WO2021026662A1 - Appareil, système et procédé de communication électrique avec des régions du cerveau - Google Patents

Appareil, système et procédé de communication électrique avec des régions du cerveau Download PDF

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Publication number
WO2021026662A1
WO2021026662A1 PCT/CA2020/051116 CA2020051116W WO2021026662A1 WO 2021026662 A1 WO2021026662 A1 WO 2021026662A1 CA 2020051116 W CA2020051116 W CA 2020051116W WO 2021026662 A1 WO2021026662 A1 WO 2021026662A1
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WO
WIPO (PCT)
Prior art keywords
electrode
probe
neurological
sheath
flexible circuit
Prior art date
Application number
PCT/CA2020/051116
Other languages
English (en)
Inventor
Syed Kazim HAIDER
Pierre Jean Jacques WIJDENES
Colin Dalton
Original Assignee
Neuraura Biotech Inc.
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Filing date
Publication date
Application filed by Neuraura Biotech Inc. filed Critical Neuraura Biotech Inc.
Publication of WO2021026662A1 publication Critical patent/WO2021026662A1/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
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0526—Head electrodes
    • A61N1/0529—Electrodes for brain stimulation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0004—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by the type of physiological signal transmitted
    • A61B5/0006—ECG or EEG signals
    • 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]
    • A61B5/293—Invasive
    • 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
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6867—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive specially adapted to be attached or implanted in a specific body part
    • A61B5/6868—Brain
    • 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
    • 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
    • A61B2562/028—Microscale sensors, e.g. electromechanical sensors [MEMS]
    • 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
    • A61B2562/12—Manufacturing methods specially adapted for producing sensors for in-vivo measurements
    • A61B2562/125—Manufacturing methods specially adapted for producing sensors for in-vivo measurements characterised by the manufacture of electrodes
    • 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
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0526—Head electrodes
    • A61N1/0529—Electrodes for brain stimulation
    • A61N1/0531—Brain cortex electrodes
    • 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
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0526—Head electrodes
    • A61N1/0529—Electrodes for brain stimulation
    • A61N1/0534—Electrodes for deep brain stimulation

Definitions

  • the present disclosure generally relates to stimulating and acquiring information from a subject.
  • the present disclosure relates to at least one apparatus, system and method for electrically communicating with one or more predetermined regions of a subject’s brain.
  • Known neurological probes for data acquisition from, and stimulation of, deeper regions of a subject’s brain are in the form of an elongated tube that is inserted into a subcortical region of the subject’s brain.
  • These known neurological probes include a set of electrode rings positioned on a distal end of the tube that gets inserted into the subcortical region of interest and a set of metal rings that are positioned on a proximal end of the tube.
  • the electrode rings electrically communicate with the metal rings by one or more wires that run through a lumen within the tube.
  • the proximal end is configured to connect to an external system that collects the electrical data captured from the subcortical region by the electrode rings.
  • the electrode rings are sized in a millimeter scale for both data capture and stimulation.
  • Embodiments of the present disclosure relate to a probe configured to electrically communicate with the brain of a subject.
  • the probe comprises an elongate body and a plurality of electrodes couplable to the elongate body.
  • the elongate body comprises a first end and a second end and is configured to be insertable into or proximal to a portion of a subject’s nervous system.
  • the plurality of electrodes comprises at least one 3-dimensional electrode feature and are configured selectably to communicate with the subject’s nervous system.
  • the plurality of electrodes are coupled to the elongate body by a flexible circuit substrate.
  • Some embodiments of the present disclosure relate to a system comprised of a probe and an external system for data acquisition, wherein the probe is configured to connect to the external system for the transmission and reception of electric signals.
  • the embodiments of the present disclosure may allow for improved communication with subcortical regions of the subject’s brain.
  • the electrode rings used in known neurological probes are sized in the millimeter scale and such sizing/scale renders the known probes: unable to generate captured data signals of a preferred resolution (i.e. a low signal-to-noise ratio, which is also referred to as SNR); unable to precisely stimulate smaller regions of a subject’s brain; and, potentially cytotoxic to any stimulated region due to an excessive stimulator signal and the physical perturbation of inserting the known electrode rings into the subcortical region.
  • a preferred resolution i.e. a low signal-to-noise ratio, which is also referred to as SNR
  • SNR signal-to-noise ratio
  • the embodiments of the present disclosure comprise electrodes that are of a much smaller size/scale than the electrode rings used in known probes and this smaller size/scale can provide an improved resolution of the captured-data signal’s SNR, which can provide for collection of more accurate information.
  • the embodiments of the present disclosure can also provide an increased precision of stimulation, which is desirable to provide more effective and less damaging treatments to the subject.
  • Some embodiments may relate to improved transmission of signals from and to one or more subcortical regions of a subject’s brain. Some embodiments of the present disclosure may relate to improved capture of signals from the subcortical regions and some embodiments may relate to both types of communication.
  • Some embodiments of the present disclosure relate to a subcortical probe that is configured to communicate with subcortical regions of a subject’s brain.
  • the probe comprises a plurality of electrodes, wherein one or more of the electrodes comprise at least one 3- dimensional electrode feature.
  • the plurality of electrodes can be coupled along an elongate body of the probe to allow for electrical communication from near the proximal first end to near the distal second end of the probe, or any point there between.
  • the 3-dimensional electrode features on the surface of the electrodes increase the surface sensing-area of each applicable electrode by providing an increased area of contact between the electrode and the subject’s subcortical region.
  • the increased surface sensing-area may improve the signal-to-noise ratio, the signal resolution, the signal accuracy or combinations thereof.
  • Embodiments of the present disclosure may be useful for increasing the understanding and treatment options of neuro-degenerative diseases such as, but not limited to, epilepsy.
  • the present disclosure provides a neurological probe comprising:
  • the neurological probe comprises at least one characteristic selected from the group consisting of: (i) wherein the neurological probe further comprises a macroelectrode ring comprising the at least one electrode, wherein the macroelectrode ring encloses the flexible circuit substrate at the distal end; (ii) wherein the neurological probe further comprises a sheath enclosing the elongated probe body, the at least one electrode, at least part of the conductive trace, and at least part of the flexible circuit substrate, wherein the sheath comprises a sheath distal end and a sheath prox
  • the neurological probe comprises two of the characteristics. In some embodiments, the neurological probe comprises three of the characteristics. In some embodiments, the neurological probe comprises four of the characteristics.
  • the flexible circuit substrate supports the at least one electrode, the at least one connector, and the conductive trace. In some embodiments, the flexible circuit substrate is at least partially wrapped around the elongated probe body. In some embodiments, the neurological probe further comprises at least one macroelectrode ring, wherein the at least one macroelectrode ring comprises the at least one electrode, and wherein the at least one macroelectrode ring connects with and encloses at least part of the flexible circuit substrate at the distal end. In some embodiments, a cross section of the at least one macroelectrode ring is partially circular, fully circular, partially oval, or fully oval.
  • the at least one ring structure comprises a plurality of electrodes, and wherein the plurality of electrodes comprises the at least one electrode.
  • the at least one macroelectrode ring comprises a conductive layer or a metal layer. In some embodiments, at least one macroelectrode ring in electrical communication with the flexible circuit substrate or the conductive trace.
  • the at least one macroelectrode ring is disposed on top of the flexible circuit substrate.
  • the neurological probe comprises the sheath enclosing the elongated probe body, the at least one electrode, the at least part of the conductive trace, and the at least part of the flexible circuit substrate, wherein the sheath comprises the sheath distal end and the sheath proximal end.
  • the sheath comprises a hole on the surface of the sheath and at the sheath distal end, wherein the hole is configured to expose the at least one electrode at the distal end.
  • the sheath comprises no holes above the at least one electrode, thereby the at least one electrode is not exposed.
  • the sheath comprises an opening at the sheath distal end through which the distal end of the elongated probe body is exposed.
  • the sheath comprises an insulating material.
  • the insulating material is polyethylene, polyimide, polyether ether ketone (PEEK), polycarbonate, polyolefin, polyether block amides (PEBAX), nylon 6, nylon 66, nylon 12, polypropylene, polyesters, polyurethanes, polytetrafluoroethylene (PTFE), poly(phenylene sulfide) (PPS), poly(butylene terephthalate) (PBT), polysulfone, polyamide, polyimide, poly(p-phenylene oxide) (PPO), acrylonitrile butadiene, styrene (ABS), polystyrene, poly (methyl methacrylate) (PMMA), polyoxymethylene (POM), ethylene vinyl acetate, styren
  • the sheath is rigid.
  • the sheath is a biologically friendly metal, metal alloys, steel alloys, sintered metal, etched materials, molded materials, extruded materials.
  • the sheath is titanium, nickel titanium alloy or nitinol, stainless steel alloys, cobalt chromium alloys, titanium alloy, tantalum, tungsten and tungsten alloys, platinum, platinum-iridium alloy, platinum-nickel alloy, niobium, iridium, conichrome, gold and gold alloy, magnesium alloy, or a mixture thereof.
  • the sheath further comprises a lengthwise opening configured to allow the elongated probe body and the at least one electrode to be inserted into the sheath. In some embodiments, the sheath is configured to move along or around the elongated probe body. In some embodiments, the sheath is coupled to the elongated probe body. [0016] In some embodiments, the at least one electrode is in direct contact with a flexible circuit layer. In some embodiments, the flexible circuit layer is flexible or rigid. In some embodiments, the flexible circuit layer is part of the flexible circuit substrate, attached to the flexible circuit substrate, connected to the flexible circuit substrate, or in electrical communication with the conductive trace.
  • the flexible circuit layer is in a cylindrical shape wrapped around the elongated probe body at the distal end.
  • a cross section of the cylindncal shape of the flexible circuit layer is partially circular, fully circular, partially oval, or fully oval.
  • the cross section of the cylindrical shape of the flexible circuit layer is fully circular or fully oval.
  • the flexible circuit layer is in a spiral shape wrapped around the elongated probe body at the distal end.
  • the conductive trace is at least partially wrapped around the elongated probe body.
  • the at least one connector is in a cylindrical shape wrapped around the elongated probe body at the proximal end.
  • a cross section of the cylindrical shape of the at least one connector is partially circular, fully circular, partially oval, or fully oval.
  • the cross section of the cylindrical shape of the at least one connector is fully circular or fully oval.
  • the at least one electrode comprises at least one metal layer. In some embodiments, the at least one electrode further comprises an adhesive layer. In some embodiments, the at least one electrode further comprises another substrate layer that is biocompatible and dielectric. In some embodiments, the at least one metal layer is a plurality of metal layers. In some embodiments, the plurality of metal layers are stacked in tandem. In some embodiments, the other substrate layer is between the at least one metal layer and the adhesive layer, or between the two members of the plurality of metal layers. In some embodiments, the at least one electrode comprises an exposed surface. In some embodiments, the at least one electrode further comprises a 3-dimentional micro-electrode disposed on top of the exposed surface.
  • the at least one electrode further comprises at least one insulating layer.
  • the at least one insulating layer is in direct contact with the at least one metal layer.
  • the at least one insulating layer is in direct contact with the 3-dimensional micro-electrode.
  • the at least one insulating layer comprises a first insulating layer and a second insulating layer, wherein the first insulating layer is in direct contact with the at least one metal layer, and wherein the second insulating layer is in direct contact with the 3-dimentional micro-electrode.
  • the 3-dimentional micro-electrode is a bump micro-electrode, a spike micro-electrode, or any 3-dimentional shaped micro-electrode.
  • the at least one electrode comprises a flexible circuit which may comprise at least one substrate/dielectric layer and at least one metal layer.
  • the flexible circuit may comprise at least one tandem of metal layers and at least one substrate/dielectric layer.
  • any two member of the metal layers or any tandems of the metal layers can be separated by the substrate/dielectric layer to form two separate conductive layers, each of which comprises a member of the metal layer or a tandem of metal layers.
  • One, two, three, four, five or six, or all conductive layers on the flexible circuit can be etched to form at least one conductive trace and at least one electrode/pad.
  • a conductive trace as used herein, can be configured to pass through one, two, three, four, five, or six, or all, substrate/dielectric layers by way of a vertical interconnection access (or “via” standard terminology by circuit fabrication houses) and connect to a conductive layer.
  • the at least one electrode/pad can be exposed on one of, or both parts, the top part or the bottom part of the flexible circuit.
  • Circuit fabrication may include multiple layers of material built on a substrate.
  • the material layers may include conductive metal layers, also known as metal levels, which interconnect circuit devices.
  • Elongate conductive lines of metal levels in an integrated circuit may include interconnects as well as electrode that function as electrodes for semiconductor devices.
  • Conductive lines formed from a layer or layers at the same vertical level can be referred to collectively as a metal level, and the lines can be referred to metal lines or wires, even though the material may be formed from non-metal conductors such as doped semiconductor layers (e.g., polysilicon) or metallic alloys such as metal nitrides, metal carbides and metal silicides.
  • Contacts formed between metal levels can be referred to as vertical connectors.
  • Such vertical connectors or vertical interconnections can be formed separately from the conductive lines they connect, or can be simultaneously formed with overlying conductive lines in a dual damascene process.
  • Another aspect of the present disclosure herein provides a method of making the neurological probe, comprising: step (a) making the flexible circuit substrate from a flat flexible printed circuit, wherein the flexible circuit substrate supporting the at least one electrode, power transformer for the tabletop aligner, the at least one connector; and the conductive trace; and step (b) wrapping at least one portion of the flexible circuit substrate into a circular shape or around the elongated probe body, wherein the at least one portion of the flexible circuit substrate comprises the at least one electrode.
  • the at least one portion of the flexible circuit substrate further comprises the at least one connector.
  • the wrapping in step (b) results in a spiral shape or a cylindrical shape.
  • the method further comprises applying an adhesive layer between the flexible circuit substrate and the elongated probe body.
  • the method further comprises sliding a sheath over the elongated probe body wrapped with the at least one portion of the flexible circuit substrate, wherein the sheath comprises an insulating material.
  • the method further comprises opening a lengthwise opening on a sheath; inserting the elongated probe body wrapped with the at least one portion of the flexible circuit substrate; and closing the lengthwise opening, thereby enclosing at least partially the elongated probe body wrapped with the at least one portion of the flexible circuit substrate.
  • a neurological probe configured to electrically communicate with a subject’s nervous system, the probe comprising: (a) an elongate probe body comprising a distal end and a proximal end and configured to be insertable into or proximal to a portion of the subject’s nervous system; and (b) an electrode assembly that is couplable to the distal end of the elongate body with aid of a flexible circuit substrate, wherein the electrode assembly comprises at least one ring structure, and wherein the electrode assembly is configured to selectably communicate with the subject’s nervous system.
  • the at least one ring structure comprises a plurality of electrodes.
  • the at least one ring structure is a metal ring or comprise a metal layer. In some embodiments, the at least one ring structure is in electrical communication with the flexible circuit substrate. In some embodiments, the at least one ring structure is disposed on top of the flexible circuit substrate. In some embodiments, a cross section of the at least one ring is partially circular, fully circular, partially oval, or fully oval. In some embodiments, the cross section of the at least one ring is fully circular or fully oval. In some embodiments, at least one member of the plurality of electrodes comprises a 3-dimensional micro-electrode.
  • a neurological probe assembly configured to electrically communicate with a subject’s nervous system, the assembly comprising: (a) an elongate probe body comprising a distal end and a proximal enter and configured to be insertable into or proximal to a portion of the subject’s nervous system; (b) an electrode that is couplable to the distal end of the elongate body, and configured to selectably communicate with the subject’s nervous system; and (c) a sheath configured to enclose the elongated probe body and the electrode coupled to the distal end of the elongated probe body.
  • the sheath comprises a sheath distal end and a sheath proximal end, and wherein the sheath comprises a hole on the surface of the sheath and at the sheath distal end, wherein the hole is configured to expose the at least one electrode at the distal end.
  • the sheath comprises no holes above the electrode, thereby the electrode is not exposed.
  • the sheath comprises an opening at the sheath distal end through which the distal end of the elongated probe body is exposed.
  • the sheath comprises an insulating material.
  • the insulating material is polyethylene, polyimide, polyether ether ketone (PEEK), polycarbonate, polyolefin, polyether block amides (PEBAX), nylon 6, nylon 66, nylon 12, polypropylene, polyesters, polyurethanes, polytetrafluoroethylene (PTFE), poly(phenylene sulfide) (PPS), poly (butylene terephthalate) (PBT), polysulfone, polyamide, polyimide, poly(p-phenylene oxide) (PPO), acrylonitrile butadiene, styrene (ABS), polystyrene, poly(methyl methacrylate) (PMMA), polyoxymethylene (POM), ethylene vinyl acetate, styrene acrylonitrile resin, polybutylenea biocompatible polymer, silicone, polyether block amide (PEBAX), polyurethanes, silicone polyurethane copolymers, nylon, polyethylene terephthalate
  • the sheath is rigid. In some embodiments, the sheath is a biologically friendly metal, metal alloys, steel alloys, sintered metal, etched materials, molded materials, extruded materials. In some embodiments, the sheath is titanium, nickel titanium alloy or nitinol, stainless steel alloys, cobalt chromium alloys, titanium alloy, tantalum, tungsten and tungsten alloys, platinum, platinum-iridium alloy, platinum-nickel alloy, niobium, iridium, conichrome, gold and gold alloy, magnesium alloy, or a mixture thereof. In some embodiments, the sheath further comprises a lengthwise opening configured to allow the elongated probe and the electrode to be inserted into the sheath. In some embodiments, the sheath is configured to move along or around the elongated probe body. In some embodiments, the sheath is coupled to the elongated probe body.
  • Another aspects of the present disclosure herein provides a method for assembling a neurological probe assembly, comprising: (a) providing an elongated probe body comprising a distal end and a proximal end; (b) coupling an electrode to the distal end of the elongated probe body; and (c) enclosing at least part of the elongated probe body and the electrode coupled to the distal end of the elongated probe body into a sheath.
  • the method further comprises: exposing the electrode through a hole on the surface of the sheath at the sheath distal end.
  • the enclosing in (c) is sliding the sheath over the elongated probe body and the electrode.
  • the enclosing in (c) is inserting the elongated probe body and the electrode into the sheath from a lengthwise opening on the sheath; and closing the lengthwise opening.
  • the method further comprises: after (b) and before (c), inserting the sheath into a human subject.
  • the method further comprises: after (c), removing the sheath from the human subject.
  • the method further comprises: after (c), adjusting the position of the elongated probe body within the sheath, and exposing the electrode through a hole on the surface of the sheath at the sheath distal end. In some embodiments, there are additional holes along the sheath body to expose additional electrodes.
  • a neurological probe configured to electrically communicate with a subject’s nervous system, the probe comprising: (a) an elongate probe body comprising a distal end and a proximal end and configured to be insertable into or proximal to a portion of the subject’s nervous system; and (b) a flexible circuit substrate comprising (i) a first elongated portion comprising one or more conductive traces; and (ii) a second portion comprising one or more electrodes in electrical communication with the one or more conductive traces, wherein the second portion is configured to wrap around the elongate probe body to form a tubular shape, and wherein the one or more electrodes are configured to selectably communicate with the subject’s nervous system.
  • the tubular shape is a cylindrical shape.
  • a cross section of the cylindrical shape is partially circular, fully circular, partially oval, or fully oval.
  • the second portion is flexible.
  • the second portion is rigid.
  • the one or more electrodes are configured to form one or more rings wrapped around the elongate probe body.
  • Another aspect of the present disclosure herein provides a method of manufacturing a neurological probe, comprising: (a) making a flexible circuit substrate comprising (i) a first elongated portion comprising one or more conductive traces; and (ii) a second portion comprising one or more electrodes in electrical communication with the one or more conductive traces; and (b) wrapping the second portion around a distal end of an elongated probe body.
  • the method further comprises: wrapping the first elongated portion around the elongated probe body. In some embodiments, the wrapping in (b) results in a spiral shape or a cylindrical shape. In some embodiments, a cross section of the cylindrical shape is partially circular, fully circular, partially oval, or fully oval. In some embodiments, the method further comprises: applying an adhesive layer between the flexible circuit substrate and the elongated probe body.
  • a neurological probe configured to electrically communicate with a subject’s nervous system, the probe comprising: (a) an elongate probe body comprising a distal end and a proximal end and configured to be insertable into or proximal to a portion of the subject’s nervous system; and (b) an electrode that is couplable to the distal end of the elongate body and comprising at least one three-dimensional electrode feature, and configured to selectably communicate with the subject’s nervous system.
  • the electrode is coupled to the elongate probe body by a flexible circuit substrate.
  • the flexible circuit substrate is coupled to the elongate probe body by being inserted into the elongate probe body.
  • the elongate body defines at least one aperture with a first end configured to receive the flexible circuit substrate therein.
  • the elongate body comprises at least one hole along the longitudinal axis of the elongate body that is alignable with the electrode.
  • the electrode is coupled to the elongate probe body by wrapping the flexible circuit substrate about the elongate probe body.
  • the flexible circuit substrate further comprises an adhesive layer coupled to the electrode.
  • the elongate body comprises at least one set of slots configured for coupling the flexible circuit substrate to the elongate probe body.
  • the electrodes are dimensioned on a micrometer scale, a millimeter scale, or a combination thereof.
  • the electrode is a plurality of electrodes.
  • the electrode comprises a 3- dimensional electrode feature.
  • the electrode comprises a plurality of 3- dimensional electrode features.
  • the flexible circuit substrate is a flexible printed circuit board.
  • the elongate probe body also comprises at least one circular lumen configured to accept a guidewire.
  • Another aspect of the present disclosure herein provides a system comprised of the neurological probe of claim 88 and an external system for data acquisition and/or signal generation.
  • Another aspect of the present disclosure herein provides a method for utilizing a neurological probe to electrically communicate with a subject’s nervous system, the method compnsing: (a) providing an elongate probe body that is inserted into or proximal to a portion of the subject’s nervous system; and (b) selectably communicating with the subject’s nervous system via an electrode that is couplable to a distal end of the elongate probe body and that comprises at least one three-dimensional electrode feature.
  • FIG. 1 shows a schematic of an embodiment of a system that includes a neurological probe according to embodiments of the present disclosure for use with an external system that is configured to communicate with a subject’s nervous system.
  • FIGS. 2A-2B shows a depiction of an embodiment of a probe body for use with a neurological probe according to embodiments of the present disclosure, wherein: FIG. 2A is an isometric view of the elongate body and FIG. 2B is an enlarged view of the box (hashed line) in FIG. 2A.
  • FIGS. 3A-3D shows a number of views of an embodiment of a flexible circuit substrate for use with the probe body of FIG. 2A, wherein: FIG. 3A is an isometric view of the flexible circuit substrate; FIG. 3B is an enlarged isometric view of a proximal end of the flexible circuit substrate of FIG. 2A; FIG. 3C is an enlarged isometric view of a distal end of the flexible circuit substrate of FIG. 2A; and FIG. 3D is a top plan view of an electrode surface of the distal end upon which one or more 3-dimensional (3D) electrode features can be positioned.
  • FIG. 3A is an isometric view of the flexible circuit substrate
  • FIG. 3B is an enlarged isometric view of a proximal end of the flexible circuit substrate of FIG. 2A
  • FIG. 3C is an enlarged isometric view of a distal end of the flexible circuit substrate of FIG. 2A
  • FIG. 3D is a top plan view of an electrode surface of the distal end upon which one or
  • FIGS. 4A-4C show cross-sectional views of an embodiment of the electrode surface taken through line 3-3 1 of FIG. 3D, wherein: FIG. 4A shows the electrode surface without any 3D electrode feature positioned thereupon; FIG. 4B shows the electrode surface with a “bump” 3D electrode feature thereupon; and, FIG. 4C shows the electrode surface with a “spike” 3D electrode feature thereupon.
  • FIG. 5 shows an embodiment of the distal end of an elongate body wherein the elongate body combines with the flexible printed circuit board (fPCB) comprising the plurality of electrodes by means of inserting the fPCB into at least one lumen that extends along the longitudinal axis of the elongate body to form a probe.
  • fPCB flexible printed circuit board
  • FIGS. 6A-6C show a number of isometric views of an embodiment of a neurological probe according to embodiments of the present disclosure, wherein: FIG. 6A shows the neurological probe as comprising a flexible circuit substrate positioned about an elongate body. FIG. 6B shows a proximal end of the neurological probe; and FIG. 6C shows a distal end of the neurological probe.
  • FIG.S 7A-7B show another embodiment of an elongate body for use with neurological probes according to embodiments of the present disclosure, wherein: FIG. 7A shows an isometric view of the elongate body; and FIG. 7B shows an enlarged view of a proximal end of the elongate body.
  • FIGS. 8A-8B show another embodiment of neurological probe, wherein FIG. 8A shows an isometric view of one end of the probe; and, FIG. 8B shows an enlarged view of the one end with an electrode ring.
  • the electrode nng is covered by 3-dimensional features such as, for example but not limited to, bumps.
  • the electrode ring may be smooth with no 3-dimensional features.
  • FIG. 9 shows an example electrode assembly formed by a flat flex circuit wrapped around a core.
  • FIGS. 10A-10C show a number of views of an embodiment of a spiral electrode formed by a flat flex circuit wrapped around a core without a sheath.
  • FIGS. 11A-11C show a number of views of an embodiment of a spiral electrode formed by a flat flex circuit wrapped around a core with a sheath having holes.
  • FIGS. 12A-12C show a number of views of an embodiment of a spiral electrode formed by a flat flex circuit wrapped around a core with a sheath having no holes.
  • the invention provides apparatus, systems and methods for electrical communication with a target region of a subject, such as a region of a brain.
  • a target region of a subject such as a region of a brain.
  • Various aspects of the invention described herein may be applied to any of the particular applications set forth below.
  • the invention may be applied as a part of a diagnostic or treatment system. It shall be understood that different aspects of the invention can be appreciated individually, collectively or in combination with each other.
  • Electrode may refer to a microelectrode with dimensions on the micrometer (pm) scale, a macroelectrode (millimeter with dimensions on the mm scale), or both. Macroelectrodes may be ring electrodes or planar electrodes.
  • the terms “3-dimensional electrode feature” and “3D electrode feature” may be used interchangeably and they may refer to a metallic component on the surface on the electrode that increases the surface area of the electrode.
  • the 3D electrode feature can have dimensions that are sized on the micrometer (pm) scale when part of a microelectrode, according to embodiments of the present disclosure.
  • the 3D electrode feature can have dimensions that are sized on the pm scale or mm scale when part of a macroelectrode, according to embodiments of the present disclosure. More than one size of 3D electrode feature, in one or both of the pm scale or mm scale, may be present on a macroelectrode, according to embodiments of the present disclosure.
  • Examples of 3D electrode features can be geometric shapes embedded on planar surface such that the surface is no longer planar.
  • the geometric shapes can be regular or irregular, the same or different among a plurality of 3D electrode features.
  • the geometric shapes can be sphere, partial sphere, a cube, a cylinder, a pyramid, a cone, a rectangular prism, an irregular shape, and a combination thereof.
  • the 3-D electrode feature can be above or below the planar surface.
  • neurological probe may refer to a tool that is positionable within a subject’s body and is configured to electrically communicate via electrical signals with the subject’s nervous system. This term includes tools that are positionable within a subject’s central nervous system, brain, and one or more sub-cortical regions thereof.
  • the term “depth electrode” may refer a neurological probe having a plurality of microelectrodes or at least one macroelectrode on an elongate probe body.
  • the depth electrodes disclosed or contemplated herein can not only detect the action potentials of active neurons in the brain, but can detect the magnitude of the action potentials and the direction from which the action potentials are originating (such as, for example, the “vector” of the action potentials). For example, when in use, as few as three depth electrodes can be used to “triangulate” the location of the brain activity.
  • the terms “electrical communication” and “electrically communicate” may refer to a one-way flow of an electrical signal and/or a two-way exchange of electrical signals.
  • the one-way flow of the electrical signal may originate in: at least one electrically-excitable cell or an external system that is operatively coupled with a neurological probe according to embodiments of the present disclosure.
  • the two-way exchange of electrical signals refers to both the transmission and receipt of electrical signals by the external system and at least one electrically-excitable cell.
  • Electrical communication may also refer to the detection, capture and/or transmission of an electrical signal between the external system and at least one electrically-excitable cell.
  • the term “electrically-excitable cell” may refer to a cell that has the potential to communicate charged ions across the cellular membrane in response to an electric, chemical or physical stimuli.
  • sheath may refer to a hollow tube or cover that may be placed around other objects, such as, for example a depth electrode.
  • the sheath may enclose the other object and prevent the object from contacting the environment into which the object is placed
  • the sheath may be made from a biocompatible polymer, or other suitable materials. In some embodiments, wherein the sheath comprises an insulating material.
  • the insulating material is polyethylene, polyimide, polyether ether ketone (PEEK), polycarbonate, polyolefin, poly ether block amides (PEBAX), nylon 6, nylon 66, nylon 12, polypropylene, polyesters, polyurethanes, polytetrafluoroethylene (PTFE), poly(phenylene sulfide) (PPS), poly(butylene terephthalate) (PBT), polysulfone, polyamide, polyimide, poly(p- phenylene oxide) (PPO), acrylonitrile butadiene, styrene (ABS), polystyrene, poly(methyl methacrylate) (PMMA), polyoxymethylene (POM), ethylene vinyl acetate, styrene acrylonitrile resin, polybutylenea biocompatible polymer, silicone, polyether block amide (PEBAX), polyurethanes, silicone polyurethane copolymers, nylon, polyethylene tere
  • the sheath is rigid. In some embodiments, the sheath is a biologically friendly metal, metal alloys, steel alloys, sintered metal, etched materials, molded materials, extruded materials. In some embodiments, the sheath is titanium, nickel titanium alloy or nitinol, stainless steel alloys, cobalt chromium alloys, titanium alloy, tantalum, tungsten and tungsten alloys, platinum, platinum-iridium alloy, platinum-nickel alloy, niobium, iridium, conichrome, gold and gold alloy, magnesium alloy, or a mixture thereof. In some embodiments, the sheath may have holes to allow the enclosed object to expose to the environment into which the object is placed.
  • the sheath may have no holes and the sheath may be inserted into tissues first to allow the enclosed object, such as, for example, a depth electrode, to be inserted into the sheath and reduce the injuries to the tissues surrounding the insertion site. Such injuries could have been caused by 3-D electrodes such as bump electrodes, spike electrodes, or other electrodes having protruding objects.
  • the sheath after the insertion of the depth electrode, the sheath can be removed from the insertion site to expose the electrode to the tissues.
  • the sheath may be a hollow tubular structure having a lumen therethrough.
  • the sheath may have a lengthwise opening.
  • the sheath may have one open end and one closed end. In some embodiments, the sheath may have two open ends.
  • biocompatible polymer may refer to polymers which, in the amounts employed, are non-toxic, chemically inert, and substantially non-immunogenic when used internally in the patient and which are substantially insoluble in physiologic liquids.
  • biocompatible polymers include but are not limited to, cellulose acetates (including cellulose diacetate), ethylene vinyl alcohol copolymers, hydrogels (e.g., acrylics), poly(Ci-C6) acrylates, acrylate copolymers, polyalkyl alkacrylates wherein the alkyl groups independently contain one to six carbon atoms, polyacrylonitrile, polyvinylacetate, cellulose acetate butyrate, nitrocellulose, copolymers of urethane/carbonate, copolymers of styrene/maleic acid, and mixtures thereof.
  • Copolymers of urethane/carbonate include polycarbonates that are diol terminated which are then reacted with a diisocyanate such as methylene bisphenyl diisocyanate to provide for the urethane/carbonate copolymers.
  • a diisocyanate such as methylene bisphenyl diisocyanate
  • copolymers of styrene/maleic acid refer to copolymers having a ratio of styrene to maleic acid of from about 7:3 to about 3:7.
  • the biocompatible polymer is also non-inflammatory when employed in situ.
  • the polymers of polyacrylonitrile, polyvinylacetate, poly(C 1 -Cr > ) acrylates, acrylate copolymers, poly alkyl alkacrylates wherein the alkyl groups independently contain one to six carbon atoms, cellulose acetate butyrate, nitrocellulose, copolymers of urethane/carbonate, copolymers of styrene/maleic acid and mixtures thereof typically may have a molecular weight of at least 50,000, at least 75,000, from 50,000 to 500,000, or from 75,000 to 300,000.
  • a flexible printed circuit board may comprise a thin, flexible electrically insulating layer (such as polyester, polyimide, thermoplastic), on which a patterned electrically conducting layer (such as a copper layer or a gold layer, or another metal layer) is disposed.
  • a further protective cover layer may be partially disposed over the conducting layer to protect it. The cover layer may have apertures to provide electrical access to the conducting layer.
  • a fPCB may comprise multiple electrically conducting layers and/or multiple insulating layers.
  • the neurological probe is configured for acquiring, which may also be referred to as detecting or capturing, a signal that represents information of physiological relevance from the subject’s brain.
  • the physiologically relevant information may include thermal information, chemical information, electrical information, electrochemical information, anatomical information, or combinations thereof.
  • the physiologically relevant information is electrochemical information that is acquired from one or more subcortical regions of the subject’s brain.
  • the physiologically relevant information is electrical information that is acquired from one or more subcortical regions of the subject’s brain.
  • While the present description discusses various non limiting embodiments that relate to a neurological probe that can be positioned at, near or within one or more subcortical regions of the subject’s brain, the person skilled in the art appreciate that the embodiments of the present disclosure may be equally useful for acquiring information from other regions of the subject’s central nervous system, as well as other organs, tissue, cell types, for example cardiac tissue, spinal cord tissue and various other tissue types that comprise electrically-excitable cells.
  • a subject may be any type of organism.
  • a subject may be a live being.
  • a subject may comprise a brain.
  • the subject may be a human or animal.
  • a subject may be a rodent (e.g., mouse, rat, rabbit, etc.), primate, bird, fish, reptile, amphibian, insect, or any other type of live being.
  • the apparatus, systems, and methods provided herein may be capable of interacting with a subj ect that is or is not under the influence of anesthesia.
  • the subject may be restrained, immobile, or capable of moving about.
  • FIG. IOC show representations of an apparatus and a system according to the present disclosure that may be useful electrically communicating with a subject’s brain.
  • FIG. 1 shows a system 1000 that comprises a neurological probe 1002 and an external system 1004.
  • the neurological probe 1002 has a proximal end 1002A and a distal end 1002B.
  • the proximal end 1002 A is positionable exterior to the subject A, for example supported by a stereotaxic apparatus B and in a position to communicate 1006 with the external system 1004.
  • the distal end 1002B is positionable within a subject’s (shown as A in FIG. 1) nervous system (shown as C in FIG. 1), for example within a sub-cortical region of the subject’s nervous system.
  • the system 1000 is configured to communicate with the subject’s nervous system C by utilizing the neurological probe 1002 to capture physiologically relevant electrical signals from the nervous system C and to communicate 1006 those electrical signals to the external system 1004.
  • the external system 1004 comprises hardware, firmware and software components for receiving, interpreting and displaying the communicated electrical signals from the neurological electrode 1002.
  • the external system 1004 can also generate electrical signals that can be communicated to the subject’s nervous system C, via the neurological probe 1002, for therapeutic purposes such as stimulating one or more regions of the subject’s nervous system C.
  • the same components (e.g., same electrodes) of the system may be used for receiving electrical signals from and for sending electrical signals to one or more regions of the subject’s nervous system.
  • different components of the system e.g., different electrodes
  • the neurological probe 1002 comprises a probe body 100 and a flexible circuit substrate 200 that is coupled to the probe body 100 and that is configured to include one or more electrode features 210.
  • the electrode feature may be a 3- dimensional (3D) electrode feature 210A or 210B.
  • the electrode feature may be a substantially planar electrode feature 206A.
  • a 3-dimensional electrode feature may comprise a component on the surface on the electrode that increases the surface area of the electrode.
  • Embodiments of a three- dimensional (3D) micro-electrode may include a spike micro-electrode, which is an electrically conductive, elongate body with: a base that is electrically connectible to a recording system; a tip that is opposite the base and that is configured to establish electrical communication with an excitable cellular-network (ECN); and an elongate portion between the base and the tip.
  • ECN excitable cellular-network
  • the elongate portion is optionally covered with at least one layer of an electrical-insulator coating that extends from the base to proximal the tip.
  • the 3D-microelectrode may come into contact with or penetrate at least partially into a subject's tissue (either in vitro, ex vivo or in vivo) so that the tip is in electrical communication with the one or more cells of the ECN.
  • the electrical- insulator coating may reduce the signal artifact that may arise from passing through the outer layer of the subject's tissue.
  • the feature may protrude out of a surface of the electrode or fall beneath a surface of the electrode.
  • the feature may allow an electrode to have a surface area to lateral cross-sectional area ratio that exceeds, 1, 1.1, 1.2, 1.3, 1.4, 1.5, 1.7, 2.0, 2.2, 2.5, 2.7, 3.0, 3.5, 4.0, 5.0, 7.0, or 10.0.
  • the surface area to cross-sectional area ratio may be less than any of the values provided or fall within any two of the values provided. Having an increased surface area to cross-sectional area may advantageously permit an increased area of contact between the electrode and the subject’s subcortical region.
  • the increased surface sensing-area may improve the signal-to-noise ratio, the signal resolution, the signal accuracy or combinations thereof.
  • the 3D electrode feature can have any dimension.
  • the 3D electrode feature can have dimensions that are sized on the pm scale or mm scale when part of a macroelectrode, according to embodiments of the present disclosure.
  • the 3D electrode feature may have a diameter less than about 1 pm, 2 pm, 3 pm, 5 pm, 10 pm, 20 pm, 50 pm, 100 pm, 500 pm, 1 mm, 1.5 mm, 2 mm, 2.5 mm, 3 mm, 4 mm, or 5 mm.
  • a 3D electrode feature may have a diameter greater than any of the values provided or falling in a range between any two of the values provided.
  • a 3D electrode feature may have any height relative to a planar surface of a macroelectrode upon which it is provided.
  • the 3D electrode may have a height of at least 1 pm, 2 pm, 3 pm, 5 pm, 10 pm, 20 pm, 50 pm, 100 pm, 500 pm, 1 mm, 1.5 mm, 2 mm, 2.5 mm, 3 mm, 4 mm, or 5 mm.
  • the 3D electrode may have a height less than any of the values provided or falling within a range between any of the values provided.
  • a single 3D electrode feature may be provided on a given planar surface or electrode.
  • more than one size of 3D electrode feature, in one or both of the pm scale or mm scale may be present on a macroelectrode, according to embodiments of the present disclosure.
  • multiple 3D electrode features may be arranged in one or more line, one or more rows, one or more arrays, one or more staged configurations, one or more concentric configurations, or in any other manner on a macroelectrode.
  • Examples of 3D electrode features can be geometric shapes embedded on planar surface such that the surface is no longer planar.
  • the geometric shapes can be regular or irregular, the same or different among a plurality of 3D electrode features.
  • the geometric shapes can be sphere, partial sphere, a cube, a cylinder, a pyramid, a cone, a rectangular prism, an irregular shape, and a combination thereof.
  • the 3D electrode feature may have a pointed tip, flat tip, blunted tip, or may have a rounded tip.
  • the 3-D electrode feature can be above or below the planar surface.
  • the 3D electrode may comprise surface features that may increase the roughness of the electrode surface.
  • any description herein of an electrode may apply to a planar electrode or to a 3D electrode, or a macroelectrode with or without one or more 3D electrode features, and vice versa.
  • FIG. 2A shows one embodiment of an elongate probe body 100 that is a component of the neurological probe 1002. Similar to the neurological probe 1002, the probe body 100 comprises a proximal end 100 A and a distal end 100B that define a longitudinal axis lOOC of the probe body 100 (parallel to the double arrowed line lOOC shown in FIG. 2A).
  • the probe body 100 defines at least one first bore 102 that extends between the first end 100 A and 100B and that is coaxial with the longitudinal axis lOOC.
  • the at least one first bore 102 has a proximal end 102A (FIG.
  • the proximal first end 102A is configured to receive a flexible circuit substrate 200 therein so that the flexible circuit substrate 200 can be advanced through the central first bore 102 towards, proximal or extending through the second end 102B.
  • the first end 102A can be configured to communicate (receive and transmit) data and/or other information from other devices, such as but not limited to: oxygen sensors, blood oxygen sensors, thermal sensors, chemical sensors and other types of biosensing probes.
  • the at least one first bore 102 in the embodiment shown in FIG. 2 A and FIG. 2B is illustrated with a crescent-like shape, the person skilled in the art appreciate that the at least one first bore 102 can be a number of different geometric profiles and depths to accommodate the insertion and advancement of the flexible circuit substrate 200.
  • the probe body 100 also defines a second bore 104.
  • the second bore 104 may comprise a proximal first end 104A (FIG. 2B) and a distal second end 104B (not shown).
  • the proximal first end 104A can be configured to receive a gui dewire (not shown) that increases the rigidity of the probe body 100 during a procedure for inserting the neurological probe 1000 into the subject A.
  • the guidewire may be a tungsten wire that can be removed after the probe body 100 is positioned within the desired position into the subject A.
  • the second bore 104 may be centered on the longitudinal axis lOOC of the probe body 100, or not. In some embodiments of the present disclosure the probe body 100 defines further longitudinal bores.
  • the probe body 100 may comprise a cross-sectional diameter of about 1-1.2 mm. In some embodiments of the present disclosure, if present, the diameter of the circular lumen 104 may be about 0.3-0.5 mm. The dimensions of the at least one first bore 102 that can be configured to receive the flexible circuit substrate 200.
  • the probe body 100 can be composed of one or more materials that provide a sufficient rigidity to permit positioning of the probe body 100 without the necessity of using a guidewire.
  • the probe 100 may be composed of a polymer, a metal or combinations thereof.
  • a flexible, dielectric, hydrophobic, and biocompatible polymer can be suitable for use in a subcortical region of the subject’s nervous system C.
  • this polymer may be a polyimide, parylene, a silicone-based polymer or combinations thereof.
  • the polymer may be a co polymer including, but not limited to, a polyamide and polyether block co-polymer.
  • the probe body 100 may be fabricated using one of the existing polymer manufacturing methods, such as extrusion, 3D printing and the like.
  • FIG. 3A, FIG. 3B, FIG. 3C, and FIG. 3D show different views of one embodiment of the flexible circuit substrate 200 that is configured to support one or more 3D electrode features 210 thereupon.
  • the flexible circuit substrate 200 comprises a proximal first end 200A and a distal second end 200B, which together define a longitudinal axis 200C (shown as the double arrowed line 200C shown in FIG. 3A).
  • the application and desired position of the distal end 1000B of the neurological probe 1000 can determine the length of the flexible circuit substrate 200.
  • the flexible circuit substrate 200 is configured to support at least one electrode
  • the flexible circuit substrate 200 has a length that is defined between the ends 200A and 200B of between about 5 cm and about 25 cm, between about 7.5 cm and about 22.5 cm, between about 10 cm and about 20 cm, between about 12.5 cm and about 17.5 cm.
  • the electrodes 206 can be spaced along the longitudinal axis 200C of the flexible circuit substrate 200 and may be configured to provide selectable communication along the longitudinal axis 200C.
  • Selectable communication refers to the ability to precisely select which electrode 206, and potentially which 3D electrode feature 210, electrically communicate with which precise region of the subject’s nervous system.
  • each electrode 206 may be individually coupled to the proximal end 200A via one or more discrete electrical conductors, which may also be referred to as wires. So that when the neurological probe 1002 is in communication with the external system 1004, the user can select which electrodes 206 receives or transmits electrical information.
  • the flexible circuit substrate 200 is a flexible printed circuit board (fPCB).
  • the proximal end 200A of the flexible circuit substrate 200 may comprise at least one connection region 202 and one or more connection pads 204.
  • the connection pads 204 are configured to communicate with the external system 1004
  • FIG. 3B shows one embodiment wherein the at least one connection region 202 and the connection pads 204 are rectangular, the skilled person appreciates that the geometries of both the at least one connection region 202 and the connection pads 204 can vary to accommodate different communication protocols with the external system 1004.
  • connection region 202 can be any type of electrical coupling device that can distinguish between the electrodes 206 for example through discrete channels, wherein each channel is electrically coupled, which may also be referred to as being in electrical communication with, one or more specific electrodes 206.
  • connection region 202 is a zero insertion force (ZIF) connection.
  • the flexible circuit substrate 200 may comprise more than one connection region 202, each having a distinct geometry, type, and connection style, or not.
  • each of the connection pads 204 may connect to the electrodes 206 by means of a conductive trace 208 that extends along the longitudinal axis 200C.
  • the conductive trace 208 comprises the distinct electrical conductors with one conductor, or a predetermined group of conductors, forming a channel of the neurological probe 1002 by establishing electrical communication with one or more specific electrodes 206 and the predetermined connection pad 204.
  • each electrode 206 is between about 50 pm and about 250 pm, or between about 100 pm and about 200 pm, or between about 125 pm and about 175 pm.
  • each electrode 206 may also be referred to as a microelectrode.
  • the electrodes 206 may be sized on the millimeter (mm) scale, such electrodes are referred to herein as macroelectrodes.
  • the width of the flexible circuit substrate 200 at the distal end 200B is between about be about 0.25 mm and about 3 mm, or between about 0.5 mm and about 2.5 mm, or between about 1 mm and about 2 mm.
  • the electrodes 206 illustrated m FIG. 3C and FIG. 3D are circular shaped when viewed from above, the electrodes 206 can be a different geometry including, but not limited to, a square or an octagon. Each of the electrodes 206 may have the same shape, or not.
  • the conductive trace 208 may connect to one of the electrodes 206 at a smooth right angle (FIG. 3C), or at no angle, or at an angle therebetween.
  • the curvature of the conductive trace 208 may be smooth, or not. In some embodiments of the present disclosure a smooth curvature is preferred because it may provide superior performance under mechanical stresses such as bending.
  • the width of the conductive trace 208 may vary but a preferred width is between about 5 pm and 100 pm, between about 15 pm and about 90 pm, or between about 30 mhi and about 75 mih.
  • the conductive trace 208 may be made from the same material as the electrodes 206, or not.
  • the electrodes 206 may comprise an exposed surface 206A that may be a biocompatible, non- biofouling metal such as, but not limited to, gold, platinum, iridium, platinum-iridium alloys, stainless steel, titanium nitride.
  • an insulating layer 206F that is made up of one or more non-conductive materials, which are also referred to as electrically insulating materials or dielectric materials.
  • the 206A is configured to support one or more of the 3D electrode features 210.
  • the 3D electrode feature 210 can be a bump 210A or a spike 210B.
  • the insulation layer 206F can be added before or after the 3D electrode feature 210 is formed.
  • the 3D electrode feature 210 can be added to the exposed surface 206A prior to, after, or during the coupling of the flexible circuit substrate 200 - comprising the one or more electrodes 206 - with the probe body 100.
  • FIG. 4 illustrates a cross-sectional view of the flexible circuit substrate 200 at a locations of three different types of electrodes 206. These electrodes are provided by way of example only and are not limiting. In some embodiments of the present disclosure, the electrodes 206 are made up only of the exposed metal layer 206A, a flexible circuit substrate 206C, a first metal-layer 206D, a second metal-layer 206 E, and an insulation layer 206F.
  • the flexible circuit substrate 206C and the insulation layer 206F may be comprised of a biocompatible, dielectric, hydrophobic material such as, but not limited to, a polyimide, or a combination of two or more materials.
  • the first metal-layer 206D can be a primary electrical signal conductor layer and the second metal-layer 206E and the exposed metal-layer 206A create a surface for supporting one or more 3D electrode features 210A/B and to form a barrier layer to prevent the leakage of copper ions into the subject.
  • the exposed metal layer 206A can be gold
  • the first metal-layer 206D can be copper
  • the second metal-layer 206E can be palladium, or any combination thereof.
  • FIG. 4 illustrates three metal layers, the skilled person appreciates that different numbers and types of metal layers can be used.
  • One or more insulation layers may optionally be provided between the metal layers.
  • an adhesive layer for example a pressure-sensitive adhesives (PSA) or a thermoset adhesive, 206B may be present on the side of the flexible circuit substrate 206C that is opposite to the metal layers, or not.
  • PSA pressure-sensitive adhesives
  • thermoset adhesive thermoset adhesive
  • the 3D electrode feature 210 extends above the insulation layer 206F for increasing the surface area of the electrode 206 that is in contact with - or close enough proximity to electrically communicate with - the subject A.
  • the 3D electrode feature 210 may have different profiles such as a bump 210A or a spike 210B.
  • the 3D electrode feature 210 may take on other profiles that can increase the surface area contact with the subject.
  • the 3D electrode feature may have any other shape, configuration, or characteristic, as described elsewhere herein. In some instances, multiple 3D electrode features may be provided on an electrode.
  • the 3D electrode feature 210 can be made upon the surface 106A by various methods including, but not limited to: wire bonding, electroplating, electrolysis plating, chemical or physical vapor depositions, or combinations thereof. In some embodiments of the present disclosure, the 3D electrode feature 210 may be made out of gold, platinum, iridium, platinum- iridium alloys, stainless steel, titanium nitride or combinations thereof. In some embodiments of the present disclosure, the electrodes 206 may be on the millimeter scale and can accommodate more than one 3D electrode feature 210, which are on the microscale, to further increase the surface area in contact with or close proximity to the subject.
  • the flexible circuit substrate 200 comprising the plurality of electrodes 206, can be inserted into the first bore 102 of the probe body 100.
  • the distal end 100B of the probe body 100 can be configured with longitudinally spaced openings 100D, wherein the shape and spacing of the openings 100D correspond to the spacing of the electrodes 206 along the longitudinal axis 200C of the flexible circuit substrate 200. So that when the flexible body 200 is advanced to the desired position, at least one electrode 206 can be aligned in a fashion that is generally perpendicular to the longitudinal axis of the probe body 100.
  • the spacing of the electrodes is between about 1 mm and about 15mm, between about 5 mm and about 10 mm, or between about 2.5 mm and about 7.5 mm.
  • the first bore 102 has a termination point 100E that is a predetermined distance from the distal end 100B of the probe body 100 to assist in properly positioning the flexible body 200 within the first bore 102.
  • the distal end 100B of the probe body 100 may be domed or a different shape to facilitate positioning the neurological probe 1000 at the desired site within the subject A.
  • the 3D electrode feature 210 may be added onto the electrodes 206 either before, during or after the placement of the flexible circuit substrate 200 within the probe body 100.
  • the insertion of the flexible body 200 within a bore of the probe body 100 is one non-limiting example of coupling the flexible body 200 with the probe body 100 to make a neurological probe according to implementations of the present disclosure and this can be done with or without the adhesive layer 206B.
  • a neurological probe 1000A may also be formed by wrapping the flexible circuit substrate 200, comprising the plurality of electrodes 206 with or without the 3D electrode feature 210, around the outside of the probe body 100.
  • the flexible body 200 that is wrapped about the probe body 100 can be secured in place by the presence of the adhesive layer 206B.
  • This described wrapping is another non-limiting example of coupling the flexible body with the probe body 100 to make a neurological probe according to implementations of the present disclosure with or without the adhesive layer 206B.
  • the adhesive layer 206B may be a biocompatible, waterproof, pressure-sensitive adhesive.
  • the 3D electrode features 210 of the neurological probe 1000A may be added onto the metallic surface 206A of each electrode 206 before, during or after the flexible circuit substrate 200 is wrapped about the probe body 100.
  • the flexible circuit substrate 200 may be wrapped around the probe body 100 in a helical or other manner.
  • the probe body 100 may comprise a single, multiple, or no bores, depending on the rigidity of the probe body 100.
  • the flexible circuit substrate may be wrapped around the probe body in a manner that may provide a desired range of electrical communication.
  • a single flexible circuit substrate may be wrapped around in a helical manner in order to form at least one, two, three, four, five, six, seven, eight, nine, ten, or more loops around the probe.
  • the flexible circuit substrate may be wrapped at a desired angle relative to a longitudinal axis that extends along the length of a probe body.
  • the flexible circuit substrate may be at substantially at least a 15 degree or more, 30 degree or more, 45 degree or more, 60 degree or more, 80 degree or more angle relative to the longitudinal axis.
  • multiple flexible circuit substrates may be wrapped around the probe body.
  • the flexible circuit substrates may be wrapped around the probe body in the same direction or in different directions (e.g., clockwise and counterclockwise when viewed from a cross-sectional view).
  • the electrodes may be positioned relative to the flexible circuit substrate in any manner. For instance, a row of electrodes may be positioned along the length of the flexible circuit substrate. In some instances, multiple rows of electrodes may extend along the length of the flexible circuit substrate. In some instances, one or more arrays of electrodes may be provided on the flexible circuit substrate. The electrodes may be positioned so that when the flexible circuit substrate is wrapped around the probe body, the electrodes are positioned at a desired position, so that when the probe is inserted into a brain or located proximal to the brain, the electrodes will stimulate a desired region of the brain. The density of the electrodes on the flexible circuit substrate may remain the same along the length of the flexible circuit substrate, or may vary along the length of the flexible circuit substrate depending on usage.
  • FIG. 7A shows another embodiments of a probe body 100 1 that can be used with the flexible body 200 of the present disclosure.
  • the probe body 100 1 defines a senes of slots KXfF along probe body 100.
  • each slot 100'F may have an opposing slot 100 1 E that is aligned opposite to each slot 100'F or the probe body 100 1 may have a number of non-aligned slots 100'F.
  • a neurological probe (not shown) can be made by weaving the flexible circuit substrate 200 - comprising the electrodes 206 - through the slots lOO'F/C (as the case may be). This weaving is another non-limiting example of how to make a neurological probe according to implementations of the present disclosure with or without the adhesive layer 206B.
  • one or more 3D electrode features 210 may be added on to the metallic surface 206A of one or more electrodes 206 before, after or during the weaving of the flexible circuit substrate 200 through the slots 100 1 F/F. (as the case may be).
  • FIG. 8A shows one embodiment of the neurological probe 1002 1 as comprising the flexible body 200 and three macroelectrode rings 300 that each comprises at least one 3D electrode feature 210, which in some embodiments may be multiple features 210.
  • the macroelectrode rings 300 are shown positioned about the flexible body 200 distal end 1002 1 B of the probe 1002 1 .
  • Each macroelectrode ring 300 can be comprised of a biocompatible, non-biofouling metal such as, but not limited to, gold, platinum, iridium, platinum-iridium alloys, stainless steel, titanium nitride.
  • the 3D electrode features 210 that is formed thereupon by various methods, including but not limited to metal swaging, and connected to the metal contacts on the proximal end with wires that transverse the first bore of the probe body 100.
  • the 3D electrode feature 210 may be added to the surface of the macro-electrode rings before, during or after attaching the rings to the flexible body 200.
  • the flexible body 200 can be configured to receive and house one or more conductors for communicating electrical signals between the one or more 3D electrode features 210 and a proximal end 1002' A of the probe 1002 1 .
  • the macroelectrode ring may comprise one or more, two or more, three or more, four or more, six or more, ten or more, twenty or more, thirty or more, forty or more, fifty or more, sixty or more, seventy or more, eighty or more, ninety or more, one hundred or more, two hundred or more, three hundred or more, four hundred or more, or five hundred or more 3D electrode features.
  • one or more rows of 3D electrode features may be provided on a macroelectrode ring. An array of 3D electrode features may be presented.
  • 3D electrode features may be provided with any density, such as at least 1, 2, 3, 4, 5, 6, 7, 10, 12, 15, 20, 25, 30, 40, 50 or more per square mm surface, on the macroelectrode ring, or any other type of surface provided elsewhere herein.
  • the 3D electrode features may be electrically insulated from one another. Alternatively, there may be electrical communication between the 3D electrode features.
  • a macroelectrode ring may be a ring shaped electrode, or may comprise multiple planar electrodes on a surface of a ring.
  • the multiple planar electrodes may be electrically insulated from one another on the ring.
  • the macroelectrode ring may be connected to the flexible body.
  • FIGS. 9 and 10A-C Provided per FIGS. 9 and 10A-C are different embodiments of a neurological probe assembly configured to electrically communicate with a subject’s nervous system.
  • FIG. 9 shows an electrode assembly formed by a flat flex circuit wrapped around a core.
  • a flat flex circuit 910 may comprises a flexible circuit substrate layer 922.
  • a plurality of electrodes 921 can be embedded in or disposed on the flexible circuit substrate layer 922. Then the flat flex circuit 910 may be wrapped around the core 900 to provide a wrapped ring electrode 920.
  • Each member of the plurality of electrodes 921 may have an independent width 930. In some embodiments, the independent width 930 may be the same or substantially the same.
  • the electrodes When the electrode assembly is wrapped around the core, the electrodes may be curved to form a substantially ring shape.
  • One or more ring electrode may be formed via the electrode assembly.
  • the one or more ring electrodes are used together with a cable connector that interfaces with an external recording system.
  • a ring electrode is used as a passive implantable sensor.
  • the core comprises polyethylene, Teflon, or both, other biocompatible polymers, or other suitable materials.
  • the one or more ring electrodes are integrated with the flexible circuit substrate, i.e., the one or more ring electrodes and the flexible circuit substrate are one-piece and cannot be physically separated without damaging the flexible circuit substrate.
  • the one or more ring electrodes can slide over or move around or be physically separated from the flexible circuit substrate without damaging the flexible circuit substrate.
  • the one or more ring electrodes are in electrical communication with the flex circuit substrate or one or more conductive trace.
  • electrode assembly or a portion of the electrode assembly is made into a cylinder shape by wrapping the flex circuit around a core.
  • the cylindrical shape is extended an entire length of the electrode assembly.
  • the cylindrical shape is extended along at least 20%, 25%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 95% of a length of the electrode assembly.
  • the wrapped electrode assembly may have a shape of a full cylinder or a portion of a cylinder.
  • the wrapped electrode assembly may cover the full circumference of the underlying probe body.
  • the wrapped electrode assembly may cover at least 40%, 50%, 60%, 70%, 80%, 90%, 95%, 97% or 99% of the circumference of the underlying probe body.
  • the electrodes in the flexible circuit substrate may wrap around to form a substantially ring shape.
  • the ring electrodes may wrap around a full conference of the underlying probe body.
  • the wrapped ring electrodes may circumscribe at least 40%, 50%, 60%, 70%, 80%, 90%, 95%, 97% or 99% of the circumference of the underlying probe body.
  • the ring electrodes may have any width.
  • the ring electrode feature may have a width less than about 100 nm, 200 nm, 300 nm, 400 nm, 500 nm, 600 nm, 700 nm, 800 nm, 900 nm, 1 pm, 2 pm, 3 pm, 5 pm, 10 pm, 20 pm, 50 pm, 100 pm, 500 pm, 1 mm, 1.5 mm, 2 mm, 2.5 mm, 3 mm, 4 mm, or 5 mm
  • a ring electrode feature may have a width greater than any of the values provided or falling in a range between any two of the values provided. [The ring electrodes may have any thickness.
  • the ring electrode feature may have a thickness less than about 10 nm, 20 nm, 30 nm, 40 nm, 50 nm, 60 nm, 70 nm, 80 nm, 90 nm, 100 nm, 200 nm, 300 nm, 400 nm, 500 nm, 600 nm, 700 nm, 800 nm, 900 nm, 1 pm, 2 pm, 3 pm, 5 pm, 10 pm, 20 pm, 50 pm, 100 pm, 500 pm, or 1 mm.
  • a ring electrode feature may have a thickness greater than any of the values provided or falling in a range between any two of the values provided.
  • the ring electrodes may be formed with sufficient flexibility to enable wrapping around the underlying probe body. The ring electrodes may be wrapped around to lie flush against the underlying probe body.
  • the ring electrode comprises an adhesive to bond the flat flex circuit to the core. In some embodiments, the ring electrode does not comprise an adhesive to bond the flat flex circuit to the core. In some embodiments, the ring electrode is rigid. In some embodiments, the ring electrode is flexible. In some embodiments, the electrode, the core, or both is patterned with 3-dimensional micro-electrode features (e.g. spikes, bumps, or other 3- dimensionl shapes). In some embodiments, the ring electrode may be partially circular, fully circular, partially oval, or fully oval. In some embodiments, each electrode may have a corresponding conductive trace to convey the detected electronic signals to an external recording/control system and/or to transmit commands from the external recording/control system. In some embodiments, the length of the conductive trace between the connector and the depth electrode can vary. In some embodiments, the length of the conductive trace may be between the connector and the depth electrode can vary from 300 mm to 900 mm.
  • Each electrode may be electrically connected with at least one conductive trace, which runs from the corresponding electrode at the distal end to the connector at the proximal end. Each conductive trace may interact with the corresponding electrode. Different electrodes may connect with different conductive traces. Each conductive trace may be electrically insulated from one another. The connector and the conductive trace may connect the electrodes to an external recording device, such as, for example, a signal processing device, so that bioelectrical signals received from the electrodes can be relayed to the signal processing device. Each conductive trace may end at a predetermined location within the connector.
  • the conductive traces may be arranged into several groups, each group comprising parallel traces serving the electrodes residing in the same selected areas of the depth electrode. Each such group of traces may be placed between adjacent columns of electrodes, allowing some of the traces to reach electrodes located close to each other.
  • Conductive traces may be formed on a flexible circuit substrate by a number of methods, such as flexographic printing with conductive inks or chemical etching of metals.
  • both the conductive traces can be screen printed onto the substrate using silver-doped conductive ink, such as SILVER ELECTRODAG PF 410, manufactured by NOR- COTE® International, Inc.
  • the conductive traces may be formed on only one side of the flexible circuit substrate.
  • a layer of non- conductive ink can be printed over the conductive traces once the conductive ink is dried under a heat or UV curing process.
  • Non-conductive ink is SD 2460 Flex ink, also manufactured by NOR-COTE®.
  • This insulating layer may prevent moisture from accumulating between two parallel conductive traces and effectively shorting the two traces.
  • the widths of conductive traces may be determined by a combination of factors, such as conductivity, impedance, cost of conductive ink, and/or precision of pnnting.
  • traces may have variable widths so that impedance remains the same for traces of different lengths.
  • the spacing between adjacent traces may also depend on a combination of factors. For example, in the case of screen printing, placing traces very close to each other may result in conductive ink seeping from one trace to another and effectively shorting the two traces. Moreover, since a group of parallel traces may be placed between two adjacent columns of electrodes, the amount of available lateral space for the group of traces may be limited by the distance between the two adjacent electrode columns.
  • FIGS. 10A-10C show that a flat flex circuit can be wrapped around a core (polyethylene, Teflon, a biocompatible polymer, or other suitable materials) to form a depth electrode and/or a sheath can enclose the electrodes and the core.
  • a core polyethylene, Teflon, a biocompatible polymer, or other suitable materials
  • FIGS. 10A-10C show a number of views of an embodiment of an elongate flat flex circuit 1020 comprising a plurality of electrodes 1021 can be manufactured, and then the elongate flat flex circuit 1020 can be wrapped around a core 900 to form the wrapped spiral depth electrode.
  • FIGS. 11A-11C depict a number of views of another embodiment in which the electrodes 1021 are wrapped around a core 900.
  • the wrapped spiral depth electrode is then inserted into a sheath/cover 1010 having holes 1011 along the body of the sheath/cover 1010.
  • the electrodes 1021 can be aligned with the hole 1011 such that the hole 1011 may align with and lie above the electrodes 1021 to make the electrodes 1021 exposed to tissues at the insertion site via the holes.
  • FIGS. 11A-11C depict a number of views of another embodiment in which the electrodes 1021 are wrapped around a core 900.
  • the wrapped spiral depth electrode is then inserted into a sheath/cover 1010 having holes 1011 along the body of the sheath/cover 1010.
  • the electrodes 1021 can be aligned with the hole 1011 such that the hole 1011 may align with and lie above the electrodes 1021 to make the electrodes 1021 exposed to tissues at the insertion site via the holes.
  • the sheath 1010 encloses a core 900; the electrode 1021 wrapped around the core 900, and the sheath 1010 comprising at least one hole 1011 at the sheath distal end to expose the electrode 1021.
  • the electrode 1021 is disposed on an elongate flat flex circuit 1020.
  • FIGS. 12A-12C show a number of views of still another embodiment of the depth electrode enclosed in a sheath/cover 1010 without any holes.
  • the elongate flat flex circuit 1020 comprising a plurality of electrodes 1021 can be manufactured, and then the elongate flat flex circuit 1020 can be wrapped around a core 900 to form the wrapped spiral depth electrode.
  • the wrapped spiral electrode may be placed into a sheath 1010.
  • the distal end of the core 900 may extend through an opening at the sheath distal end.
  • the sheath 1010 may not have any holes on its surface except for the opening at the distal sheath end. Hence, the electrode 1021 may not be exposed to the environment outside the sheath.
  • the sheath may be inserted into the insertion site without causing much injury to the tissues; the wrapped spiral depth electrode can be inserted into the sheath; then the sheath can be removed to have the electrodes exposed to the tissues at or near the insertion site.
  • the depth electrode can be delivered as is (FIGS. 10A-10C); or with a sheath with holes that align with the passive sensors/electrodes of the depth electrode (FIGS. 11A- 1 IB); or with a sheath/cover without any holes that align with the passive sensors/electrodes (FIGS. 12A-12C).
  • the depth electrode and the sheath can be inserted together as an assembly into the body of a human subject.
  • the sheath alone is first inserted into the body of a human subject, followed by the insertion of the depth electrode into the void in the middle of and defined by the inserted sheath.
  • the position of the depth electrode can be adjusted after the insertion of the depth electrode. For example, the align the electrode with the corresponding hole on the sheath.
  • the sheath may be left in the body of the human subject; or the sheath may be removed from the body of the human subject after initial device placement.
  • a sheath may be inserted in the brain of the human subject, slide over the implanted depth electrode, engage with the enclosed electrode, and be removed from the bram of the human subject together with depth electrode.
  • the electrodes may comprise 3-dimensional electrodes, including, for example, bump microelectrodes or spike microelectrodes.
  • the presence of the sheath over the 3-dimensional electrodes may cause less injury or damage to tissues at the implant site when compared with the insertion of the depth electron in the absence of the sheath over the depth electrode.
  • the presence of the sheath may provide better signal-to-noise profiles to the electronical signals detected by and reported from the depth electrode.
  • the sheath remains in the brain of the subject when electrical communication between the electron and the brain is occurring.
  • the sheath may be fully bonded with the depth electrode.
  • the sheath may be separate and detachable from the depth electrode.
  • the sheath may move independently of the enclosed depth electrode.
  • the depth electrode may be inserted into and removed from the sheath.
  • the sheath may be made from an insulating material.
  • the sheath may comprise laser cut holes at selected positions to expose the electrodes.
  • the sheath may comprise polyethylene, polyimide, another biocompatible polymer, or a mixture thereof.
  • the sheath with an opening end or two opening ends may be slid over the depth electrode; or the sheath may have a lengthwise opening to allow the entry of the depth electrode.
  • the sheath may be made from rigid material or flexible material.
  • the sheath may be stretchable along the axis or radially.
  • the sheath may not be stretchable along the axis or radially.
  • the sheath may have elasticity of a predetermined value, such as, for example, a Young's modulus of about 3.0 GPa or less, 2.5 GPa or less, 2.3 GPa or less, 2.1 GPa or less, 2.0 GPa or less, 1.8 GPa or less, 1.6 GPa or less, 1.4 GPa or less, 1.2 GPa or less, 1.0 GPa or less, 0.8 GPa or less, 0.5 GPa or less, 0.4 GPa or less, 0.3 GPa or less, 0.2 GPa or less, or 0.1 GPa or less.
  • the predetermined value for the elasticity of the sheath may have fall in a range between any two of the values provided.
  • the sheath may have any thickness.
  • the sheath may have a thickness less than about 20 nm, 30 nm, 40 nm, 50 nm, 60 nm, 70 nm, 80 nm, 90 nm, 100 nm, 200 nm, 300 nm, 400 nm, 500 nm, 600 nm, 700 nm, 800 nm, 900 nm, 1 pm, 2 pm, 3 pm, 5 pm, 10 pm, 20 pm, 50 pm, 100 pm, 500 pm, 1 mm, or2 mm.
  • a sheath may have a thickness greater than any of the values provided or falling in a range between any two of the values provided.
  • the sheath may be shorter than, the same as, or longer than the length of the depth electrode or the elongate probe body.
  • the sheath may have a cross-section that is partially circular, fully circular, partially oval, and full oval.
  • the sheath and the enclosed probe body can be co-axial.
  • the sheath may be concentric with the enclosed probe body.
  • the sheath and its enclosed probe body may have a pair of relatively or substantially cylindrical sections slidable and telescoping within one another.
  • the microelectrodes on the depth electrode of the present disclosure may be 350x smaller in size or dimension, and provide 20x better spatial resolution, and/or 3x better signal resolution
  • the depth electrode of the present disclosure can record more accurately, and stimulate more safely than a traditional depth electrode.

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Abstract

Des modes de réalisation de la présente invention concernent une sonde neurologique qui est conçue pour communiquer électriquement avec le système nerveux d'un sujet. La sonde comprend un corps de sonde allongé et une ou plusieurs électrodes. Le corps de sonde comprend une première extrémité et une seconde extrémité et est conçu pour être inséré dans une partie du système nerveux du sujet ou à proximité de celle-ci. L'électrode peut être couplée au corps allongé et comprend au moins une caractéristique d'électrode tridimensionnelle, et l'électrode est conçue pour communiquer de manière sélective avec le système nerveux du sujet.
PCT/CA2020/051116 2019-08-15 2020-08-14 Appareil, système et procédé de communication électrique avec des régions du cerveau WO2021026662A1 (fr)

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