WO2019094609A1 - Électrode biopotentielle solide à faible bruit - Google Patents

Électrode biopotentielle solide à faible bruit Download PDF

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Publication number
WO2019094609A1
WO2019094609A1 PCT/US2018/059851 US2018059851W WO2019094609A1 WO 2019094609 A1 WO2019094609 A1 WO 2019094609A1 US 2018059851 W US2018059851 W US 2018059851W WO 2019094609 A1 WO2019094609 A1 WO 2019094609A1
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WO
WIPO (PCT)
Prior art keywords
subject
skin
electrode
prongs
polymer
Prior art date
Application number
PCT/US2018/059851
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English (en)
Inventor
Yu Mike Chi
Alfredo Lucas DIAZ
Yen Chi FANG
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Cognionics, Inc.
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Filing date
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Application filed by Cognionics, Inc. filed Critical Cognionics, Inc.
Publication of WO2019094609A1 publication Critical patent/WO2019094609A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0472—Structure-related aspects
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/291—Bioelectric electrodes therefor specially adapted for particular uses for electroencephalography [EEG]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0408—Use-related aspects

Definitions

  • the invention generally pertains to biopotential electrodes, and is specifically directed to EEG electrodes that are optimized to achieve rapid and reliable scalp contact through hair, without electrolytic gels, and to provide low-noise signal acquisition.
  • EEG signals generally requires the use of wet electrodes that adhere to the scalp.
  • the standard wet electrode provides for a secure, low-resistance electrical connection between the scalp and the recording device to produce a low-noise recording.
  • electrolytic gels combined with the need for scalp preparation is often time consuming, irritating and uncomfortable to the subject.
  • dry EEG electrodes which do not require conductive gels or scalp preparation, have been explored as an alternative.
  • Soft polymer electrodes have been explored as an alternative to metal and other hard materials to improve comfort.
  • polymers based on hydrophilic materials also potentially offer superior signal quality.
  • hydrogels which are commonly used for skin- surface biopotential sensing, such as ECG.
  • ECG skin- surface biopotential sensing
  • hydrogel approaches suffer from several key drawbacks for use through scalp hair.
  • their inherently soft structure and tacky surface make them prone to picking up debris, difficult to clean and fragile.
  • Licata US 6,510,333 B l
  • a hollow bristle loaded with hydrogel is a difficult structure to manufacture at the dimensions required for hair penetration.
  • soft hydrogels are not mechanically robust and will decay after just a few uses - since some portion of it still must be exposed and unprotected by the sheath. Reloading such a structure with fresh hydrogel is typically not practical, such a the sensor is inconvenient and potentially expensive on a per use basis.
  • hydrocolloid based polymers As an alternative to hydrogel formulations, other prior art has taught the use of hydrocolloid based polymers.
  • Toyama et al. A Non- Adhesive Solid-Gel Electrode for a Non- Invasive Brain-Machine Interface, Frontiers in Neurology, July 2012) utilizes a hydrocolloid based polymer containing ionically conductive salts. HydrocoUoids can achieve high levels of volume conductivity, comparable to conventional wet gels, if loaded with sufficient water content (Toyama et. al.).
  • the consistency of the hydrocolloid due to the high water content, resembled that of the aforementioned soft hydrogels and must be manually pushed, deformed and manipulated through hair to establish electrical contact with the scalp or combined with a sheathing system, such as that taught by Licata, to provide for artificial mechanical rigidity.
  • the hydrocolloid polymer taught by Toyama resembles that of conventional EEG gels, with the primary advantage being faster cleanup since the hydrocolloid can be more easily removed from the subject.
  • the invention provides an electrode, comprising: a solid, ionically conductive polymer having at least one prong for contacting the skin of a subject; a metal plate; and an electrical connector: wherein the solid polymer is supported by a rigid structure for limiting the bending of the at least one prong: wherein the solid polymer is in electrical contact with the metal plate; wherein the metal plate is in electrical contact with the electrical connector; and wherein electrical signals can be coupled from said subject, through the conductive polymer and to the electrical connector when the prong is applied to the skin of said subject.
  • the invention also provides a method of detecting a biopotential electrical signal from the skin of a subject, comprising the steps of:
  • an electrode in communication with said subject's skin, said electrode comprising: a solid, ionically conductive polymer having at least one prong for contacting the skin of a subject; a metal plate; and an electrical connector: wherein the solid polymer is supported by a rigid structure for limiting the bending of the at least one prong: wherein the solid polymer is in electrical contact with the metal plate; wherein the metal plate is in electrical contact with the electrical connector; and wherein electrical signals can be coupled from said subject, through the conductive polymer and to the electrical connector when the prong is applied to the skin of said subject;
  • FIG. 1 is an isometric view of one embodiment of the invention.
  • FIG. 2 is an isometric view of one embodiment of the invention from the opposing angle.
  • FIG. 3 is a blow apart view of one embodiment of the invention.
  • FIG. 4 is a second embodiment of the invention utilizing angled openings to direct the prongs in an outward radial expansion show in the blow apart view.
  • FIG. 5 is a second embodiment of the invention utilizing angled openings to direct the prongs in an outward radial expansion shown in the assembled view.
  • FIG. 6 is a second embodiment of the invention utilizing angled openings to direct the prongs in a cutaway view.
  • FIG. 7 is a third embodiment using an internal rigid structure for reinforcement in the blow apart view.
  • FIG. 8 is a third embodiment using an internal rigid structure for reinforcement in the cutaway view.
  • FIG. 1 and FIG. 2 depict one embodiment of the invention from opposing angles.
  • FIG. 3 is a depiction of the same embodiment in a blow apart view.
  • the primary conductive medium for the electrode 1 is a conductive, water-bearing but solid polymer 110 with prongs 100 to penetrate the hair for scalp contact.
  • the solid polymer 110 include a section with one or more prongs 100 for penetrating hair to establish electrical contact with the scalp.
  • the electrode 1 utilizes six prongs 100.
  • Embodiments of the invention normally include multiple prongs 100 to maximize the probability that at least some of the prongs will make adequate contact with the subject's skin or scalp.
  • the exact number of prongs 100 for an embodiment of the invention can be varied depending on the desired tradeoff between comfort, hair penetration and size.
  • at least three or four prongs 100 are desirable to ensure that the electrode 1 is resistant to tipping over during usage.
  • embodiments may include anywhere from a single prong 100 to as many as many prongs 100 as can be shaped and fit within the dimensions of the electrode 1.
  • the length of the prongs 100 can also vary depending on the specific application. Shorter prongs 100 are more stable and resistant to tipping but do not penetrate easily through thick hair. Longer prongs 100 are less stable, and are more easily broken but also work better through dense hair.
  • the dimensions of the prongs 100 need not be constant in the same electrode 1 with some embodiments having different shape or length prongs 100 in the same unit. Exemplary dimensions for the prongs 100 range from about 0.5mm to 8mm for the diameter of the prong.
  • the length of the prongs 100 in embodiments can vary from about 1.5mm to 18mm.
  • the solid polymer 110 can be made from any hydrophilic polymer material that has sufficient mechanical rigidity to be shaped into prongs 100 while containing enough water and ionic content to enable electrical conductivity. Embodiments of the invention need not achieve conductivity on par with conventional gels due to the high resistance of unprepped stratum corneum. Volume conductivities of 20 ohms per cm or greater or effective electrode impedances ranging from a few kilohms up to 5 megaohms is sufficient for dry applications, especially if combined with local amplification and shielding.
  • the solid polymer comprises a hydrogel, a foam, a film, a hydrocolloid, or an alginate.
  • Any combination of solid conductive polymer materials is acceptable as long as the material achieves the required level of conductivity and can be formed into a shape having hair penetrating prongs.
  • One exemplary class of polymer materials are hydrocoUoids. HydrocoUoids typically include, but are not limited to, carboxymethyl cellulose (CMC), guar gum, xanthan gum, karaya gum, locus gum, polyvinyl alcohol pectin, gelatin, carbowax, carboxypolymethylene, maize starch, alginic acid, and combinations.
  • one embodiment utilizes carboxymethyl cellulose (CMC) based hydrocoUoids (conventionally called gums) that are mixed with ionically conductive salts such calcium chloride or magnesium chloride.
  • CMC carboxymethyl cellulose
  • hydrocoUoids conventionally called gums
  • the hydrocolloid material provides a solid medium, while providing a hydrophilic, ionically conductive interface to the skin.
  • the CMC based hydrocolloid polymer was utilized to form the solid polymer.
  • the ingredients, by weight, are: 32% water, 5% CaC12 salt, 27% CMC and 36% glycerol.
  • the exact ratios can be easily tuned to adjust the effective durometer of the resulting polymer. For example, water and glycerol can be increased for a softer polymer, which may be desirable for some populations (e.g., children).
  • different salts can be utilized (e.g., MgC12 instead of CaC12).
  • the ingredients in this embodiment are mixed together and poured or injected into a mold to form the solid polymer 110 with prongs 100.
  • an alternative formulation for a stiffer, yet still sufficiently conductive, polymer is 7.15% CaC12 salt, 19.05% water, 40.47% glycerol and 33.33% CMC.
  • the stiffer polymer, necessary for penetrating hair, is primarily the result of lowering the water content while increasing the binder content (CMC), compared to prior art formulations such as Toyama. Although the lower water content results in a substantially higher bulk resistivity, the net effect for dry electrode EEG applications is minimal since the skin impedance will still dominate over the impedance of the electrode.
  • the water content can generally be less than 43% by weight. This results in a polymer that has sufficient hardness to be shaped into a structure with the necessary prongs for hair penetration.
  • the lower water content compared to prior art formulations will result in lower volume conductivity, in the range of 20 ohms per cm and greater, as the water content is decreased, either at mixing time or due to dehydration over extended use.
  • this is not an issue since the stratum corneum itself will be the dominating factor in the overall electrode to skin impedance.
  • the polymer will have sufficient rigidity to be formed into prongs, it may still be too soft and fragile to penetrate thicker hair, especially after repeated use, which will stress the pronged section of the electrode. As the prongs 100 bend and flex when pushed onto the subject's head, stress forces propagate across the prongs 100, especially at the joint between the prongs 100 and the solid polymer 110.
  • rigid structure 102 is a bottle cap shaped enclosure that includes a set of openings 104 that match the prongs 100.
  • the rigid structure 102 and openings 104 serve to limit the range of motion and flexure on the prongs 100 by partially enclosing the prongs 100 near where the prongs 100 meet the body of the solid polymer 110. As a result, the prongs 100 cannot flex or bend as much as when it is outside the rigid structure 102. This effectively serves to boost the hardness of the prongs 100 which help it penetrate through even dense hair.
  • the skin contacting tip area of the prongs 100 retain a degree of softness which maximizes comfort for the subject.
  • limiting the range of bend and motion for the prongs 100 help to minimize stress concentrations at the point where the prongs 100 meet the main body of the solid polymer 110. This ensures that the prongs 100 do not detach from the main body of the solid polymer 110 even after repeated use.
  • the solid polymer 110 is placed within the rigid body 102 with the prongs 100 extending through the openings 104. On the side opposing the prongs, the rigid body 102 is closed by a removable lid 106, which allows the solid polymer 110 to be periodically replaced as necessary. This is advantageous since the cost of solid polymer 110 is likely to be substantially less expensive than the rigid housing 102, especially combined with the other elements below.
  • the prongs 100 are designed to make electrical contact with the subject's scalp and skin.
  • the solid polymer 110 which also contains water and ions.
  • the solid polymer 110 contacts a metal plate 112 inside the rigid housing 102.
  • the metal plate is ideally a material that is suitable for low-noise transduction between ionic and electrical currents.
  • Ag/AgCl is preferred.
  • the Ag/AgCl may be a sintered pellet or a thin layer painted or plated. In the case of a painted or layered Ag/AgCl coat, it may be advantageous to cover the Ag/AgCl with a semi-permeable, ionically conductive membrane, such as dialysis tubing, to protect the coating from wear and tear over extended use.
  • the metal plate 112 is joined to a connector 108 on the outside of the electrode 1 for connection to a suitable amplifier and data acquisition system. Note that embodiments of the invention may simply combine the metal plate 112 and the connector 108 into one unit. The descriptions here separate the two to better illustrate functionality and the signal pathway.
  • the electrode 1 In normal usage, the electrode 1 is "dry" in the sense that no additional water, gel or source of moisture is required for operation.
  • the solid polymer contains bound water molecules and conductive ions to enable electrical coupling to the subject's skin once physical contact is established.
  • the water molecules are bound to the solid polymer 110, the subject's stratum corneum is not hydrated, as with conventional wet gel electrodes. Dry stratum corneum presents a high impedance interface which may generate excess noise compared to wet gel electrodes, particularly at low frequencies. Adding extra moisture to the stratum corneum may be desirable for improved signal quality by lowering the impedance of the subject's stratum corneum. This can be accomplished by manually wetting the prongs 100 immediately before usage.
  • the liquid to wet the electrode may be simply water or saline. Alternatively, a solution that is both skin-safe while resisting evaporation loss may be used to extend the lifetime of the moisture.
  • Dipropylene glycol is one such suitable moisturizer.
  • Other similar hydrophilic liquids with moisture retention properties include glycerol and other similar compounds.
  • the moisturizing agent may be dispensed on the surface of the electrode 1 before placing the electrode on the subject's head. Because the electrode 1 uses a hydrophilic polymer, the moisture sticks closely to the surface of the electrode rather than running off or quickly evaporating. This allows the moisture to stay on the surface of the electrode 1 as it is being manipulated to place on the scalp and hydrate the stratum corenum. The moisture also enhances the bulk conductivity of the electrode 1 allowing for a signal quality that is equivalent to a conventional wet electrode while minimizing the amount of skin prep and setup time by still providing a structure that can easily penetrate hair.
  • a source of moisture may be added to the electrode by utilizing a reservoir (e.g., foam or cavity) located within the rigid housing 102. In this case, the prongs 100 are moisturized via capillary action from the reservoir.
  • the solid polymer 110 may be doped with an abrasive material such as sand or silica microspheres.
  • the abrasive particles are small enough to be suspended within the solid polymer 110 and do not affect its electrical or mechanical properties, besides adding a rougher surface.
  • the sensor is gently rubbed into the subject's scalp to slightly abrade the stratum corneum, thus lowering the contact impedance, without the need for extra moisture.
  • FIG. 4 shows a second embodiment of the invention. Like the first embodiment from
  • the electrode 2 comprises of a solid polymer 210 with prongs 200 and enclosed within and supported by a rigid housing 204 with openings 204.
  • the openings 204 are angled to direct the prongs 200 in an outwardly radial pattern, as shown in FIG. 5, unlike the straight angled prongs of the first embodiment shown in FIG 1-3.
  • Forcing the prongs 200 angled outwards in a radially expansive pattern helps the prongs 200 penetrate hair as a group. In addition, it offers improved comfort for the subject by ensuring that the legs have an amount of flexure under pressure.
  • the second embodiment likewise contains a metal plate 212 for electrically connecting the solid polymer 210 to a connector 208.
  • the second embodiment may also involve variants utilizing different geometries for the openings 204 to direct the prongs 200 in different angles or directions to provide a range of options that trade-off between hair penetration and comfort all while using the same design for the solid polymer 210.
  • one variant may sharply angle the prongs 200 outwards which will decrease hair penetration but may work well over areas with light skin.
  • the first two embodiments described have utilized a solid polymer 110 supported by a rigid housing 102.
  • Other embodiments of the invention may alternatively utilize a different rigid structure to support a solid conductive polymer.
  • FIG. 7 shows a third embodiment of the invention utilizing an internal rigid frame.
  • the electrode 3 consists of the solid polymer 310 with prongs 300.
  • a rigid frame 302 is located within the solid polymer 310 with fingers 304 that span at least partially into the length of the prongs 310, as shown in FIG. 8.
  • the rigid frame 302 is either metallic and/or coated with a conductive layer such as Ag/AgCl to electrically couple with the solid polymer 310.
  • the rigid frame 302 with fingers 304 are analogous to the rigid housing 102 and openings 104 from the first embodiment and serve to limit the flexure of the solid polymer 310 and prongs 300.
  • the overall flexibility and hardness of the electrode 3 can be controlled by varying the hardness of both the solid polymer 310 as well as the hardness of the rigid frame 302.
  • Suitable materials for the rigid frame 302 may range from inflexible metals to flexible plastics coated with a conductive layer such as Ag/AgCl ink or paint to conduct electrical signals from the solid polymer 310.
  • a connector or lead wire can be attached to the conductive portion of the rigid frame 302 to interface the electrode 3 to amplification and data acquisition circuitry.
  • the electrode 3 may be manufactured by overmolding the solid polymer 310 on top of the rigid frame 302.
  • the rigid frame may be manually inserted into the solid polymer 310 by the user.
  • inventions of the invention may dispense with the rigid housing altogether and comprise solely of a solid polymer. Although this will likely compromise mechanical rigidity, resulting in less efficient hair penetration and longevity, such an embodiment would be low cost and is ideal for single use, disposable applications. Finally, other embodiments of the invention may not need to include prongs.
  • the CMC hydrocolloid polymer of the first embodiment may be shaped into flat discs which are ideal for use on areas with low hair density.
  • the described application has focused on sensing of biopotentials such as EEG, ECG or EMG.
  • the invention is also broadly applicable for the transduction of signals from or to the body such as direct or alternating electrical current stimulation.
  • the current invention is capable of operating through hair both with or without the addition of liquids preparation, while offering signal quality more comparable to wet electrodes than conventional metal dry electrodes.
  • the present invention utilizes a conductive, hydrophilic, waterbearing polymer of medium stiffness, between Shore A 10 and Shore A 90 (or their Shore D equivalents).
  • medium stiffness polymers exist such as certain classes of hydrogels, hydrocolloids, foams or alginates.
  • Medium stiffness polymers usually contain enough water content to maintain some conductivity over extended periods of time (days or even weeks, unlike prior art hard hydrogels that degrade over the course of a few hours, while also being able to hold and maintain a pre-determined shape over repeated use.
  • the medium stiffness and mechanical shape retention properties of the polymer allows the material to be shaped into a structure having prongs.
  • the prongs reach out to penetrate through hair and create contact with the scalp.
  • Biopotential signals are transmitted from the scalp, into the polymer then to a metal connector.
  • EEG electrodes medium hardness polymers have not been considered suitable for use as EEG electrodes. There are two issues. First, for gel-free EEG, the electrode must contain one or more thin prongs to penetrate through hair and establish contact with the scalp. At durometers between Shore A 10 and Shore A 90 (or their Shore D equivalents), the thin prongs are too soft and collapse or get trapped as pressure is applied before reaching the scalp.
  • a separate rigid structure is used to reinforce the prongs of the electrode.
  • a rigid structure enables the electrode to achieve the correct hardness, by mechanically limiting the amount of bend that the prongs can undergo, without compromising the electrical and material properties of the conductive polymer.
  • the medium stiffness of the polymer in the current invention means the rigid structure does not need to extend across the body of the polymer down to the tips of the prongs. Leaving the skin contact ends of the prong exposed and therefore softer helps ensure subject comfort.
  • the rigid structure only loosely clamps around the polymer making the polymer easy to remove and change as the polymer degrades from use.
  • the second issue confronting attempts to build sensors from medium hardness polymers is that lowering the water content of the polymer to achieve a medium stiffness generally results in lower volume conductivity as compared to wet gels: in the range of hundreds of ohms or more per cm vs tens of ohms per cm for wet gels and pastes.
  • Conventional wisdom suggests that the gel must achieve very low levels of volume conductivity, typically in the range of tens of ohms per cm (on par with conventional wet gels), accomplished by having a high water content versus binders and plasticizers, as taught by Toyama. This results in a polymer that is soft, amorphous and incapable of being shaped into prongs that can penetrate hair.
  • a medium stiffness polymer of lower water content and lower volume resistance compared to standard gels or pastes is not detrimental to signal quality when applied to unprepped, dry skin since the noise characteristics of a system is dominated almost purely by the layer with the highest impedance (e.g., the unprepped skin).
  • the electrode can be optionally wetted and still retain many of the desired benefits including fast setup and rapid hair penetration due to the pronged structure.
  • the combination of the rigid structure and the medium stiffness polymer enables an electrode that can achieve a high-level of conductivity, robustness and signal quality.
  • the combination of the medium stiffness polymer and rigid structure results in a device that can get through hair while still retaining a softer point for maximum comfort.
  • the combination allows the polymer section to be easily replaced as needed for an electrode that is reusable and inexpensive.

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Abstract

Une électrode comprend un polymère solide conducteur ionique ayant au moins une dent pour entrer en contact avec la peau d'un sujet; une plaque métallique; et un connecteur électrique. Le polymère solide est supporté par une structure rigide pour limiter la flexion de l'au moins une dent. Le polymère solide est en contact électrique avec la plaque métallique. La plaque métallique est en contact électrique avec le connecteur électrique. Des signaux électriques peuvent être couplés à partir du sujet, à travers le polymère conducteur et au connecteur électrique lorsque la dent est appliquée sur la peau du sujet. Dans des modes de réalisation donnés à titre d'exemple, le polymère conducteur comprend un polymère hydrocolloïde contenant de l'eau et des ions pour faciliter la conduction ionique à la peau du sujet, et/ou les ingrédients hydrocolloïdes peuvent contenir de l'eau, du sel, du glycérol et de la carboxyméthylcellulose.
PCT/US2018/059851 2017-11-09 2018-11-08 Électrode biopotentielle solide à faible bruit WO2019094609A1 (fr)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN116019455A (zh) * 2022-07-29 2023-04-28 天津理工大学 柔性高密度头皮脑电电极及其制备方法
EP4101382A4 (fr) * 2020-02-07 2024-03-13 Nok Corp Bioélectrode

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US20060258788A1 (en) * 2005-05-13 2006-11-16 Scott Coggins Polymeric hydrogel compositions
US20130102874A1 (en) * 2011-10-19 2013-04-25 Cognionics, Inc. Apparatuses, systems and methods for biopotential sensing with dry electrodes
US20160089045A1 (en) * 2014-09-26 2016-03-31 NeuroRex Inc. Bio-potential sensing materials as dry electrodes and devices
US20170164862A1 (en) * 2014-07-13 2017-06-15 Nibs Neuroscience Technologies Ltd. Electrode headset grid and use thereof in the non-invasive brain stimulation and monitoring

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US20060258788A1 (en) * 2005-05-13 2006-11-16 Scott Coggins Polymeric hydrogel compositions
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Title
CHEN ET AL.: "Soft, Comfortable Polymer Dry Electrodes for High Quality ECG and EEG Recording", SENSORS 2014, vol. 14, 10 December 2014 (2014-12-10), pages 23758 - 23780, XP055498820, Retrieved from the Internet <URL:https://www.mdpi.com/1424-8220/14/12/23758> DOI: doi:10.3390/s141223758 *
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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4101382A4 (fr) * 2020-02-07 2024-03-13 Nok Corp Bioélectrode
CN116019455A (zh) * 2022-07-29 2023-04-28 天津理工大学 柔性高密度头皮脑电电极及其制备方法

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