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
  • A61N1/0492—Patch electrodes
• • 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
  • A61B5/251—Means for maintaining electrode contact with the body
  • A61B5/257—Means for maintaining electrode contact with the body using adhesive means, e.g. adhesive pads or tapes
• • 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
  • A61B5/263—Bioelectric electrodes therefor characterised by the electrode materials
  • A61B5/266—Bioelectric electrodes therefor characterised by the electrode materials containing electrolytes, conductive gels or pastes
• • 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
  • A61B5/6833—Adhesive patches
• • 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
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
  • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
  • A61B2562/0209—Special features of electrodes classified in A61B5/24, A61B5/25, A61B5/283, A61B5/291, A61B5/296, A61B5/053
  • A61B2562/0217—Electrolyte containing
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N1/00—Electrotherapy; Circuits therefor
  • A61N1/18—Applying electric currents by contact electrodes
  • A61N1/20—Applying electric currents by contact electrodes continuous direct currents
  • A61N1/30—Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis

Definitions

• the invention relates to electrode apparatus configured to electrically couple to an area of skin of a subject in order to provide electro-stimulation and/or to obtain
• Conventional electrodes for stimulation typically include hydrogels that facilitate electrical conduction between the electrodes and the skin of a subject. These hydrogels are solid jelly-like materials. Due to inconsistent current density (i.e., "hot spots") delivered to a stimulation area of a subject's skin from irregular skin contact and/or edge effects, these stimulation electrodes may often cause undesired tingling or burning sensation for subjects at the stimulation area.
• hydrogels that facilitate electrical conduction between the electrodes and the skin of a subject.
• These hydrogels are solid jelly-like materials. Due to inconsistent current density (i.e., "hot spots") delivered to a stimulation area of a subject's skin from irregular skin contact and/or edge effects, these stimulation electrodes may often cause undesired tingling or burning sensation for subjects at the stimulation area.
• Some existing measurement electrodes include a liquid gel encapsulated in a
• liquid-gel-in-sponge configurations may be sufficient for measurement applications.
• stimulation applications however, the decreased skin contact area of liquid-gel-in-sponge configurations can lead to similar undesired tingling for subjects as with hydrogels.
• the apparatus may include a current spreader and a spongeless volume.
• the current spreader may be configured to spatially distribute electrical current across a stimulation area of a subject's skin.
• the spongeless volume may be disposed adjacent to the current spreader.
• the spongeless volume may be configured to carry a fluent conductive substance.
• the fluent conductive substance may be configured to conduct electrical current between the current spreader and the stimulation area of the subject's skin to provide electro-stimulation.
• the method may include disposing an electrode on a stimulation area of a subject's skin, wherein the electrode includes a current spreader and a spongeless volume carrying a fluent conductive substance.
• the method may include conducting electrical current between the current spreader and the stimulation area of the subject's skin via the fluent conductive substance, wherein the conducted electrical current is spatially distributed across the stimulation area of the subject's skin by the current spreader.
• the apparatus may include current spreading means and spongeless liquid gel carrying means.
• the current spreading means may be configured to spatially distribute electrical current across a stimulation area of a subject's skin.
• the spongeless liquid gel carrying means may be disposed adjacent to the current spreading means.
• the spongeless liquid gel carrying means may be configured to carry a fluent conductive substance.
• the fluent conductive substance may be configured to conduct electrical current between the current spreader and the stimulation area of the subject's skin to provide electro-stimulation.
• FIG. 1 illustrates an electrode assembly configured to electrically couple to an area of skin of a subject to provide electro-stimulation and/or to obtain measurements, in accordance with one or more embodiments of the invention.
• FIG. 2 illustrates an assembly view of an electrode assembly, in accordance with one or more embodiments of the invention.
• FIG. 3 illustrates current density gradients that may be provided by an exemplary electrode assembly to an area of skin of a subject, in accordance with one or more embodiments of the invention.
• FIG. 4 is a flow chart illustrating a method for providing electro-stimulation, in
• FIG. 1 illustrates an electrode assembly 100 configured to electrically couple to an area of skin 102 of a subject 104 to provide electro-stimulation and/or to obtain
• the area of skin 102 may be located at any position on the subject 104 where electro-stimulation and/or measurements are to be performed.
• Use of liquid gel or other fluent (i.e., capable of flowing) conductive substance may provide full skin contact and may decrease high current density hotspots.
• conventional electrodes are prepared with gel only (i.e., not encapsulated in a sponge) the skin contact may be difficult to ensure, for example, due to seepage of the liquid gel away from the area of skin 102.
• the electrode assembly 100 may be configured to utilize liquid gel for electrical coupling to the area of skin 102 for stimulation and/or measurement, while ensuring proper skin contact.
• the electrode assembly 100 may include one or more of a current spreader 106, a liquid gel receptacle 108, an adhesive element 1 10, a liquid gel reservoir 1 12, a liquid gel supply chamber 1 14, a suction tool 1 16, a permeable netting 1 18, a dissolvable film 120, and/or other components.
• the electrode assembly 100 may include, or be coupled to, a power source 122 configured to provide electrical power to one or more components of the electrode assembly 100.
• the electrode assembly 100 may include, or be coupled to, a controller 124 configured to control one or more components of the electrode assembly 100.
• one or more of components 106, 108, 1 10, 1 12, 1 14, 1 16, 1 18, and/or 120 may be physically separate and distinct from the other components.
• the description of the functionality provided by the different components 106, 108, 1 10, 1 12, 1 14, 1 16, 1 18, and/or 120 described below is for illustrative purposes, and is not intended to be limiting, as any of components 106, 108, 1 10, 1 12, 1 14, 1 16, 1 18, and/or 120 may provide more or less functionality than is described.
• one or more of components 106, 108, 1 10, 1 12, 1 14, 1 16, 1 18, and/or 120 may be eliminated.
• two or more of the components 106, 108, 1 10, 1 12, 1 14, 1 16, 1 18, and/or 120 may be combined into one or more single components with some or all of the functionalities attributed to the combined components.
• the current spreader 106 may be configured to spatially distribute electrical current across a stimulation area (e.g., the area of skin 102) of the subject 104. Spatial distribution of electrical current may serve to avoid severe variances in current density delivered to the subject 104 during electro-stimulation.
• the current spreader 106 may include, for example, a metal plate, a conducting plate, and/or other apparatus configured to spatially distribute electrical current across an area.
• a conductive medium e.g., liquid gel
• the liquid gel receptacle 108 may be disposed adjacent to the current spreader 106.
• the liquid gel receptacle 108 may be configured to carry liquid gel such that, when the electrode assembly 100 is applied to the area of skin 102 of the subject 104, liquid gel carried by the liquid gel receptacle 108 contacts the area of skin 102.
• the liquid gel receptacle 108 does not contain a sponge to encapsulate liquid gel. In such embodiments, full contact is provided between the liquid gel carried by the liquid gel receptacle 108 and the area of skin 102 of the subject 104.
• the liquid gel is configured to conduct electrical current between the current spreader 106 and a stimulation area (e.g., the area of skin 102) of the subject 104 to provide electrostimulation.
• the liquid gel may include dissolved salts, polyelectrolytes, other ionic species, salt-free liquid gel, and/or other fluent conductive substance.
• a salt-free liquid gel is Spectra 360 Electrode Gel available from Parker Laboratories, Inc. of Fairfield, New Jersey.
• the liquid gel includes a conditioning ingredient configured to locally increase the electrical conductivity of the skin of the subject 104 at the stimulation area. Examples of the conditioning ingredient include glycerin and/or other substances configured to enhance electrical properties of skin.
• the adhesive element 1 10 may be configured to removably couple the electrode assembly 100 to the area of skin 102 of the subject 104 such that liquid gel carried by the liquid gel receptacle 108 contacts the area of skin 102.
• the adhesive element 1 10 may include any number of adhesive materials known in the art. It is noteworthy, however, that the adhesive element 1 10 should be capable of sufficiently adhering the electrode assembly 100 to the area of skin 102 to ensure consistent contact area of the liquid gel to preclude any hot spots (i.e., areas of high current density).
• liquid gel carried by the liquid gel receptacle 108 may become at least partially depleted.
• some of the liquid gel carried by the liquid gel receptacle 108 may remain on the packaging or cover.
• some of the liquid gel carried by the liquid gel receptacle 108 may seep out of the liquid gel receptacle 108.
• Exemplary embodiments may be configured to prevent and/or compensate for depletion of liquid gel from the liquid gel receptacle 108, as described further below.
• the liquid gel reservoir 1 12 may be in fluid communication with the liquid gel
• the liquid gel reservoir 1 12 may be configured to store liquid gel.
• the liquid gel stored by the liquid gel reservoir 1 12 may be communicated to the liquid gel receptacle 108 by flowing through a structure configured to communicate fluids. Examples of such structures may include a channel, conduit, and/or other structure configured to communication fluids.
• Liquid gel stored by the liquid gel reservoir 1 12 may not directly contact the area of skin 102 or the current spreader 106, in some embodiments.
• the liquid gel reservoir 1 12 may be configured to provide additional liquid gel to the liquid gel receptacle 108 responsive to liquid gel in the liquid gel receptacle 108 being at least partially depleted.
• liquid gel in the liquid gel reservoir 1 12 may flow to the liquid gel receptacle 108, as a result of pressure applied to the electrode assembly 100 for proper adhesion, to replace any depleted liquid gel, according to some embodiments.
• the liquid gel supply chamber 1 14 may be configured to store liquid gel.
• the liquid gel supply chamber 1 14 may be included in the electrode assembly 100 and be in fluid communication with the liquid gel receptacle 108.
• the liquid gel stored by the liquid gel supply chamber 1 14 may be communicated to the liquid gel receptacle 108 by flowing through a structure configured to communicate fluids. Examples of such structures may include a channel, conduit, and/or other structure configured to communication fluids.
• the liquid gel supply chamber 1 14 may be physically separate and distinct from the electrode assembly 100. In such embodiments, the liquid gel supply chamber 1 14 may by configured to couple to the electrode assembly 100 to establish fluid communication with the liquid gel receptacle 108.
• the suction tool 1 16 may be configured to reduce a fluid pressure (e.g., air pressure and/or liquid gel pressure) within the liquid gel receptacle 108. By reducing the fluid pressure within the liquid gel receptacle 108, liquid gel may be drawn from the liquid gel supply chamber 1 14 to the liquid gel receptacle 108.
• the suction tool 1 16 may be included in the electrode assembly 100.
• the suction tool 1 16 may be physically separate and distinct from the electrode assembly 100.
• the liquid gel supply chamber 1 14 and the suction tool 1 16 may be combined into a single device that is physically separate and distinct from the electrode assembly 100. Examples of the suction tool 1 16 may include a suction cup, a deformable bulb, and/or other apparatus configured to reduce a fluid pressure.
• the permeable netting 1 18 may be configured to cover a portion of the liquid gel receptacle 108 by partially enclosing the liquid gel receptacle 108. That portion may be the portion of the liquid gel receptacle 108 that is closest to the subject 104 when the electrode assembly 100 is applied.
• the permeable netting 1 18 may include a permeable netting, a permeable membrane, and/or other flat or planar permeable materials.
• the permeable netting 1 18 may include a SN42 net available from Smith & Nephew Extruded Films Limited of East Yorkshire, England.
• the permeable netting 1 18 may be configured to communicate liquid gel therethrough from the liquid gel receptacle 108 to the area of skin 102 of the subject 104.
• the permeable netting 1 18 may serve to hold liquid gel within the liquid gel receptacle 108 until the electrode assembly 100 is applied to the subject 104. Force applied to the electrode assembly 100 during application may cause liquid gel to travel through the permeable netting 1 18 so that the area of skin 102 is fully contacted by liquid gel.
• the permeable netting 1 18 may provide greater skin contact area, relative to existing liquid-gel-in-sponge configurations, to achieve a desirable decrease in current density hotspots.
• the dissolvable film 120 may be configured to cover a portion of the liquid gel
• the dissolvable film 120 may be configured to dissolve responsive to the dissolvable film 120 contacting the skin of the subject 104. When the dissolvable film 120 has dissolved, liquid gel in the liquid gel receptacle 108 may contact the area of skin 102 of the subject 104.
• the dissolvable film 120 may include one or more additives. Such additives may include a conditioning ingredient configured to locally increase the electrical conductivity of the skin of the subject 104, an ingredient that aids in adhesion of the electrode assembly 100 to the subject 104, and/or other additives.
• some embodiments may include a sponge configured to
• the electrode assembly 100 may include a sponge configured to encapsulate liquid gel that is disposed within the liquid gel receptacle 108, the liquid gel supply chamber 1 14, and/or other locations within the electrode assembly 100.
• FIG. 2 illustrates an assembly view of an electrode assembly 200, in accordance with one or more embodiments of the invention.
• the electrode assembly 200 may include one or more components described in connection with the electrode assembly 100.
• the electrode assembly 200 may include an adhesive element 202, liquid gel 204, a masking element 206, a current spreader 208, a carbon element 210, a metal plate 212, backing 214, and/or other components. It should be appreciated that the depiction of the electrode assembly 200 in FIG. 2 is not intended to be limiting.
• one or more of relative size, shape, assembly order, or other characteristics attributed to the adhesive element 202, the liquid gel 204, the masking element 206, the current spreader 208, the carbon element 210, the metal plate 212, and/or the backing 214 may be varied, according to some embodiments.
• one or more components of the electrode assembly 200 may be combined into a single component, and/or be omitted.
• the adhesive element 202 may include some or all of the characteristics and/or functionalities attributed the adhesive element 1 10 described in connection with FIG. 1 .
• the adhesive element 202 and the masking element 206 may form a liquid gel receptacle (e.g., the liquid gel receptacle 108) configured to carry the liquid gel 204.
• the masking element 206 may be configured to electrically isolate a subject and/or other components of the electrode assembly 200 from the current spreader 208 and/or the liquid gel 204.
• the current spreader 208 may include some or all of the characteristics and/or functionalities attributed to the current spreader 106 described in connection with FIG. 1.
• the carbon element 210 may be configured to spatially distribute electrical current from the metal plate 212 to the current spreader 208.
• the carbon element 210 may be configured to provide adhesive properties to assure long-term electrical contact between the current spreader 208 and the metal plate 212.
• the metal plate 212 may be configured to receive electrical current from a power source (e.g., the power source 122).
• the metal plate 212 may be configured to provide removable magnetic coupling to a power source (e.g., the power source 122). It is noteworthy that some embodiment may include other mechanisms for physically coupling and/or electrical coupling to a power source such as a snap connector and/or other connectors.
• the backing 214 may be configured to support and/or carry components of the electrode assembly 200.
• the electrode assembly 200 may include one or more other components not depicted in FIG. 2.
• a permeable netting e.g., the permeable netting 1 18
• a dissolvable film e.g., the dissolvable film 120
• the backing 214 may include a reservoir (e.g., the liquid gel reservoir 1 12).
• the current spreader 208 may include a correspondingly positioned hole providing fluid communication from the reservoir of the backing 214 to a liquid gel receptacle formed by the adhesive element 202 and the masking element 206.
• FIG. 3 illustrates current density gradients 300 that may be provided by an
• the grey scale intensity of the current density gradients 300 correspond to magnitude of current density, where dark regions represent higher current density.
• the edges of the current density gradients 300 may have lower current densities than the center regions. This may reduce effects of edges common in conventional electrodes, such as tingling during electro-stimulation.
• the shapes, sizes, and current density profiles of the current density gradients 300 illustrated in FIG. 3 are not intended to be limiting, as the current density gradients 300 may include other shapes, sizes, current density profiles, and/or other characteristics.
• current density gradients may be provided by a current spreader (e.g., the current spreader 106 and/or current spreader 208).
• a current spreader e.g., the current spreader 106 and/or current spreader 208.
• Conventional electrodes are generally made with current spreaders having a continuous conductivity over the bulk material, which may lead to current density issues at edges.
• Use of a current density spreader configured to provide a density gradient across a stimulation area of a subject's skin may reduce or eliminate current density hotspots at edges.
• a current spreader may include conductive material patterned so as to provide a current density gradient.
• a current spreader may include a conductivity gradient where the current spreader is more conductive near the center relative to the edges of the current spreader such that a current density gradient may be provided.
• a current spreader may include a conductive material that is thicker near the center relative to the edges of the current spreader such that a current density gradient may be provided.
• current density gradients may be provided by liquid gel carried by the liquid gel receptacle 108 described in connection with FIG. 1.
• Conventional electrodes are generally made with gels (e.g., hydrogels and/or liquid gel encapsulated by a sponge) having continuous conductivity over the bulk material, which may lead to current density issues at edges.
• gels e.g., hydrogels and/or liquid gel encapsulated by a sponge
• Use of liquid gel configured to provide a current density gradient across a stimulation area of a subject's skin may reduce or eliminate current density hotspots at edges.
• liquid gel carried by the liquid gel receptacle 108 may include a conductive substance distributed across the volume of the liquid gel receptacle 108 so as to provide a current density gradient, wherein higher local concentrations of the conductive substance lead to higher current densities and vice versa.
• liquid gel carried by the liquid gel receptacle 108 may include a non-conductive component (e.g., non-conductive spheres) distributed across the volume of the liquid gel receptacle 108 so as to provide a current density gradient, wherein higher local concentrations of the non- conductive component lead to lower current densities and vice versa.
• current density gradients may be provided by netting partially enclosing the liquid gel receptacle 108.
• the netting may have a lower hole density near the edges such that less liquid gel is delivered at the edges to the skin of a subject, thereby decreasing current density.
• Some embodiments include a dissolvable film having a conductive substance or a non-conductive component distributed across the area of the film so as to provide a current density gradient.
• FIG. 4 is a flow chart illustrating a method 400 for providing electro-stimulation, in accordance with one or more embodiments of the invention.
• the operations of the method 400 presented below are intended to be illustrative. In some implementations, the method 400 may be accomplished with one or more additional operations not described, and/or without one or more of the operations discussed. Additionally, the order in which the operations of the method 400 are illustrated in FIG. 4 and described below is not intended to be limiting.
• a spongeless volume (e.g., the liquid gel receptacle 108) is removably coupled to a stimulation area of a subject's skin. Removable coupling may be achieved via an adhesive element (e.g., the adhesive element 1 10 and/or the adhesive element 202).
• the spongeless volume may carry liquid gel configured to conduct current from an adjacent current spreader to the stimulation area.
• Such liquid gel may include a conditioning ingredient to increase conductivity of the subject's skin at the stimulation area.
• liquid gel is provided to the stimulation area.
• the liquid gel is provided to the stimulation area directly from the spongeless volume, from the spongeless volume via a netting (e.g., the permeable netting 1 18), from the spongeless volume via a dissolvable film (e.g., the dissolvable film 120), and/or by use of the liquid gel supply chamber 1 14 and the suction tool 1 16, as described in connection with FIG. 1.
• additional liquid gel may be provided to the stimulation area from the liquid gel reservoir 1 12, as described in connection with FIG. 1.
• operation 406 may include providing a current density gradient across the stimulation area of the subject's skin such that a current density at an edge of the stimulation area is less than a current density at an interior region of the stimulation area.

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• 2011
  • 2011-09-19 CN CN201180045159.XA patent/CN103118738B/zh active Active
  • 2011-09-19 WO PCT/IB2011/054086 patent/WO2012038878A2/en not_active Ceased
  • 2011-09-19 EP EP11776538.8A patent/EP2618888B1/en active Active
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