WO2023151496A1 - Électrode de stimulation nerveuse, dispositif de stimulation nerveuse et système de stimulation nerveuse - Google Patents

Électrode de stimulation nerveuse, dispositif de stimulation nerveuse et système de stimulation nerveuse Download PDF

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Publication number
WO2023151496A1
WO2023151496A1 PCT/CN2023/074138 CN2023074138W WO2023151496A1 WO 2023151496 A1 WO2023151496 A1 WO 2023151496A1 CN 2023074138 W CN2023074138 W CN 2023074138W WO 2023151496 A1 WO2023151496 A1 WO 2023151496A1
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Prior art keywords
stimulation
electrode
nerve stimulation
stimulating
nerve
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PCT/CN2023/074138
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English (en)
Chinese (zh)
Inventor
姜传江
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苏州景昱医疗器械有限公司
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Publication of WO2023151496A1 publication Critical patent/WO2023151496A1/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
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • 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
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/3606—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
    • A61N1/36064—Epilepsy
    • 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
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/3606—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
    • A61N1/36067—Movement disorders, e.g. tremor or Parkinson disease
    • 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
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/3606—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
    • A61N1/36082—Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
    • A61N1/36089—Addiction or withdrawal from substance abuse such as alcohol or drugs
    • 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
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/3606—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
    • A61N1/36082—Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
    • A61N1/36096—Mood disorders, e.g. depression, anxiety or panic disorder

Definitions

  • the present application relates to the field of implantable medical devices, such as nerve stimulation electrodes, nerve stimulation devices and nerve stimulation systems.
  • the neurostimulation electrodes of related interventional neurostimulation devices usually have multiple fixed stimulation contacts.
  • the medical staff implants the electrodes into a specific area in the tissue such as the brain according to the existing knowledge and experience of the specific disease. , so as to electrically stimulate the tissue, so as to achieve the purpose of treating certain diseases.
  • stimulation contacts will be preset as many as possible, for example, 8 contacts, 12 contacts, 24 contacts, etc., and correspondingly set for each stimulation contact Wires are connected to deliver electrical stimulation energy.
  • it is difficult to set too many stimulation contacts and corresponding lines and thus limits the flexibility of the doctor's identification of disease sites and theoretical research and treatment of more stimulation contact sites .
  • the purpose of this application is to provide nerve stimulation electrodes, nerve stimulation devices and nerve stimulation systems.
  • the nerve stimulation electrodes can use fewer stimulation contacts to achieve electrical stimulation to different parts of biological tissues, and collect and analyze electrical signals from different parts. signal to achieve precise stimulation.
  • the present application provides a nerve stimulation electrode, and the nerve stimulation electrode includes:
  • an electrode housing which is a hollow tube
  • the stimulating tip is arranged inside the electrode housing, and the stimulating tip is used to conduct electrical stimulation energy to the surface of the tissue to electrically stimulate the tissue, and collect electrical signals of the tissue,
  • the stimulating tip can move in the electrode housing along the axial direction of the electrode housing, and/or, the stimulating tip can rotate in the electrode housing along the circumferential direction of the electrode housing.
  • the nerve stimulation electrode further includes a shaft part, and the shaft part is set inside the electrode housing and extending axially of the electrode housing,
  • the stimulating head end is connected with the shaft component and can rotate around the axial direction of the electrode housing, so that the stimulating head end can rotate along the circumferential direction of the electrode housing.
  • the stimulation head end includes:
  • stimulation contacts for conducting electrical stimulation energy to a tissue surface to electrically stimulate said tissue
  • a signal collection contact which is used to collect the electrical signal.
  • the shape of the stimulation contact is one or more of ellipse, circle, rounded rectangle, rectangle, triangle and ring.
  • the number of the stimulating head end is greater than one.
  • the electrode casing includes a honeycomb insulating part and a plurality of conductive parts separated by the insulating part, any two conductive parts are kept insulated, and at least two The stimulation tips are respectively in contact with different conductive parts.
  • the electrode shell includes a honeycomb insulating part and a plurality of semiconductor parts separated by the insulating part, any two semiconductor parts are kept insulated, and each semiconductor part has a control end, a first connection end and a second connection end, the first connection end of each semiconductor part is connected to the signal transmission end to conduct the electrical stimulation energy or collect the electrical signal, and the second connection end of each semiconductor part extends to said organization;
  • the types of diseases that the nerve stimulation electrodes are used for treatment include epilepsy, tremor, Parkinson's disease, depression, obsessive-compulsive disorder, Alzheimer's disease, autism and drug addiction one or more of .
  • the present application provides a nerve stimulation device, which includes at least one nerve stimulation electrode described in any one of the foregoing.
  • the nerve stimulation device further includes a driving unit, and the driving unit is used to drive the stimulation head end to move along the axial direction of the electrode casing and to move along the circumference of the electrode casing. to rotate.
  • the nerve stimulation device further includes a control unit, and the control unit The unit is used for analyzing the electrical signal and moving the stimulating head end according to the analysis result of the electrical signal, so as to realize precise stimulation.
  • the present application provides a nerve stimulation system, and the nerve stimulation system includes any one of the above nerve stimulation devices.
  • nerve stimulation electrode nerve stimulation device and nerve stimulation system for household medical equipment provided by the present application has at least the following advantages: electrical stimulation to different parts of biological tissues can be realized with fewer stimulation heads.
  • Fig. 1 is a schematic structural diagram of a nerve stimulation electrode provided by an embodiment of the present application
  • Fig. 2 is a perspective view of a stimulating head end and shaft parts provided by the embodiment of the present application;
  • Fig. 3 is a schematic structural diagram of a stimulation head end provided by an embodiment of the present application.
  • Fig. 4 is a perspective view of another stimulation head and shaft parts provided by the embodiment of the present application.
  • Fig. 5 is a perspective view of another stimulation head end and shaft components provided by the embodiment of the present application.
  • Fig. 6 is a perspective view of another stimulation head end and shaft parts provided by the embodiment of the present application.
  • Fig. 7 is a perspective view of another stimulation head end and shaft parts provided by the embodiment of the present application.
  • Fig. 8 is a schematic structural view of an electrode casing provided in an embodiment of the present application.
  • Fig. 9 is a schematic structural view of another electrode casing provided by the embodiment of the present application.
  • Fig. 10 is a schematic structural diagram of a nerve stimulation device provided by an embodiment of the present application.
  • Fig. 11 is a schematic structural diagram of a sliced electrode provided in the related art.
  • nerve stimulation device 10, nerve stimulation electrode; 101, electrode shell; 1011, insulating part; 1012, conductive part; 1013, semiconductor part; 102, stimulating head; 1021, stimulating contact; Signal acquisition contacts; 103, shaft components; 11, drive unit; 12, energy supply unit; 13, control unit.
  • An implantable neurostimulator system mainly includes a stimulator implanted in a patient (ie, an implanted neurostimulator, a neurostimulation device) and a program-controlled device placed outside the patient's body.
  • the related neuromodulation technology mainly uses stereotaxic surgery to implant electrodes in specific parts of the organism's tissues (ie, targets), and the stimulator implanted in the patient's body sends electrical pulses to the targets through the electrodes to regulate the corresponding neural structures. And network electrical activity and its function, thereby improving symptoms and relieving pain.
  • the stimulator can be an implantable electrical nerve stimulation device, an implantable cardiac electrical stimulation system (also known as a cardiac pacemaker), an implantable drug infusion device (Implantable Drug Delivery System, referred to as IDDS) and a wire switch. Any one of the connected devices.
  • Implantable electrical nerve stimulation devices are, for example, Deep Brain Stimulation (DBS), Implantable Cortical Nerve Stimulation (CNS), Implantable Spinal Cord Stimulation , referred to as SCS), implanted sacral nerve stimulation system (Sacral Nerve Stimulation, referred to as SNS), implanted vagus nerve stimulation system (Vagus Nerve Stimulation, referred to as VNS), etc.
  • the stimulator can include IPG, extension wires and electrode wires.
  • IPG implantable pulse generator, implantable pulse generator
  • IPG implantable pulse generator
  • the electrical stimulation energy through the implanted extension lead and electrode lead, delivers one or two controllable specific electrical stimulations to specific areas of tissues in the body.
  • the extension wire is used in conjunction with the IPG as a transmission medium for the electrical stimulation signal, and transmits the electrical stimulation signal generated by the IPG to the electrode wire.
  • the electrode leads may be neurostimulation electrodes that deliver electrical stimulation to specific regions of tissue in the body through multiple electrode contacts.
  • the stimulator is provided with one or more electrode wires on one side or both sides, and a plurality of electrode contacts are arranged on the electrode wires, and the electrode contacts can be arranged uniformly or non-uniformly in the circumferential direction of the electrode wires.
  • the electrode contacts may be arranged in an array of 4 rows and 3 columns (a total of 12 electrode contacts) in the circumferential direction of the electrode wire.
  • Electrode contacts may include stimulation contacts and/or collection contacts.
  • the electrode contacts can be in the shape of, for example, a sheet, a ring, or a dot.
  • the stimulated body tissue can be the patient's brain tissue, and the stimulated site can be a specific part of the brain tissue.
  • the stimulated site is generally different, the number of stimulation contacts (single source or multi-source) used, one or more channels (single-channel or multi-channel) specific electrical stimulation signals
  • the application and stimulus parameter data are also different.
  • the embodiment of this application is suitable for The type of disease used is not limited, and it may be the type of disease applicable to deep brain stimulation (DBS), spinal cord stimulation (SCS), pelvic stimulation, gastric stimulation, peripheral nerve stimulation, and functional electrical stimulation.
  • DBS disorders that DBS can be used to treat or manage include, but are not limited to: spasticity disorders (e.g., epilepsy), pain, migraine, psychiatric disorders (e.g., major depressive disorder (MDD)), bipolar disorder, anxiety disorders, Post-traumatic stress disorder, hypodepression, obsessive-compulsive disorder (OCD), conduct disorder, mood disorder, memory disorder, mental status disorder, mobility disorder (eg, essential tremor or Parkinson's disease), Huntington's disease, Al Alzheimer's disease, drug addiction, autism, or other neurological or psychiatric conditions and impairments.
  • spasticity disorders e.g., epilepsy
  • pain migraine
  • psychiatric disorders e.g., major depressive disorder (MDD)
  • bipolar disorder e.g., anxiety disorders, Post-traumatic stress disorder, hypodepression, obsessive-compulsive disorder (OCD)
  • OCD obsessive-compulsive disorder
  • conduct disorder mood disorder
  • the program-controlled device when the program-controlled device and the stimulator establish a program-controlled connection, can be used to adjust the stimulation parameters of the stimulator (different stimulation parameters correspond to different electrical stimulation signals), and the stimulator can also be used to sense the deep brain of the patient.
  • the bioelectric activity of the stimulator can be used to collect the electrophysiological signal, and the stimulation parameters of the electrical stimulation signal of the stimulator can be adjusted continuously through the collected electrophysiological signal.
  • Stimulation parameters can include: frequency (for example, the number of electrical stimulation pulse signals per unit time 1s, unit is Hz), pulse width (duration of each pulse, unit is ⁇ s), amplitude (generally expressed by voltage, that is, The intensity of each pulse, the unit is V), timing (for example, it can be continuous or triggered), stimulation mode (including one or more of current mode, voltage mode, timed stimulation mode and cycle stimulation mode), doctor's control upper limit One or more of upper and lower limits (range adjustable by doctors) and upper and lower limits of patient control (range adjustable by patients).
  • frequency for example, the number of electrical stimulation pulse signals per unit time 1s, unit is Hz
  • pulse width duration of each pulse, unit is ⁇ s
  • amplitude generally expressed by voltage, that is, The intensity of each pulse, the unit is V
  • timing for example, it can be continuous or triggered
  • stimulation mode including one or more of current mode, voltage mode, timed stimulation mode and cycle stimulation mode
  • doctor's control upper limit One or more of upper and lower limits (range adjustable
  • various stimulation parameters of the stimulator can be adjusted in current mode or voltage mode.
  • the program-controlled device may be a doctor-programmed device (ie, a program-controlled device used by a doctor) or a patient-programmed device (ie, a program-controlled device used by a patient).
  • the doctor's program-controlled device can be, for example, a tablet computer, a notebook computer, a desktop computer, a mobile phone and other smart terminal devices equipped with program-controlled software.
  • the patient program-controlled device can be, for example, smart terminal devices such as tablet computers, notebook computers, desktop computers, and mobile phones equipped with program-controlled software, and the patient program-controlled device can also be other electronic devices with program-controlled functions (such as chargers with program-controlled functions, data collection device).
  • the embodiment of the present application does not limit the data interaction between the doctor's program-controlled device and the stimulator.
  • the doctor's program-controlled device can perform data interaction with the stimulator through the server and the patient's program-controlled device.
  • the doctor’s program-controlled device can interact with the stimulator through the patient’s program-controlled device, and the doctor’s program-controlled device can also directly interact with the stimulator.
  • the patient programmable device may include a host (communicating with the server) and a slave (communicating with the stimulator), the host and slave being communicatively connected.
  • the doctor's program-controlled equipment can exchange data with the server through the 3G/4G/5G network
  • the server can exchange data with the host through the 3G/4G/5G network
  • the host can exchange data with the slave through the Bluetooth protocol/WIFI protocol/USB protocol.
  • the sub-machine can exchange data with the stimulator through the 401MHz-406MHz working frequency band/2.4GHz-2.48GHz working frequency band, and the doctor's program-controlled equipment can directly exchange data with the stimulator through the 401MHz-406MHz working frequency band/2.4GHz-2.48GHz working frequency band interact.
  • FIG. 1 shows a schematic structural diagram of a nerve stimulation electrode 10 provided in an embodiment of the present application
  • FIG. 2 shows a structure of a stimulating head end 102 and a shaft part 103 provided in an embodiment of the present application. stereogram.
  • the embodiment of the present application provides a nerve stimulation electrode 10, the nerve stimulation electrode 10 includes:
  • An electrode casing 101 which is a hollow tube
  • Stimulation head end 102 the stimulation head end 102 is arranged inside the electrode housing 101, and the stimulation head end 102 is used to conduct electrical stimulation energy to the tissue surface to electrically stimulate the tissue, and collect the tissue pair electrical signal,
  • the stimulating head end 102 can move in the electrode housing 101 along the axial direction of the electrode housing 101, and/or, the stimulating head end 102 can move along the electrode housing 101 in the electrode housing 101 101 circumferential rotations.
  • the nerve stimulation electrode 10 includes an electrode housing 101 and a stimulation tip 102 .
  • the electrode casing 101 is a hollow tube, and the stimulating tip 102 is accommodated inside the electrode casing 101 .
  • the electrode housing 101 may be a flexible elongated hollow tube.
  • the stimulation head end 102 is connected to the energy supply unit 12 (described in detail below) through a wire, and is used to apply the electrical stimulation energy from the energy supply unit 12 to a specific part of the tissue of the living body, so as to realize Electrical stimulation of specific parts of the tissue (also sometimes referred to herein as "neural stimulation").
  • the stimulating head end 102 can also collect electrical signals of tissues in the living body.
  • the stimulated tissue is brain tissue, such electrical signals are, for example, electroencephalogram signals.
  • the embodiment of the present application does not limit the generated electrical signal, which can be a single-cell electrical signal generated by a single cell (electrical changes at the neuron level), or a local field potential (electrical changes at the central level such as the nuclei level). Variety).
  • This application does not limit the type of organism, which can be human, or monkey, rabbit, cat, Dogs and other animals.
  • the stimulation tip 102 can move inside the electrode housing 101 .
  • the stimulating head end 102 can move (translate) along the axial direction of the electrode housing 101, or the stimulating head end 102 can move along the circumferential direction of the electrode housing 101 Rotate (rotate to move).
  • the stimulating head end 102 can rotate 360 degrees along the circumference of the electrode shell 101, and the control precision of the rotation angle can be millimeter, micron or nanometer level, so as to achieve a smooth, Continuous adjustment function.
  • a small number of stimulating head ends 102 can respectively stimulate different parts of the biological tissue and collect electrical signals of these parts.
  • the nerve stimulation electrode 10 further includes a shaft part 103 .
  • the shaft member 103 is disposed inside the electrode casing 101 and extends along the axial direction of the electrode casing 101 .
  • the shaft member 103 is set to coincide with the central axis of the electrode casing 101 .
  • the stimulation head 102 is connected with the shaft part 103 to rotate around the axis of the electrode housing 101 (for example, the central axis of the shaft part 103 itself), so as to realize the circumferential rotation of the electrode housing 101 .
  • the material of the shaft member 103 is not particularly limited.
  • the present application does not limit the ways in which the stimulating head end 102 conducts electrical stimulation energy and collects electrical signals, which can be realized by the same set of electrodes or by two sets of electrodes set separately.
  • a single electrode can conduct electrical stimulation energy and/or acquire electrical signals.
  • the electrical signal collected may be a single cell EEG signal, or a local field potential (LFP) EEG signal, or may include the above two signals at the same time.
  • LFP local field potential
  • FIG. 3 shows a schematic structural diagram of a stimulation head end 102 provided by an embodiment of the present application.
  • the stimulation head end 102 may include a stimulation contact 1021 and a signal collection contact 1022 .
  • the stimulation contacts 1021 and the signal collection contacts 1022 There is no particular limitation on the specific materials of the stimulation contacts 1021 and the signal collection contacts 1022 .
  • the stimulating contact 1021 is used to conduct electrical stimulation energy to the surface of the tissue to electrically stimulate the tissue, while the signal collection contact 1022 is used to collect electrical signals of tissues in the body.
  • FIG. 4 shows a perspective view of another stimulating head end 102 and a shaft part 103 provided in the embodiment of the present application
  • Fig. 5 shows another stimulating head end 102 provided in the embodiment of the present application and a perspective view of the shaft member 103.
  • two stimulating head ends 102 are arranged on the shaft component 103 , and the angle between the two stimulating head ends 102 is 60 degrees.
  • the included angle between them may be 15 degrees, 30 degrees, 45 degrees, 90 degrees, 120 degrees, 180 degrees, etc., which is not limited in this embodiment of the present application.
  • FIG. 4 shows a perspective view of another stimulating head end 102 and a shaft part 103 provided in the embodiment of the present application
  • Fig. 5 shows another stimulating head end 102 provided in the embodiment of the present application and a perspective view of the shaft member 103.
  • the angle between the two stimulating head ends 102 is 60 degrees.
  • the included angle between them may be 15 degrees, 30 degrees, 45 degrees, 90 degrees, 120 degrees, 180 degrees, etc., which is not limited
  • the 15 stimulating head-ends 102 there are 15 stimulating head-ends 102, and the 15 stimulating head-ends 102 are arranged in a circular array of 5 rows and 3 columns.
  • the embodiment of the present application does not limit the arrangement of the plurality of stimulating head ends 102 , which may be evenly distributed on the shaft member 103 or unevenly distributed.
  • the number of stimulating head-ends 102 may be one, and in other possible manners, the number of stimulating head-ends 102 may be greater than one.
  • Each stimulating tip 102 may be provided with one stimulating contact 1021 , or each stimulating tip 102 may be provided with more than one stimulating contact 1021 that is insulated from each other.
  • There is no particular limitation on the specific number of total stimulation contacts 1021 and the number is, for example, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and so on.
  • the specific shape of the stimulation contact 1021 is not particularly limited, for example, it may be one or more of oval, circular, rounded rectangle, rectangle, triangle and ring.
  • the number of signal collection contacts 1022 is the same as the number of stimulation contacts 1021 , and each signal collection contact 1022 is set at the center of the stimulation contact 1021 in a one-to-one correspondence.
  • the signal collection contacts 1022 and the stimulation contacts 1021 are insulated from each other, that is, in the embodiment of the present application, any two signal collection contacts 1022 are insulated from each other, and any two stimulation contacts 1021 are insulated from each other.
  • the contacts 1021 are insulated from each other, and any signal collection contact 1022 and any stimulation contact 1021 are insulated from each other.
  • FIG. 6 shows a perspective view of another stimulation head end 102 and shaft component 103 provided by the embodiment of the present application.
  • the number of stimulating head-ends 102 is 8
  • each stimulating head-end 102 is provided with 1 stimulating contact 1021 and 1 signal collecting contact 1022, like this, the quantity of signal collecting contact 1022 and stimulating contact 1021
  • the quantity is 8.
  • the stimulation contacts 1021 form four ring structures with the same diameter arranged in sequence along the axial direction, the first and last ring structures are composed of a ring electrode, and the middle two ring structures are respectively arranged at intervals along the circumference of the electrode housing 101 It consists of 3 sliced electrodes (located on the 3 stimulating head ends 102 respectively).
  • the stimulating tip 102 may be in a shape corresponding to the stimulating contact 1021 , such as a ring shape.
  • FIG. 7 shows a perspective view of another stimulation head end 102 and shaft component 103 provided by the embodiment of the present application.
  • the connection part between it and the shaft part 103 One (as shown in FIG. 6 ) may be provided, or multiple (as shown in FIG. 7 , a plurality of connecting parts are arranged in a structure uniformly distributed along the circumference of the electrode casing 101), when multiple When there are two connecting parts evenly distributed along the circumference of the electrode shell 101, the shaft member 103 can be prevented from being deformed due to uneven force, thereby improving the service life of the entire nerve stimulation electrode 10.
  • FIG. 8 shows a schematic structural diagram of an electrode casing 101 provided by an embodiment of the present application.
  • the electrode casing 101 includes a honeycomb insulating portion 1011 and a plurality of conductive portions 1012 separated by the insulating portion 1011, and insulation between any two conductive portions 1012 is maintained. , at least two stimulating head ends 102 are in contact with different conductive parts 1012 respectively.
  • the cellular shape in the embodiment of the present application refers to the porous shape, and the application does not limit the number, shape, and size of the holes, and the number of holes can be 3, 5, 8, 16, 24 pcs, 32 pcs, 100 pcs, 1000 pcs, 10000 pcs, etc.
  • the shape of each hole can be circular as shown in Figure 8, or oval, rounded rectangle, rectangle, triangle, ring, regular pentagon , regular hexagon, regular octagon, etc., the shapes of the multiple holes may be the same or different.
  • a plurality of conductive parts 1012 are disposed in a plurality of holes of the honeycomb insulating part 1011, and the number of the conductive parts 1012 may be the same as the number of holes.
  • the electrode shell 101 can form a relatively airtight environment, which isolates the contact between the internal tissues of the living body and the stimulation head 102 .
  • the present application does not limit the material of the insulating part 1011 and the conductive part 1012.
  • the material of the insulating part 1011 is, for example, parylene or other silicon-based materials
  • the material of the conductive part 1012 is, for example, copper, tin, silver, gold and platinum. one or more of.
  • the honeycomb-shaped insulating part 1011 is set to provide mutual insulation conditions for a plurality of conductive parts 1012, and at least two stimulating head ends 102 are respectively contacted with different conductive parts 1012 to realize the wire function (conduction) of a traditional nerve stimulation electrode.
  • Electrical stimulation, transmission of collected electrical signals) compared with traditional nerve stimulation electrodes that need to use multiple wires to realize the interactive function between multiple electrodes and pulse generators, only the movable stimulation head 102 is required to be fixed
  • the provided electrode casing 101 can play an interactive role, avoiding a sharp increase in process cost and maintenance cost caused by too many wires.
  • Each stimulating head end 102 is connected to the pulse generator respectively, and the stimulating head end 102 can reach any position during use (the conduction between the stimulating head ends 102 is realized through the corresponding conductive part 1012), so that the doctor can control the internal tissue of the patient.
  • the various parts of the body need to be stimulated and collected.
  • Fig. 9 shows a schematic structural view of another electrode housing 101 provided by the embodiment of the present application picture.
  • the electrode shell 101 includes a honeycomb insulating portion 1011 and a plurality of semiconductor portions 1013 separated by the insulating portion 1011, any two semiconductor portions 1013 are kept insulated, each Each semiconductor part 1013 has a control terminal, a first connection terminal and a second connection terminal, the first connection terminal of each semiconductor part 1013 is connected to the signal transmission terminal to conduct the electrical stimulation energy or collect the electrical signal, each semiconductor the second connection end of portion 1013 extends to the tissue;
  • At least two stimulating head terminals 102 are respectively in contact with the control terminals of different semiconductor parts 1013 for turning on and off the first connection terminal and the second connection terminal of the semiconductor part 1013 they contact.
  • a semiconductor is a material whose conductivity is between a conductor and an insulator at room temperature.
  • Common semiconductor materials include silicon (Si), germanium (Ge), compound semiconductors such as gallium arsenide (Gas), etc., doped or made into other compound semiconductors Materials such as boron (B), phosphorus (P), indium (In) and antimony (Sb), etc. Silicon is the most commonly used semiconductor material. Semiconductors usually have the following characteristics:
  • the conductivity of semiconductors is between that of conductors and insulators
  • the application does not limit the components selected for the semiconductor part 1013, which may be a single transistor, MOS transistor, JFET, etc., or a circuit including a transistor, MOS transistor or JFET.
  • MOS tube that is, Metal-Oxide Semiconductor Field-Effect Transistor, referred to as Metal-Oxi de-Semiconductor Field-Effect Transistor (MOSFET).
  • MOSFET Metal-Oxi de-Semiconductor Field-Effect Transistor
  • JFET refers to the junction field effect transistor (Junction Field-Effect Transistor, JFET).
  • the control terminal can be its base, and the first connection terminal and the second connection terminal can be its emitter and collector; for MOS tubes and JFETs, the control terminal can be its gate, and the first connection terminal and the second connection terminal may be its source and drain.
  • the first connection terminal and the second connection terminal can be turned on and off by inputting different electrical signals to their control terminals.
  • the honeycomb-shaped insulating part 1011 is set to provide mutual insulation conditions for a plurality of semiconductor parts 1013, and at least two stimulating head ends 102 contact different semiconductor parts 1013 respectively to realize the wire function of the traditional nerve stimulation electrode (conduction electrical stimulation) , transmission of collected electrical signals), compared with traditional nerve stimulation electrodes that need to use multiple wires to realize the interactive function between multiple electrodes and pulse generators, only the movable stimulation head 102 is required to cooperate with the fixed set
  • the electrode casing 101 can play an interactive role, avoiding a sharp increase in process cost and maintenance cost caused by too many wires.
  • Each stimulation head end 102 is respectively connected to The pulse generator can make the stimulation head end 102 reach any position during use (the conduction between the stimulation head end 102 is realized through the corresponding semiconductor part 1013), so as to realize the needs of doctors to stimulate and collect various parts of the tissue in the patient's body.
  • FIG. 10 shows a schematic structural diagram of a nerve stimulation device 1 provided by an embodiment of the present application.
  • the present application also provides a nerve stimulation device 1 .
  • the nerve stimulation device 1 includes at least one nerve stimulation electrode 10 of the present application.
  • the electrical stimulation of the tissue of the organism is realized by implanting the nerve stimulation electrode 10 of the nerve stimulation device 1 into the tissue of the organism and providing electrical stimulation energy to the nerve stimulation electrode 10 .
  • the nerve stimulation device 1 further includes a driving unit 11 for driving the movement of the stimulation head 102 within the electrode housing 101 (including forward and backward movement and rotational movement).
  • the specific form of the drive unit 11 is not particularly limited, for example, it may be a super micro-motion motor.
  • the nerve stimulation device 1 further includes an energy supply unit 12 for supplying power to the drive unit 11 .
  • the drive unit 11 may be a micro motor with a very small size, and may be a micro motor with dimensions on the order of millimeters or smaller manufactured using microfabrication technology in modern microelectronics manufacturing technology. It consists of a miniature winding coil, a magnetoresistive sensor, a magnetic rotor and a control circuit.
  • a miniature resonant ultrasonic motor uses the inverse piezoelectric effect of piezoelectric ceramics to excite the resonance of the elastic body, and converts the micro-deformation of the elastic body into the macroscopic motion of the rotor or mover through frictional coupling, so as to realize the satellite resonance type Operation of the ultrasonic motor.
  • a miniature non-resonant stepping motor which uses the precise displacement output characteristics of the piezoelectric laminate, combined with the principle of inertial impact or the principle of inchworms, to achieve continuous and precise stepping motion of moving parts.
  • the shaft component 103 can be driven to rotate by the driving unit 11 , and in a possible implementation manner, the shaft component 103 can be integrated or integrally formed with the base or the output shaft of the driving unit 11 .
  • the energy supply unit 12 may include a rechargeable battery, and the energy supply unit 12 may be charged in a wireless charging manner or a wired charging manner, so that the energy supply unit 12 has sufficient electric energy, and the electrical stimulus The energy is released at a specific part of the tissue of the organism through the wire and the stimulating head end 102, so as to realize the electrical stimulation of the specific part of the tissue.
  • the power supply unit 12 can also be used to supply power to the driving unit 11 .
  • the nerve stimulation device 1 may further include a gear box (not shown in the figure) arranged between the drive unit 11 and the shaft member 103, and a first stage may be arranged in the gear box. Or multi-stage gears to provide transmission and speed regulation functions.
  • the nerve stimulation device 1 may further include a control unit 13 .
  • the control unit 13 controls the drive unit 11 to move the stimulation head end 102 .
  • the control unit 13 can also control the stimulation head end 102 to supply electrical stimulation energy.
  • the control unit 13 can also analyze the electrical signal collected by the signal collection contact 1022, and then further adjust the position of the stimulation head 102 according to the analysis result, so as to realize precise stimulation.
  • the control unit 13 can control the driving unit 11 to move the stimulation head end 102 To the part where the electric signal is relatively strong, in order to achieve precise stimulation.
  • the relatively strong electrical signal means that the collected electrical signal satisfies one or more of the following conditions: the intensity of the electrical signal is greater than the preset intensity; the waveform of the electrical signal conforms to the preset waveform; the pulse width of the electrical signal is within the preset pulse width range.
  • the nerve stimulation electrode 10 of the present application can realize 360-degree electrical stimulation energy conduction in the circumferential direction, it can precisely locate the part with strong electrical signal, which cannot be achieved by the technical route of setting a limited number of segmented electrodes in the circumferential direction.
  • FIG. 11 shows a schematic structural diagram of a sliced electrode provided in the related art.
  • Related technologies provide a technical route for stimulating and collecting using sliced electrodes. If 3 sliced electrodes are set in the circumferential direction, the stimulation range corresponding to a single electrode is a fan-shaped area approximately 120 degrees; if 4 electrodes are set, the stimulation range corresponding to a single electrode is 90 degrees; if 6 electrodes are set, a single electrode The corresponding stimulation range is 60 degrees, and the more the number of sliced electrodes arranged in the circumferential direction, the complexity of the process and the cost of manufacturing will rise sharply, and the product yield will decrease accordingly, which is not conducive to the large-scale promotion and application of the product.
  • the stimulation head 102 can be controlled to move axially and circumferentially after being implanted in the patient. And stimulate the tissue in real time, collect electrical signals, manually explore the parts with strong electrical signals (or stimulate the pose of the head end 102) or intelligently analyze the parts with strong electrical signals (or stimulate the pose of the head end 102) through software algorithms , so as to help doctors locate the best part suitable for treatment.
  • pose refers to position information and attitude information.
  • An embodiment of the present application also provides a nerve stimulation system, the nerve stimulation system including any one of the above nerve stimulation devices.
  • the nerve stimulation system of the present application can utilize fewer stimulation contacts to achieve stimulation of biological tissues Electrical stimulation is performed on different parts of the body, and precise stimulation is achieved by collecting and analyzing electrical signals from different parts.

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Abstract

La présente invention concerne une électrode de stimulation nerveuse, un dispositif de stimulation nerveuse et un système de stimulation nerveuse. L'électrode de stimulation nerveuse comprend : un boîtier d'électrode comprenant un tube creux et une extrémité de tête de stimulation, l'extrémité de tête de simulation étant disposée à l'intérieur du boîtier d'électrode et étant utilisée pour conduire une énergie de stimulation électrique vers la surface de tissu de façon à stimuler électriquement le tissu et à collecter des signaux électriques du tissu, l'extrémité de tête de stimulation pouvant se déplacer dans le boîtier d'électrode dans une direction axiale du boîtier d'électrode, et/ou l'extrémité de tête de stimulation pouvant tourner dans le boîtier d'électrode dans une direction circonférentielle du boîtier d'électrode. Selon l'électrode de stimulation nerveuse de la présente invention, une stimulation électrique peut être effectuée sur différentes parties du tissu d'organisme en utilisant moins de contacts de stimulation, et une stimulation précise est réalisée par collecte et analyse des signaux électriques des différentes parties.
PCT/CN2023/074138 2022-02-11 2023-02-01 Électrode de stimulation nerveuse, dispositif de stimulation nerveuse et système de stimulation nerveuse WO2023151496A1 (fr)

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CN202210130156.6 2022-02-11
CN202210130156.6A CN114534094A (zh) 2022-02-11 2022-02-11 神经刺激电极、神经刺激装置和神经刺激系统

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CN114534094A (zh) * 2022-02-11 2022-05-27 苏州景昱医疗器械有限公司 神经刺激电极、神经刺激装置和神经刺激系统

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106512206A (zh) * 2016-11-04 2017-03-22 清华大学 植入式闭环脑深部刺激系统
WO2021221322A1 (fr) * 2020-04-28 2021-11-04 사회복지법인 삼성생명공익재단 Structure de dérivation pour application d'une stimulation électrique à un organe du corps, et système d'électrodes l'utilisant
WO2021221326A1 (fr) * 2020-04-28 2021-11-04 사회복지법인 삼성생명공익재단 Fil pour appliquer une stimulation électrique à un organe du corps, et système d'électrode l'utilisant
CN114534094A (zh) * 2022-02-11 2022-05-27 苏州景昱医疗器械有限公司 神经刺激电极、神经刺激装置和神经刺激系统

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106512206A (zh) * 2016-11-04 2017-03-22 清华大学 植入式闭环脑深部刺激系统
WO2021221322A1 (fr) * 2020-04-28 2021-11-04 사회복지법인 삼성생명공익재단 Structure de dérivation pour application d'une stimulation électrique à un organe du corps, et système d'électrodes l'utilisant
WO2021221326A1 (fr) * 2020-04-28 2021-11-04 사회복지법인 삼성생명공익재단 Fil pour appliquer une stimulation électrique à un organe du corps, et système d'électrode l'utilisant
CN114534094A (zh) * 2022-02-11 2022-05-27 苏州景昱医疗器械有限公司 神经刺激电极、神经刺激装置和神经刺激系统

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