US-12622609-B2 - Wearable systems, devices and methods for measurement and analysis of body fluids

US12622609B2US 12622609 B2US12622609 B2US 12622609B2US-12622609-B2

Abstract

Systems, devices and methods are described herein for various embodiments of a sample analysis system that is worn by a user, the sample analysis system configured to collect a sample of bodily fluid, and measure and analyze the bodily fluid to determine a property of the bodily fluid and/or a health parameter (e.g., degree of hydration, electrolyte losses, perspiration rate, etc.) of the user.

Inventors

Kenneth Ritsher
Shawn MISHRA
Brett Cochran
Daniel TONDERYS
Michael Roberts
Meridith Unger CASS

Assignees

NIX, INC.

Dates

Publication Date: 20260512
Application Date: 20210513

Claims (19)

1 . A wearable apparatus, comprising: a processor; a sample collection region having an inlet and configured to receive, via the inlet, an initial volume of bodily fluid of a user; an access port in fluidic 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 towards a set of electrodes, the set of electrodes including an excitation electrode and a sensing electrode, the excitation electrode configured to apply an excitation signal to the portion of the initial volume of bodily fluid, and the 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; and a temperature sensor configured to measure a temperature associated with the portion of the initial volume of bodily fluid, the temperature sensor configured to transmit the measured temperature to the processor, the processor configured to estimate (a) a core body temperature of the user based on the measured temperature, and (b) a rate of loss of hydration of the user based on a correlation between the impedance and a salinity of the bodily fluid.
2 . The wearable apparatus of claim 1 , wherein the flow channel is further configured to direct the portion of initial volume of bodily fluid to an outlet.
3 . The wearable apparatus of claim 1 , wherein the set of electrodes includes two pairs of electrodes, each pair of the two pairs of electrodes including at least one excitation electrode and at least one sensing electrode, the two pairs of electrodes being positioned at a predefined distance from each other.
4 . The wearable apparatus of claim 3 , wherein the flow channel is further configured to direct the portion of initial volume of bodily fluid to each pair of the two pairs of electrodes such that the portion of initial volume of bodily fluid passes through the two pairs of electrodes in a sequential manner.
5 . The wearable apparatus of claim 1 , wherein at least a portion of the flow channel is defined to include at least one of a linear, curvilinear, looped, planar, non-planar, serpentine, or tortuous shape.
6 . The wearable apparatus of claim 1 , wherein at least one of the flow channel or the set of electrodes includes a hydrophilic coating configured to encourage the flow of the bodily fluid.
7 . The wearable apparatus of claim 1 , wherein the flow channel has a cross-sectional area of between about 0.2 mm and about 5.0 mm.
8 . The wearable apparatus of claim 1 , wherein at least a portion of the set of electrodes includes about 80% silver, by weight, and about 20% silver chloride by weight.
9 . The wearable apparatus of claim 1 , wherein the set of electrodes includes bipolar electrodes configured to supply a 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.
10 . The wearable apparatus of claim 1 , wherein the sample collection region is configured such that the portion of the initial volume of bodily fluid is urged from the sample collection region to the flow channel via the access port in a continuous manner upon the initial volume of bodily fluid collected exceeding a threshold volume.
11 . The wearable apparatus of claim 10 , the threshold volume is a first threshold volume, further comprising a spacer portion defined in the sample collection region and configured to reduce a fluid capacity of the sample collection region such that the portion of the initial volume of bodily fluid is urged from the sample collection region via the access port and via the flow channel upon the initial volume of bodily fluid collected exceeding a second threshold volume smaller than the first threshold volume.
12 . The wearable apparatus of claim 1 , wherein the set of electrodes are configured to sense a signal indicating a presence of a quantity of at least one of Na + , Cl − , Ca 2+ , K + , or Mg 2+ ions in the portion of the initial volume of bodily fluid.
13 . The wearable apparatus of claim 1 , wherein at least one electrode of the set of electrodes includes a carbon coating configured to reduce corrosive of the set of electrodes.
14 . The wearable apparatus of claim 1 , wherein the set of electrodes are configured to sense a signal indicating a presence of a quantity of at least one of lactase, glucose, lactates, or pyruvates in the portion of the initial volume of bodily fluid.
15 . A system, comprising: a memory storing a set of instructions; a processor coupled to the memory, and configured to execute the instructions stored in the memory; and a wearable device including a sample collection region configured to receive an initial volume of bodily fluid of a user; an access port in fluidic 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 towards a set of electrodes; the set of electrodes, including an excitation electrode and a sensing electrode, the excitation electrode configured to apply an excitation signal to the portion of the initial volume of bodily fluid, and the sensing electrode configured to receive a response signal from the portion of the initial volume of bodily fluid and 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; wherein the instructions, when executed, are configured to cause the processor to: send the excitation signal to the excitation electrode; receive the response signal from the sensing electrode; calculate, based on the response signal, an impedance associated with the portion of the initial volume of bodily fluid; receive, from the temperature sensor, a signal associated with the measured temperature, and calculate, (a) a core body temperature of the user based on the measured temperature, and (b) a rate of loss of hydration of the user based on a correlation between the impedance and a salinity of the bodily fluid.
16 . The system of claim 15 , the portion of the initial volume of bodily fluid being a first portion, wherein the flow channel is further configured to direct the first portion to an outlet and sequentially urge a second portion of the initial volume of bodily fluid to flow towards the set of electrodes.
17 . The system of claim 15 , wherein the instructions, when executed, are further configured to cause the processor to: determine an osmolality of the initial volume of bodily fluid, and a state of hydration associated with a source of the bodily fluid; and indicate, via the wearable device, a signal representing a state of hydration of the user.
18 . The system of claim 17 , wherein the instructions, when executed, are further configured to cause the processor to: identify the state of hydration to be lesser than a predefined value, and produce, based on the identification and via the wearable device, an alert advising replenishment of the source of bodily fluid.
19 . The system of claim 17 , further comprising: an accelerometer wherein the instructions, when executed, are further configured to cause the processor to: identify a state of acceleration of the system, and estimate, based on the state of acceleration, a predicted optimal rate of replenishment of the source of bodily fluid.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation of International Patent Application No. PCT/US2019/061301, entitled “Wearable systems, devices, and methods for measurement and analysis of body fluids,” filed Nov. 13, 2019, which claims priority to and the benefit of U.S. Provisional Application No. 62/760,202, entitled “Wearable systems, devices, and methods for measurement and analysis of body fluids”, filed Nov. 13, 2018, the entire contents of which are hereby expressly incorporated by reference for all purposes. TECHNICAL FIELD Embodiments described herein relate to systems, devices, and methods for use in the near instantaneous measurement and analysis of body fluids and potential analytes contained therein. Embodiments described herein also relate to the implementation of a real-time hydration detection system and hydration strategizing system for use during activity. SUMMARY Systems, devices and methods are described herein for various embodiments of a sample analysis system that is worn by a user, the sample analysis system configured to collect a sample of bodily fluid, and measure and analyze the bodily fluid to determine a property of the bodily fluid and/or a health parameter (e.g., degree of hydration, electrolyte losses, perspiration rate, etc.) of the user. BRIEF DESCRIPTION OF THE FIGURES FIG. 1 is a schematic illustration of an example use of a sample handling device on a skin surface of a user, according to an embodiment. FIGS. 2A and 2B are schematic illustrations of a Sample Handling Device, according to an embodiment. The Sample Handling Device can be used with a Sample Analysis System (“SA system”). FIG. 3 is a schematic illustration of an example Sample Analysis System (“SA system”) including the sample handling device of FIGS. 2A, 2B, according to an embodiment. FIG. 4 is a schematic illustration of structural components of a sample handling device, according to one embodiment. FIG. 5A is a schematic illustration of a perspective view of an example sample handling device, according to an embodiment. FIG. 5B is a schematic illustration of a top view of the example sample handling device in FIG. 3A. FIG. 6 is a schematic illustration of an exploded view of the example sample handling device of FIG. 5A, illustrating the component layers of the sample handing device. FIG. 7A-7C schematically illustrate the component layers of the sample handling device of FIGS. 5A, 5B, and 6. FIG. 8 is a schematic illustration of a portion of an electrode and channel layer of the sample handling device of FIGS. 5A, 5B, and 6. FIG. 9 is a schematic illustration of a set of electrodes in the interface layer FIG. 8. FIG. 10 is a schematic illustration of a perspective view of an example sample processing device of a SA system, according to an embodiment. FIGS. 11A-11C are schematic illustrations of a top view, a bottom view, and a perspective view of an example sample processing device of a SA system, according to an embodiment. FIG. 12 is a schematic illustration of a cross-section of the sample processing device of FIG. 11A, taken along the line 12-12. FIG. 13 is a schematic illustration of a perspective view of a cross-section of the sample processing device of FIG. 11A, taken along the line 13-13. FIG. 14 is a schematic illustration of a perspective view of a cross-section of the sample processing device of FIG. 11C, taken along the line 14-14. FIG. 15 is a schematic illustration of a top view of a sample handling device that can be used with an example SA system, according to an embodiment. FIG. 16 is a schematic illustration of an exploded view of the sample handling device of FIG. 15, illustrating the component layers of the sample handing device. FIG. 17 is a schematic illustration of an electrode and channel layer of the sample handling of FIGS. 15-16, according to an embodiment. FIG. 18 illustrates a schematic flowchart of an example method of using a SA system to measure and analyze a degree of hydration of a user, according to an embodiment. FIG. 19 is a schematic illustration of a perspective view of an example SA system integrated with an example wearable device, according to an embodiment. FIG. 20 is a schematic illustration of a perspective view of the rear of the SA system of FIG. 19 integrated with the example wearable device of FIG. 19. FIG. 21 is a schematic illustration of a top view of a sample handling device that can be used with an example SA system, according to an embodiment. FIG. 22 is a top view image of the sample handling device of FIG. 21, according to an implementation. FIG. 23A is a schematic illustration of a perspective exploded view of the sample handling device of FIG. 21, illustrating the component layers of the sample handing device, according to an implementation. FIG. 23B is a schematic illustration of an exploded view of the sample handling device of FIG. 21, illustrating the component layers of the sample handing device, according to an