WO2018065656A1 - Capteur de transpiration - Google Patents

Capteur de transpiration Download PDF

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Publication number
WO2018065656A1
WO2018065656A1 PCT/ES2017/070656 ES2017070656W WO2018065656A1 WO 2018065656 A1 WO2018065656 A1 WO 2018065656A1 ES 2017070656 W ES2017070656 W ES 2017070656W WO 2018065656 A1 WO2018065656 A1 WO 2018065656A1
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WO
WIPO (PCT)
Prior art keywords
sweat
sensor
sensor according
microchannel
reference composition
Prior art date
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Ceased
Application number
PCT/ES2017/070656
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English (en)
Spanish (es)
Inventor
Antoni Baldi Coll
César FERNÁNDEZ SÁNCHEZ
Emma Paola CÓRCOLES PERPIÑAN
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Consejo Superior de Investigaciones Cientificas CSIC
Original Assignee
Consejo Superior de Investigaciones Cientificas CSIC
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Publication of WO2018065656A1 publication Critical patent/WO2018065656A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/84—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving inorganic compounds or pH

Definitions

  • the object of the present invention is a sensor for measuring the pH and measuring the concentration of various analytes in a sweat sample of an individual. More specifically, this sensor is intended to be carried by the individual, so that the sensor is in contact with the user's skin to absorb sweat and measure the pH and concentration of analytes such as glucose, lactic acid, alanine, or electrolytes such as chlorides, sodium or potassium, BACKGROUND OF THE INVENTION
  • US2015057515A1 describes a device that collects and analyzes a plurality of sweat samples that have previously been collected over a discrete period of time to allow the analysis of biomarkers in blood in relation to time.
  • a single sensor selected from a chemical condenser, a chemical field effect transistor, an ion selective electrode, a sensor based on electrical-chemical impedance spectroscopy and an electrochemical potentiostat.
  • sensors potentiometric includes a reference electrode (for example Ag / AgCI) to perform the measurements.
  • This Ag / AgCI electrode exhibits interference with the sample chlorides if it does not have an internal solution of constant concentration. Additionally, even if it has said internal solution, said internal solution is difficult to integrate into the device itself, as well as to ensure that it lasts a long measurement time without being contaminated. Additionally, the device described in this document is limited to the direct measurement of biomarkers.
  • WO2007146047A1 discloses patches, systems and methods for measuring glucose in sweat.
  • a preferred embodiment of this document is a patch to monitor the concentration of sweat glucose in real time. To do this, it uses glucose oxidase (GOx) as a reagent. More specifically, this patch collects the sweat by storing it in a reservoir using a permeable membrane, and measures the concentration of peroxide obtained from the reaction of the glucose with the GOx.
  • this device requires valves and pumps to perform the different operations that comprise a measurement, such as for the addition of GOx solution in the chamber where the detection electrodes are. Valves and pumps are difficult elements to integrate into a small space, and therefore increase both the manufacturing complexity of the device and the price of obtaining and selling.
  • amperometric measurement by means of the detection of hydrogen peroxide resulting from the enzymatic reaction of glucose oxidase is problematic because it is carried out at a high potential to which other species present in sweat can also be oxidized and produce interference.
  • mediators such as ferrocyanide or ferrocene are recommended for glucose measurement; Most glucose meters on the market use mediators, since it greatly reduces the potential for glucose detection. The mediator cannot be immobilized since, once it has reacted, it has to be diffused to the working electrode in order to be detected.
  • these devices are based on the use of at least one electrode. selective and of an Ag / AgCi reference electrode to measure the concentration of ions in the sweat with the intention of, for example, detecting signs of dehydration in individuals during physical exercise.
  • Ag / AgCl reference electrodes are not accurate because they suffer from interference due to variations in chloride concentration.
  • some of these devices comprise an additional structure on the Ag / AgCl electrode that is formed by depositing a hydrogel containing a known concentration of salts so that this electrode behaves as a reference electrode with internal electrolyte.
  • This hydrogel makes the device an impractical solution to manufacture and with a very limited life time, since the hydrogel can be dried or the salts can be depleted. Furthermore, it is known that the hydrogel introduces interference due to the potential of Donan that is established between the interior and exterior of said material, and which depends on the concentration of salts in the contained solution. Therefore, it is necessary to develop new sensors for the detection of anaiites and pH that solve the aforementioned technical problems.
  • the present invention relates to a portable sensor by an individual for continuously measuring a pH and a concentration of anaiites in the sweat of an individual, wherein the sensor comprises a support linkable with fluid transport means for transport and analyze sweat. More specifically, the means of transporting fluids include:
  • a first microcanai with a first entry and a first exit, where the first entry is intended to understand sweat
  • the support includes:
  • a second ion selective transistor intended to contact the second microchannel to perform a second measurement comprising the pH value of the reference composition
  • An electrochemical sensor intended to contact the third microchannel to perform a third measurement comprising the value of the concentration of at least one product obtained from the reaction between sweat and the reference composition
  • each microchannel has a width between 0.5 mm to 4 mm, a thickness of 0.01 to 0.5 mm and a length between 0.5 mm to 100 mm and the material that it constitutes has a porosity between 10% to 90%.
  • this support comprises a memory unit to store the value of! pH of! sweat and the value of sweat analyte concentration.
  • the support comprises a data transmission unit linked to the processing unit to establish communication with an external device that represents and / or stores e! pH value of sweat and the value of the concentration of sweat analytes.
  • the external device is a tablet, computer or smartphone,
  • the support comprises a display unit to represent the pH value of sweat and the concentration of sweat analytes.
  • the support comprises a printed circuit board which in turn comprises the first and second ion selective transistor, the electrochemical sensor, the data transmission unit and the processing unit.
  • the support comprises a first fastening means linked to the printed circuit to removably fix the sensor to a part of the individual's body, where when the sensor is in use the first entry is in contact with the skin of the user allowing the first entry to understand the sweat of the individual.
  • the support incorporates a second fastening means linked to the printed circuit to removably fix the means of transporting fluids to the printed circuit.
  • the first, the second and the third microchannel form a single disposable body and are made of a material with absorbent properties that make both the sweat and the reference composition transported by capillarity from the first and the second inlet to the third output, and that in the third microchannel the sweat and the reference composition are mixed by diffusion.
  • the material with absorbent properties is selected from paper, cellulose, nitroceiuous, vinylidene polyfluoride, polyisulfone, nylon, and a combination of the above.
  • the reference composition comprises:
  • hydrolytically active salts selected from sodium phosphate and sodium chloride
  • At least one enzyme reagent selected from the list consisting of glucose oxidase, peroxidase, lactate oxidase, peroxidase, aianine dehydrogenase, diaphorase, nicofinamide adenine dinucieotide (NAD + ) and a combination of the above, and
  • the product of the reaction between the sweat and the reference composition comprises the reaction of the sweat with the enzymatic reagents and / or the mediators and is hydrogen peroxide, alanine dehydrogenase, diaphorase, ferricinium cation, or hexaminorutenium cation (II).
  • This reference composition is comprised in dehydrated form in an absorbent container that is in contact with the second inlet, so that when the sensor is in use, sweat travels from the first inlet to the second inlet, so that The reference composition dissolves in the sweat and when the second microchannel is completely wet the reference composition is wetted and a concentration gradient of the reference composition is established that travels by diffusion to the second outlet and then is dragged by the sweat flow to the absorbent pad.
  • the reference composition is comprised in liquid form in a container, where this container is in contact with the second inlet, so that when the sensor is in use, the container releases the reference composition, which moves from the second entrance to the absorbent pad.
  • the first inlet comprises a patch with a first layer of material with absorbent properties to contact the individual's skin, a second layer of adhesive material to fix the first layer to the individual's skin and a third layer of insulating material to cover The second layer
  • the first and second ion selective transistor measure sweat pH by measuring the changes in a threshold voltage of the transistor caused by variations in the concentration of hydrogen ions present in the sweat and in contact with the dielectric of the door.
  • the second ion selective transistor is in contact with the hydrolytically active salts of the reference composition that are in a stable concentration.
  • the first ion selective transistor is a measurement ion selective transistor (ISFET) and the second reference ion selective transistor (REFET) to obtain a differential measurement of! Sweat pH and obtain highly reliable measurements.
  • ISFET measurement ion selective transistor
  • REFET reference ion selective transistor
  • hydrogen peroxide is a product of the reaction of sweat glucose with glucose oxidase
  • ferricinium cation is the product of the reaction of hydrogen peroxide generated in the previous reaction with peroxidase
  • hexaminorutenium ( II) is the product of the reactions between alanine and alanine dehydrogenase in the presence of nicotinamide adenine dinucleotide in oxidized form NAD + and its coupled reaction with diaphorase.
  • AIDH Alanine Dehydrogenase
  • the measures of lactic acid, chlorides and alanine are indicative of low blood oxygen levels, dehydration stages and muscle damage, respectively.
  • the fluid transport means comprise several second microchannels, so that each second microchannel carries a different reference composition, for example one of these second microchannels would be intended for hydrolytically active salts, another for enzymes, and another for ios mediators In this way, the dimensions of each second microchannel can be optimized and flow rate controlled.
  • enzymes are immobilized in the third channel, to reduce the use of enzymes.
  • a new high sensitivity sensor is obtained that allows to measure the pH of the sweat continuously and the concentration of sweat analytes continuously for a prolonged period of time that can reach several hours, unlike the state devices of the technique that are usually designed for a single use or for discrete measurements over time. Additionally, this new sensor has a better sensitivity due to the use of two ion selective transistors, where one measures the pH of sweat and the other measures the pH of the reference composition that has a constant pH. In this way, not only the sensitivity is improved but also the problems derived from using Ag / AgCI electrodes in the presence of a high content and variability of sweat chlorides are avoided, which makes it difficult to obtain reliable results.
  • Figure 1. Shows a schematic view of a preferred embodiment of the sensor.
  • Figure 2 - Shows a schematic view of the sensor holder.
  • Figure 3.- Shows a graph of a first example of measurement using the sensor.
  • Figure 4.- Shows a graph of a second example of measurement using the sensor.
  • Figure 5. Shows a graph of a third example of measurement using the sensor. PREFERRED EMBODIMENT OF THE INVENTION
  • the senor (1) is used to continuously measure a pH and a concentration of various analytes in sweat, of an individual while performing sports.
  • This sensor (1) is designed to be carried, or adjusted, in accessories, and / or clothing, thus keeping in contact with the individual's skin to continuously measure the pH and concentration of certain individual sweat analytes, and thus produce an early diagnosis of possible health adversities.
  • the sensor (1) comprises a support (2) linked to fluid transport means (3) for transporting and analyzing sweat.
  • This support (2) comprises a first fastening means (4), as well as a bracelet, to fix, removably, the sensor to an individual's wrist, as well as a second fastening means (5), to fix, of removable form, the means of transport of fluids (3) to the sensor (1), because said means of transport of fluids (3) are disposable and are composed of a strip of paper in a substantially Y-shaped form. It should be noted that both parts are easily aligned and snapped with 4 posts in the corresponding holes of a PCB,
  • the support contains some fasteners that ensure good contact and alignment of the paper! With the chips in the reader.
  • the means for transporting fluids (3) comprise: a first microcanny (6), a second microcanny (7), a third microcanny (8) and an absorbent pad (9).
  • the first microcanai (6) comprises a first inlet and a first outlet, where the first inlet is linked with a patch (10) intended to be fixed on the individual's skin to contact and absorb sweat.
  • a patch (10) intended to be fixed on the individual's skin to contact and absorb sweat.
  • the second microcanai (7) comprises a second inlet and a second outlet, where the second inlet is linked to a container (11), as well as a "blister", which in turn contains a reference composition with enzymatic reagents in liquid form, and the second outlet is linked to the first outlet of the first microcanny (8).
  • the individual presses the container (11) that releases the reference composition and this moves from the second inlet to the absorbent pad (9).
  • the third microcanai (8) comprises a third inlet and a third outlet, where the third inlet is linked to the first and second outlets, and the third outlet is linked to the absorbent pad (9).
  • the absorbent pad (9) causes the movement of sweat through the first microcannet, and the reference composition through the second microcanny; and said sweat and said reference composition are mixed by diffusion along the third microcanai. More specifically, the absorbent pad (9) continuously maintains the pumping by capillarity of the sweat and of the reference composition.
  • the reference composition comprises hydrolytically active salts, glucose oxidase between 8 and 640U / mi, peroxidase between 64 and 2580 U / mi and ferrocene between 2.5 and 10 mM.
  • the reference composition is a pH 7 buffer that also contains enzymes and mediators, preferably redox mediators, which directs the biorecognition and transduction of biochemical species.
  • enzymes and mediators preferably redox mediators, which directs the biorecognition and transduction of biochemical species.
  • these enzymes and mediators react with sweat glucose, obtaining a complete chemical reaction resulting from the total sweat mixture with the reference composition as follows:
  • the ratio between ferricinium, hydrogen peroxide and glucose is 2: 1: 1, and therefore the sensor (1) can monitor the glucose level of the individual.
  • the support (2) comprises a printed circuit board (12) which in turn comprises a first and a second ion selective transistor (13 , 14), an electrochemical sensor (15) with three electrodes, and a data transmission unit (17), all linked to a processing unit (16).
  • the first ion selective transistor (13) is intended to contact the first microchannel (8) to perform a first measurement comprising the pH value of sweat, while the second ion selective transistor (14) is intended to contact the second microchannel (7) to perform a second measurement comprising the pH value of the reference composition.
  • the first ion selective transistor (13) is a selective measurement ion transistor (ISFET)
  • the second ion selective transistor (14) is a selective ion reference transistor (REFET)
  • the first ion selective transistor (13) is an ISFET with a selective membrane that allows to detect other ions, other than hydrogen ions, such as chlorides, sodium, potassium or calcium.
  • the support (2) comprises a plurality of first ion selective transistors (13) so that the concentration of several ions in the first microchannel (6) can be measured simultaneously.
  • the polarization of the gate of the first and the second ion selective transistor (13, 14) is performed with a common electrode that is in contact with the sweat mixture and reference composition in the liquid state, for example one of the electrochemical sensor electrodes (15). More specifically, the electrochemical sensor (15) is intended to contact the third microchannel (8) to perform a third measurement of the concentration of products selected from hydrogen peroxide and the ferricinium cation.
  • the processing unit (18) calculates differentially the pH of sweat, and from the third measurement, the processing unit (16) calculates the glucose concentration value .
  • the data transmission unit (17) forms a wireless network, preferably bluetooth type, with an external device such as a Tablet, computer or smartphone, not shown, to represent and / or store the pH value of sweat and the value of the concentration of products selected from hydrogen peroxide, ferricinium cation, and hexaminorutenium (II) cation.
  • an external device such as a Tablet, computer or smartphone, not shown, to represent and / or store the pH value of sweat and the value of the concentration of products selected from hydrogen peroxide, ferricinium cation, and hexaminorutenium (II) cation.
  • support (2) comprises a power supply system that feeds: the first and second ion selective transistor (13, 14), the electrochemical sensor (15), the data transmission unit (17), and the processing unit (16). Additionally, the support (2) comprises an electrical regulation unit, linked to said power supply system that provides adequate potentials for complete chemical reactions to occur.
  • a series of measures have been carried out to demonstrate the correct operation of the sensor (1), as well as to verify that it can take measurements greater than one hour. It should be noted that these measures have been carried out considering that an individual when exercising produces on average an amount of ⁇ ⁇ / ⁇ / ⁇ 2 , thus the first, second and third microcanai (6, 7, 8) must have 2 mm wide and 4 cm long to generate a flow of 2 pL / min in this way the patch (10) has an area of at least 2 cm 2 . It should be noted that the first, the second and the third microcanna! (6, 7, 8) are made on Whatman No.1 paper.
  • a first measurement example is shown in Figure 3 and continuously represents the difference in power over time! between the first and the second measurement (mV) over a period of 3000 s.
  • a second example of measurement is shown in Figure 4 and continuously represents over time the relationship between the current (mA) of the third measurement and the concentration of sweat glucose (mM) over a period of 12000 s.
  • a third example of measurement is shown in Figure 5 and continuously represents the difference in power over time! between the first and the second measurement (mV) for different sweat pH values, and the current (A) of the third measurement for different sweat glucose concentrations (mM) over a period of 5000 s.
  • the reference composition is dehydrated in an absorbent container, which is in contact with the second inlet, so that when the sensor is in use, sweat travels from the first inlet to reaching the second inlet, so that the reference composition dissolves in sweat and when the second microcanai is completely wet a diffusion concentration gradient of the reference composition is established, which travels to the second outlet and then is dragged by the flow of sweat to the absorbent pad.

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Abstract

L'objet de la présente invention concerne un capteur (1) pour mesurer le pH et la concentration de divers analytes dans un échantillon de sueur d'un individu. Plus concrètement, ce capteur (1) peut être porté par un individu pour effectuer des mesures de manière continue, et comprend un support (2) pouvant être relié à des moyens de transport de liquides (3) pour transporter et analyser la sueur au moyen au moins d'un premier transistor de sélection d'ions (13), d'un second transistor de sélection d'ions (14) et d'un capteur électrochimique (15) qui sont en contact avec différences parties des moyens de transport de liquides (3).
PCT/ES2017/070656 2016-10-07 2017-10-09 Capteur de transpiration Ceased WO2018065656A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ESP201631304 2016-10-07
ES201631304 2016-10-07

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WO2018065656A1 true WO2018065656A1 (fr) 2018-04-12

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110133407A (zh) * 2019-05-21 2019-08-16 出门问问信息科技有限公司 可穿戴设备的充电触点测试方法和测试装置

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0951877A (ja) * 1995-08-11 1997-02-25 Nobuyuki Tsutsui 発汗記録装置
US20150126834A1 (en) * 2012-05-10 2015-05-07 The Regents Of The University Of California Wearable electrochemical sensors
WO2016007944A2 (fr) * 2014-07-11 2016-01-14 University Of Cincinnati Détection combinatoire de biomarqueurs de la sueur par des mesures d'impédance et potentiométriques

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0951877A (ja) * 1995-08-11 1997-02-25 Nobuyuki Tsutsui 発汗記録装置
US20150126834A1 (en) * 2012-05-10 2015-05-07 The Regents Of The University Of California Wearable electrochemical sensors
WO2016007944A2 (fr) * 2014-07-11 2016-01-14 University Of Cincinnati Détection combinatoire de biomarqueurs de la sueur par des mesures d'impédance et potentiométriques

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
CURTO VINCENZO F ET AL.: "Real-time sweat pH monitoring based on a wearable chemical barcode micro-fluidic platform incorporating ionic liquids", SENSORS AND ACTUATORS B: CHEMICAL: INTERNATIONAL JOURNAL DEVOTED TO RESEARCH AND DEVELOPMENT OF PHYSICAL AND CHEMICAL TRANSDUCERS, vol. 171-172, 1 August 2012 (2012-08-01), pages 1327 - 1334, XP055451404, ISSN: 0925-4005, Retrieved from the Internet <URL:https://doi.org/10.1016/j.snb.2012.06.048> *
WEBER J ET AL.: "Novel lactate and pH biosensor for skin and sweat analysis based on single walled carbon nanotubes", SENSORS AND ACTUATORS B: CHEMICAL: INTERNATIONAL JOURNAL DEVOTED TO RESEARCH AND DEVELOPMENT OF PHYSICAL AND CHEMICAL TRANSDUCERS, vol. 117, no. 1, 12 September 2006 (2006-09-12), pages 308 - 313, XP027971529, ISSN: 0925-4005, Retrieved from the Internet <URL:https://doi.org/10.1016/j.snb.2005.12.025> *

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110133407A (zh) * 2019-05-21 2019-08-16 出门问问信息科技有限公司 可穿戴设备的充电触点测试方法和测试装置
CN110133407B (zh) * 2019-05-21 2022-01-18 出门问问信息科技有限公司 可穿戴设备的充电触点测试方法和测试装置

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