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EP-4205648-B1 - WEARABLE BIOFLUID VOLUME AND COMPOSITION MEASUREMENT SYSTEM

EP4205648B1EP 4205648 B1EP4205648 B1EP 4205648B1EP-4205648-B1

Inventors

  • LEE, Stephen, P
  • LEECH, Adam
  • LI, WEIHUA
  • SCARTH, Alan, P
  • MODEL, Jeffrey, B
  • GHAFFARI, ROOZBEH
  • ARANYOSI, Alexander, J
  • SEIB, MELISSA
  • WALLACE, JESSICA

Dates

Publication Date
20260506
Application Date
20221214

Claims (7)

  1. A wearable biofluid (72) volume and composition system (10, 248, 296) comprising: a microfluidic flexible fluid capture substrate (14, 92, 120, 170, 300) having a microfluidic channel (30, 98, 126, 174, 306) configured as a sweat collection channel, and configured to be worn on a human body and to collect and sense biofluid (72), the microfluidic flexible fluid capture substrate (14, 92, 120, 170, 300) further having a plurality of conductive traces (36, 138, 328) and electrodes; wherein the sweat collection channel has a first end defining a sweat inlet port (128, 176, 308) and a second end defining a sweat outlet port (34, 102, 130, 178, 310); and an electronic module configured to measure and analyze data from the biofluid (72) collected by the microfluidic flexible fluid capture substrate (14, 92, 120, 170, 300) and to transmit the analyzed data to a smart device (46); wherein the microfluidic flexible fluid capture substrate (14, 92, 120, 170, 300) includes a flexible substrate body (15, 94, 122, 172, 302) having a first, outwardly facing surface (26, 96, 124, 304), a second, skin-facing surface (28, 86), and a striated adhesive (132, 312) is on the skin-facing surface (28, 86) thereof that bonds to skin of a wearer, the striated adhesive (132, 312) defining fluidic channels and an opening (316) having a diameter larger than a diameter of the sweat inlet port (128, 176, 308) and configured to allow sweat to pool on the skin and to be forced into the sweat inlet port (128, 176, 308); wherein a first portion of the plurality of fluidic channels in the striated adhesive (132, 312) is formed transversely relative to a longitudinal axis of the striated adhesive (132, 312), and each of the first portion of the fluidic channels in the striated adhesive (132, 312) extends between opposing side edges of the microfluidic flexible fluid capture substrate (14, 92, 120, 170, 300) wherein a second portion of the fluidic channels in the striated adhesive (132, 312) extends from one of the side edges inwardly through a portion of the striated adhesive (132, 312;, and wherein the plurality of fluidic channels in the striated adhesive (132, 312) prevent sweat from building up underneath the microfluidic flexible fluid capture substrate (14, 92, 120, 170, 300) and allow sweat to flow within the plurality of fluidic channels in the striated adhesive (132, 312) to at least one of the opposing side edges of the microfluidic flexible fluid capture substrate (14, 92, 120, 170, 300).
  2. The wearable biofluid (72) volume and composition system (10, 248, 296) according to Claim 1, wherein the electronic module includes an electronic circuit therein configured to measure a volume of biofluid (72) in the physiological range from about 1 µL to about 130 µL, and measure a sweat conductivity associated with a quantity of sodium in the physiological range from about 1 mg to about 5 g.
  3. The wearable biofluid (72) volume and composition system (10, 248, 296) according to Claim 1 or 2, wherein the electronic module is configured to analyze sweat loss and/or component sweat biomarkers in a wearer of the wearable biofluid (72) volume and composition system (10, 248, 296), and provide real-time alerts and wirelessly transmit the analyzed sweat loss data the smart device (46), and wherein the real-time alerts are one of vibration, sound, audible acoustic signals, lights, and text or other visual notification on a smart device (46) display screen.
  4. The wearable biofluid (72) volume and composition system (10, 248, 296) according to any preceding Claim, wherein the conductive traces (36, 138, 328) and electrodes are in contact with the sweat collection channel, and wherein electrodes contain one of an immuno-assay, an enzymatic assay, and an aptamer-based assay that create a voltage due to an electrochemical reaction with the biofluid (72).
  5. The wearable biofluid (72) volume and composition system (10, 248, 296) according to any preceding Claim, wherein the electronic module is configured to measure one or more of: voltages and currents generated by electrochemical reactions that occur on the microfluidic flexible fluid capture substrate (14, 92, 120, 170, 300); biomarker characteristics over time to provide temporal data; biomarker characteristics and temperature to calibrate volume fill; biomarker characteristics and motion data to reject volume measurement fluctuation and to provide biomarker and fluid volume recommendations; biomarker characteristics, temperature, and motion data to calculate sweat loss and metabolic rate to compute sustained heat exposure; and motion values that have been correlated to one of a work task activity and an athletic activity workload, wherein the motion values are used as inputs in a rehydration recommendation algorithm and a re-hydration alert warning algorithm.
  6. The wearable biofluid (72) volume and composition system (10, 248, 296) according to any preceding Claim, wherein the electronic module includes an alarm configured to alert the wearer to perform a task.
  7. The wearable biofluid (72) volume and composition system (10, 248, 296) according to any preceding Claim, wherein sweat data that is measured, logged, and analyzed by the wearable biofluid (72) volume and composition system (10, 248, 296) is wirelessly transmitted to a health management database, wherein the receiving health management database is configured to allow the wearer to view and track one or more of the wearer's hydration, nutrition, and dietary needs before, during, and after physical activity, wherein sweat data that is measured, logged, and analyzed by the wearable biofluid (72) volume and composition system (10, 248, 296) is wirelessly transmitted to a health management database, and wherein the receiving health management database is configured to prepare incident reports in accordance with at least one of local, national, and industry safety regulations.

Description

BACKGROUND OF THE INVENTION This invention relates in general to wearable fluidic systems for collecting, measuring, and/or monitoring biofluid rate, biofluid loss, biofluid volume, biofluid composition, and/or biochemical information about one or more persons. In particular, this invention relates to an improved, wearable fluid collection device for continuous measuring and/or monitoring biofluid volume, rate, and biomarker composition. Such biofluids include, but are not limited to, sweat, wound exudate, blood, interstitial fluid, and urine. Biomarkers include, but are not limited, to sodium, chloride, bacterial load, viral load, pH, glucose, lactate, cortisol, hormones, cytokines, and other proteins. Access to real-time monitoring of electrolytes, micronutrients, chemical toxins, heavy metals, and metabolites for consumers, industrial workers, athletes, military personnel, firefighters, heart failure patients, kidney failure patients, diabetic patients, cystic fibrosis patients, mental health patients, preterm newborns, and others is critical to mitigate risks of dehydration, other life threatening situations, and diseases, including sepsis, acidosis, anemia, hyperbilirubinemia, and active symptoms of dehydration. For industrial workers, athletes, military, and emergency personnel, monitoring the rate at which fluids, electrolytes, and other essential body components are lost and consumed during exertion is essential for reducing the risk of injury or death due to dehydration, hyponatremia, or hypernatremia. In many cases the available tools for measuring these fluid body component losses are bulky and non-portable, for example, scales for measuring body weight, and high-performance liquid chromatography (HPLC) for measuring ionic composition. These limitations preclude the measurement of fluid losses at the most relevant times, i.e., when the person being monitored is most active. Real-time monitoring can alert individuals of immediate risk and allow users to conduct preventative measures or remove themselves from the environment. Point-of-care wearable sensors with real-time data collection and monitoring have the potential to actively measure bioanalyte levels non-invasively, and could shift routine care and metabolite management from a laboratory setting to remote field environments, emergency or intensive care environments, or home settings. Several forms of wearable, electronic, interstitial fluid and sweat analysis systems exploit electrochemical approaches for monitoring biomarker concentrations, but do not allow for real-time monitoring or analysis. Thus, it would be desirable to provide an improved wearable sweat monitoring system having an improved data transmission system: that allows for real-time analysis and collection of data that overcomes the limitations of current sweat collection systems and conventional wearable sensors, that is high quality, delivers real-time data, and is a readily accessible component of a health monitoring system or work environment monitoring system, that provides diagnostics needed to monitor workers, athletes, patients, etc. in a real time manner outside of the laboratory or clinic, and that can actively report collected data to clinicians, data collection systems, and/or a centralized repository. US 2020/0155047 Al discloses microfluidic systems comprising optical components to facilitate detection of a biofluid property or characteristic. A patterned layer of skin-compatible adhesive enables attachment to the skin and it defines openings as interfaces between the skin and inlet ports in the bottom side of the microfluidic structure. SUMMARY OF THE INVENTION This invention relates to an improved, wearable sweat collection device for continuous measuring and/or monitoring biofluid volume, rate, and biomarker composition and to systems using such devices. The invention is defined in the appended claims. Advantageously, the body-worn sweat and/or biofluid monitoring system described herein can measure biomarkers, volume, location, and temperature of biofluid instantaneously, or over a period of time. The wearable sweat collection system is comprised of a wearable, wireless, electronic measurement module and a complimentary, wearable, flexible, disposable, microfluidic substrate or moisture absorbent material with embedded electrode or electrochemical sensor array. In one embodiment, a wearable biofluid volume and composition system includes a microfluidic flexible fluid capture substrate having a microfluidic channel configured as a sweat collection channel and is configured to be worn on a human body and to collect and sense biofluid. The microfluidic flexible fluid capture substrate further has a plurality of conductive traces and electrodes. An electronic module is attached to the microfluidic flexible fluid capture substrate and is configured to measure and analyze data from the biofluid collected by the microfluidic flexible fluid capture substrate and to t