120, which are configured to interface with a bodily fluid sample flowing through the test area 118. The collection of electrodes 120 may include any suitable number of electrodes and the sample end of each electrode may be configured to deliver an excitation signal to the bodily fluid sample to be tested (e.g., as a current delivery electrode), or to sense a response signal from the bodily fluid sample tested with the excitation signal (e.g., as a voltage sensing electrode). In some embodiments, the electrodes 120 may include electrodes configured to power one or more components (e.g., one or more sensors, such as a temperature sensor, etc.) included in the sample handling device 110 and / or carry signals from one or more components to the sample handling device (e.g., a signal reporting a temperature measurement value through a temperature sensor). The number of electrodes may be appropriately optimized in different embodiments of the sample handling device taking into account parameters such as the number of electrodes required to effectively deliver the excitation signal, the number of electrodes required for a predetermined signal-to-noise ratio in the response signal obtained from the test sample of the bodily fluid, the number of electrodes suitable for meeting a predetermined form factor or structural and / or functional constraints, etc. For example, in some embodiments, the set of electrodes may include four electrodes, two of which are configured to deliver an excitation signal in the form of a test current signal, and two of which are assigned to record a response voltage from a body fluid sample after applying the test current signal. As an example, electrode 120 may be configured as a quadrupole impedance cell. As another example, in some other embodiments, the set of electrodes may include two electrodes, one configured to deliver an excitation signal and the other configured to read a voltage and / or current from a body fluid sample being tested. For example, electrode 120 may be configured as a bipolar impedance cell.

[0108] The set of electrodes may have a test end at the test area (one or more) 118, configured to interact with the body fluid sample in the test area (one or more) 118. The set of electrodes may include an excitation electrode and a sensing electrode. In some embodiments, each electrode in the set of electrodes 120 may be configured to be used as either an excitation electrode or a sensing electrode. In some embodiments, the set of electrodes 120 may include an excitation electrode designated to deliver an excitation signal to a portion of the body fluid sample at the test area (one or more) 118, and a sensing electrode designated to sense a response signal from the body fluid sample in response to the application of the excitation signal. The set of electrodes may include a terminal (not shown) configured to interact with a portion of the sample processing device described herein and a sample end configured to interact with a portion of the sample fluid at the one or more test areas 118. In some embodiments, for example, the excitation electrode may be configured to receive an excitation signal from a power source at a terminal and deliver the excitation signal at a sample end to a portion of the body fluid sample guided with a flow channel and guided to the test area 118. Take another example. The sensing electrode can be configured to receive a response signal emitted from a portion of the bodily fluid sample at the test area 118 at a sample end that interfaces with a portion of the bodily fluid sample at the test area 118 and deliver the received response signal to a terminal that interfaces with a portion of the sample processing device so that the response signal can be appropriately processed and / or analyzed by a processor, and / or stored in a memory associated with the sample processing device. In some embodiments, the sample processing device can be configured to receive response signals from electrodes 120 associated with two or more test areas 118 so that the response signals from each of the two or more test areas 118 can be compared to determine the characteristics of the sample bodily fluid.

[0109] In some cases, the distance between electrodes 118 associated with two or more test areas 118 can be used to determine characteristics of the sample fluid. For example, the impedance associated with the response signal from each test area 118 can be used to estimate the flow rate and / or volumetric flow rate of the sample fluid. In some embodiments, the known geometry of the flow path connecting the test area(s) 118 can be used to calculate the volumetric flow rate.

[0110] The secretion rate of the sample body fluid (e.g., the rate of sweating) can be estimated or inferred from the volume flow rate of the sample body fluid. In some embodiments, the user's sweat rate can be calculated using known attributes of the user (height, weight, etc.). In some embodiments, the sweat rate can be used to estimate the cumulative body fluid loss over time and / or the cumulative electrolyte loss over time.

[0111] In some embodiments, the excitation signal can be a test current signal. In some embodiments, the electrode 120 is configured so that the test current signal is in the form of a direct current. In some embodiments, the electrode is configured so that the applied test current signal is in the form of an alternating current (AC). In an embodiment using an alternating current, the electrode 120 can be configured so that the alternating polarity of the test current signal experienced by the electrode allows a partial reversal of the effect of the salinity of the body fluid sample on the electrode. Therefore, using AC to excite can help prevent rapid corrosion and / or ionization of the electrical interface of the electrode in the test area, which otherwise can be the result of a direct current excitation signal. In some embodiments, one or more of the electrodes 120 can have a coating with one or more suitable materials (e.g., carbon) to reduce the corrosive effects of the tested body fluid. In some embodiments, the electrode can be capacitively coupled or AC coupled to an electronic device so that no DC can flow through the sample, thereby reducing the risk of corrosion or ionization.

[0112] In some embodiments, electrode 120 can be configured to detect the presence of one or more ions in a body fluid sample. For example, in some embodiments, electrode 120 can be configured to detect Na+ in a portion of an initial body fluid volume. + , Cl - , Ca 2+ , K + or Mg 2+ The presence and / or quantification of one or more of the ions.

[0113] Although described with reference to detecting the presence of ions, the systems, devices, and methods described herein may be equally suitable and / or used to detect and / or quantify the presence of analytes in bodily fluid samples. For example, the presence of lactose, glucose, etc. may be detected and / or quantified.

[0114] In some embodiments, the sample handling device 110 may optionally include one or more temperature sensors 140. The temperature sensor 140 may be appropriately located at or near the one or more test areas 118 and configured so that the temperature sensor 140 can record the temperature of the body fluid sample being tested at the one or more test areas 118. In some embodiments, the temperature sensor 140 may be positioned to monitor and measure the temperature of the body fluid sample during testing in the one or more test areas 118. The temperature sensor 140 may be any suitable temperature sensing device that may be appropriately positioned adjacent to the test area 118 and used to measure the temperature of the body fluid sample. For example, the temperature sensor 140 may be a thermistor or a thermistor assembly. In some embodiments, the sample handling device 110 may include additional sensors (not shown) to record environmental conditions. For example, the sample handling device 110 may include a temperature sensor to measure the user's skin temperature and / or the ambient air temperature. In some embodiments, the sample handling device 110 and / or a sample handling device coupled thereto may include any number of additional sensors to sense pressure, humidity, etc. In some embodiments, the temperature sensor 140 may be used to calculate the temperature of the body fluid sample, from which an estimate of the user's core body temperature may be calculated. In some embodiments, core body temperature can be used to estimate a user's hydration and / or electrolyte loss and / or cumulative rate of loss and / or to estimate the impact of hydration and / or electrolyte loss.

[0115] In use, the sample handling device 110 is positioned on the surface of the user's body to collect and guide body fluids for testing and analysis to determine the user's health status. For example, the sample handling device 110 can be positioned on the arm of an athlete participating in a sporting event to collect and test the user's sweat and analyze the salinity of the collected sweat, from which the user's hydration status, electrolyte loss, and sweat rate can be determined. The sweat is collected in the sample collection area 112 of the sample handling device 110 and is continuously guided through the entry port 114 to the flow channel 116. In some cases, the spacer portion included in the sample collection area 112 can occupy space within the sample collection area 112 and reduce the amount of body fluid sample that needs to be collected to promote or start the flow of body fluid via the flow channel 116. The portion of the flow channel 116 is configured to guide the collected sweat to (one or more) test areas 118 at a continuous flow rate, where the sweat interacts with the collection of electrodes 120 in the test area 118. An excitation or test current signal is delivered to the sample sweat in the test area 118 via one or more electrodes (current delivery electrodes) in the set of electrodes 120. The response voltage generated by the sweat sample in response to the excitation or test current signal is read from the set of electrodes 120 by one or more electrodes (voltage sensing electrodes, different from the current delivery electrodes). In some cases, the excitation or test current signal can be delivered and the response voltage can be read in a continuous manner. The voltage read from the sweat sample is used to calculate the impedance associated with the sweat sample, and the impedance can be associated with the quantification or measurement of the sweat salinity and other physiological information of the user. Therefore, the sweat of the user can be continuously tested over a period of time, and the salinity measurement of the user's sweat can be associated with the continuous measurement of the degree of hydration electrolyte loss and the sweat rate of the user over a period of time when the user is engaged in an activity.

[0116] Example Sample Analysis System

[0117] Figure 3 is a schematic diagram of a sample analysis system 100 according to an embodiment. The SA system includes a sample handling device 110 and a sample processing device 130 as described above, which are coupled to each other via a connector 125. In some embodiments, the connector 125 can be permanently connected to the sample handling device 110 and / or the sample processing device 130 or can be removable. In some cases, the sample analysis system 100 can be configured to be integrated into, integrated into, or integrated with a wearable device 145 (e.g., a watch, an odometer, an activity tracker, a heart rate monitor, etc.). Although Figure 3 The SA system 100 illustrated in FIG. 1 includes a sample processing device 130 and is coupled to a wearable device 145 , but in some cases, the sample handling device 110 may be directly integrated with the wearable device 145 without the sample processing device 130 .

[0118] The connector 125 can be a mechanical connector defined on the sample processing device 130, configured to engage with a portion of the sample processing device 110 so that the sample processing device 110 can be installed on the sample processing device 130 before being worn by the user. In some embodiments, the sample processing device 130 can be constructed as a durable multiple-use device, and the sample processing device 110 can be constructed as a disposable device, which can be installed and / or connected to the sample processing device for a use period (e.g., an active period) and discarded to be replaced by another sample processing device 110. The connector 125 can be configured so that it allows the sample processing device 110 to be easily removed and replaced. In addition to the physical connection, the connector 125 can also include a collection of suitable electrical connections to electrically couple the sample processing device 110 to the sample processing device 130. For example, the connector can be in the form of spring pins and / or flexible contacts that can be engaged to provide an electrical connection when the sample processing device 110 is mechanically coupled to the sample processing device 130, such as using a snap ring interface.

[0119] The sample handling device 130 can have a suitable form factor to be easily worn by a user while performing strenuous activities so that the sample handling device 110 can properly interface with the user's body (e.g., a portion of the user's skin). The sample handling device 130 can include a processor 132, a memory 136, a communicator 138, and a display 142.

[0120] The processor 132 may be, for example, a hardware-based integrated circuit (IC) or any other suitable processing device configured to run and / or execute an instruction set or code. For example, the processor 132 may be a general-purpose processor, a central processing unit (CPU), a microcontroller, an accelerated processing unit (APU), an application-specific integrated circuit (ASIC), a field programmable gate array (FPGA), a programmable logic array (PLA), a complex programmable logic device (CPLD), a programmable logic controller (PLC), etc. The processor 132 is operably coupled to the memory 136 via a system bus (e.g., an address bus, a data bus, and / or a control bus). The processor 132 may be configured to perform a set of functions to test, measure, and analyze the characteristics of the sample body fluid collected by the sample handling device in near-instantaneous or real-time. For example, the processor 132 may be configured to generate a set of excitation signals to detect a body fluid sample, provide instructions for delivering the excitation signal via the electrodes in the sample handling device 110, receive a response signal obtained from a body fluid sample read by the electrodes in the sample handling device 110, and interpret the response signal to determine the characteristics of the sample body fluid, thereby indicating the health status of the user. In some embodiments, the processor 132 may also be configured to perform additional functions, such as indicating to the user via a display 142 (e.g., a graphical display) relevant information about the characteristics of the sample fluid being analyzed and / or the state of the user at the time of the test. In some embodiments, the processor 132 may also be configured to transmit the collection, interpretation, and / or analysis results of the signals to a remote computing device for further processing, as described herein.

[0121] The memory 136 of the sample processing device 130 can be, for example, a random access memory (RAM), a memory buffer, a portable hard drive, a read-only memory (ROM), an erasable programmable read-only memory (EPROM), etc. The memory 136 can store, for example, user data for later use / analysis and / or one or more software modules and / or codes, which can include instructions for causing the processor 132 to perform one or more processes, functions, etc. described herein (e.g., generation of excitation signals, delivery of test signals, reading and analysis of response signals, etc.). In some embodiments, the memory 136 can be a portable memory (e.g., a flash drive, a portable hard disk, etc.) that can be operably coupled to the processor 132. In other cases, at least a portion of the memory can be remotely operably coupled to the sample processing device 130. For example, a remote database server can be operably coupled to the sample analysis system 100 via the sample processing device 130.

[0122] The communicator 138 may be a hardware device operably coupled to the processor 132 and the memory 136 and / or software stored in the memory 136 and executed by the processor 132. The communicator 138 may be, for example, a compact network interface card (NIC), a Wi-Fi module, a Bluetooth Module, radio frequency communication module and / or any other suitable wired and / or wireless communication device. In addition, the communicator may include a switch, a router, a hub and / or any other network device. The communicator 138 may be configured to connect the sample processing device 130 to a communication network or one or more computing devices. In some cases, the communicator 138 can facilitate receiving and / or transmitting files and / or collections of files to one or more computing devices (e.g., computers, smart phones, remote databases, servers, etc.) via a communication network.

[0123] The display 142 can be a low-power module that is configured to indicate one or more results from the analysis of the bodily fluid sample collected and tested by the sample analysis system 100. For example, the display 142 can be configured to have a collection of backlit icons that indicate the user's hydration status, or an indication of increased hydration of the user, etc. In some embodiments, the display 142 can also be configured to include a status indicator associated with the sample processing device 130 or the sample handling device 110. For example, the display 142 can be configured to remind the user that the sample handling device 110 needs to be replaced or the sample processing device 130 needs to be charged. For example, the sample processing device 130 can be configured to be powered by a disposable or rechargeable battery power unit. In an embodiment including a rechargeable power supply, the sample processing device 130 may include an adapter for recharging the power supply unit when plugged into an electrical outlet. In some embodiments, the sample processing device 130 may include a device that indicates the charging status.

[0124] Figure 4 An example configuration of a sample handling device 210 according to an embodiment is illustrated. The sample handling device 210 may be similar in form and / or function to the above referenced Figure 2A and 2B The sample handling device 110 described is substantially similar. For example, the sample handling device 210 may include a sample collection area, an entry port, a flow channel, a testing area, and a collection of electrodes, as described with reference to the sample handling device 110. Thus, such similar parts and / or aspects will not be described in further detail herein.

[0125] As described above with reference to the sample handling device 110 , one method of constructing the sample handling device 210 includes assembling elements or portions or layers of particular shapes in particular configurations to form various components or elements of the sample handling device 210 . Figure 4An example set of structural layers that can be used to assemble the sample disposal device 210 described herein is illustrated. The layers of the sample disposal device 210 can be made of suitable materials to confirm the requirements of the sample disposal device 210 during use. For example, one or more layers can be rigid, while one or more layers can be flexible. The layers can be made of biocompatible materials (e.g., biocompatible polymers). In some embodiments, the layers can be made of cut pieces of suitable materials to confirm a specific shape including specific features.

[0126] like Figure 4 As shown in , the sample handling device 210 can be in the form of a patch composed of a collection of layers, including an interface layer 211, an adhesive layer 213, an access port layer 215, and an electrode and channel layer 217 (either a single layer or two discrete layers). In some embodiments, the sample handling device 210 can include additional layers 219 to provide interface advantages with a user or with a sample handling device, or to provide additional support during use of the sample handling device 210, etc. In some embodiments, as previously described, the sample handling device 210 can be configured as a disposable device for use with an appropriately compatible durable, multi-use sample handling device.

[0127] Interface layer 211 can be a cushioning layer (e.g., a release liner) having one or more adhesive portions on the proximal and / or distal sides. Interface layer 211 can be configured to be placed on a surface of a user's body, with the proximal side facing the user's body. In some embodiments, the adhesive properties of the proximal side can be used to secure sample disposal device 210 to the user's body. In some embodiments, the adhesive properties of the distal side of the interface layer can be used to secure interface layer 211 to a subsequent layer in the assembly of layers, adhesive layer 213, to form sample disposal device 210. In some embodiments, interface layer 211 can include an adaption to allow a user to manipulate sample disposal device 210 while mounting sample disposal device 210 on a sample processing device or on a user. For example, interface layer 211 can include tabs that protrude or extend beyond the contours of other layers of sample disposal device 210, which can be used to hold sample disposal device 210.

[0128] The adhesive layer 213 is configured to be positioned or assembled on the interface layer 211 and to have adhesive properties on the proximal and / or distal sides thereof. The adhesive layer 213 can be assembled on the interface layer 211 using the adhesive properties on the distal side. The adhesive layer 213 is configured to form an opening and a boundary wall of the sample collection area of ​​the sample handling device 210. The adhesive layer 213 may include and / or define an opening of a suitable size corresponding to the opening of the sample collection area of ​​the sample handling device 210. The opening in the adhesive layer may be a portion (e.g., a centrally located cutout portion) cut out from the adhesive layer and without any adhesive properties. The thickness of the adhesive layer 213 may form a sample collection-enabled boundary wall and determine the volume or fluid capacity of the sample collection area of ​​the sample handling device 210. For example, the thickness of the adhesive layer 213 may be selected so that the opening defined in the adhesive layer 213 and the thickness of the opening together define a volume or space in which a body fluid sample may be collected to form a sample collection area. Although Figure 4 A single adhesive layer 213 is indicated, but in some embodiments, two or more adhesive layers may be assembled to collectively form a sample collection area having a common thickness for all adhesive layers. In assembly of the sample handling device 210, the adhesive properties of the distal side (facing away from the user's body) of the adhesive layer 213 may be used to secure the adhesive layer 213 to subsequent layers, entering the port layer 215.

[0129] The access port layer 215 may have adhesive properties on its proximal side facing the adhesive layer 213, which may be used to assemble the access port layer 215 on the adhesive layer 213. The portion of the access port layer 215 near the cutout portion of the adhesive layer 215 forms a bottom or wall portion of a sample collection area defined by the opening and thickness of the adhesive layer 213. The access port layer 215 includes an opening defined in the bottom or wall portion of the sample collection area to serve as an access port for the sample disposal device 210. The opening in the access port layer 215 may be positioned in any suitable position so that it provides access to the sample collection area. The opening forming the access port of the sample disposal device 210 may have a suitable size to form a conduit through the access port layer 215 and fluidly connect the sample collection area to the other side or proximal side of the access port layer for the flow of the collected body fluid sample. The thickness of the access port layer 215 may determine the length of the conduit defined by the access port. In some embodiments, the access port layer 215 may be made of a flexible material such as polyethylene terephthalate (PET) having a suitable thickness, such as 3 mil PET. In some embodiments, any suitable material, such as polydimethylsiloxane (PET), silicon, polyurethane, glass, or any other suitable material, may be used to form one or more layers of the sample handling device 210. In some embodiments, the material may be selected based on one or more properties, such as stiffness, compliance, thickness, thinness, transparency, receptivity to interfaces with various adhesives, receptivity to screen printing one or more conductive traces (e.g., using conductive ink to form electrodes), etc.

[0130] The electrode and channel layer 217 includes a proximal side and a distal side, both of which may include surface portions with adhesive properties to assist in assembling the sample handling device 210. The proximal side of the electrode layer may include and / or define a flow channel, while the distal side of the electrode and channel layer 217 includes a collection of electrodes. The electrode and channel layer 217 may be configured to form a flow channel on the proximal side by defining one or more grooves in the thickness of the electrode and channel layer 217, such that when assembled on the entry port layer 215, the depth of the groove determines the cross-sectional area of ​​the flow channel of the sample handling device 210. The remaining portion of the proximal side of the electrode and channel layer 217 in contact with the entry port layer 215 may have adhesive properties to attach to the distal side of the entry port layer 215. In such a configuration, the flow channel is formed such that a portion of the wall of the flow channel along the length is formed by the grooves defined in the electrode and channel layer 217, while another portion of the wall of the flow channel is formed by the entry port of the distal layer 215 layer. The flow channel may be formed to include a test area.

[0131] The distal side of the electrode and channel layer 217 may include a conductive portion made of a conductive ink etched, printed, coated or applied to form a collection of electrodes. For example, the electrode can be formed by printing an ink containing 80% silver and 20% silver chloride. The collection of electrodes may include an excitation or test current signal delivery electrode and a voltage sensing electrode. The electrode layer 217 includes a non-conductive portion surrounding the electrode portion to form a defined path or trace for the electrode. In some cases, the proximal side of the portion of the electrode and channel layer 217 containing the distal electrode may be coated or applied with a dielectric material to protect the electrode traces in the distal side. The electrode includes a test end located near or in the flow channel path, at the test area, allowing access to a portion of the sample body fluid that can flow through the flow channel. In other embodiments, another type of material may be selected for the electrode ink depending on the sensing method.

[0132] In use, similar to the sample handling device 110, some embodiments of the sample handling device 210 can be configured to conduct the collected sweat from a small area of ​​sweat glands on the user's skin in a sample collection area and at a suitable flow rate for testing. The collected sweat can be continuously guided through the entry port to the test area via a flow channel and pass through a collection of conductive electrodes in the test area. At the test area, an excitation signal is applied via a collection of electrodes (e.g., current delivery electrodes), and the response is read by a collection of electrodes (e.g., voltage sensing electrodes). The resulting impedance reading is obtained using the sensed voltage and is associated with the salinity measurement of the collected sweat. After passing through the electrodes, the sweat is continuously guided further through the outflow portion of the flow channel and discharged into the environment at a suitable flow rate. This allows the salinity measurement of the user's sweat to be continuously read, which can be used to infer the user's hydration level during intense activity. The sample handling device 210 can be applied to any part of the body that is large enough to fit the size of the device 210.

[0133] The sample handling device 210 can be connected to a reusable electronic sample handling device via a mechanical connector. This allows the sample handling device 210 to be disconnected and discarded while retaining the durable electronic sample handling device for use with a different sample handling device 210 in the future. The mechanical connection also allows for electrical connection between a durable electronic device and a patch having features that prevent sweat from contaminating the electrical connection between the components. As previously described, the durable electronic sample handling device can be powered via a disposable or rechargeable battery. The durable sample handling device has a simple display and communication method via either an LED or a small screen. The durable electronic sample handling device can also have the ability to communicate wirelessly with a smart phone or base station, which allows real-time monitoring of more than one user (e.g., athletes or sports teams participating in an event, etc.).

[0134] Figure 5A and 5BAn example sample handling device 310 according to an embodiment is illustrated. The sample handling device 310 may be similar in form and / or function to the above referenced Figure 2A-2B 4. For example, sample handling device 310 may include a sample collection area, an entry port, a flow channel, a test area, and a collection of electrodes, as described with reference to sample handling device 110. Sample handling device 310 may be constructed similarly to sample handling device 210, such that it includes an interface layer 311, an adhesive layer 313, an entry port layer 315, and an electrode and channel layer 317, as described with reference to sample handling device 210. Thus, such similar parts and / or aspects will not be described in further detail herein.

[0135] Figure 5A A perspective view of the assembled sample handling device 310 is illustrated, showing the distal side (away from the user's body) of the sample handling device 310 during use. Figure 5B A top view of the distal side of the sample handling device 310 is illustrated, and outlines of features in more proximal layers of the sample handling device 310 are also shown. Figure 6 An exploded view of a sample handling device 310 is shown, indicating the various layers and their order and configuration. The layers include a proximal or bottommost interface layer 311, with an adhesive layer 313, an access port layer 315, and an electrode and channel layer 317 forming a continuous distal layer.

[0136] The layers used to assemble and form the sample handling devices described herein may be generated by cutting predetermined shapes or contours along predetermined contours from suitable sheets of material. Fig. 7A , 7B 7C illustrate, respectively, an interface layer 311, an adhesive layer 313, and an access port layer 315 of a sample handling device 310, which are generated by cutting out materials along predetermined contours of each layer. For example, the cutting contour used to generate the adhesive layer 313 includes a cutting portion defining an opening and a volume of the sample collection area 312. The cutting contour used to generate the access port layer 315 includes an opening defining an access port 314.

[0137] Figure 8 A top view of the far side or surface of the electrode and channel layer 317 is shown. The outline indicates the electrode traces etched or marked by printing conductive ink with 80% silver and 20% silver chloride. The electrode traces follow a path that includes a serpentine shape. This configuration can be used to make the electrode more stress-tolerant and incorporate flexible electrical and electronic coupling. Figure 8The example electrode trace indicated in includes four electrodes, four terminal ends are located at the circular stylus, and four test ends are located in the test area. The four electrodes include two current delivery electrodes 320A configured to deliver the excitation signal and two response carrying or voltage sensing electrodes 320B configured to read the voltage or test current across the sample fluid (e.g., sweat) in response to the applied excitation signal and carry the response signal to the sample processing device. The sample processing device can be connected via Figure 8 The circular terminal contacts on the electrode traces shown in FIG. 5 are electrically coupled to the sample handling device 510 .

[0138] Fig. 9 The proximal side or surface of the electrode and channel layer 317 is illustrated, indicating the flow channel 316, the testing area 318, the testing end of the collection of current delivery electrodes 320A and voltage sensing electrodes 320B, and an outlet 324 for discharging the sample after testing. Fig. 9 The schematic diagram in also illustrates an adhesive portion 323 of the electrode and channel layer 317 for fixing the electrode and channel layer 317 to the adjacent proximal layer, i.e., the entry port layer 315. In some embodiments, portion 323 can be printed with a thickened ink of approximately 0.9 mm thick before applying the adhesive layer. These layers can be assembled so that the entry port in the entry port layer 315 directly covers the test area in the electrode and channel layer 317. In some embodiments, the entry port can cover the receiving portion of the flow channel outside the test area but upstream of the test area. The receiving portion can guide the collected sample flow to the test area located downstream. The flow channel follows a path including a serpentine shape. This construction can be used to increase tolerance to stress and include a local trap to prevent air from outside the sample handling device 310 from entering the flow channel.

[0139] Fig.10 A perspective view of an example sample processing device 330 that can be used with the above-mentioned sample handling device 310 is illustrated. For example, the sample handling device 310 can be connected to the durable electronic sample handling device 330 via a mechanical connector. After use, the sample handling device 310 can be disconnected and disposed of, while retaining the durable electronic sample handling device 330 for use with different sample handling devices 310. The mechanical connector may include a suitable adapter for providing an electrical connection between the durable electronic device and the sample handling device. The electrical connection may include features to prevent sweat from contaminating the electrical connection between the components. As previously described, the durable electronic sample handling device can be powered via a disposable or rechargeable battery. The durable sample handling device has a simple display and communication method via either an LED or a small screen. The durable electronic sample handling device may also have the ability to communicate wirelessly with a smart phone or a base station, which allows real-time monitoring of more than one user (e.g., athletes or sports teams participating in an event, etc.).

[0140] Fig.11A A top view of a sample processing device 330 is illustrated, showing the distal surface facing away from the user's body during use. Fig. 11B A bottom view is illustrated showing a proximal surface of a sample processing device 330 configured to interface with the sample handling device 310 prior to being worn by a user. Fig. 11C A perspective view of a sample processing device 330 is illustrated. Fig.12 , 13 14 and 15 illustrate cross-sectional views of the sample processing device 330, respectively, and the cross-sections are respectively along Fig.11A Lines 12-12 and 13-13 in Fig. 11C The cross-sectional view shows the internal components of the sample processing device 330.

[0141] Fig.15 A top view of an example sample handling device 510 according to an embodiment is illustrated, while also showing the outlines of features in the intermediate layers of the sample handling device 510. The sample handling device 510 can be substantially similar in form and / or function to the sample handling devices 110, 210, and 310 described above. For example, the sample handling device 510 can include a sample collection area, an entry port, a flow channel, a collection of testing areas, and electrodes, as described with reference to the sample handling device 110. The sample handling device 510 can be constructed similarly to the sample handling device 210 and / or the sample handling device 310, such that it includes an interface layer 511, an adhesive layer 513, an entry port layer 515, and an electrode and channel layer 517, as described with reference to the sample handling devices 210 and 310. Thus, such similar parts and / or aspects are not described in further detail herein.

[0142] Fig.16 An exploded view of a sample handling device 510 is shown, indicating the various layers and their order and configuration. The layers include a proximal or bottommost interface layer 511, with an adhesive layer 513, an access port layer 515, and an electrode and channel layer 517 forming a continuous distal layer.

[0143] Fig.17 A bottom view of the electrode and channel layer 517 is illustrated showing the proximal surface of the layer 517, which is configured to interface with an adjacent layer (i.e., the entry port layer 515) of the sample handling device 510. As described with reference to the electrode and channel layer 317 of the sample handling device 310, the electrode and channel layer 517 includes electrode traces or tracks having serpentine portions that are configured to better withstand stress.

[0144] Reference now Fig.18, a flow chart illustrating a method 450 of using a sample analysis system is shown, the system including a sample handling device and a sample processing device, such as those described herein. The sample analysis system can be used to collect, test, and analyze body fluid samples (e.g., sweat) at a nearly instantaneous real-time rate. In some embodiments, the sample handling device can be similar and / or substantially the same as any of the sample handling devices 110, 210, 310, and / or 510 described herein.

[0145] Method 450 includes collecting a sample of a body fluid via a sample handling device of a sample analysis system at 451. In some cases, for example, the source of the body fluid can be sweat. As the sample collection area of ​​the sample handling device is filled or when a large amount of sample body fluid has been collected, the collected sample is directed to contact the electrochemical interface at 453. In some cases, the collected samples are continuously directed to the electrochemical interface, tested, and discharged as new samples are continuously collected. For example, the sample fluid is directed through an entry port via a flow channel to a test area where the sample body fluid is contacted with a test end of a collection of electrodes.

[0146] The sample analysis system is configured to apply an excitation signal to the sample fluid in contact with the electrical interface via the electrical interface at 455. For example, the excitation signal is delivered via the test end of the set of current delivery electrodes. The sample analysis system is configured to receive a response signal from the sample fluid at 457 after applying the excitation signal at 455. For example, the response voltage is read via the test end of the set of voltage sensing electrodes.

[0147] At 459, the sample analysis system calculates an impedance measurement via the sample processing device based on the excitation signal applied at 455 and the response signal received at 457. The impedance measurement is then analyzed at 461 to obtain information related to the user's hydration level, electrolyte loss, and / or sweat rate. Based on the analysis, the sample analysis system updates a display or peripheral device associated with the sample processing device with information related to the user's hydration level at 463. For example, the impedance measurement is related to a salinity measurement of the user's sweat, and the salinity measurement is used to infer the user's hydration level, electrolyte loss, and sweat rate. In some cases, applying an excitation signal at 455, reading a response at 457, calculating an impedance measurement at 459, and inferring a hydration level, electrolyte loss, and / or sweat rate at 463 can be performed in a continuous manner, and the sample sweat is directed to flow at a suitable flow rate. After the body fluid sample is tested, the sample is continuously directed to an outlet or exit port at 465 to be discharged into the environment.

[0148] In some embodiments, as previously described, the sample handling device of the sample analysis system can be configured to continuously collect samples or volumes of body fluids and guide them to the test area, test samples and discharge samples to make room for the next sample. Therefore, method 450 can be repeated for multiple samples, thereby providing intermittent or continuous results from testing and analysis. The sample analysis system can be configured so that the time spent by collecting body fluid samples sufficient for testing, the time spent by guiding fluid to the test area and testing samples, and the time spent by analyzing test results and discharging samples can be reduced as needed to suit the needs of users. In some cases, one or more parts of the sample handling device can be adjusted to form a series of sample handling devices with different response rates, so that different users can obtain customized or personalized sample analysis systems with personalized sample handling devices or personalized sample processing devices. In some embodiments, data from different users (e.g., teams) can be stored, retained and / or displayed to monitor the hydration level, electrolyte loss and / or sweat rate of multiple users. In some continuous cases, users can select a suitable sample analysis system according to the type of activity they may engage in or the sample analysis amount or rate they may need.

[0149] For example, a user with a high history of sweating may use a sample handling device including a sample collection area with appropriately smaller openings to cover a smaller portion of a sweat gland than a sample handling device used by a user with little sweating. In some cases, a high performance athlete who requires a higher sample analysis rate may use a sample handling device with a sample collection area with a smaller fluid capacity so that a smaller amount of sweat is tested more frequently when the high performance athlete user uses the sample analysis system while engaged in an activity.

[0150] In some cases, the sample processing device can be personalized to store and retain the history of the results from the user's health status analysis for future use by the sample analysis system. In some embodiments, the sample analysis system can be configured to output the collected data and / or analysis collection from the memory of the sample processing device to the remote device after a predetermined interval. For example, in some embodiments, the sample analysis system can export the data and / or analysis results to a wearable device or a smart phone at each change or replacement of the sample handling device. In some embodiments, the exported data can be retained and recorded and associated with a suitable identifier marked to the user. Then, the data associated with the user can be used to draw the progress of the user's health, performance, etc., and in some cases, used to predict their health status before the individual user performs a planned activity. In some embodiments, the sample analysis system may include a remote application running on a remote server or computing device to provide a plan to the user, such as a hydration strategy that may be most suitable for the user (such as a performing athlete) when planning an important sporting event. Remote applications may include prediction algorithms that can be used to formulate strategic plans to replenish water, maintain electrolyte balance, etc.

[0151] As previously mentioned, the sample analysis system and / or sample handling device described herein may be integrated with wearable devices such as smart watches, odometers, GPS systems, and the like. Fig.19 and 20An example embodiment of a sample analysis system 600 is illustrated, including a sample handling device 610, which is integrated with a wearable smart watch device 645. In some cases, when a sample analysis system including a sample handling device is integrated with a wearable device, the sample handling device may include an interface element to physically and electrically connect to the sample handling device. The sample handling device may perform functions such as providing instructions about the transmission of an excitation signal, providing an excitation signal to a terminal of an electrode in the form of a test current, and receiving a response signal obtained from a sample to be tested via an electrode. The sample handling device may include electronic devices required to analyze the response signal and / or transmit data to a remote computing device. For example, the electronic device may be programmed with a unique analysis code to interpret the collected readings. The interpreted readings may be output to a display of the sample handling device to provide information about sweat rate and overall hydration status to the wearer. In the case where the sample handling device can be directly interfaced with a wearable device, the wearable device may be configured to directly physically and electrically engage with the sample handling device and perform functions such as providing instructions, providing an excitation signal, receiving and analyzing a response signal. The electronics included in the wearable device can be used to execute a program with a unique analysis code to interpret the collected readings. The interpreted readings can be output to a display of the wearable device or a display associated with a remote computing device (e.g., a smartphone) to provide the wearer with information about sweat rate and overall hydration status.

[0152] Fig.21 is a schematic diagram of a top view of a sample handling device 710 according to an embodiment, with the layers rendered transparent to show underlying features in the middle layers of the sample handling device 710. Fig. 22 yes Fig.21 A top view image of an example implementation of a sample handling device 710 is shown. Fig.23A is a schematic diagram of an exploded view of a sample handling device 710 according to an example embodiment. Fig. 23B is a schematic diagram of an exploded view of a sample handling device 710 according to another example embodiment. Fig.24A 24B shows a perspective view of the device 710, and 24B shows Fig.24A An enlarged view of a portion of the Fig.24C Shown in a top view, these layers are rendered transparent so that the features below are visible.

[0153] The sample handling device 710 can be substantially similar in structure and / or function to the sample handling devices 110, 210, 310, and / or 510 described herein. For example, the sample handling device 710 can include a sample collection area 712, an entry port 714, a flow channel 716, a testing area 718, a collection of electrodes 720, and a temperature sensor 740, which can be substantially similar to those described with reference to the sample handling device 110. The sample handling device 710 can be constructed similarly to the sample handling device 210 and / or the sample handling device 310, such that it includes an interface layer 711, which can be a release liner, an adhesive layer 713 including an opening 722 of the sample collection area 712, an entry port layer 715 defining an entry port 714, and an electrode and channel layer 717, as described with reference to the sample handling devices 210 and 310. Thus, such similar parts and / or aspects will not be described in further detail herein.

[0154] In some embodiments, the flow channel 716 can be composed of Fig.21 The tortuous shape shown is defined to reduce and / or prevent air ingress and / or undesirable fluid movement, such as backflow or "mixing" in the flow channel. In some embodiments, the tortuous shape of the flow channel 716 can be configured so that the flow rate of the body fluid sample being tested is determined by the supply rate of the body fluid (e.g., sweat rate) and is not affected by other lateral effects (such as gravity, user's body movement, etc.). The sample handling device 710 may include a reinforcement layer 727A, which is configured to provide structural support to a portion of the electrode and channel layer 717, for example, at a portion that will be contacted by a sample processing device (e.g., sample processing device 130, 330, etc.). In some embodiments, as shown, the sample handling device 710 may include a reinforcement layer 727B, which is configured to provide support to a cell portion of the coverage area, which includes the entry port 714, the test area 718, etc. As shown Fig.23A and 23BAs can be seen in FIG. 7 , the reinforcing layer 727B may include a hole defined to allow space for the temperature sensor 740 when the layers are assembled. In some embodiments and / or in some examples, the sample handling device 710 may include one or more spacer portions 729 that are included to occupy space in the sample collection area 712 so that the initial volume of body fluid required to propel fluid flow through the flow path 716 can be reduced compared to an embodiment without the spacer layer 729. In some embodiments, the spacer portion 729 may be included in the entry port layer 715. For example, the entry port layer 715 may be made of a clear polyester (PET) material (e.g., Melinex 454 or equivalent material) of a specified thickness (e.g., 3 mils (75 microns)). The entry port layer 715 may include a spacer portion 729 defined by a thickness increased by a printed spacer ink (e.g., a thickness of 4 mil (0.10 mm) spacer ink). As shown, the spacer portion 729 can define a through hole aligned with the entry port 714 so that the fluid capacity of the sample collection area is reduced (e.g., the volume of the spacer portion 727 is reduced) and the fluid collected in the available portion of the sample collection area 712 can be pushed toward the test area 718 defined on the electrode and channel layer 717 via the hole and the entry port 714.

[0155] Fig.25A is a schematic diagram of a bottom view of the electrode and channel layer 717, showing the channel layer 717B. Fig.25B and 25C Schematic diagrams of the bottom view and side view of the electrode layer with the channel layer removed. Fig.25B An electrode layer 717A is shown including electrode tracks 717C and electrical vias 717D on the bottom surface of the electrode layer 717A. Fig.25D is a top view of electrode layer 717A, showing electrode trace 717C on the top surface of electrode layer 717A. Fig.25E is a schematic diagram of an enlarged view of a unit cell portion of electrode layer 717A, indicating electrode tracks 717C on the top and bottom surfaces of electrode layer 717A and electrical vias 717D.

[0156] The electrode and channel layer 717 may be made of an electrode layer 717A and a channel layer 717B, such as Fig. 23BAs shown in . The electrode layer 717A and / or the channel layer 717B can be made of any suitable material with a suitable thickness. For example, the electrode and channel layer 717 can be formed using transparent 5mil PET. The channel layer 717B can be defined at the bottom or proximal surface of the electrode and channel layer 717, closer to the user's body when in use, and includes a cell portion and an electrode track portion. The cell portion of the channel layer 717B can be formed using a spacer ink so that the contour of the flow channel 7176 defines the groove that forms the flow channel 716. The spacer ink can have any suitable thickness, which can at least partially determine the cross-sectional thickness of the flow channel. The spacer ink thickness can be, for example, 2 mils (0.05mm). In some embodiments, the spacer ink can be applied to the channel layer 717B and then the adhesive is sprayed within a suitable specified maximum thickness (e.g., a maximum of 1 mil (0.025mm)). The channel layer 717B may include an electrode track portion 717E printed on the proximal or bottom surface (toward the user's body) with a dielectric ink of a specified thickness (e.g., 1 mil (0.025 mm)). In some embodiments, the electrode track portion may be substantially straight to avoid entanglement with the user's clothing, etc. during use. The electrode layer 717A may be defined on the top or distal portion of the electrode and channel layer 717, such as Figures 25B-25D As shown. The electrode track portion 717A of the electrode layer may include an electrode track 717C defined on a bottom or proximal surface (closer to the user's body when in use) to form a sample end of an electrode 720, which sample end may be in fluid communication with at least a portion of the flow channel 716 at a collection of test areas 718 so that body fluids flowing through the flow channel 716 at the test areas 718 may be tested. The electrode track may be configured to provide an electrical connection between the sample end of the collection of electrodes 720 and their corresponding terminals configured to be connected to a portion of a sample processing device (e.g., sample processing devices 130, 330, etc.). In some embodiments, the sample handling device 710 may include a temperature sensor 740 and the electrode layer 717A may include an electrical via or vias 717D and an electrode track defined in a top or distal surface (away from the user's body during use) to communicate with the electrical via 717D, ​​as shown. Fig.25D The electrode traces on the distal surface and in communication with the electrical vias 717D may be configured to provide electrical connections to the temperature sensor 740 to send and / or receive signals to and / or from the temperature sensor 740 . Fig.25E Shown are enlarged views of the top (distal) and bottom (proximal) surfaces of a unit cell portion of electrode layer 717A, according to some embodiments.

[0157] The electrodes 720 may include an excitation electrode 720A and a sensing electrode 720B positioned to define a test area 718. In use, a bodily fluid sample may be collected at the sample collection area 712 and directed to flow through the flow channel 716 and through the test area 718 via the entry port 714. The temperature sensor 740 may be appropriately positioned to measure the fluid temperature at the test area 718. An excitation signal (e.g., current) may be applied via the excitation electrode 720A and a response signal (e.g., voltage response) may be received by the sensing electrode 720B to calculate the impedance associated with the bodily fluid sample at the test area. The temperature associated with the bodily fluid sample may be measured by the temperature sensor 740. At each test time point, the response signal and the measured temperature may be sent to the sample processing device via the electrode track. As the bodily fluid is collected, tested, and ejected at the outlet 724 in a continuous manner, multiple bodily fluid samples may be tested at multiple time points. The sample processing device may receive response signals and / or temperature measurements associated with the bodily fluid sample over a period of time and analyze the signals and / or measurements, or store / transmit the signals for further processing.

[0158] Fig.26A is a schematic diagram of a top view of a sample handling device 810 according to an embodiment, wherein layers are rendered transparent to show underlying features. The sample handling device 810 may be substantially similar in structure and / or function to the sample handling devices 110, 210, 310, 510, and / or 710 described herein. For example, the sample handling device 810 may include a sample collection area 812, an entry port 814, a flow channel 816, a test area 818, and a collection of electrodes 820, which may be substantially similar to those described with reference to the above-mentioned sample handling devices. In some embodiments, the sample handling device 810 may include a temperature sensor (not shown). In some embodiments, the temperature sensor may be included in the sample processing device to couple to the sample handling device 810.

[0159] The sample handling device 810 can be constructed similarly to the sample handling devices 210, 310, and / or the sample handling device 710. For example, the sample handling device 810 includes an interface layer 811 that can be a release liner, an adhesive layer 813 that is configured to be peeled off and adhered to the user's skin. The adhesive layer 813 includes an opening 822 of the sample collection area 812. The sample handling device 810 includes an entry port layer that defines an entry port 814 and an electrode and channel layer 817, as described with reference to the sample handling devices 210, 310, and / or 710. In some embodiments, the entry port layer can be combined with the electrode and channel layer to form an intermediate layer 817. Therefore, such similar parts and / or aspects are not described in further detail herein.

[0160] One or more layers of the sample handling device 810 may include alignment aids, such as alignment holes 837 . Fig.26B is a schematic diagram of a bottom view of the sample handling device 810 after the release liner forming the interface layer 811 is removed. Fig.26C Illustrated is a top view of a sample handling device 810 mounted on a mounting interface 835 (eg, a retaining ring interface) in accordance with an embodiment. Fig.27A yes Figures 26A-26C A perspective top view of an example embodiment of a sample handling device 810. Fig.27B According to an example implementation Fig.27A Schematic diagram of an exploded view of a sample handling device 810. Fig.28 is a schematic diagram of an exploded view of a sample handling device 810 according to an embodiment. FIG29 shows a perspective top view of the device 810. Fig.30 An exploded view of a sample handling device 810 mounted on a mounting structure is shown according to one embodiment.

[0161] The interface layer 811 and / or the adhesive layer 813 can be substantially similar to the interface layers and / or adhesive layers described herein (e.g., interface layers 211, 711, etc. and adhesive layers 213, 713, etc.). In some embodiments, the access port 814 can be formed on the access port layer 817 and at a suitably defined position relative to the sample collection area 812 and its opening 822, as shown in Figures 26 and 29. For example, the access port 814 can be positioned at an off-center position relative to the opening 822 of the sample collection area 812 to reduce and / or prevent the formation of bubbles in the collected body fluid sample. The opening 822 can be appropriately shaped to accommodate the off-center positioning of the access port 814, as shown by the notch in Figures 26 and 29.

[0162] In some embodiments, the intermediate layer 817 defines an access port 814 defined as a through hole and includes a flow channel defined on the distal surface and an electrode track and test area defined on the proximal surface. In some embodiments, the intermediate layer 817 can be made of a suitable material, such as polyester (PET), PDMS, etc. In some embodiments, the intermediate layer 817 can be made of a suitably coated material such that one or both surfaces are hydrophilic. For example, the intermediate layer 817 can be made of (For example, 0.100mm (4 mil) HNW) is made, which includes a surface with a hydrophilic coating. The hydrophilic coating can improve the wicking effect of the fluid and guide the body fluid to flow through the defined flow channel 816 during use. In some embodiments, the hydrophilic coating can be applied to the proximal surface and the electrode layer 817A can be printed on the hydrophilic surface. In some embodiments, the hydrophilic coating can be added to any surface or surface portion that contacts the fluid. The hydrophilic coating can be configured to reduce bubble formation and / or improve the flushing of any bubbles entering the system.

[0163] In some embodiments, a hydrophilic coating can be applied on the distal surface and the channel layer 817B can be printed on the hydrophilic surface. The hydrophilic coating can be applied in any suitable shape. For example, in some embodiments, the hydrophilic coating can be preferentially applied to the portion of the inner surface defining the flow channel 816 to assist in the flow of the body fluid sample.

[0164] The sample handling device 810 may include three testing areas 818A, 818B, and 818C. Fig.26A 29. Each test area includes a set of electrodes 820A, 820B and 820C, respectively. Test areas 818A, 818B and 818C are positioned at increasing distances from the entry port 814 and along the flow path 816 before the body fluid sample is ejected at 824. The sample handling device 810 may include a reinforcement layer 827A, which is configured to provide structural support to a portion of the electrode and channel layer 817, for example, the reinforcement layer 827A can be configured to provide a wall of the flow path 816 and support for the unit partial coverage area, which includes the entry port 814, the test areas 818A, 818B, 818C, etc.

[0165] Electrode layer 817A may include a collection of electrodes 820A, 820B, and 820C and an electrode track connecting the electrodes to the terminals. In some embodiments, the collection of electrodes 820 may be configured so that each test area is assigned one or more excitation electrodes to apply an excitation signal and one or more sensing electrodes to receive a response signal from the fluid sample being tested. In some embodiments, electrode 820 may be configured so that each test area is equipped with a bipolar electrode to excite and sense the response from the sample fluid being tested. Electrode 820 and electrode tracks may be printed using any suitable conductive and / or electrode ink. For example, electrodes and / or electrode tracks may be printed using Ercon (80 / 20 silver / silver chloride ink) or any other electrode material with any suitable thickness (e.g., 0.015 mm). The terminals of the electrodes may be any suitable configuration to be electrically connected to a portion of a sample processing device. For example, the terminals may be configured to be connected via spring pins, spring-loaded pins, etc.

[0166] In some embodiments, the flow channel 816 can be composed of Fig.26A816. The channel layer 817B can be formed by printing thickened ink in a predetermined area to form the flow path 816. For example, the channel layer 817B can be formed by printing a 0.05 mm thick NAZDAR NFX52 ink. The flow path 816 can be formed together when the intermediate layer 817 and the reinforcing layer 827A are assembled, and the reinforcing layer 827A forms the distal wall of the flow path 816. The channel layer 817B may include test areas 818A, 818B, and 818C defined at designated portions along the flow path 816. The test areas 818A, 818B, and 818C and the flow path 816 can be defined on the distal surface of the intermediate layer 817, and the sample ends of the electrode tracks and electrodes 820A, 820B, and 820C can be defined on the proximal surface of the intermediate layer. The test area can be configured to include one or more through holes that provide electrical connections between the distal surface of the intermediate layer 817 defining the flow path 816 and the proximal surface of the intermediate layer 817 defining the electrodes, so that when the body fluid flows through the flow path 816 and flows through each test area, the excitation signal applied by the excitation electrode can be delivered to the fluid sample at the test area and can cause a response from the body fluid sample, which can be sensed by the sensing electrode located at that test area. In some embodiments, the temperature sensor can be configured to be housed in the sample processing device and measure the temperature of the fluid sample being tested at one or more test areas defined on the channel layer 817B.

[0167] Fig.29B is a schematic diagram of a top view with the channel layer removed, and shows the near side of the intermediate layer 817 including the electrode layer 817A. Fig.29C The top or far side of the intermediate layer 817 is illustrated including the channel layer 817B. Fig.29D is a side view and Fig.29E A bottom view of a spacer portion 829 to be overlaid on the proximal surface of the intermediate layer 817 including the electrode layer 817A is shown.

[0168] In some embodiments, the sample handling device 810 can include a spacer portion 829, as previously described with reference to the spacer portion 729, which is incorporated to occupy the space in the sample collection area 812. The spacer area 829 can be formed by printing a thickened ink (e.g., 0.10 mm NAZDAR NFX52). In some embodiments, the device 810 can include an additional adhesive layer 833 to help adhere to an alignment and / or mounting interface (e.g., a snap ring interface).

[0169] Fig.30Illustrated is an exploded view of a sample handling device 810 mounted to a retaining ring interface 835 and an assembly fixture 871 utilizing an alignment structure 869 interfacing with an alignment aid in accordance with an example embodiment. Fig.30 Also illustrated is an electrical interface assembly 872 , which in some embodiments may be used to test and / or optimize the functionality of the sample handling device 810 .

[0170] Fig.31 is a schematic diagram of a top view of a sample handling device 910 according to an embodiment, in which layers are rendered transparent to show underlying features. Fig.32 967 (e.g., a snap ring interface) in an example embodiment. The sample handling device 910 can be substantially similar in structure and / or function to the sample handling devices 110, 210, 310, 510, 710, and / or 810 described herein. For example, the sample handling device 910 can include a sample collection area 912, an entry port 914, a flow channel 916, test areas 918A and 918B, and a collection of electrodes 920, which can be substantially similar in structure and / or function to those described with reference to the above-mentioned sample handling devices. In some embodiments, the sample handling device 910 can include a temperature sensor (not shown). In some embodiments, the temperature sensor can be included in the sample processing device to couple with the sample handling device 910, and the temperature sensor can be configured so that the temperature of the sample fluid being tested at one or more test areas 918 can be measured. Fig.33A and 33B is a schematic diagram of a perspective top view and a top view of a sample handling device 910 showing the layers used for packaging according to one embodiment.

[0171] Fig.34 According to one embodiment Fig.33A , 33B Schematic diagram of an exploded view of the sample handling device 910. Fig.35A and 35B is a schematic diagram of a bottom view and a top view of a sample handling device 910 according to one embodiment. Figures 36 and 37 are exploded views of two perspective views of a sample handling device 910 mounted on a mounting structure according to one embodiment. Fig.38 is an exploded view of a sample handling device 910 mounted to a mounting structure according to another embodiment.

[0172] In some embodiments, the sample handling device 910 can be constructed similarly to the sample handling devices 210, 310, 710, and / or the sample handling device 810. For example, the sample handling device 910 includes an interface layer 911 that can be a release liner and an adhesive layer 913 that is configured to be peeled off and adhered to the user's skin. The adhesive layer 913 includes an opening 922 of the sample collection area 912. The sample handling device 910 includes an access port layer that defines an access port 914 in combination with an electrode and channel layer 817, as described with reference to the sample handling devices 210, 310, 710, and / or 810. Thus, such similar parts and / or aspects are not described in further detail herein.

[0173] One or more layers of the sample handling device 910 may include an alignment aid 937. The interface layer 911 and / or the adhesive layer 913 may be substantially similar to the interface layers and / or adhesive layers described herein (e.g., interface layers 211, 711, 811, etc. and adhesive layers 213, 713, 813, etc.). In some embodiments, the access port 914 may be formed on the electrode layer 917A (also serving as the access port layer) and at a suitably defined position relative to the opening 922 of the sample collection area 812, such as Fig.35A and 35B For example, the access port 914 can be positioned off-center relative to the opening 922 of the sample collection area 912 to reduce, flush and / or prevent the formation of bubbles in the collected bodily fluid sample and / or to prepare for the flow of bodily fluid during use.

[0174] In some embodiments, the electrode layer 917A defines an access port 914 defined as a through opening. In some embodiments, the electrode layer 917A can be made of a suitable material, such as transparent polyester (PET), PDMS, etc. In some embodiments, the intermediate layer 817 can be made of a suitably coated material such that one or both surfaces are hydrophilic. For example, the electrode layer 917A can be made of (For example, 0.100mm (4 mil) HNW) including one surface with a hydrophilic coating. The hydrophilic coating can improve the wicking effect of the fluid and guide the body fluid to flow through the defined flow channel 916 during use. The electrode track and test area can be defined on the proximal surface of the electrode layer 917A. The hydrophilic coating can be applied on the proximal surface and the electrode layer 917A can be printed on the hydrophilic surface.

[0175] The sample handling device 910 may include a channel layer 917B having a precisely predefined thickness and determining the cross-sectional dimensions and volume of a portion of the flow channel 916. In some embodiments, the channel layer 917B may include an adhesive surface that can be configured to be attached to a portion of a sample processing device (e.g., sample processing device 130, 330, etc.). In some embodiments, the sample handling device 910 can be a disposable portion used with a durable portion, wherein the adhesive surface of the channel layer 917B is used to attach the sample handling device 910 to the durable portion (e.g., to a plastic portion). In some embodiments, the sample handling device 910 can be used with and attached to a plastic portion or surface of a disposable sample processing device via the adhesive surface of the channel layer 917B. In some embodiments, the adhesive surface of the channel layer 917B can be configured to attach to a reinforcing layer 927A. The reinforcing layer 927A can be made of any suitable plastic material. In some embodiments, the flow channel 916 can be defined by a linear portion in the channel layer 917B that is connected via a through hole in the reinforcing layer 927A and via an interface (e.g., Fig.37 and 38 924) defined by the snap ring interface 924 shown in FIG. 815. The outlet 924 can be defined in the snap ring interface 935 to eject the fluid sample being tested. The flow path 916 can be formed together on the assembly of the adhesive layer 912, the electrode layer 917A, the channel layer 917B, the reinforcement layer 927A and the snap interface 935. The channel layer 917B can include test areas 918A and 918B defined at designated portions along the flow path 816. Electrode tracks and sample ends 920C of electrodes 920A, 920B, and 920B may be defined on the proximal side of electrode layer 917A and test areas 918A and 918B, and flow path 916 may be defined on the distal surface of electrode layer 917A and channel layer 917B, so that when a bodily fluid sample flows through flow path 916 and through each test area, an excitation signal applied by excitation electrode 920B may be delivered to the fluid sample at the test area and may induce a response from the bodily fluid sample, which may be sensed by sensing electrodes 920A, 920C located at that test area 918A, 918B, respectively. In some embodiments, a temperature sensor may be configured to be housed in a sample processing device and to measure the temperature of a fluid sample being tested at one or more of test areas 918A and 918B defined on channel layer 917B.

[0176] In some embodiments of the sample handling device, the electrodes 920 can be configured such that multiple electrode pairs can share one or more electrodes. Multiple electrode pairs can be directed to multiple test areas such that the shared electrodes can have a common terminal and multiple sample ends located at or near the multiple test areas. For example, the electrodes 920 can be configured such that two or more electrode pairs share an excitation electrode rather than one excitation electrode per pair of electrodes. The sample handling device 910 can include two predefined test areas 918A and 918B, such as Fig.35A As shown in . Test area 918A includes a collection of electrodes 920A and 920B, and test area 918B includes electrodes 920B and 920C, respectively, where electrode 920B serves two test areas. Test areas 918A and 918B are positioned at increasingly distant distances from entry port 914 and at known distances from each other along flow path 916 before the bodily fluid sample is ejected at 924. Sample handling device 910 may include a reinforcement layer 927A, which is configured to form a distal wall of flow path 916 (away from the user's body when in use), and the distal surface of electrode layer 917A forms a proximal wall of flow path 916. Reinforcement layer 927A is also configured to provide structural support to a portion of electrode and channel layers 917A and 917B, such as a cell portion covering an area including entry port 914, test areas 918A and 918B.

[0177] In some embodiments, electrode 920B can be a common excitation electrode serving both test areas 918A and 918B, and electrodes 920A and 920C can be configured as sensing electrodes operating in combination with electrode 920B. An excitation signal can be applied via electrode 920B, and electrodes 920A and 920C can receive response signals from the fluid sample tested at each test area. In some embodiments, the electrode can be configured to operate as a bipolar electrode to excite and sense the response from the sample fluid tested. Electrodes 920A, 920B and 920C and electrode tracks can be printed using any suitable conductive and / or electrode ink. For example, electrodes and / or electrode tracks can be printed using Ercon (80 / 20 silver / silver chloride ink) or any other suitable thickness of electrode material. The terminal of the electrode can be any suitable structure to be electrically connected to a part of the sample processing device. For example, the terminal can be configured to be connected by spring pins, spring pins, etc.

[0178] Fig.36A is a schematic diagram of the top or far side of electrode layer 917A. Fig.36B is a side view and Fig.36CThe bottom or proximal side of electrode layer 917B is illustrated and shows a bottom view of spacer portion 929 to be overlaid on the proximal surface of electrode layer 917A. As shown, channel layer 917B includes through holes that allow electrical pathways between a sample handling device attached to the distal side of sample handling device 910 and the connection points of electrodes 920A, 920B, and 920C on the distal side of electrode layer 917A.

[0179] In some embodiments, the sample handling device 910 may include a spacer portion 929, as previously described with reference to spacer portions 729 and / or 829, that is incorporated to occupy space in the sample collection area 912. The spacer area 929 can be formed by printing a thickened ink (e.g., 100 μm or approximately 0.004" NAZDAR NFX52). In some embodiments, the device 910 can include an additional adhesive layer (not shown) to aid in adhesion to an alignment and / or mounting interface (e.g., a snap ring interface).

[0180] Fig.37 and 38 Illustrated are two perspective exploded views of a sample handling device 910 mounted to a retaining ring interface 935 according to one embodiment. Fig.39 An exploded view of the sample handling device 910 mounted to a collection of retaining ring interfaces and mounting structures 971 using alignment structures 969 interfacing with alignment aids 935 is shown in accordance with an example embodiment.

[0181] Figures 40A-40D Schematic diagrams of a bottom view, a top view, a side view, and a perspective side view, respectively, of a sample handling device 1010 according to an embodiment. Fig.41 is a schematic diagram of an exploded view of a sample handling device 1010 according to an example embodiment. Fig.42 is a schematic diagram of a top view of a sample handling device 1010 according to an embodiment, with layers rendered transparent to show underlying features in intermediate layers.

[0182] The sample handling device 1010 can be substantially similar in structure and / or function to the sample handling devices 110, 210, 310, 510, 710, 810, and / or 910 described herein. For example, the sample handling device 1010 can include a sample collection area 1012, an entry port 1014, a flow channel 1016, test areas 1018A and 1018B, and a collection of electrodes 1020, which can be substantially similar in structure and / or function to those described with reference to the above sample handling devices. In some embodiments, the sample handling device 1010 can include a temperature sensor (not shown). In some embodiments, the temperature sensor can be included in the sample handling device to couple with the sample handling device 1010, and the temperature sensor can be configured so that the temperature of the sample fluid being tested at one or more test areas 1018A, 1018B can be measured.

[0183] Fig.41 is a schematic diagram of an exploded view of a sample handling device 1010 according to one embodiment. In some embodiments, the sample handling device 1010 can be constructed similarly to the sample handling devices 210, 310, 710, 810, and / or the sample handling device 910. For example, the sample handling device 1010 includes an interface layer 1011, which can be a release liner, and interface and adhesive layers 1013A and 1013B. The adhesive layer 1013A can be configured to be peeled off and adhered to the user's skin. The adhesive layers 1013A and 1013B include an opening 1022 of the sample collection area 1012. The sample handling device 1010 includes an additional electrode layer adhesive 1019A to attach the electrode layer 1017A to the distal layer (e.g., the interface layer 1011, the adhesive layers 1013A, 1013B, etc.). The sample handling device 1010 includes an access port layer defining an access port 1014 in combination with an electrode layer 1017A as described with reference to sample handling devices 210, 310, 710, 810, and / or 910. Thus, such similar parts and / or aspects are not described in further detail herein.

[0184] The interface layer 1011 and / or the adhesive layers 1013A, 1013B can be substantially similar to the interface layers and / or adhesive layers described herein (e.g., interface layers 211, 711, 811, 911, etc. and adhesive layers 213, 713, 813, 913, etc.). In some embodiments, the access port 1014 can be formed on the electrode layer 1017A (also serving as the access port layer) and at a suitably defined position relative to the opening 1022 of the sample collection area 1012, such as Fig.41 and 42For example, the access port 1014 can be positioned off-center relative to the opening 1022 of the sample collection area 1012 to reduce, flush and / or prevent the formation of bubbles in the collected bodily fluid sample and / or to prepare the flow of bodily fluid during use.

[0185] In some embodiments, electrode layer 1017A defines an entry port 1014 defined as a through hole. In some embodiments, electrode layer 1017A can be substantially similar in structure and / or function to electrode layers described herein (e.g., electrode layer 917A). Therefore, similar aspects of electrode layer 1017A are not further described in detail.

[0186] The sample handling device 1010 may include a channel layer 1017B having a precisely predefined thickness and determining the cross-sectional dimensions and volume of a portion of the flow channel 1016. In some embodiments, the sample handling device 1010 may include a vent layer 1073 configured to define vents 1024. In some embodiments, the vent layer 1073 may be adjacent to a vent layer adhesive 1019B, which also defines vents 1024 and has an adhesive surface that can be configured to attach to a portion of a sample handling device (e.g., sample handling device 130, 330, etc.). In some embodiments, the sample handling device 1010 may be a disposable portion used with a durable portion, and the adhesive surface of the channel layer 1017B is used to attach the sample handling device 1010 to the durable portion (e.g., to a plastic portion). In some embodiments, the sample handling device 1010 may be used with and attached to a plastic portion or surface of a disposable sample handling device via the adhesive surface of the channel layer 1017B.

[0187] In some embodiments, the adhesive surface of the channel layer 1017B can be configured to attach to a release liner layer 1027A. Release liner layer 1027A can be made of any suitable material to be peeled off before attaching sample handling device 1010 to a sample processing device (e.g., sample processing device 130, 330, etc.). In some embodiments, flow channel 1016 can be defined by a curved portion in channel layer 1017B that extends to vent 1024 defined by vent layer 1073.

[0188] As previously described with reference to device 910, channel layer 1017B may include test areas 1018A and 1018B defined at designated portions along flow path 1016. Electrode tracks and sample ends of electrodes 1020A, 1020B, and 1020C may be defined proximal to electrode layer 1017A and test areas 1018A and 1018B. Flow path 1016 may be defined by distal surfaces of electrode layer 1017A and channel layer 1017B such that as a bodily fluid sample flows through flow path 1016 and through each test area, an excitation signal applied by excitation electrode 1020B (shared between test areas 1018A and 1018B) may be delivered to the fluid sample at the test area and may induce a response from the bodily fluid sample that may be sensed by sensing electrodes 1020A, 1020C located at that test area 1018A, 1018B, respectively. In some embodiments, the temperature sensor may be configured to be housed in a sample processing device and measure the temperature of a fluid sample being tested at one or more of the testing regions 1018A and 1018B defined on the channel layer 1017B.

[0189] In some embodiments of the sample handling device, the electrodes 1020 can be configured such that multiple electrode pairs can share one or more electrodes. Multiple electrode pairs can be directed to multiple test areas such that the shared electrodes can have a common terminal and multiple sample ends located at or near the multiple test areas. For example, the electrodes 1020 can be configured such that two or more electrode pairs share one excitation electrode rather than one excitation electrode per pair of electrodes. The sample handling device 1010 can include two predefined test areas 1018A and 1018B, such as Fig.35A . Test area 1018A includes a collection of electrodes 1020A and 1020B, and test area 1018B includes electrodes 1020B and 1020C, respectively, with electrode 1020B serving both test areas simultaneously. Test areas 1018A and 1018B are positioned at increasing distances from entry port 1014 and at known distances from each other along flow path 1016 before the bodily fluid sample is ejected at 1024.

[0190] The sample handling device 1010 may include a top release liner layer 1027A configured to be peeled away prior to attaching the device to a sample processing device as described herein.

[0191] In some embodiments, electrode 1020B can be a common excitation electrode serving both test areas 1018A and 1018B, and electrodes 1020A and 1020C can be configured as sensing electrodes operating in combination with electrode 1020B. Excitation signals can be applied via electrode 1020B and electrodes 1020A and 1020C can receive response signals from the fluid sample tested at each test area. In some embodiments, the electrodes can be configured to operate as bipolar electrodes to excite and sense responses from the sample fluid being tested. Electrodes 1020A, 1020B, and 1020C and electrode tracks can be printed using any suitable conductive and / or electrode inks, as described above. The terminals of the electrodes can be any suitable configuration to be electrically connected to a part of a sample processing device. For example, the terminals can be configured to be connected by spring pins, spring-loaded pins, flexible electrical connections, etc.

[0192] In some embodiments, the sample handling device 1010 may include a spacer portion 1029 that is incorporated to occupy space in the sample collection area 1012, as previously described with reference to the spacer portions 729, 829, and / or 929. The spacer region 1029 can be formed by printing a thickened ink as previously described. In some embodiments, the device 1010 can include an additional adhesive layer (not shown) to aid in adhesion to an alignment and / or mounting interface (e.g., a snap ring interface).

[0193] in conclusion

[0194] In summary, the systems and methods described herein provide for instantaneous measurement and analysis of bodily fluid samples to assess characteristics of the bodily fluid and / or health parameters (eg, hydration level, electrolyte loss, sweat rate, etc.).

[0195] Although various embodiments have been described above, it should be understood that they are presented only by way of example and not limitation. In the case where the above schematic diagram and / or embodiment indicate certain components arranged in certain directions or positions, the arrangement of the components can be modified. Although embodiments have been specifically shown and described, it should be understood that various changes can be made in form and detail. Although various embodiments have been described as having a combination of specific features and / or components, other embodiments with a combination of any features and / or components from any of the above-mentioned embodiments are also possible. Except for mutually exclusive combinations, any part of the device and / or method described herein can be combined in any combination. The embodiments described herein can include various combinations and / or sub-combinations of the functions, components and / or features of the different embodiments described.

[0196] Where the above method indicates that certain events occur in a particular order, the ordering of the certain events may be modified. In addition, certain events may be performed concurrently in parallel processes where possible, as well as sequentially as described above.

Claims

1. A method comprising: collecting a sample of a bodily fluid of a user from a source of the bodily fluid in a sample collection area of ​​the wearable device; directing a portion of the sample of bodily fluid from the sample collection region to a collection of electrodes, the collection of electrodes comprising an excitation electrode and a sensing electrode; applying an excitation signal through the portion of the sample of body fluid; sensing a response signal in response to the excitation signal; measuring an impedance associated with the portion of the sample of bodily fluid based on the response signal; determining a solute concentration of a source of body fluid based on the impedance; measuring a temperature associated with the portion of the sample of bodily fluid with a temperature sensor; calculating a molar concentration associated with the portion of the sample of bodily fluid based on the impedance and the measured temperature; and The user's hydration loss rate is estimated based on the impedance and the measured temperature.

2. The method of claim 1 , further comprising estimating the user's core body temperature based on the measured temperature.

3. The method of claim 1, wherein the body fluid is sweat, the method further comprising: Based on the molar concentration, the user's hydration status is estimated.

4. The method of claim 1, wherein the body fluid is sweat, the method further comprising: Based on the molar concentration, it predicts the water replenishment plan for the user.

5. The method of claim 1 , wherein the body fluid is sweat, the portion of the sample of body fluid is a first portion, the excitation signal is a first excitation signal generated at a first point in time, and the response signal is a first response signal, the method further comprising: applying a second excitation signal through a second portion of the sample of bodily fluid; sensing a second response signal in response to the second excitation signal; measuring an impedance associated with a second portion of the sample of bodily fluid based on the second response signal; determining a volumetric flow rate associated with the portion of the initial sample of bodily fluid based on the impedance of the first portion and the second portion of the sample of bodily fluid; as well as Based on the volumetric flow rate, the user's sweat rate is determined.

6. The method of claim 5, further comprising: Estimate the user's electrolyte loss rate; as well as Through the wearable device, the user is given a signal to replenish electrolytes.

7. The method of claim 1, further comprising: Provides recommendations for hydration.

8. A wearable device comprising: processor; a sample collection region having an inlet and configured to receive an initial volume of body fluid via the inlet; an access port in fluid communication with the sample collection region; as well as a flow channel in fluid communication with the access port and configured to direct a portion of the initial volume of bodily fluid toward the set of electrodes, a collection of electrodes including an excitation electrode configured to apply an excitation signal to the portion of the initial volume of bodily fluid and a sensing electrode configured to receive a response signal from the portion of the initial volume of bodily fluid in response to the excitation signal, the sensing electrode configured to transmit the response signal to the processor to calculate an impedance associated with the portion of the initial volume of bodily fluid; as well as A temperature sensor is configured to measure a temperature associated with the portion of the initial volume of bodily fluid and transmit the measured temperature to the processor to estimate a rate of hydration loss of the user based on the calculated impedance and the measured temperature.

9. The wearable device of claim 8, wherein the processor further estimates the core body temperature of the user based on the measured temperature.

10. The wearable device of claim 8, wherein the flow channel is further configured to direct the portion of the initial volume of bodily fluid to an outlet.

11. The wearable device of claim 8, wherein the set of electrodes comprises two pairs of electrodes, each pair of the two pairs of electrodes comprising at least one excitation electrode and at least one sensing electrode, the two pairs of electrodes being located at a predefined distance between each other.

12. A wearable device as described in claim 11, wherein the flow channel is also configured to direct the portion of the initial volume of body fluid to each of the two pairs of electrodes so that the portion of the initial volume of body fluid passes through the two pairs of electrodes in a sequential manner.

13. The wearable device of claim 8, wherein at least a portion of the flow channel is defined to include at least one of a linear, curvilinear, annular, planar, non-planar, serpentine, or tortuous shape.

14. The wearable device of claim 8, wherein at least one of the flow channel or the set of electrodes comprises a hydrophilic coating configured to promote flow of bodily fluids.

15. The wearable device of claim 8, wherein the flow channel has a cross-sectional area defined by a diameter between 0.2 mm and 5.0 mm.

16. The wearable device of claim 8, wherein at least a portion of the set of electrodes is formed from a printed ink comprising 80% by weight silver and 20% by weight silver chloride.

17. The wearable device of claim 8, wherein the set of electrodes comprises a bipolar electrode configured to provide current to the portion of the initial volume of bodily fluid and to sense a voltage associated with the portion of the initial volume of bodily fluid.

18. A wearable device as described in claim 8, wherein the sample collection area is constructed so that after the initial volume of collected body fluid exceeds a threshold volume, the portion of the initial volume of body fluid is pushed from the sample collection area to the flow channel via the entry port in a continuous manner.

19. A wearable device as described in claim 18, wherein the threshold volume is a first threshold volume, and the wearable device further includes a spacer portion defined in the sample collection area and configured to reduce the fluid capacity of the sample collection area, so that after the initial volume of the collected body fluid exceeds a second threshold volume that is smaller than the first threshold volume, the portion of the initial volume of the body fluid is pushed from the sample collection area via the entry port and via the flow channel.

20. The wearable device of claim 8, wherein the set of electrodes is configured to sense a signal indicating the presence of an amount of Na in the portion of the initial volume of the body fluid. + , Cl - , Ca 2+ , K + or Mg 2+ A signal of at least one of the ions.

21. The wearable device of claim 8, wherein at least one electrode in the set of electrodes comprises a carbon coating configured to reduce corrosion of the set of electrodes.

22. The wearable device of claim 8, wherein the set of electrodes is configured to sense a signal indicating the presence of an amount of at least one of lactase, glucose, lactate, or pyruvate in the portion of the initial volume of bodily fluid.

23. A system comprising: Memory, which stores a collection of instructions; a processor coupled to the memory and configured to execute instructions stored in the memory; as well as A wearable device operatively coupled to the processor and comprising a sample collection area configured to receive an initial volume of a user's bodily fluid; an access port in fluid communication with the sample collection region; a flow channel in fluid communication with the access port and configured to direct a portion of the initial volume of bodily fluid toward the set of electrodes, a collection of electrodes, including an excitation electrode and a sensing electrode, the excitation electrode being configured to apply an excitation signal to the portion of the initial volume of bodily fluid, and the sensing electrode being configured to receive a response signal from the portion of the initial volume of bodily fluid in response to the excitation signal, and a temperature sensor configured to measure a temperature associated with the portion of the initial volume of bodily fluid; The instructions, when executed, are configured to cause the processor to: Sending an excitation signal to the excitation electrode, receiving a response signal from the sensing electrode, calculating an impedance associated with the portion of the initial volume of bodily fluid based on the response signal; receiving a signal associated with a measured temperature from a temperature sensor; as well as The user's hydration loss rate is calculated based on the impedance and the measured temperature.

24. The system of claim 23, wherein the instructions, when executed, are configured to cause the processor to calculate a core body temperature of the user based on the measured temperature.

25. The system of claim 23, wherein the portion of the initial volume of bodily fluid is a first portion, and wherein the flow channel is further configured to direct the first portion to an outlet and sequentially push a second portion of the initial volume of bodily fluid toward the set of electrodes.

26. The system of claim 23, wherein the instructions, when executed, are further configured to cause the processor to: determining the osmotic pressure of the initial volume of body fluid and the state of hydration associated with the source of the body fluid; Identifying that the hydration state is below a predefined value; and Based on the identification result and via the wearable device, an alert is generated suggesting a source for replenishing bodily fluids.

27. The system of claim 23, further comprising: An accelerometer, wherein the instructions, when executed, are further configured to cause the processor to: Identify the state of the system's acceleration; as well as Based on the state of acceleration, a predicted optimal replenishment rate of the source of body fluid is estimated.

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