US20170245788A1 - Sweat sensing with analytical assurance - Google Patents

Sweat sensing with analytical assurance Download PDF

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Publication number
US20170245788A1
US20170245788A1 US15/512,982 US201515512982A US2017245788A1 US 20170245788 A1 US20170245788 A1 US 20170245788A1 US 201515512982 A US201515512982 A US 201515512982A US 2017245788 A1 US2017245788 A1 US 2017245788A1
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sensor
calibration
sweat
calibration medium
analyte
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Jason C. Heikenfeld
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University of Cincinnati
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University of Cincinnati
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14507—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue specially adapted for measuring characteristics of body fluids other than blood
    • A61B5/14517—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue specially adapted for measuring characteristics of body fluids other than blood for sweat
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1495—Calibrating or testing of in-vivo probes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/42—Detecting, measuring or recording for evaluating the gastrointestinal, the endocrine or the exocrine systems
    • A61B5/4261—Evaluating exocrine secretion production
    • A61B5/4266—Evaluating exocrine secretion production sweat secretion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/683—Means for maintaining contact with the body
    • A61B5/6832—Means for maintaining contact with the body using adhesives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/02—Operational features
    • A61B2560/0223—Operational features of calibration, e.g. protocols for calibrating sensors

Definitions

  • Sweat sensing technologies have enormous potential for applications ranging from athletics, to neonatology, to pharmacological monitoring, to personal digital health, to name a few applications.
  • Sweat contains many of the same biomarkers, chemicals, or solutes that are carried in blood and can provide significant information enabling one to diagnose ailments, health status, toxins, performance, and other physiological attributes even in advance of any physical sign.
  • sweat itself, the action of sweating, and other parameters, attributes, solutes, or features on, near, or beneath the skin can be measured to further reveal physiological information.
  • a sweat sensor device with analytical assurance includes at least one sensor for detecting a first analyte, and at least one calibration medium containing at least the first analyte.
  • the concentration medium provides a calibration of the at least one sensor.
  • a method of detecting a solute in sweat includes directing a calibration medium in a device to at least one sensor for detecting the solute in the device, calibrating the at least one sensor, positioning the device on skin, directing sweat to the device, and measuring the solute in the sweat using the device.
  • a method of detecting a solute in sweat using a device for detecting the solute in sweat includes providing fluidic access to the at least one sensor through an aperture in a first backing element, directing at least one calibration medium to the at least one sensor through the aperture, calibrating the at least one sensor, placing the device on skin, directing sweat to the device, and measuring the solute in the sweat using the device.
  • FIG. 1A is a cross-sectional view of a device according to an embodiment of the present invention.
  • FIG. 1B is a cross-sectional view of the device of FIG. 1A during calibration.
  • FIG. 1C is a cross-sectional view of the device of FIG. 1A positioned on skin.
  • FIG. 2A is a cross-sectional view of a device and a calibration module according to an embodiment of the present invention.
  • FIG. 2B is a cross-sectional view of the device and calibration module of FIG. 2A during calibration.
  • FIG. 2C is a cross-sectional view of a portion of the device of FIG. 2A .
  • FIG. 3 is a cross-sectional view of a device and a calibration module according to an embodiment of the present invention.
  • FIG. 4 is a cross-sectional view of a device according to an embodiment of the present invention.
  • FIG. 5 is a cross-sectional view of a device according to an embodiment of the present invention positioned on skin.
  • FIG. 6A is a cross-sectional view of a device according to an embodiment of the present invention positioned on skin.
  • FIG. 6B is a cross-sectional view of the device of FIG. 6A during calibration.
  • FIG. 6C is a cross-sectional view of a device according to an embodiment of the present invention positioned on skin.
  • FIG. 7A is a cross-sectional view of a device according to an embodiment of the present invention positioned on skin.
  • FIG. 7B is a cross-sectional view of the device of FIG. 7A during calibration.
  • FIG. 7C is a cross-sectional view of the device of FIG. 7A after calibration.
  • FIG. 8 is a cross-sectional view of a device according to an embodiment of the present invention.
  • Embodiments of the present invention apply at least to any type of sweat sensor device that measures sweat, sweat generation rate, sweat chronological assurance, sweat solutes, solutes that transfer into sweat from skin, properties of or items on the surface of skin, or properties or items beneath the skin.
  • Embodiments of the present invention further apply to sweat sensing devices that have differing forms including: patches, bands, straps, portions of clothing, wearables, or any suitable mechanism that reliably brings sweat stimulating, sweat collecting, and/or sweat sensing technology into intimate proximity with sweat as it is generated by the body. While certain embodiments of the present invention utilize adhesives to hold the device near the skin, other embodiments include devices held by other mechanisms that hold the device secure against the skin, such as a strap or embedding in a helmet.
  • Sweat stimulation can be achieved by known methods.
  • sweat stimulation can be achieved by simple thermal stimulation, by orally administering a drug, by intradermal injection of drugs such as methylcholine or pilocarpine, and by dermal introduction of such drugs using iontophoresis.
  • Sweat can also be controlled or created by asking the subject using the patch to enact or increase activities or conditions which cause them to sweat. These techniques may be referred to as active control of sweat generation rate.
  • Sensors are preferably electrical in nature, but may also include optical, chemical, mechanical, or other known biosensing mechanisms. Sensors can be in duplicate, triplicate, or more, to provide improved data and readings. Sensors may be referred to by what the sensor is sensing, for example: a sweat sensor; an impedance sensor; a sweat volume sensor; a sweat generation rate sensor; and a solute generation rate sensor.
  • a sweat sensor device is capable of providing analytical assurance as described below.
  • Analytical assurance means (but is not limited to) an assurance of the precision, accuracy, or quality of measurements provided by the sweat sensor device.
  • analytical assurance could further refer to improved confidence in the precision, accuracy, or quality of measurements made.
  • a sweat sensor device is designed to be calibrated before use.
  • the sweat sensor device 100 has an adhesive side supported by carrier 150 and carrier 152 .
  • Carriers 150 , 152 could be a variety of materials.
  • carriers 150 , 152 could be wax or siliconized paper, such as that used in bandage backings.
  • Carrier 150 is sufficiently sealed against the underside of the device 100 such that it covers and seals the adhesive side of the device 100 with exception to aperture 120 a.
  • Aperture 120 a allows access to one or more sensors (not shown) via direct access or through microfluidic connections.
  • Carriers 150 , 152 are removable from device 100 . In the illustrative embodiment, the carrier 152 may be removed without removing the carrier 150 .
  • the carrier 152 of the device 100 may be removed to expose the aperture 120 a.
  • a sponge 160 which is permeated with a calibrating solution or medium, is pressed against the device 100 to bring the solution in contact with the sensors of the device 100 .
  • the carrier 150 shields the rest of the device 100 from the application of the calibrating solution but allows the calibration solution or medium to contact at least one sensor though the aperture 120 a.
  • the calibrating solution is provided with pre-determined concentration of solutes or other properties of sweat (e.g., pH).
  • the sponge 160 is held against the device 100 for a period of time adequate to allow the sensors to be calibrated based on measurements of analytes in the solution.
  • the time required for a sensor to be calibrated may vary depending on the sensor stabilization time.
  • the time required for a sensor to stabilize can be, for example, as short as several minutes, to as long as 30 minutes for a nM or pM sensor, or as long as multiple hours for ion-selective electrodes that require wetting periods.
  • Carrier 150 may be subsequently removed, and the device 100 may be applied to skin 12 to be used, as shown in FIG. 1C .
  • the calibration techniques disclosed herein significantly improve the ease with which sensors in patches or wearable devices may be calibrated. Conventional sensor calibration techniques require the sensor to be dipped into a beaker or vial containing a calibration solution. For a sensor in a patch or wearable device, as taught herein, such techniques are generally impractical for commercial usage (e.g. a non-laboratory setting such as a home, or may damage or degrade the sweat sensor device.
  • a calibration solution may be used where the solution composition is based on properties of skin, contaminants on skin, or other solutes or properties that would affect analytical assurance for a sensor placed on skin.
  • a collected human sweat sample or an artificial sweat sample (e.g., such as one available from Pickering Laboratories) may also be used to calibrate a sensor.
  • the solution could be concentrated, diluted, or spiked with a solute or property of interest.
  • the selected concentration of solutes could be, for example: low enough to confirm the lower limit of detection for the sensor, or could be near or below physiological levels to confirm the accuracy of the sensor.
  • the concentration of solutes in the applied sponge 160 could be designed to calibrate all of the sensors, one of the sensors, or a subset of the sensors.
  • sponge 160 can be replaced by any other technique to apply a calibrating solution, including for example using a spray bottle (not shown).
  • more than one calibration solution may be applied with similar or different concentrations or properties of sweat to calibrate a sensor.
  • more than one sponge 160 may be applied in sequence (not shown) to the device 100 .
  • the different sponges 160 may have calibration solutions, for example, that increase in concentration, or properties to calibrate sensor response or linearity with change in concentration.
  • the different sponges 160 may have solution concentrations that increase or decrease to determine the rate of response or adaptation of sensors. Determining the sensor response rate improves analytical assurance because some sensors experience a lag between the change in analyte concentration in solution and the change in measured analyte concentration that is caused by the analytes' tendency to adhere to the sensor.
  • a calibration solution e.g., using the sponge 160
  • a sponge 160 may be applied for a sufficient time such that sensor drift can be determined to improve the analytical assurance for the sensor. For high quality sensors, drift typically is observable only after a period of hours or more.
  • a sweat sensor device 200 is coupled to a calibration module 240 .
  • the calibration module 240 includes a housing 250 that defines a reservoir 254 .
  • the calibration module 240 acts as a carrier for the device 200 similar to the carrier 150 of FIG. 1A .
  • Housing 250 includes aperture 220 a that provides fluidic access from the reservoir 254 to at least one sensor 220 (shown in FIG. 2C ) within the device 200 .
  • a calibration solution 270 is sealed inside the housing 250 by a membrane 260 .
  • On the other side of the membrane 260 i.e., the side of the reservoir 254 adjacent the aperture 220 a ) is a gas, inert gas, or fluid 278 .
  • the application of pressure (as indicated by arrow 280 ) to the housing 250 causes the membrane to rupture, as shown in FIG. 2B .
  • the calibration module 240 has been activated by the pressure applied in the direction of arrow 280 and the calibration solution 270 comes into contact with one or more sensors of the device 200 near aperture 220 a.
  • the pressure may be applied, for example, by a user pressing against the housing 250 .
  • the calibration module 240 may include a sponge material (not shown) on the side of the membrane 260 adjacent to the aperture 220 a.
  • the housing 250 may be designed such that gravity is not a factor in the movement of the calibration solution 270 past the sensor and/or that a shaking motion could be applied to ensure calibration solution 270 comes into contact with one or more sensors of the device 200 .
  • the device 200 may include a flow restricting element.
  • the flow restricting element 290 may be positioned adjacent the aperture 220 a between the device 200 and the housing 250 .
  • a wicking material 230 surrounds a sensor 220 and the flow restricting element 290 .
  • the flow restricting element 290 may be, for example, a flow limiting element (e.g., reduced porosity in a textile), a flow constriction element (e.g., small pore or aperture), or a flow stopping element.
  • the restricting element 290 is a polymer film with a flow restriction component, such as a small gap. In this configuration, the gap restricts the flow of sweat from the skin to wicking material 230 .
  • the flow restricting element may prevent a sweat pumping element, such as wicking material 230 , within the device 200 from being saturated with the calibration solution 270 .
  • the flow restricting element 290 prevents the calibration solution 270 from saturating the sweat pumping capacity of device 200 .
  • the restricting element 290 in FIG. 2C is shown as being part of device 200 , other configurations and techniques are capable of being used to restrict the flow of sweat to the device 200 .
  • the flow restricting element 290 could be a component of element 250 shown in FIGS. 2A and 2B .
  • pumping or wicking elements could be removed or not fluidically connected to sensors during calibration and added or connected after calibration is complete.
  • the calibration solution 270 could be a gel and component 278 may be a gel (rather than the gas 278 discussed above).
  • the calibration gel 270 comes in contact with the gel 278 .
  • the solutes in the calibration gel 270 will diffuse, rather than flow by advection, through the gel 278 to come into contact with one or more sensors of the device 200 near aperture 220 a.
  • the materials for gels 270 , 278 could be similar or different gel materials, so long as the diffusion of solutes in gel 270 can occur through the gel 278 . This configuration allows for calibration of the sensors over a varying concentration level as the calibration solution diffuses into gel 278 .
  • a sensor could be calibrated between a zero concentration level—which is the starting concentration for gel 270 —and the maximum concentration of the solutes which results from slow diffusion-based mixing of concentrations between gel 270 and gel 278 where gel 270 contains a concentration of at least one solute to be used for calibration.
  • a calibration involving a concentration gradient could be achieved where components 270 , 278 are liquids, such a calibration would be less predictable, because fluid mixing is often more chaotic than the diffusion of solutes where components 270 , 278 are gels, which are more homogeneous.
  • the rupture of membrane 260 could be caused by removing the housing 250 from the device 200 .
  • This may be convenient for use, since the device 200 cannot be adhered onto skin until housing 250 is removed.
  • the calibration solution 270 could be quickly (as little as seconds) brought into contact with sensors of the device 200 , and the device may be applied to the skin.
  • the calibration of the sensors may continue until sweat from the skin replaces the calibration solution, which is a process that may take at least several minutes, if not much longer.
  • This approach ensures that the user always calibrates the device before use, without any extra steps beyond the expected minimum (i.e., removal of the housing 250 ) for applying an adhesive patch to the skin.
  • This may be more broadly referred to as calibration which occurs as backing element or material, or housing material, is removed from the adhesive side of a device.
  • a calibration module may include more than one calibration solution or medium.
  • FIG. 3 a device and a calibration module according to another embodiment of the invention are shown.
  • the device 300 and calibration module 340 are similar in construction to those shown in FIGS. 2A and 2B , and similar reference numerals refer to similar features shown and described in connection with FIGS. 2A and 2B , except as otherwise described below.
  • the calibration module 340 includes multiple solutions 370 , 372 , 374 within the reservoir 354 .
  • the solutions 370 , 372 , 374 could sequentially flow over aperture 320 a past the sensors (as indicated by arrow 380 ) inside calibration module 340 .
  • the solutions 370 , 372 , 374 displace gas 378 as they flow past aperture 320 a.
  • the calibration module 340 may include a mechanism for pumping, gating, or introducing fluids as known by those skilled in the art.
  • component 378 could be a sponge material (not shown) that wicks the solutions 370 , 372 , 374 against the sensor.
  • the device 300 may include an electrowetting gate (not shown) to form a capillary between the solutions 370 , 372 , 374 and the sponge. It will be recognized that more complex arrangements with mechanical pumps and valves could be also used in other embodiments of the present invention.
  • the solutions 370 , 372 , 374 may have the same or varying concentrations. In one embodiment, the solutions 370 , 372 , 374 contain a lowest concentration, a middle concentration, and a highest concentration, respectively, for calibration.
  • a calibration module may include one or more calibration solutions containing more than one solute.
  • a calibration module e.g., module 340
  • a calibration module may include a first solution containing a high concentration of K + and a low concentration of NH 4 + .
  • a second solution in the calibration module may contain a low concentration of K + and a high concentration of NH 4 + .
  • Further solutions may contain equal concentrations of K + and NH 4 + , which could be high, moderate, or low. In this manner, any cross-interference between K + and NH 4 + for a device (e.g., device 300 ) may be determined.
  • device 400 includes an external introduction port 490 , a microfluidic component 480 that moves fluid to or past sensors, and an optional outlet port 492 with absorbing sponge 460 .
  • Microfluidic component 480 may be, for example, a 50 micron polymer channel that is 500 microns wide.
  • One or more calibration solutions could be introduced at port 490 while the device 400 is on the skin 12 .
  • the calibration solution may be introduced at port 490 using a variety of methods.
  • the calibration solution could be introduced at port 490 by the application of droplets, by using a cartridge, by using a carrier, such as those discussed above, or using another approach.
  • a fluid that refreshes the usability of sensors may also be introduced to the device 400 though port 490 and be wicked through the microfluidic component 480 across sensors by sponge 460 .
  • the fluid may change the pH level or cause a sensor probe to release an analyte.
  • a refreshing fluid could be introduced to the device 400 , followed by the introduction of the calibration fluid.
  • the introduction of a fluid e.g., a calibration solution
  • the sponge 460 could be removed after collection of the refreshing fluid and disposed of.
  • the sponge 460 could be a wicking sponge material, a textile, hydrogel, or other material capable of wicking and collecting a fluid.
  • a device 500 includes a first reservoir 530 and a second reservoir 532 that are fluidically coupled by microfluidic component 580 .
  • the first reservoir 530 includes a calibrating solution 570
  • the second reservoir 532 includes a displaceable gas 578 .
  • Microfluidic component 580 is designed to provide access to a sensor (not shown). Calibration of the device 500 using aspects of the present invention could occur before device 500 operation begins, before sweat from skin 12 is sampled, or at times during the use of the device 500 using one more methods of timed microfluidic operation known by those skilled in the art.
  • the device 500 may include gates that swell (close) or dissolve (open) after prolonged exposure to a fluid.
  • the gates may be formed by a swellable polymer or a soluble salt or sugar, for example.
  • the calibration solution 570 could stay in contact with the sensors for a determined period of time before it is removed.
  • the calibration solution 570 may be removed, for example, by wicking or by pumping. Pumping may be accomplished through gas pressure (not shown) using the release of an internal pressurized gas source or generated gas source (e.g., electrolysis of water). Alternatively, the calibration solution 570 could remain in contact with sensors until it is replaced by sweat.
  • a device 600 which includes a substrate 610 carrying two similar sensors 620 , 622 and a membrane 615 that covers the sensor 620 .
  • the sensors 620 , 622 are similar in that, if one is calibrated, they are similar enough that calibration for one can be used for the others.
  • the sensors are of the same generation type (e.g. amperometric) but have different analyte targets (e.g. glucose and lactate).
  • the sensors target the same analyte, and calibration for one sensor will typically best predict the calibration for the second.
  • Device 600 further includes a dry dissolvable calibration medium 670 for one or more analytes between the membrane 615 and the sensor 620 .
  • the calibration medium 670 could also be a liquid or a gel.
  • FIG. 6B shows a flow of sweat 690 generated by the skin 12 as indicated by arrows 690 a.
  • the water in the sweat 690 penetrates through membrane 615 and dissolves calibration medium 670 to create a calibration solution 670 a.
  • Membrane 615 allows water transport through the membrane 615 , while delaying or preventing transport of analytes to be sensed from the sweat 690 at least during a calibration between sensors.
  • the membrane 615 could be made of a dialysis membrane, Nafion membrane, track-etch membrane, reverse-osmosis membrane, or sealed reference electrodes. In this configuration, sensors 620 , 622 can be compared in their readings of an analyte.
  • concentration of an analyte in solution 670 a is known, then the concentration of the analyte in sweat 690 can be better determined through comparison of the measured signal from sensors 620 , 622 .
  • membrane 615 creates a defined volume around sensor 620 such that the concentration of analytes is predictable (i.e., known amount of dilution as the calibration medium 670 dissolves).
  • a porous polymer or polymer textile could be used which has a finite porous volume in it to fix the volume of calibration solution 670 a around the sensor 620 .
  • calibration solution 670 a may include a concentration of the analyte that is greater than the concentration of that analyte present in sweat.
  • the calibration solution 670 a may include an analyte at a concentration roughly 10 times or more than that found in the sweat that wets the calibration medium 670 .
  • element 620 of the device 600 represents two or more different sensors 620 a and 620 b requiring calibration.
  • the first sensor 620 a in element 620 could be for detecting cortisol, and often these types of sensors require calibration.
  • Sensor 622 shown in FIG. 6A would, in this example, also be for detecting cortisol and would measure cortisol found in sweat directly.
  • the second sensor 620 b in element 620 could be for detecting Na + (such as an ion-selective electrode or through simple electrical conductance of solution).
  • the dry dissolvable calibration medium 670 includes a known starting concentration of cortisol 672 a and Na + 672 b.
  • the Na + sensor 620 b may be configured so that it would not need calibration using the calibration solution 270 a.
  • sensor 620 b may be an ion-selective electrode having a sealed reference electrode (not shown) to allow it to accurately quantify Na + concentrations.
  • the amount of water is also indirectly measured (by measuring Na + ), and therefore the amount of dilution of cortisol would be known from the time when the water began moving through the membrane 615 until the water fills the space between the membrane 615 and the sensors 620 a, 620 b.
  • the measurement of Na + would be used to determine the total dilution that has occurred as water moves into the calibrating solution 670 a, and therefore the amount of dilution of cortisol in calibrating solution 670 a is also known. Therefore a dilution calibration curve could be provided for the first sensor 620 a, which would then provide a dilution calibration for sensor 622 as well.
  • membrane 615 may act as a binding medium that binds solutes in sweat such that sweat is diluted of one or more analytes before it reaches the calibrating medium.
  • a binding medium would be in the sweat flow path between sweat glands and at least one sensor.
  • the binding medium may provide specific binding (e.g., a layer of beads doped with ionophores) or non-specific binding (e.g., cellulose).
  • the calibration medium 670 would not need to provide a concentration of analyte or analytes greater than that found in real sweat, as the initial sweat which reaches the calibration sensor would be diluted of the analyte to be calibrated.
  • Specific binding materials include beads or other materials those known by those skilled in the art that promote specific absorption.
  • conditions can be provided that denature or alter an analyte in sweat such that its concentration is effectively lowered before reaching a calibration medium.
  • a binding solute in solution that binds to the analyte in a way similar to how the analyte binds to a probe on the sensor is provided at a location between the sensor and skin.
  • the binding solute may be present in a wicking textile (not shown) that brings sweat from skin to the sensors. Because the analyte will bind with the binding solute, the sensor probes are prevented from binding with such analytes.
  • the senor could be an electrochemical aptamer or antibody sensor, and the binding solute could be an aptamer or antibody that is suspended in solution.
  • the binding solute could be an aptamer or antibody that is suspended in solution.
  • a device 700 includes a sensor 720 for sensing a first analyte and a sensor 722 for sensing a second analyte, and the device 700 further includes a polymer substrate 710 , and calibration mediums 770 , 772 for calibrating the first and second sensors 720 , 722 , respectively.
  • the calibration mediums 770 , 772 may be positioned adjacent to the sensors 720 , 722 using a variety of techniques.
  • the calibration mediums 770 , 772 could be a dry powder placed adjacent to a sensor, held in place by a glue or a dissolvable medium, or held in place by another technique until wetted by sweat.
  • the calibration mediums 770 , 772 generally: (1) can rapidly take up sweat and allow wetting of sweat against sensors 720 , 722 ; (2) release a concentration of calibrating analytes into sweat near sensors 720 , 722 quickly enough to alter the concentration of said analytes in sweat; (3) maintain calibration concentrations of analytes in sweat long enough for sensor 720 , 722 calibration to be performed; and (4) promote a generally fixed fluid volume initially as they uptake sweat such that calibration analyte concentrations are repeatable.
  • calibration mediums 770 , 722 may be made of a material that would rapidly swell to a known volume as it wets but would more slowly dissolve and wash away, therefore allowing adequate time for calibration (discussed further below). With reference to FIG.
  • calibration solutions 770 a, 772 a are formed. Over time, the calibration analytes within calibration solutions 770 a, 772 a are transported away from sensors 720 , 722 by the sweat 790 such that sensing can be performed on new sweat, as shown in FIG. 7C .
  • Calibration mediums useful in embodiments of the present invention can be constructed using a variety of methods.
  • calibration mediums 770 , 772 may release the analytes contained therein initially upon contact with sweat, or at some time thereafter, through time-release techniques.
  • a calibration medium could be formed from a dissolvable polymer, such as a water soluble polymer or a hydrogel.
  • Exemplary polymers include polyvinylpyrolidone (PVP), polyvinylachohol (PVA), and poly-ethylene oxide.
  • PVP can be used as a dissolvable polymer that can swell with up to 40% water in a humid environment or can be used as a hydrogel if cross-linked using, for example, UV light exposure.
  • PVA can be used as a water dissolvable material or as a hydrogel.
  • polymers can have a wide range of molecular weights that can affect the rate at which such polymers dissolve.
  • a calibration medium of PVP with a known concentration of at least one analyte is coated onto a sensor or is positioned adjacent to a sensor. When wetted or hydrated, the PVP will act as a calibration solution.
  • Such a calibration medium could also contain one or more preservatives.
  • the polymer itself could provide a predictable volume and dilution of calibrating analytes confined inside the polymer for a period of time (seconds, or minutes) before it fully dissolves.
  • the calibrating analyte confined in the polymer could be a protein, such as a cytokine.
  • the calibration medium may be adapted to prevent outside proteins from being absorbed based on the size of the proteins, based on properties such as the solubility or lipophilicity of the proteins.
  • the calibration medium may also include ionophores to allow certain solutes and the water from sweat to electronically activate the sensor while excluding other solutes. Therefore, a predictable dilution or concentration of the calibration medium could be provided long enough to allow sensor calibration (e.g., on the order of seconds or minutes) before the polymer dissolves.
  • the calibrating analytes may be absorbed by the sensor underneath the polymer, and the sensor will be calibrated when water and salt (i.e., sweat) reaches the sensor, which enables the proper electrical connection needed for a complete sensing circuit.
  • hydrogels could be used as calibration mediums as long as a suitable time period for calibration is provided.
  • the thickness of the hydrogel provides adequate time for the calibrating analyte inside the hydrogel to calibrate the sensor before external analytes in sweat enter the hydrogel and dominate the signal provided from the sensor. It should be recognized that calibration mediums may have alternative configurations.
  • the calibration medium may be constructed of may be a textile that is coated with analytes or may include multiple layers of polymers or gels having different properties. Additionally, various techniques, such as altering the pH, may be used to remove the calibrating analytes from sensors to prevent interference with measurements of new sweat.
  • a device 800 contains two sensors 820 , 822 for example, and two identical calibration mediums 870 .
  • Sensors 820 , 822 and calibration mediums 870 are enclosed by substrate 810 and seal 817 .
  • Seal 817 includes fluidic gates 880 , 882 .
  • Fluidic gates 880 , 882 only allow sweat to reach sensors 820 , 822 as determined by the design of the fluidic gates 880 , 882 (e.g., based on a dissolution rate of the gate). In one embodiment, when gates 880 , 882 allow the passage of fluid, sweat would first enter the space between the membrane 810 and seal 817 and dissolve calibration mediums 870 .
  • sensors 820 , 822 may be calibrated similarly to the calibration methods discussed above. After a period of time (e.g., 30 minutes), the calibration medium 870 would diffuse out through the microfluidic gates 880 , 882 as new sweat enters. As the medium 870 diffuses, the analyte concentrations near the sensors 820 , 822 would be increasingly dominated by those in new sweat.
  • the device 800 of FIG. 8 is useful when a sensor is to be calibrated and used only when needed.
  • sensors 820 , 822 are one-time use, and the device 800 is configured to perform multiple readings. Where more than one microfluidic gate is used, the gates may be designed to open and close at the same time or at different times.
  • thermo-capillary thermo-capillary, electrowetting, melting of wax barriers, or other known techniques.
  • a wicking element could also be included (not shown) to bring a continuous flow of sweat to the sensor 820 or 822 , and mitigate the need for a calibration medium to diffuse out, thereby decreasing the time required to calibrate the device.
  • one or both of gates 880 , 882 could be a dissolvable polymer (e.g., PVP or PVA) and seal 817 could be a membrane (e.g., a dialysis membrane) that is permeable to water but highly impermeable to at least one analyte to be calibrated. Therefore, as sweat wets the membrane 817 , water moves though the membrane 817 and dissolves calibration medium 870 and creates a calibrating solution for calibrating at least one of the sensors 820 , 822 .
  • a dissolvable polymer e.g., PVP or PVA
  • seal 817 could be a membrane (e.g., a dialysis membrane) that is permeable to water but highly impermeable to at least one analyte to be calibrated. Therefore, as sweat wets the membrane 817 , water moves though the membrane 817 and dissolves calibration medium 870 and creates a calibrating solution for calibrating at least one of the sensors 820 , 822
  • gates 880 , 882 dissolves away, sweat including the analytes that were previously excluded by membrane 817 enters through the dissolved gate 880 , 882 and begins to be sensed by the now-calibrated sensor 820 or sensor 822 .
  • the exact dimensions shown in FIG. 8 are non-limiting and are provided as an example only.
  • gates 880 , 882 could have larger area than membrane 817 .

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CA2962340A1 (fr) 2016-03-31
US11317835B2 (en) 2022-05-03
JP2017529216A (ja) 2017-10-05
EP3197343A1 (fr) 2017-08-02
EP3197343A4 (fr) 2018-04-18
US20190059795A1 (en) 2019-02-28
WO2016049019A1 (fr) 2016-03-31

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