Wearable biofluid volume and composition measurement system
Inventors
Lee, Stephen P. • LEECH, Adam • Li, Weihua • Scarth, Alan P. • Model, Jeffrey B. • Ghaffari, Roozbeh • ARANYOSI, Alexander J. • Seib, Melissa • WALLACE, Jessica
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Assignees
Member
Epicore BiosystemsEpicore Biosystems is a digital health company specializing in biowearables for non-invasive monitoring of hydration, metabolic health, and stress through sweat analysis. Their solutions support industrial workers, athletes, and clinical researchers by converting sweat biomarkers and physiological data into actionable insights for real-time health, safety, and performance management. The company combines expertise in data science, material science, and biomedical engineering to create validated, user-centric wearable technologies, and partners with organizations across healthcare, academia, industry, and public health sectors.
Epicore Biosystems is a digital health company specializing in biowearables for non-invasive monitoring of hydration, metabolic health, and stress through sweat analysis. Their solutions support industrial workers, athletes, and clinical researchers by converting sweat biomarkers and physiological data into actionable insights for real-time health, safety, and performance management. The company combines expertise in data science, material science, and biomedical engineering to create validated, user-centric wearable technologies, and partners with organizations across healthcare, academia, industry, and public health sectors.
Publication Number
US-11559225-B1
Publication Date
2023-01-24
Expiration Date
Abstract
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 analyze 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 transmit the analyzed data to a smart device.
Core Innovation
This invention relates to an improved, wearable fluid collection device for continuous measuring and/or monitoring biofluid volume, rate, and biomarker composition and to systems using such devices. 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 analyze biofluid. The microfluidic flexible fluid capture substrate further has a plurality of conductive traces and electrodes, and 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 transmit the analyzed data to a smart device.
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. 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, and it would be desirable to provide an improved wearable sweat monitoring system that allows for real-time analysis and collection of data that overcomes the limitations of current sweat collection systems and conventional wearable sensors.
Claims Coverage
This coverage extracts the main inventive features from the two independent claims and identifies seven main inventive features.
Microfluidic flexible fluid capture substrate
a microfluidic flexible fluid capture substrate having a microfluidic channel configured as a sweat collection channel, and configured to be worn on a human body and to collect and sense biofluid, the microfluidic flexible fluid capture substrate further having a plurality of conductive traces and electrodes;
Electronic module measuring and transmitting data
an electronic module configured to measure and analyze data from the biofluid collected by the microfluidic flexible fluid capture substrate and to transmit the analyzed data to a smart device;
Striated adhesive on skin-facing surface
wherein the microfluidic flexible fluid capture substrate includes a flexible substrate body having a first, outwardly facing surface, a second, skin-facing surface, and a striated adhesive is on the skin-facing surface thereof that bonds to skin of a wearer, the striated adhesive defining fluidic channels that prevent sweat from building up underneath the microfluidic flexible fluid capture substrate.
Sweat collection channel with inlet opening and removable liner
a flexible substrate body having a first, outwardly facing surface, a second, skin-facing surface, and a sweat collection channel formed therein, wherein the sweat collection channel has a first end defining a sweat inlet port, and a second end defining a sweat outlet port, a striated adhesive on the skin-facing surface thereof that bonds to skin of a wearer, the striated adhesive defining fluidic channels that prevent sweat from building up underneath the microfluidic flexible fluid capture substrate and further defining an opening having a diameter larger than a diameter of the sweat inlet port, the opening configured to allow sweat to accumulate on the skin and to be forced into the sweat inlet port, and a removable adhesive liner covering the striated adhesive;
First flexible substrate layer with traces and connector pad
a first flexible substrate layer having electrical traces, electrodes, and an electrical connector pad printed thereon, and attached to a surface of the flexible substrate body;
Upper layer skirt with vent holes providing mechanical transition
an upper layer defining a skirt, the skirt formed from a flexible, soft material that is softer and larger than the flexible substrate body, such that peripheral edges of the skirt extend outwardly beyond a peripheral edge of the flexible substrate body and contact the skin of the wearer, wherein the portion of the skirt that contacts the skin of the wearer includes an adhesive to adhere to skin, wherein the skirt provides a mechanical transition between a mechanical modulus of the skin to which it is adhered and a modulus of the flexible fluid capture substrate, and wherein the portion of the skirt that contacts the skin includes a plurality of vent holes configured to allow sweat that is not captured in the sweat collection channel to exit from between the flexible fluid capture substrate and the skin to which it is adhered.
Electronic module with PCB assembly and contact pins
an electronic module configured to measure and analyze data from the sweat collected by the microfluidic flexible fluid capture substrate and to transmit the analyzed data to a smart device, the electronic module including: a base; a cover; a PCB assembly mounted therein, the PCB assembly including a PCB, a microcontroller, a plurality of functional electronic components mounted to the PCB, and a plurality of electrical connection pins configured to contact the electrical connector pad of the microfluidic flexible fluid capture substrate;
Button to deactivate alarm and latch system
a button operative to allow the wearer to deactivate an alarm; and a latch system configured receive and retain the electronic module to the microfluidic flexible fluid capture substrate.
The independent claims center on a wearable microfluidic flexible fluid capture substrate with conductive traces and electrodes and a striated adhesive, coupled to an electronic module that measures, analyzes, and wirelessly transmits biofluid data, with specific substrate layer, skirt, connector, PCB assembly, contact pins, alarm button, and latch system features.
Stated Advantages
Can measure biomarkers, volume, location, and temperature of biofluid instantaneously, or over a period of time.
Provides real-time analysis and collection of data to overcome limitations of current sweat collection systems and conventional wearable sensors.
Enables real-time monitoring and alerts to allow users to conduct preventative measures or remove themselves from the environment.
Improved ability to measure an amassed fluid volume with high precision, at low-cost, while minimizing the number of electrical connections to the electrodes.
Real-time monitoring of wound moisture with notification alarms and/or alerts to inform caretakers about wound dressing viability and optimize healing.
Documented Applications
Monitoring 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.
Real-time monitoring of dehydration, hyponatremia, hypernatremia, and other risks outside of laboratory or clinic settings for workers, athletes, military, emergency personnel, and patients.
Use as a wound care dressing sensor to estimate wound moisture levels and inform caretakers when a dressing should be replaced.
Integration into moisture absorbent products such as incontinence pads or diapers to monitor fluid fill and alert caregivers when replacement is needed.
Monitoring mask moisture (for example N95 masks) to alert users when filter efficacy falls as the mask becomes wet.
Streaming real-time sweat profile data to smart fitness equipment, smartphones, and smart watches for athletes and fitness class participants, including aggregation of sweat data across multiple participants to assess average or weighted sweat rate for fitness activities.
Transmission of measured, logged, and analyzed sweat data to a health management database for wearer tracking of hydration, nutrition, and dietary needs, and for preparing incident reports in accordance with local, national, and industry safety regulations.
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