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WO2012140629A1 - Électrode à base de polymère pour un enregistrement de bio-signal - Google Patents

Électrode à base de polymère pour un enregistrement de bio-signal Download PDF

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Publication number
WO2012140629A1
WO2012140629A1 PCT/IB2012/051880 IB2012051880W WO2012140629A1 WO 2012140629 A1 WO2012140629 A1 WO 2012140629A1 IB 2012051880 W IB2012051880 W IB 2012051880W WO 2012140629 A1 WO2012140629 A1 WO 2012140629A1
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WO
WIPO (PCT)
Prior art keywords
electrode
previous
electrode according
reservoir
fluid
Prior art date
Application number
PCT/IB2012/051880
Other languages
English (en)
Inventor
José Carlos MAGALHÃES DUQUE DA FONSECA
João Miguel DE AMORIM NOVAIS DA COSTA NÓBREGA
Ana Vera ALVES MACHADO NÓBREGA
José Filipe VILELA VAZ
Luís Miguel FIGUEIREDO OLIVEIRA DUARTE
Armando Rafael MACEDO DA MOTA
Original Assignee
Universidade Do Porto
Universidade De Coimbra
Universidade Do Minho
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
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Application filed by Universidade Do Porto, Universidade De Coimbra, Universidade Do Minho filed Critical Universidade Do Porto
Publication of WO2012140629A1 publication Critical patent/WO2012140629A1/fr

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/24Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25Bioelectric electrodes therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/24Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25Bioelectric electrodes therefor
    • A61B5/279Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/291Bioelectric electrodes therefor specially adapted for particular uses for electroencephalography [EEG]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/24Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25Bioelectric electrodes therefor
    • A61B5/279Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/296Bioelectric electrodes therefor specially adapted for particular uses for electromyography [EMG]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0209Special features of electrodes classified in A61B5/24, A61B5/25, A61B5/283, A61B5/291, A61B5/296, A61B5/053
    • A61B2562/0215Silver or silver chloride containing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0209Special features of electrodes classified in A61B5/24, A61B5/25, A61B5/283, A61B5/291, A61B5/296, A61B5/053
    • A61B2562/0217Electrolyte containing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/24Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25Bioelectric electrodes therefor
    • A61B5/251Means for maintaining electrode contact with the body
    • A61B5/252Means for maintaining electrode contact with the body by suction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801Arrangements 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
    • A61B5/6802Sensor mounted on worn items
    • A61B5/6803Head-worn items, e.g. helmets, masks, headphones or goggles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801Arrangements 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
    • A61B5/6802Sensor mounted on worn items
    • A61B5/681Wristwatch-type devices

Definitions

  • the present invention relates to electrodes for non ⁇ invasive bio-signal recording.
  • the subject- matter comprises electrodes for use in medicine, for uses in electroencephalogram (EEG) , electrocardiogram (ECG) or electromyogram (EMG) .
  • the silver/silver chloride (Ag/AgCl) electrodes have been the main choice of physicians for the non-invasive recording of electrophysiological signals like EEG (electroencephalographic) , ECG (electrocardiographic) and EMG (electromyographic) signals.
  • EEG electroencephalographic
  • ECG electrocardiographic
  • EMG electrocardiographic
  • the main advantages of these electrodes for signal transduction are their electric potential reproducibility, excellent signal to noise ratio, reliability and biocompatibility [1,2].
  • They require a previous skin preparation and a conductive paste application in order to reduce the electric resistance at the scalp-electrode interface. Both operations, as well as the positioning of the electrodes themselves, require the intervention of trained personnel.
  • the application of the gel is often the source of significant discomfort to the patient, may damage the hair and sometimes may even cause skin allergic reactions.
  • Griss et al . [4] developed an electrode for EEG monitoring consisting in an array of micro-needles obtained by micro-machining, which penetrate the stratum corneum layer upon the application of a certain pressure, thus drastically decreasing the impedance for signal transfer.
  • the patent US6.662035 refers to a device based on the same principle and Rufinni [6] proposed a similar solution based in carbon nanotubes.
  • Griss states that 5% of the needles break down during the exam and remain embedded in the outer skin layer. Because of its invasive nature this technology may generate inflammatory reactions and infections and therefore it is not expected to be well accepted by patients.
  • a radically different approach consists in the so-called dry electrodes, which do not require skin preparation or the use of any conductive paste.
  • the sensor consists of an inert conductive material, which is mechanically coupled to the scalp for signal transfer. However, it requires the presence of local pre-amplificat ion to compensate for the high interfacial impedance.
  • the first prototypes appeared in the second half of the twentieth century for electrocardiogram (ECG) recording and were composed of a metallic substrate coated with a metal oxide (TiC>2, Ta20 5 , etc.) [7,8] . Since then, several examples have been described in literature, varying primarily in the type of metal and coating applied to the sensor [9-12] .
  • EGI Electrical Geodesies Incorporated
  • US2002/0173710 describes an electrode solution, lying between the common wet and the dry electrodes, which consists in using a group of elastomeric bristles to penetrate through the hair layer.
  • Each bristle is filled with a wick material saturated with an electrically conductive liquid for local skin hydration.
  • a reservoir located at the electrode top supplies the fluid to the bristles by a capillary/gravity action.
  • the electric sensors may be either the wick material itself or metal electrodes immersed in the reservoir. According with this invention the hydrating solution is thus supplied by an electrode concept but certainly difficult to fabricate.
  • the polymers pointed out by the authors for the wick material are hydrophobic and thus will not display wicking properties with water based fluids without a specific surface modification.
  • the hydrating fluid is also kept within the electrode reservoir, but it is fed to the electrode tip all at once just before the starting of the exam.
  • US6201982B1 refers to a complex multi-part electrode that fixes to patient's head by trapping the hair. A sponge swollen with the electrolytic gel is used to achieve a liquid contact when it is compressed. This solution has the main disadvantage of dispensing a quite large amount of liquid that spreads and eventually short-circuits adjacent electrodes.
  • the hydrating solution aims at creating low resistance electrical path through the skin, in a safe, fast and reversible way. Multiple formulations are possible, like the one of US2007/0282188 Al .
  • the presently proposed electrode may work with any electrolytic solution or gel paste .
  • the disclosure comprises a bio-electrode suitable for EEG signal monitoring that achieves a reliable skin contact by locally releasing a small amount of a hydrating fluid.
  • the electrode has a built-in internal liquid cavity that, upon the application of the electrode coupling pressure, shrinks and releases a controlled amount of a moistening fluid to the electrode/skin contact point.
  • the flexible polymeric electrode body is coated with a conductive film for bio- signal transmission. Such an electrode is also suitable for other skin contact applications, namely.
  • the present invention consists in a new electrode which, under the application of a 1-15N load (electrode/scalp coupling force), releases 0.01-2ml, in particular 0.01-1 mL, in particular about 30 l , or in particular l-2mL of an hydrating fluid from a built-in reservoir so the underneath skin layer is hydrated and an effective electrode/scalp electrical path is established. Consequently, the interfacial impedance to signal transfer is substantially reduced. Being half-way between the commercial wet and the dry electrodes, this electrode can be referred as a quasi- dry electrode.
  • a scheme of the electrode working principle is depicted in Fig.l and possible realizations of the invention are depicted in Figs.2 and 3.
  • the quasi-dry electrode With the quasi-dry electrode the 1-2 mL/electrode of the tacky gel paste commonly used with the silver/silver chloride electrodes can be replaced by a considerably lower fluid volume that will be easily absorbed by the skin, without damaging the hair or dirtying the scalp.
  • the wet contact is achieved by the releasing of a moistener solution contained in the electrode reservoir.
  • the moistener may be any aqueous solution chemically compatible with the electrode body material and the skin and including a dissolved salt, in order to improve the electrical conductivity, e.g. sodium chloride, potassium chloride or sodium bicarbonate.
  • a surfactant may also be added to improve the hydrating effect.
  • Possible surfactants already used as skin permeation enhancers are the polisorbates , polyoxyethylene alkyl ethers or polyoxyethylene alkyl esthers.
  • the hydrating solution is kept within its reservoir by a suction effect, the communication with the outside being made through a single or multiple orifice (s) .
  • the diameter of such orifice (s) must be adapted to the viscosity and specific weight of the hydrating solution, so the suction effect retains the solution inside the reservoir. In general terms, the lower the viscosity and/or the higher the specific weight of the liquid, the smaller the orifice diameter should be.
  • the Young modulus of the electrode material preferentially a polymer, is preferentially in the 2-50 MPa range.
  • the electrode body is partially or totally coated with a conductive layer to ensure an efficient bio-signal transmission.
  • the electrode conductive layer is essential to provide a conductive path to the signal.
  • the coating material is:
  • the coating may be any conductive material with appropriate conductivity and biocompatibility .
  • Possible coating techniques include (but not restricted to) those of thin film technologies, as these are usually known in the art, like physical vapour deposition (PVD) technologies, chemical vapour deposition (CVD) technologies and electroless plating. Good results were obtained with titanium nitride layers deposited by PVD and silver/silver chloride layers deposited by electroless plating.
  • a bracelet while practical in a number of uses, also comprises the electrode body comprising a reservoir covered, partially or fully, by a conductive film such that a conductive connection is obtained to a skin contact area where conductivity-improving fluid is present flowing from said reservoir.
  • Electrode body production process can be divided into four main phases: (i) electrode specifications (ii) electrode geometry, (iii) production tools design and (iv) electrode production, which are briefly described hereinafter . Electrode specifications (ii) electrode geometry, (iii) production tools design and (iv) electrode production, which are briefly described hereinafter . Electrode specifications (ii) electrode geometry, (iii) production tools design and (iv) electrode production, which are briefly described hereinafter . Electrode specifications (ii) electrode geometry, (iii) production tools design and (iv) electrode production, which are briefly described hereinafter . Electrode specifications (ii) electrode geometry, (iii) production tools design and (iv) electrode production, which are briefly described hereinafter . Electrode specifications (ii) electrode geometry, (iii) production tools design and (iv) electrode production, which are briefly described hereinafter . Electrode specifications (ii) electrode geometry, (iii) production tools design and (iv) electrode production, which are briefly
  • the load applied by the electrode cap (device that fits to the patient's head and where the electrodes are assembled for proper coupling to the scalp) was measured using a universal testing machine (Zwick/Roell Z005). This study allowed concluding that, in most situations, the electrode should be able to deform and expel the moistener solution when a compression load of about 3 N is applied.
  • the cavity of the electrode should be able to hold and expel, at least 0,01ml as above mentioned, in particular at least a volume of about 30 ⁇ of the moistener solution.
  • the geometry comprises a body (1), a spherical reservoir (2), where the hydrating solution is stored at rest. After the deformation imposed by a suitable pressure on the cap, the solution is expelled through the orifice (3) and is kept between the skin and the electrode, thus reducing the contact impedance.
  • two polymeric materials can be employed to produce the electrode body: a Thermoplastic Vulcanizate (TPV) or a thermoset polyurethane (PU) .
  • thermoplastic since it is a thermoplastic, a conventional injection moulding processing technique is envisaged. This option is adequate for large production scales .
  • the mould designed and used to produce the electrode body is illustrated in Figure 4.
  • a exploded view of the mould components is shown in Figure 4(i) .
  • the mould comprises the following main parts: “a” plate, "b” piston, “c” hopper, “dl” and “d2" mould cavity, “el” and “e2” piston support and “f” piston.
  • a cross section and a general overview of the mounted mould, are shown in Figures 4(ii) and 4(iii), respectively.
  • the parts “dl”, “d2”, “el”, “e2” and “f” form the mould cavity, that should be filled the raw material used to produce the electrode.
  • the material Prior to the mould filling, the material is placed in the cavity of the hopper "c", and is subsequently forced to the mould cavity by the action of piston “b” .
  • the plate “a” is used to apply the load required to force the mould cavity filling .
  • the PU electrode body was produced using a mixture of a diisocyanate and a diol, a two component polyurethane (PU) from BMP Europe Ltd (refs DIPRANE* 5278 Prepolymer and Phoenix Polyester blended Polyol) .
  • the mixture is prepared using a percentage of 48% of polyol and 52% of prepolymer, at a temperature of 45 °C.
  • the mixture is injected in the mould, that should preferably be at around 100°C.
  • the mould is placed in a vacuum heater during approximately 20 min, kept at around 100°C and near -1 bar, which promotes the PU curing.
  • the prototypes obtained are illustrated in Figure 5.
  • thermoplastic since it is a thermoplastic, the production process should follow the conventional injection moulding methodology.
  • a further embodiment comprises an electrode according to any one of the previously described for use in medicine.
  • a further embodiment comprises an electrode according to any one of the previously described for use in medicine in electroencephalogram - EEG, electrocardiogram - ECG or electromyogram - EMG.
  • Fig.l - quasi-dry electrode wherein (1) represents the electrode ' s body; (2) represents the reservoir and (3) represents the electrode bottom orifice through which the hydrating fluid is released to the skin, upon the application of the electrode coupling pressure.
  • Fig.2 quasi-dry electrode bracelet for ECG signal monitoring.
  • the bracelet has a fluid cavity that may be pressed for skin moisturization .
  • the whole or part of the bracelet is coated with a conductive layer for bio-signal transmission to the acquisition apparatus.
  • Fig. 3 Electrode geometry: (a) general overview, (b) Section view showing the main electrode dimensions (in mm), wherein (1) is the electrode ' s body; (2) is the reservoir and (3) is the electrode orifice.
  • Fig.4 - Mould manufactured for the production of PU electrodes (i) exploded view, (ii) mounted section view and (iii) mounted overview.
  • FIG.7 Overlay plot of the EEG data containing eye blinking artifacts in time domain, clearly showing the almost complete overlap of the measurements between a prior art electrode and the present electrode.
  • a set of four EEG electrode prototypes similar to those of Figure 7 were assembled with a Nihon-Kohden commercial device on the scalp of a volunteer, and the EEG signals monitored in parallel with commercial bridge electrodes, fixed in the Fpl, Fp2, 01 and 02 positions, according with the international 10-20 system.

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  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Medical Informatics (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Physics & Mathematics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Measurement And Recording Of Electrical Phenomena And Electrical Characteristics Of The Living Body (AREA)

Abstract

L'invention concerne une nouvelle électrode sans pâte à base de polymère appropriée pour un enregistrement d'électroencéphalogramme (EEG). Cette électrode est appropriée pour une utilisation en médecine, en particulier pour un enregistrement de bio-signal, en particulier pour une utilisation dans un électroencéphalogramme (EEG), un électrocardiogramme (ECG) ou un électromyograme (EMG). L'électrode est entre les électrodes classiques « humides » et « sèches ». Un effet localisé d'hydratation de la peau au point de contact électrode/cuir chevelu est atteint par la libération d'une petite quantité d'un agent hydratant provenant d'un réservoir sur l'électrode elle-même, déclenchée par la pression de couplage électrode /cuir chevelu. La fonctionnalité d'électrode comprend des propriétés mécaniques de polymère et la conception du réservoir d'électrode, dont le volume diminue lors de l'application de la surface spécifiée. L'électrode comprend un corps flexible polymère (1), un réservoir (2), à l'intérieur dudit corps (1), et au moins un orifice (3) dans ledit réservoir (2), et un revêtement de film conducteur sur la totalité ou une partie du corps d'électrode (1).
PCT/IB2012/051880 2011-04-15 2012-04-16 Électrode à base de polymère pour un enregistrement de bio-signal WO2012140629A1 (fr)

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PT105630 2011-04-15
PT10563011 2011-04-15

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Cited By (13)

* Cited by examiner, † Cited by third party
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WO2014138565A3 (fr) * 2013-03-07 2014-11-06 Shils Jay Lawrence Dispositif de stimulation de cerveau porté sur la tête et procédé
CN104434090A (zh) * 2013-09-23 2015-03-25 福特全球技术公司 非接触式心电图测量的传感器和传感器阵列及座椅或沙发
US9031631B2 (en) 2013-01-31 2015-05-12 The Hong Kong Polytechnic University Brain biofeedback device with radially adjustable electrodes
CN105105747A (zh) * 2015-10-13 2015-12-02 京东方科技集团股份有限公司 脑电波量测装置及电极帽
WO2016038545A1 (fr) 2014-09-10 2016-03-17 Ecole Polytechnique Federale De Lausanne (Epfl) Électrode pouvant être dessinée non-effractive pour stimulation électrique neuromusculaire et détection de signal biologique
CN105997063A (zh) * 2016-05-13 2016-10-12 新疆医科大学附属中医医院 一种干电极的制作工艺
US9980659B2 (en) 2014-09-26 2018-05-29 NeuroRex Inc. Bio-potential sensing materials as dry electrodes and devices
WO2018102499A1 (fr) * 2016-12-01 2018-06-07 Mayo Foundation For Medical Education And Research Électrode électrophysiologique et de stimulation
CN108309291A (zh) * 2018-03-12 2018-07-24 复旦大学 一种柔性接触脑电电极及其制备方法
WO2020255142A3 (fr) * 2019-06-18 2021-03-04 Eeg-Sense Ltd. Méthode et système de mesure de signaux d'eeg
DE102020115695A1 (de) 2020-06-15 2021-12-16 Karlsruher Institut für Technologie Elektrode zur nichtinvasiven Messung von elektrischen Körpersignalen auf einer Hautoberfläche
US11548719B2 (en) 2018-10-23 2023-01-10 Conmed Corporation Medical electrode dispenser with indicators
EP4400050A1 (fr) * 2023-01-12 2024-07-17 Cambridge Enterprise, Ltd. Electrodes pour enregistrements à long terme

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Cited By (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9031631B2 (en) 2013-01-31 2015-05-12 The Hong Kong Polytechnic University Brain biofeedback device with radially adjustable electrodes
WO2014138565A3 (fr) * 2013-03-07 2014-11-06 Shils Jay Lawrence Dispositif de stimulation de cerveau porté sur la tête et procédé
CN104434090A (zh) * 2013-09-23 2015-03-25 福特全球技术公司 非接触式心电图测量的传感器和传感器阵列及座椅或沙发
US20150088317A1 (en) * 2013-09-23 2015-03-26 Ford Global Technologies, Llc Contactless electrocardiographic sensor with moisture generator
US11147492B2 (en) 2014-09-10 2021-10-19 Ecole Polytechnique Federale De Lausanne (Epfl) Non-invasive drawable electrode for neuromuscular electric stimulation and biological signal sensing
WO2016038545A1 (fr) 2014-09-10 2016-03-17 Ecole Polytechnique Federale De Lausanne (Epfl) Électrode pouvant être dessinée non-effractive pour stimulation électrique neuromusculaire et détection de signal biologique
US9980659B2 (en) 2014-09-26 2018-05-29 NeuroRex Inc. Bio-potential sensing materials as dry electrodes and devices
CN105105747A (zh) * 2015-10-13 2015-12-02 京东方科技集团股份有限公司 脑电波量测装置及电极帽
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