WO2023142544A1 - 一种分片式刺激电极和刺激系统 - Google Patents

一种分片式刺激电极和刺激系统 Download PDF

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Publication number
WO2023142544A1
WO2023142544A1 PCT/CN2022/126473 CN2022126473W WO2023142544A1 WO 2023142544 A1 WO2023142544 A1 WO 2023142544A1 CN 2022126473 W CN2022126473 W CN 2022126473W WO 2023142544 A1 WO2023142544 A1 WO 2023142544A1
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WIPO (PCT)
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electrode
stimulation
stimulating
sliced
sheets
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PCT/CN2022/126473
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English (en)
French (fr)
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 WO2023142544A1 publication Critical patent/WO2023142544A1/zh

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    • 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
    • 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

Definitions

  • the present application relates to the technical field of stimulating electrodes, in particular to a sliced stimulating electrode and a stimulating system.
  • Deep Brain Stimulation For Deep Brain Stimulation (DBS, Deep Brain Stimulation), which involves delivering electrical stimulation to neural structures in specific areas of the brain to stimulate or inhibit cell activity, it can effectively treat chronic pain, Parkinson's disease, idiopathic Movement disorders such as tremors, epilepsy, and mental illnesses such as depression and obsessive-compulsive disorder.
  • the stimulating electrodes used for applying electrical stimulation act on the patient's head and stimulate designated parts of the brain to treat the patient's brain damage.
  • the other end of the stimulating electrodes is connected to the neurostimulator through electrode wires.
  • the electrode leads are usually relatively accurately implanted at the desired position in the brain using various imaging techniques.
  • imaging techniques such as Magnetic Resonance Imaging (MRI, Magnetic Resonance Imaging), Computed Tomography (CT, Computed Tomography), X-ray, Fluorescence Imaging and Stereoscopic Imaging.
  • stimulating electrodes within a patient eg, a patient's brain
  • a patient e.g, a patient's brain
  • the Chinese patent with the notification number CN104703653B discloses the implantation of directional wires guided by microelectrode recording.
  • This patent provides a method for implanting wires into the brain tissue of patients, wherein the wires include radial wires on the distal end of the wires. Segmented electrode sets.
  • the method includes performing multiple microelectrode recordings through separate multiple traces in brain tissue; generating a three-dimensional map of brain structures based on the microelectrode recordings; positioning a diagram of radially segmented electrodes on the map of brain structures to generate leads a graphical depiction of a desired depth and desired radial orientation in the brain tissue; and implanting the lead into the brain tissue according to the desired depth and desired radial orientation.
  • a device for determining the radial orientation of a wire including a radial directional scale and an indicator indicating which electrode is in contact with the scale.
  • the patent In order to position the electrodes, the patent still uses an additional radial directional scale and electrodes, Therefore, the position of the electrode can be deduced, which has certain limitations.
  • Chinese Patent Publication No. CN112292176A discloses an implantable medical lead indicator that provides electrodes at the distal portion of the lead configured to monitor a target site or provide therapy to the target site.
  • the lead may include a visual indicator visible to the clinician at a mid-portion of the lead, the visible indicator being configured to indicate when the electrodes of the lead are properly longitudinally and vertically aligned. radially aligned to monitor or treat the target site.
  • a clinician may insert the lead into the patient by using an introducer sheath inserted into the patient to a predetermined depth, and then by orienting the indicator into the introducer sheath port to align the distal portion of the lead.
  • This patent still has certain limitations by additionally setting indicators on the lead wires to cooperate with determining the orientation of the electrodes during use.
  • the position and direction of the electrodes are usually determined by setting additional marks on the stimulating electrodes, and the position and direction of the electrodes are determined by the correspondence between the predefined marking direction and the electrode stimulating sheet.
  • a method requires doctors to have a strong logical judgment Ability, not allowed to make mistakes in the process, too high requirements for doctors' experience, and relatively large limitations.
  • the present application provides a sliced stimulating electrode and a stimulating system to solve the above problems.
  • a piece-type stimulating electrode the piece-type stimulating electrode has opposite stimulating ends and connecting ends, and a plurality of electrode sheets for applying electric stimulation are arranged on the outer peripheral surface of the stimulating end of the piece-type stimulating electrode, through which
  • the plurality of electrode sheets on the same radial plane of the excessive sheet stimulation electrode is a group of electrode sheets, and in at least one group of electrode sheets, at least one electrode sheet is different in shape from the rest of the electrode sheets so that the group of electrode sheets can be The multiple electrode sheets are separated.
  • different electrode combinations can be designed according to the specific stimulation required by the specific target, not only The purpose of identifying the position of the electrode sheet can be realized, and specific stimulation can be applied to specific points to be stimulated, so as to realize the treatment of specific diseases.
  • each electrode piece in the plurality of electrode pieces is different, or the shape of each electrode piece in the group of electrode pieces is different.
  • different sliced stimulating electrodes can be distinguished according to the different shapes of each electrode piece, or can be distinguished according to the shape of a group of electrode slices. Two different sliced stimulating electrodes The marking method of the electrodes is convenient for medical staff to choose during actual use.
  • the directional shape of the electrode sheet is used to distinguish the plurality of electrode sheets of the set of electrode sheets.
  • the directional shape is, for example, an arrow, a protrusion, or an arc edge on one side of the electrode sheet.
  • the directional shape of the electrode sheet is located on one side edge or on the opposite side edges of the electrode sheet.
  • the left and right sides of the electrode sheet have a directional shape, or the upper or lower side of the electrode sheet has a directional shape at the left or right position.
  • the directional shape can directly mark the positions of at least two electrode sheets. position, so as to compare the positions of the rest of the electrode pads.
  • the directional shape of the electrode sheet is formed by a wave shape, a sinusoidal curve, a semicircle, a rounded rectangle or a rounded triangle, and the directional shape of the electrode sheet is smoothly connected with the electrode sheet, and
  • the shape of the peripheral edge of each electrode piece is a closed curve.
  • the directivity shape can also be an arc curve edge capable of quickly marking at least two electrode sheets, for example, a wavy arc curve edge, or a regular sine and cosine curve.
  • the positions of at least two electrode sheets can be visually distinguished through a wavy edge.
  • the shape of the peripheral edge of each electrode sheet is a curve of a smooth contour.
  • the smooth curve can ensure that when the stimulating electrode is inserted into the brain, when the electrode sheet applies stimulation, there will be no concentration of stimulation signals and peaks, and it can reduce the impact on the tissue during stimulation. damage.
  • the plurality of electrode sheets are distributed in an array at intervals, and the plurality of electrode sheets in a row in the length direction of the sliced stimulating electrode of the same shape.
  • the medical staff can also intuitively distinguish the position of the sliced electrodes in the vertical direction under the imaging technology, and combine the sliced electrodes in the radial direction of the stimulating electrodes.
  • the position of each electrode sheet is determined, so that it is convenient for medical staff to accurately fix the electrode sheet on the point to be stimulated in the brain.
  • the set of electrode sheets includes 2-10 electrode sheets.
  • a group is a ring of electrode sheets on the same stimulating electrode.
  • the number of electrode sheets in a ring can be 2-10.
  • the number between these electrodes can effectively maintain the good stimulation effect of the stimulating electrode and facilitate the operator to perform imaging. Observation and resolution under the technology can meet the stimulation needs of most nerve electrical stimulation.
  • the local thickness of at least one electrode sheet is different from the thickness of the rest of the electrode sheet.
  • the local thickness on the same electrode sheet is greater than the thickness of the rest.
  • the thicker part has a darker color.
  • the thickness of the electrode sheet can also be used as a distinguishing method to image in the X-ray machine.
  • the electrode pads can show different color shades according to the different local thicknesses, and different electrode pads can be distinguished through the color depth, and combined with the shape distinction, multiple electrode pads can be distinguished more quickly, which is convenient for medical staff to adjust the orientation of the stimulating electrodes , effectively stimulate the part to be tested, and prevent the negative impact of the stimulating electrodes on the brain.
  • a stimulation system includes: a stimulator, a wire and a stimulation electrode, the stimulator is connected to the stimulation electrode through a wire, and the stimulation electrode is the above-mentioned sliced stimulation electrode.
  • the beneficial effects of the present application at least include:
  • the different shapes of the identified electrode sheets are used as a method to distinguish different stimulating electrodes under imaging technology, which is convenient for the operator to quickly mark and identify the electrode orientation, and Accurately apply the stimulation point of the stimulation electrode to the designated position, effectively reduce the side effects caused by the inaccurate stimulation position of the stimulation electrode in the brain, and reduce the requirement for the operator's ability to identify the stimulation electrode; at the same time, there is no need for additional design marks to identify the location of the stimulation electrode .
  • Fig. 1 is a schematic diagram of the flattened state of the stimulating end of the sliced stimulating electrode according to an embodiment of the present application
  • Fig. 2 is a schematic diagram of another embodiment of the embodiment of the present application, the stimulation end of the sliced stimulation electrode is flattened;
  • Fig. 3 is a schematic diagram of the flattened state of the stimulating end of the sliced stimulating electrode according to another embodiment of the embodiment of the present application;
  • Fig. 4 is a schematic diagram of a flattened stimulating end of a sliced stimulating electrode according to yet another embodiment of the embodiment of the present application.
  • Electrode wire In the figure: 1. Electrode wire; 2. Electrode sheet; 3. Fragmented stimulation electrodes.
  • At least one means one or more, and “multiple” means two or more.
  • “And/or” describes the association relationship of associated objects, indicating that there may be three types of relationships, for example, A and/or B, which can mean: A exists alone, A and B exist at the same time, and B exists alone, where A, B can be singular or plural.
  • the character “/” generally indicates that the contextual objects are an “or” relationship.
  • “At least one of the following" or similar expressions refer to any combination of these items, including any combination of single or plural items.
  • At least one item (piece) of a, b or c can represent: a, b, c, a and b, a and c, b and c or a and b and c, wherein a, b and c can be It can be single or multiple. It should be noted that "at least one item (item)” can also be interpreted as “one item (item) or multiple items (item)”.
  • words such as “exemplary” or “for example” are used to mean an example, illustration or illustration. Any embodiment or design described herein as “exemplary” or “for example” is not to be construed as preferred or advantageous over other embodiments or designs. Rather, the use of words such as “exemplary” or “such as” is intended to present related concepts in a concrete manner.
  • An implantable neurostimulation system (an implantable medical system) mainly includes a stimulator implanted in a patient (ie, an implantable stimulator) and a program-controlled device installed outside the patient's body.
  • the existing neuromodulation technology mainly uses stereotaxic surgery to implant electrodes in specific structures (i.e., targets) in the body, and the stimulator implanted in the patient sends electrical pulses to the targets through the electrodes to regulate the corresponding neural structures and networks. 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. Any one of the switching 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) and so on.
  • DBS Deep Brain Stimulation
  • CNS Implantable Cortical Nerve Stimulation
  • SCS Implantable Spinal Cord Stimulation
  • SNS implanted sacral nerve stimulation system
  • Vagus Nerve Stimulation referred to as VNS
  • VNS vagus Nerve Stimulation
  • the stimulator can include IPG, extension leads and electrode leads 1.
  • the IPG implantable pulse generator, implantable pulse generator
  • the IPG is set in the patient's body, receives the program-controlled instructions sent by the program-controlled device, and relies on sealed batteries and circuits to provide implantable pulses to tissues in the body.
  • Controlled electrical stimulation energy delivers one or two controllable specific electrical stimulations to specific regions of tissues in the body through implanted extension leads and electrode leads 1 .
  • 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 1 .
  • the electrode leads 1 deliver electrical stimulation to specific areas of tissues in the body through multiple electrode contacts.
  • the stimulator is provided with one or more electrode wires 1 on one side or both sides.
  • the electrode wires 1 are provided with a plurality of electrode contacts, and the electrode contacts can be arranged uniformly or non-uniformly in the circumferential direction of the electrode wires 1 .
  • 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 1 .
  • Electrode contacts may include stimulation electrode contacts and/or collection electrode contacts.
  • the electrode contacts can be in the shape of, for example, a sheet, a ring, or a dot.
  • the stimulated body tissue may be the patient's brain tissue, and the stimulated site may 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 the present application does not limit the applicable disease types, which may be the applicable disease types for 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 at least one of the following: frequency (for example, the number of electrical stimulation pulse signals per unit time 1s, the unit is Hz), pulse width (the duration of each pulse, the unit is ⁇ s), amplitude (generally used Voltage expression, 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) , The upper and lower limits of the doctor's control (the range that can be adjusted by the doctor) and the upper and lower limits of the patient's control (the range that can be adjusted by the patient).
  • frequency for example, the number of electrical stimulation pulse signals per unit time 1s, the unit is Hz
  • pulse width the duration of each pulse, the unit is ⁇ s
  • amplitude generally used Voltage expression, 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, time
  • 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 program-controlled device may include a host (communicating with the server) and a slave (communicating with the stimulator), and the host and slave are communicably 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.
  • 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.
  • the application provides a kind of piece type stimulation electrode 3
  • piece type stimulation electrode 3 has relative stimulation end and connection end
  • the peripheral surface of the stimulation end of piece type stimulation electrode 3 is provided with for applying
  • a plurality of electrode sheets 2 for electrical stimulation a plurality of electrode sheets 2 passing through the same radial plane of the sliced stimulation electrodes 3 are a group of electrode sheets 2, and a group of electrode sheets 2 are, for example, at the same height of the sliced stimulation electrodes 3
  • a plurality of electrode sheets 2 that surround the sliced stimulation electrode 3 in the direction, in at least one group of electrode sheets 2, at least one electrode sheet 2 is different in shape from the rest of the electrode sheets 2 so that multiple electrode sheets 2 of a group of electrode sheets 2
  • Each electrode piece 2 is distinguished.
  • the output signal strength, frequency and action position of different sliced stimulating electrodes 3 are all specified, and a slight deviation will have a huge impact on stimulating parts such as the brain.
  • the electrodes are identified by marking Orientation, by distinguishing the electrode sheet 2 to determine the implantation position and direction of the sliced stimulating electrode 3, it is convenient for the operator to easily identify the sliced stimulating electrode 3, and accurately fix the sliced stimulating electrode 3 on the brain At the point to be stimulated or the desired position, there is no need to additionally set marks on the sliced stimulating electrode 3 .
  • each electrode sheet 2 in the plurality of electrode sheets 2 is different, or the shape of each electrode sheet 2 in a group of electrode sheets 2 is different.
  • the shapes of all the electrode sheets 2 can be completely different, so that it is not necessary to distinguish the positions of the electrode sheets 2 of other groups according to one group of electrode sheets 2.
  • the electrodes can be identified by marking Orientation is more convenient, or, also can be that the shape of each electrode sheet 2 in a group of electrode sheets 2 is not the same, thus can easily distinguish each electrode sheet 2 in a group of electrode sheets 2, and then according to the difference The electrode sheet 2 distinguishes the position of each electrode sheet 2 of other groups.
  • a plurality of electrode sheets 2 are fixed on the split-type stimulating electrode 3, and the plurality of electrode sheets 2 are connected to the connecting end of the split-type stimulating electrode 3 through the electrode wire 1, and then connected to the connecting end of the split-type stimulating electrode 3. Connect to the output of an external neurostimulator.
  • the stimulating end of the sliced stimulating electrode 3 is unfolded and flattened, and a plurality of electrode sheets 2 are distributed in array intervals.
  • a group of electrode sheets 2 at least A directional shape is formed on one electrode sheet 2 , and the directional shape of the electrode sheet 2 is used to distinguish a plurality of electrode sheets 2 in a group of electrode sheets 2 .
  • a plurality of electrode sheets 2 are preferably in an equidistant and evenly distributed state on the unfolded surface of the sliced stimulation electrode 3, wherein a group of electrode sheets 2 has become a row of electrode sheets 2 in the horizontal direction, and at least one group of electrode sheets 2 has
  • An electrode sheet 2 has a directional shape, and the directional shape simply refers to a directional shape.
  • the directional shape can be an arrow, an arc-shaped protrusion, or a square shape, and the directional shape preferably has a smooth edge.
  • These directional shapes are preferably integrally formed with the electrode sheet 2 .
  • the directional shape is formed on the electrode sheet 2, and basically does not affect the uniform distribution of the overall magnetic field intensity of the electrode sheet 2 when the electrode sheet 2 is working.
  • the directional shape of the electrode sheet 2 is located on one edge of the electrode sheet 2 or the edges on opposite sides.
  • the directional shape of the electrode sheet 2 can be set on any edge of the electrode sheet 2, up, down, left, or right, and at the same time, the directional shape basically does not affect the magnetic field intensity distribution of the slice electrode when the electrode sheet 2 is energized.
  • the directional shape is set on one edge of the electrode sheet 2 or the edges on opposite sides. On the one hand, it is convenient to distinguish the position of each electrode sheet 2 in a group of electrode sheets 2 through the directional shape; The influence of the magnetic field intensity distribution of the sheet electrode.
  • the directional shape of the electrode sheet 2 is formed by waves, sinusoidal curves, semicircles, rounded rectangles or rounded triangles, the directional shape of the electrode sheet 2 is smoothly connected with the electrode sheet 2, and each electrode The shape of the peripheral edge of the sheet 2 is a closed curve.
  • the directional shape of the electrode sheet 2 can also be a wavy edge formed on the electrode sheet 2, or a sine curve or a cosine curve edge formed.
  • a group of electrode sheets 2 includes three electrode sheets 2, one of the electrode sheets The upper side of 2 has a directional shape, and the other two electrode pads 2 can be quickly distinguished through the position of the directional shape.
  • Electrode orientation and accurately implant the sliced stimulation electrode 3 at the desired position in the brain under the imaging technique.
  • the directional shape is formed on the side of the arc edge of the electrode sheet 2. When the electrode sheet 2 is working, it will basically not affect the magnetic field distribution of the electrode sheet 2.
  • the directional shape is designed and formed under the premise of a uniform magnetic field.
  • each electrode sheet 2 is a curve of a smooth contour.
  • the edge of the electrode pad 2 is a smooth curve, which can ensure that when the stimulating electrode is inserted into the brain, the stimulation signal will not be concentrated and spiked when the electrode pad 2 applies stimulation, and the damage to the tissue can be reduced during stimulation.
  • a plurality of electrode sheets 2 are distributed in an array at intervals, and the shapes of the plurality of electrode sheets 2 in a row in the length direction of the sliced stimulating electrode 3 are the same.
  • the shape of a row of electrode sheets 2 in the longitudinal direction of the plurality of electrode sheets 2 is set to be the same, so that the plurality of electrode sheets 2 in each group of electrode sheets 2 can be directly distinguished.
  • a group of electrode sheets 2 includes 2-10 electrode sheets 2 , preferably includes 3 electrode sheets 2 .
  • the number of a group of electrode sheets 2 is maintained at 2 to 10, which can meet the stimulation needs of most nerve electrical stimulation.
  • the partial thickness of at least one electrode sheet 2 is different from the thickness of the rest of the electrode sheet 2 .
  • the local thickness of the same electrode sheet 2 is lower than the thickness of the rest, and the position with a smaller thickness has a lighter color than the position with a larger thickness, which can also be distinguished by the different shades of color during imaging
  • Different electrode sheets 2, so as to distinguish the position of each electrode sheet 2 in a group of electrode sheets 2, cooperate with the electrode sheet 2 distinguished by shape, so that the marking identifies the electrode orientation, determines the implantation position and location of the sliced stimulation electrode 3 The direction is more precise.
  • the present application also provides a stimulation system, including: a stimulator, a wire and a stimulation electrode.
  • the stimulator is connected to the stimulation electrode through a wire, and the stimulation electrode is the above-mentioned sliced stimulation electrode 3 .
  • the stimulator sends out a signal, and the signal is transmitted to the connection end of the slice stimulation electrode 3 through the wire, and then transmitted to the slice stimulation electrode 3 through the connection end of the slice stimulation electrode 3 and the electrode wire 1
  • On the electrode sheet 2 of the stimulating end and release signals on the electrode sheet 2 of the stimulating electrode to stimulate the designated part of the brain, and image it under the imaging equipment such as X-ray machine, and distinguish different electrode sheets 2 according to the shape and other characteristics of the electrode sheet 2 , thereby distinguishing the specific position of the electrode piece 2 on the piece-type stimulating electrode 3, preventing the electrode piece 2 of the piece-type stimulating electrode 3 from touching the part that does not need stimulation, causing the piece-type stimulating electrode 3 to cause damage to the rest of the patient's tissue damage.

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Abstract

本申请公开了一种分片式刺激电极和刺激系统，所述分片式刺激电极具有相对的刺激端和连接端，所述分片式刺激电极的刺激端的外周面上设置有用于施加电刺激的多个电极片，穿过分片式刺激电极同一径向平面的所述多个电极片为一组电极片，在至少一组电极片中，至少一个电极片与其余电极片的形状不同以能够将所述一组电极片的多个电极片区分开。通过将一组电极片中的多个电极片区分开，在使用时通过成像技术，方便医护人员快速标记识别出电极方位，并准确的将刺激电极的电极片对准待刺激部位，无需额外设置电极标记。

Description

一种分片式刺激电极和刺激系统
本申请要求于2022年1月25日提交的申请号为202220209369.3的中国专利的优先权，上述中国专利通过全文引用的形式并入。
技术领域
本申请涉及刺激电极技术领域，尤其涉及一种分片式刺激电极和刺激系统。
背景技术
对于脑深部神经电刺激治疗(DBS，Deep Brain Stimulation)，涉及将电刺激递送到大脑的特定区域中的神经结构以激发或抑制细胞活动，可以有效处理例如慢性疼痛，帕金森病，特发性震颤等运动障碍、癫痫，以及诸如抑郁症和强迫症等精神疾病。具体地，用于施加电刺激的刺激电极作用在患者的头部并刺激大脑的指定部位，对患者大脑损伤起到治疗作用，同时刺激电极的另一端通过电极导线连接神经刺激器。目前，为了满足将电极准确植入在大脑内的期望部位处，避免对大脑的其他部位产生副作用，电极导线通常使用各种成像技术相对精确地植入大脑内的期望部位处，所述成像技术如磁共振成像(MRI，Magnetic Reson ance Imaging)、计算机断层摄影(CT，Computed Tomography)、X射线、荧光成像以及立体成像。
在大多数应用中，期望将刺激电极在患者(例如患者大脑)内精确放置和定向，以将电刺激递送到预期部位并避免副作用。在一些应用中，期望将刺激电极定位成将刺激递送到非常小的目标点位而不刺激邻近大脑组织；如果没有精确地将刺激递送到期望目标点位，则可能降低疗效，并且邻近区域接受到不必要的过量刺激；故临床期望将精确地放置和定向刺激电极的能力不断提高。
公告号为CN104703653B的中国专利，公开了微电极记录引导的方向性导线的植入，该专利提供了把导线植入到患者脑部组织中的方法，其中导线包括在导线远端上的径向分段电极组。该方法包括通过脑部组织中分别多个记录道执行多个微电极记录；基于微电极记录生成脑部结构的三维映射；在脑部结构的映射上定位径向分段电极的图表以生成导线在脑部组织中期望的深度和期望的径向定向的图形化描述；以及根据期望的深度和期望的径向定向把导线植入到脑部组织 中。用于确定导线径向定向的设备，包括径向方向性标尺和指示哪个电极与标尺形成接触的指示器，该专利为了将电极定位，仍然通过额外设置的径向方向性标尺和电极配合使用，从而推算出电极的位置，具有一定的局限性。
公布号CN112292176A的中国专利，公开了植入式医疗引线指示器，该专利提供在所述引线的远侧部分处的电极，所述电极被配置成监测靶部位或向所述靶部位提供疗法。所述引线可以包含可见指示器，所述可见指示器在所述引线的中间部分处对临床医师肉眼可见，所述可见指示器被配置成指示所述引线的所述电极何时适当地纵向和径向对准以监测或治疗所述靶部位。临床医师可以通过以下将所述引线插入到所述患者中：使用插入到所述患者中预定深度的导引器护套，并且随后通过将所述指示器定向所述导引器护套的进入端口处来对准所述引线的所述远侧部分。该专利仍然通过在引线上额外设置指示器，配合确定电极在使用时的方位，仍然具有一定的局限性。
现有技术通常通过在刺激电极上额外设置标记来识别电极方位，通过预先定义的标记方向与电极刺激片的对应关系来判定电极的位置及方向，通常这样的方式需要医生具有很强的逻辑判断能力，不允许在过程中出错，对医生的经验要求过高，局限性较大。
因此，现有的刺激电极仍需要改进。
发明内容
本申请提供了解决上述问题的一种分片式刺激电极和刺激系统。
本申请的目的采用以下技术方案实现：
一种分片式刺激电极，所述分片式刺激电极具有相对的刺激端和连接端，所述分片式刺激电极的刺激端的外周面上设置有用于施加电刺激的多个电极片，穿过分片式刺激电极同一径向平面的所述多个电极片为一组电极片，在至少一组电极片中，至少一个电极片与其余电极片的形状不同以能够将所述一组电极片的多个电极片区分开。
因为不同形状的电极片，其产生的生理效能会有差别，当每个电极片形状或面积差异较大时，可根据具体靶点需要施加特殊刺激的情形，设计成不同的电极片组合，不仅能够实现电极片的位置识别的目的，而且能够对具体的待刺激点施加特定的刺激，从而实现具体病症的治疗。
在一些可能的方式中，所述多个电极片中每个电极片的形状均不相同，或者，所述一组电极片中的每个电极片的形状均不相同。在区分不同的分片式刺激电极时，可以根据每个电极片的不同形状进行区分不同的分片式刺激电极，也可以根据一组电极片上的形状进行区分，两种不同的分片式刺激电极的标记方式，方便医护人员在实际使用时进行选择。
在一些可能的方式中，在所述分片式刺激电极的刺激端平坦化状态下，所述多个电极片呈阵列间隔分布，所述一组电极片中，至少一个所述电极片上形成有指向性形状，所述电极片的指向性形状用于将所述一组电极片的多个电极片区分开。指向性形状例如是箭头、凸起、或是设在电极片一侧的弧形边缘。指向性形状在实际形成在电极片上时，能快速的标记至少两个电极片，然后在成像技术下，操作人员通过直接标记的两个电极片的位置，可以快速的确定其余的电极片的位置，方便操作人员快速准确的将刺激电极插入在待测点。
在一些可能的方式中，所述电极片的指向性形状位于所述电极片的一侧边缘或相对两侧的边缘。例如是电极片的左右边具有指向性形状，也可以是电极片的上边或下边的偏左或偏右位置具有指向性形状，指向性形状在成像技术下，能够直接标记至少两个电极片的位置，从而对比得出其余的电极片的位置。
在一些可能的方式中，所述电极片的指向性形状由波浪形、正弦曲线、半圆形、圆角矩形或圆角三角形形成，所述电极片的指向性形状与电极片圆滑连接，且每个电极片的外周边缘的形状是闭合的曲线。指向性形状也可以是能够快速标记至少两个电极片的弧形曲线边缘，例如是波浪形的弧形曲线边缘，或者是具有规律的正弦余弦曲线。通过一条波浪形边缘可以直观的分辨出至少两个电极片的位置，在加工电极片时，电极片大多通过一体成型技术制成，当一个电极分片上具有一条指向性形状时，加工一体成型的电极片时可以适当减少电极片的加工工序，提高了加工电极片的效率。
在一些可能的方式中，每个电极片的外周边缘的形状是圆滑轮廓线的曲线。当电极片的外周边缘可以是圆滑的曲线时，圆滑的曲线可以保证当刺激电极在插入脑中时，电极片施加刺激时，不会出现刺激信号集中和尖峰，在刺激时能够减少对组织的损伤。
在一些可能的方式中，在所述分片式刺激电极的刺激端平坦化状态下，所述 多个电极片呈阵列间隔分布，在分片式刺激电极的长度方向上一列的多个电极片的形状相同。当分片式刺激电极竖直方向上的电极片形状相同时，医护人员在成像技术下，同样可以直观的分辨出分片电极在竖直方向上的位置，并结合分片电极在刺激电极径向上的位置，最终将每个电极片的位置确定，从而方便医护人员准确的将电极片固定在脑部待刺激点。
在一些可能的方式中，所述一组电极片包括2-10个电极片。一组也就是同一刺激电极上的一圈电极片，一圈电极片的数量可以是2-10个，数量在此之间可以既有效的保持刺激电极良好的刺激效果，又方便操作人员在成像技术下观察分辨，能够满足大多数神经电刺激的刺激需要。
在一些可能的方式中，所述一组电极片中，至少一个电极片的局部厚度与该电极片其余部分的厚度不相同。同一个电极片上的局部厚度大于其余部分厚度，在成像技术下，厚度较大的部分颜色较深，多个电极片在工作时，也可以通过电极片的厚度作为区分方式，在X光机成像下，电极片可以根据局部厚度不同，呈现出不同的颜色深浅，通过颜色深浅进而区分不同的电极片，与形状区分相结合更加快速地将多个电极片区分开，方便医护人员调整刺激电极的方位，有效的刺激待测部位，防止刺激电极对大脑造成负面影响。
一种刺激系统，包括：刺激器、导线和刺激电极，所述刺激器通过导线连接所述刺激电极，所述刺激电极是上述的分片式刺激电极。
与现有技术相比，本申请的有益效果至少包括：
通过将分片式刺激电极的一组电极片的多个电极片区分开，在成像技术下通过识别的电极片的不同形状作为区分不同刺激电极的方法，方便操作人员快速标记识别出电极方位，并准确的将刺激电极的刺激点作用在指定位置，有效的减少由于刺激电极在大脑刺激位置不准确产生的副作用，降低对操作人员的刺激电极识别能力要求；同时，无需额外设计标记识别刺激电极方位。
附图说明
图1是本申请实施例的一种实施例的分片式刺激电极的刺激端平坦化状态下的示意图；
图2是本申请实施例的另一种实施例分片式刺激电极的刺激端平坦化状态下的示意图；
图3是本申请实施例的又一种实施例的分片式刺激电极的刺激端平坦化状态下的示意图；
图4是本申请实施例的再一种实施例的分片式刺激电极的刺激端平坦化状态下的示意图。
图中：1、电极导线；2、电极片；3、分片式刺激电极。
具体实施方式
下面，结合附图以及具体实施方式，对本申请做进一步描述，需要说明的是，在不相冲突的前提下，以下描述的各实施例之间或各技术特征之间可以任意组合形成新的实施例。
在本申请中，“至少一个”是指一个或者多个，“多个”是指两个或两个以上。“和/或”，描述关联对象的关联关系，表示可以存在三种关系，例如，A和/或B，可以表示：单独存在A，同时存在A和B，单独存在B的情况，其中A，B可以是单数或者复数。字符“/”一般表示前后关联对象是一种“或”的关系。“以下至少一项(个)”或其类似表达，是指的这些项中的任意组合，包括单项(个)或复数项(个)的任意组合。例如，a，b或c中的至少一项(个)，可以表示：a，b，c，a和b，a和c，b和c或a和b和c，其中a、b和c可以是单个，也可以是多个。值得注意的是，“至少一项(个)”还可以解释成“一项(个)或多项(个)”。
本申请中，“示例性的”或者“例如”等词用于表示作例子、例证或说明。本申请中被描述为“示例性的”或者“例如”的任何实施例或设计方案不应被解释为比其他实施例或设计方案更优选或更具优势。确切而言，使用“示例性的”或者“例如”等词旨在以具体方式呈现相关概念。
下面，首先对本申请实施例的其中一个应用领域(即可植入医疗设备)进行简单说明。
植入式神经刺激系统(一种植入式医疗系统)主要包括植入患者体内的刺激器(即植入式刺激器)以及设置于患者体外的程控设备。现有的神经调控技术主要是通过立体定向手术在体内特定结构(即靶点)植入电极，并由植入患者体内的刺激器经电极向靶点发放电脉冲，调控相应神经结构和网络的电活动及其功能，从而改善症状、缓解病痛。其中，刺激器可以是植入式神经电刺激装置、植入式 心脏电刺激系统(又称心脏起搏器)、植入式药物输注装置(Implantable Drug Deli very System，简称I DDS)和导线转接装置中的任意一种。植入式神经电刺激装置例如是脑深部电刺激系统(Deep Brain Stimulation，简称DBS)、植入式脑皮层刺激系统(Cortical Nerve Stimulation，简称CNS)、植入式脊髓电刺激系统(Spinal Cord Stimulation，简称SCS)、植入式骶神经电刺激系统(Sacral Nerve Stimulation，简称SNS)、植入式迷走神经电刺激系统(Vagus Nerve St imulation，简称VNS)等。
刺激器可以包括IPG、延伸导线和电极导线1，IPG(implantable pulse gen erator，植入式脉冲发生器)设置于患者体内，接收程控设备发送的程控指令，依靠密封电池和电路向体内组织提供可控制的电刺激能量，通过植入的延伸导线和电极导线1，为体内组织的特定区域递送一路或两路可控制的特定电刺激。延伸导线配合IPG使用，作为电刺激信号的传递媒体，将IPG产生的电刺激信号，传递给电极导线1。电极导线1通过多个电极触点，向体内组织的特定区域递送电刺激。刺激器设置有单侧或双侧的一路或多路电极导线1，电极导线1上设置有多个电极触点，电极触点可以均匀排列或者非均匀排列在电极导线1的周向上。作为一个示例，电极触点可以以4行3列的阵列(共计12个电极触点)排列在电极导线1的周向上。电极触点可以包括刺激电极触点和/或采集电极触点。电极触点例如可以采用片状、环状、点状等形状。
在一些可能的实施方式中，受刺激的体内组织可以是患者的脑组织，受刺激的部位可以是脑组织的特定部位。当患者的疾病类型不同时，受刺激的部位一般来说是不同的，所使用的刺激触点(单源或多源)的数量、一路或多路(单通道或多通道)特定电刺激信号的运用以及刺激参数数据也是不同的。本申请实施例对适用的疾病类型不做限定，其可以是脑深部刺激(DBS)、脊髓刺激(SCS)、骨盆刺激、胃刺激、外周神经刺激、功能性电刺激所适用的疾病类型。其中，DBS可以用于治疗或管理的疾病类型包括但不限于：痉挛疾病(例如，癫痫)、疼痛、偏头痛、精神疾病(例如，重度抑郁症(MDD))、躁郁症、焦虑症、创伤后压力心理障碍症、轻郁症、强迫症(OCD)、行为障碍、情绪障碍、记忆障碍、心理状态障碍、移动障碍(例如，特发性震颤或帕金森氏病)、亨廷顿病、阿尔茨海默症、药物成瘾症、孤独症或其他神经学或精神科疾病和损害。
本申请实施例中，程控设备和刺激器建立程控连接时，可以利用程控设备调整刺激器的刺激参数(不同的刺激参数所对应的电刺激信号不同)，也可以通过刺激器感测患者脑深部的生物电活动以采集得到电生理信号，并可以通过所采集到的电生理信号来继续调节刺激器的电刺激信号的刺激参数。
刺激参数可以包括以下至少一种：频率(例如是单位时间1s内的电刺激脉冲信号个数，单位为Hz)、脉宽(每个脉冲的持续时间，单位为μs)、幅值(一般用电压表述，即每个脉冲的强度，单位为V)、时序(例如可以是连续或者触发)、刺激模式(包括电流模式、电压模式、定时刺激模式和循环刺激模式中的一种或多种)、医生控制上限及下限(医生可调节的范围)和患者控制上限及下限(患者可自主调节的范围)。
在一个具体应用场景中，可以在电流模式或者电压模式下对刺激器的各刺激参数进行调节。
程控设备可以是医生程控设备(即医生使用的程控设备)或者患者程控设备(即患者使用的程控设备)。医生程控设备例如可以是搭载有程控软件的平板电脑、笔记本电脑、台式计算机、手机等智能终端设备。患者程控设备例如可以是搭载有程控软件的平板电脑、笔记本电脑、台式计算机、手机等智能终端设备，患者程控设备还可以是其他具有程控功能的电子设备(例如是具有程控功能的充电器、数据采集设备)。
本申请实施例对医生程控设备和刺激器的数据交互不进行限制，当医生远程程控时，医生程控设备可以通过服务器、患者程控设备与刺激器进行数据交互。当医生线下和患者面对面进行程控时，医生程控设备可以通过患者程控设备与刺激器进行数据交互，医生程控设备还可以直接与刺激器进行数据交互。
在一种可能的实现方式中，患者程控设备可以包括(与服务器通信的)主机和(与刺激器通信的)子机，主机和子机可通信的连接。其中，医生程控设备可以通过3G/4G/5G网络与服务器进行数据交互，服务器可以通过3G/4G/5G网络与主机进行数据交互，主机可以通过蓝牙协议/WIFI协议/USB协议与子机进行数据交互，子机可以通过401MHz-406MHz工作频段/2.4GHz-2.48GHz工作频段与刺激器进行数据交互，医生程控设备可以通过401MHz-406MHz工作频段/2.4GHz-2.48GHz工作频段与刺激器直接进行数据交互。参照图1-4，本申请提供了 一种分片式刺激电极3，分片式刺激电极3具有相对的刺激端和连接端，分片式刺激电极3的刺激端的外周面上设置有用于施加电刺激的多个电极片2，穿过分片式刺激电极3同一径向平面的多个电极片2为一组电极片2，一组电极片2例如是在分片式刺激电极3的同一高度方向上环绕分片式刺激电极3一圈的多个电极片2，在至少一组电极片2中，至少一个电极片2与其余电极片2的形状不同以能够将一组电极片2的多个电极片2区分开。不同的分片式刺激电极3的输出的信号强度和频率以及作用位置都是指定的，稍有偏差就会对大脑等刺激部位造成巨大的影响，使用本申请的分片式刺激电极3，在植入分片式刺激电极3过程中，在成像技术下，通过区分至少一组电极片2中多个电极片2的不同形状，进而区分其他组的各个电极片2的位置，标记识别出电极方位，通过区分出的电极片2来判定分片式刺激电极3的植入位置和方向，方便操作人员简易的识别分片式刺激电极3，并将分片式刺激电极3准确的固定在大脑的待刺激点上或期望位置，同时无需在分片式刺激电极3上额外设置标记。
较优的，多个电极片2中每个电极片2的形状均不相同，或者，一组电极片2中的每个电极片2的形状均不相同。同一个分片式刺激电极3上，所有的电极片2的形状可以完全不同，这样不用根据一组电极片2来区分其他组的各个电极片2的位置，在成像技术下，标记识别出电极方位更加方便，或者，也可以是一组电极片2中的每个电极片2的形状均不相同，由此可以方便地区分开一组电极片2中的每个电极片2，再根据区分开的电极片2区分其他组的各个电极片2的位置。
参照图1，多个电极片2固定在分片式刺激电极3上，多个电极片2通过电极导线1连接分片式刺激电极3的连接端，再通过分片式刺激电极3的连接端连接至外部的神经刺激器的输出端。
优选的，在分片式刺激电极3的刺激端平坦化状态下，即将分片式刺激电极3的刺激端展开铺平，多个电极片2呈阵列间隔分布，一组电极片2中，至少一个电极片2上形成有指向性形状，电极片2的指向性形状用于将一组电极片2的多个电极片2区分开。多个电极片2在分片式刺激电极3的展开面上优选呈等距均匀分布状态，其中一组电极片2也就成了横向上的一行电极片2，一组电极片2中至少有一个电极片2具有指向性形状，指向性形状简单的说就是指带有导向 性的形状，指向性形状可以是箭头、弧形凸起，也可是方块等形状，指向性形状优选具有圆滑边缘，这些指向性形状优选均和电极片2为一体成型结构。指向性形状形成在电极片2上，在电极片2工作时，基本不影响电极片2的整体磁场强度的均匀分布。
更具体的，电极片2的指向性形状位于电极片2的一侧边缘或相对两侧的边缘。电极片2的指向性形状可以设置在电极片2的上下左右任意一个边缘上，同时指向性形状在电极片2通电工作时，基本不影响分片电极的磁场强度分布，通过将电极片2的指向性形状设置在电极片2的一侧边缘或相对两侧的边缘，一方面便于通过指向性形状来区分一组电极片2中各个电极片2的位置，另一方面，能够减小对分片电极的磁场强度分布的影响。
优选的，电极片2的指向性形状由波浪形、正弦曲线、半圆形、圆角矩形或圆角三角形形成，所述电极片2的指向性形状与电极片2圆滑连接，且每个电极片2的外周边缘的形状是闭合的曲线。电极片2的指向性形状也可以是形成在电极片2上的波浪形边缘，或是形成的正弦曲线、余弦曲线边缘，当一组电极片2包括三个电极片2时，其中一个电极片2上一侧具有一个指向性形状，即可通过指向性形状的位置快速的分辨出另外两个电极片2，通过此种方式即可简易的分辨出不同的刺激电极，便于准确的标记识别出电极方位，并在成像技术下准确的将分片式刺激电极3植入在大脑内的期望部位处。指向性形状形成在电极片2的弧形边缘一侧，在电极片2工作时，基本不会影响电极片2的磁场分布，指向性形状均在磁场均匀的前提下设计成形的。
每个电极片2的外周边缘的形状是圆滑轮廓线的曲线。电极片2的边缘是圆滑的曲线，圆滑的曲线可以保证当刺激电极在插入脑中时，电极片2施加刺激时，不会出现刺激信号集中和尖峰，在刺激时能够减少对组织的损伤。
在分片式刺激电极3的刺激端平坦化状态下，多个电极片2呈阵列间隔分布，在分片式刺激电极3的长度方向上一列的多个电极片2的形状相同。在展开状态下，将多个电极片2的长度方向上的一列电极片2的形状设置为相同，可以直接对每组电极片2的多个电极片2进行区分。
优选的，一组电极片2包括2-10个电极片2，优选包括3个电极片2。刺激电极展开后，一组电极片2的数量保持在2个至10个，能够满足大多数神经电 刺激的刺激需要，一组电极片2的数量越多，能够施加的刺激越精确，例如当一组电极片2的数量达到10个时，同一个刺激电极上的多个电极片2能够分别各自精准刺激对应的待刺激点，防止一个电极片2刺激多个待刺激点，由于待刺激点的需要刺激强度不同，而导致治疗效果较差。
在另一个实施例，一组电极片2中，至少一个电极片2的局部厚度与该电极片2其余部分的厚度不相同。在成像技术下，同一个电极片2的局部厚度低于其余部分的厚度，厚度较小的位置处相较于厚度大的位置，颜色较浅，也可以通过在成像时的颜色深浅不同进行分辨不同的电极片2，从而作为区分一组电极片2中各个电极片2的位置，与通过形状区分电极片2相配合，使得标记识别电极方位、判定分片式刺激电极3的植入位置和方向更加精准。
本申请还提供一种刺激系统，包括：刺激器、导线和刺激电极，刺激器通过导线连接刺激电极，刺激电极是上述的分片式刺激电极3。刺激系统在使用时，通过刺激器发出信号，信号经过导线传递至分片式刺激电极3的连接端，再通过分片式刺激电极3的连接端和电极导线1传递至分片式刺激电极3的刺激端的电极片2上，并通过刺激电极的电极片2上释放信号刺激大脑的指定部位，并在X光机等成像设备下成像，根据电极片2的形状等特征区分不同的电极片2，从而区分出分片式刺激电极3上的电极片2的具体位置，防止分片式刺激电极3的电极片2接触到无需刺激的部位，导致分片式刺激电极3对患者的其余组织造成损伤。
尽管上面已经示出和描述了本申请的实施例，可以理解的是，上述实施例是示例性的，不能理解为对本申请的限制，本领域的普通技术人员在不脱离本申请的原理和宗旨的情况下，在申请的范围内可以对上述实施例进行变化、修改、替换和变型，所有的这些改变都应该属于本申请权利要求的保护范围之内。

Claims (10)

  1. 一种分片式刺激电极，其中，所述分片式刺激电极具有相对的刺激端和连接端，所述分片式刺激电极的刺激端的外周面上设置有用于施加电刺激的多个电极片，穿过分片式刺激电极同一径向平面的所述多个电极片为一组电极片，在至少一组电极片中，至少一个电极片与其余电极片的形状不同以能够将所述一组电极片的多个电极片区分开。
  2. 根据权利要求1所述的分片式刺激电极，其中，所述多个电极片中每个电极片的形状均不相同，或者，所述一组电极片中的每个电极片的形状均不相同。
  3. 根据权利要求1所述的分片式刺激电极，其中，在所述分片式刺激电极的刺激端平坦化状态下，所述多个电极片呈阵列间隔分布，所述一组电极片中，至少一个所述电极片上形成有指向性形状，所述电极片的指向性形状用于将所述一组电极片的多个电极片区分开。
  4. 根据权利要求3所述的分片式刺激电极，其中，所述电极片的指向性形状位于所述电极片的一侧边缘或相对两侧的边缘。
  5. 根据权利要求4所述的分片式刺激电极，其中，所述电极片的指向性形状由波浪形、正弦曲线、半圆形、圆角矩形或圆角三角形形成，所述电极片的指向性形状与电极片圆滑连接，且每个电极片的外周边缘的形状是闭合的曲线。
  6. 根据权利要求1所述的分片式刺激电极，其中，每个电极片的外周边缘的形状是圆滑轮廓线的曲线。
  7. 根据权利要求1所述的分片式刺激电极，其中，在所述分片式刺激电极的刺激端平坦化状态下，所述多个电极片呈阵列间隔分布，在分片式刺激电极的长度方向上一列的多个电极片的形状相同。
  8. 根据权利要求1所述的分片式刺激电极，其中，所述一组电极片包括2-10个电极片。
  9. 根据权利要求1所述的分片式刺激电极，其中，所述一组电极片中，至少一个电极片的局部厚度与该电极片其余部分的厚度不相同。
  10. 一种刺激系统，其中，包括：刺激器、导线和刺激电极，所述刺激器通过导线连接所述刺激电极，所述刺激电极是权利要求1至9任意一项所述的分片 式刺激电极。
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