WO2023185408A1 - Flexible conductive flexible board, split stimulation electrode, and stimulation system - Google Patents

Flexible conductive flexible board, split stimulation electrode, and stimulation system Download PDF

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Publication number
WO2023185408A1
WO2023185408A1 PCT/CN2023/080278 CN2023080278W WO2023185408A1 WO 2023185408 A1 WO2023185408 A1 WO 2023185408A1 CN 2023080278 W CN2023080278 W CN 2023080278W WO 2023185408 A1 WO2023185408 A1 WO 2023185408A1
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WO
WIPO (PCT)
Prior art keywords
electrode
electrode sheet
stimulation
flexible conductive
shape
Prior art date
Application number
PCT/CN2023/080278
Other languages
French (fr)
Chinese (zh)
Inventor
姜传江
朱为然
Original Assignee
苏州景昱医疗器械有限公司
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Application filed by 苏州景昱医疗器械有限公司 filed Critical 苏州景昱医疗器械有限公司
Publication of WO2023185408A1 publication Critical patent/WO2023185408A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605Implantable neurostimulators for stimulating central or peripheral nerve system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0526Head electrodes
    • A61N1/0529Electrodes for brain stimulation
    • A61N1/0534Electrodes for deep brain stimulation

Definitions

  • This application relates to the technical field of stimulation electrodes, for example, to a flexible conductive soft plate, a segmented stimulation electrode and a stimulation system.
  • DBS Deep Brain Stimulation
  • DBS Deep Brain Stimulation
  • the stimulating electrode used to apply electrical stimulation acts on the patient's head and stimulates a designated part of the brain to treat the patient's brain damage.
  • the other end of the stimulating electrode is connected to the neurostimulator through an electrode lead.
  • electrode leads are usually relatively accurately implanted at desired locations in the brain using various imaging technologies, such as magnetic imaging.
  • Resonance imaging MRI, Magnetic Resonance Imaging
  • CT computed tomography
  • X-ray X-ray
  • fluorescence imaging three-dimensional imaging.
  • stimulation electrodes In most applications, it is desirable to precisely place and orient stimulation electrodes within a patient (eg, the patient's brain) to deliver electrical stimulation to the intended site and avoid side effects. In some applications, it is desirable to position stimulation electrodes to deliver stimulation to very small target sites without stimulating adjacent brain tissue; if stimulation is not delivered precisely to the desired target site, efficacy may be reduced and adjacent areas Unnecessary excessive stimulation; therefore, clinical expectations will continue to improve the ability to accurately place and orient stimulation electrodes.
  • the Chinese patent with announcement number CN104703653B discloses the implantation of directional wires guided by microelectrode recording.
  • the patent provides a method for implanting the wires into the brain tissue of the patient, in which the wires include radial holes on the distal end of the wires. Segmented electrode set.
  • the method includes performing multiple microelectrode recordings through multiple separate recording tracks in brain tissue; generating a three-dimensional map of the brain structure based on the microelectrode recordings; positioning a diagram of radially segmented electrodes on the map of the brain structure to generate leads Graphical depiction of desired depth and desired radial orientation in brain tissue; and implantation of leads into brain tissue according to desired depth and desired radial orientation middle.
  • the device used to determine the radial orientation of the wire includes a radial directional ruler and an indicator indicating which electrode is in contact with the ruler.
  • the patent In order to position the electrode, the patent still uses an additional radial directional ruler and electrode, Therefore, the position of the electrode can be deduced, which has certain limitations.
  • Chinese patent publication number CN112292176A which discloses an implantable medical lead indicator, provides an electrode at a distal portion of the lead, the electrode being configured to monitor a target site or provide therapy to the target site.
  • the lead may include a visible indicator visible to the naked eye of a clinician at a middle portion of the lead, the visible indicator being configured to indicate when the electrode of the lead is properly longitudinal and Radially aligned to monitor or treat the target site.
  • the clinician may insert the lead into the patient by using an introducer sheath inserted into the patient to a predetermined depth and subsequently by directing the indicator into the introducer sheath. port to align the distal portion of the lead.
  • This patent still has certain limitations by setting an additional indicator on the lead wire to determine the orientation of the electrode during use.
  • This application provides a flexible conductive soft plate, a segmented stimulation electrode and a stimulation system that solve the above problems.
  • a flexible conductive soft plate has a stimulation section and extends along a first direction. The first direction and the second direction intersect. The outer surface of the stimulation section of the flexible conductive soft plate is provided with a stimulating section for applying electricity.
  • a plurality of electrode sheets for stimulation, each electrode sheet is provided with a connection point for connecting the lead of the electrode sheet, and the lead of the electrode sheet is embedded in the flexible conductive soft plate;
  • the plurality of electrode sheets are divided into one or more electrode sheet groups.
  • Each electrode sheet group includes a plurality of electrode sheets arranged along the second direction.
  • One or more of the electrode sheet groups are provided with one or more features. Electrode sheets, the characteristic electrode sheets have distinguishing marks, and the characteristic electrode sheets are used to distinguish multiple electrode sheets of an electrode sheet group during imaging.
  • the distinguishing mark of the characteristic electrode sheet is selected from any one or combination of the following:
  • connection point of the electrode piece is positioned relative to the side of the electrode piece
  • connection points of the electrode pads are The shape of the connection points of the electrode pads
  • connection point combination includes at least two connection points located on the electrode sheet.
  • the distinguishing mark of the characteristic electrode sheet is the shape of the electrode sheet
  • a directional shape is formed on the characteristic electrode sheet, and the directional shape of the characteristic electrode sheet is used to distinguish multiple electrode sheets.
  • the directional shape of the characteristic electrode sheet is located on one edge of one side or edges of opposite sides of the characteristic electrode sheet;
  • the directional shape of the characteristic electrode sheet is formed by a wave shape, a sinusoidal curve, a semicircle, a rounded rectangle or a rounded triangle.
  • the directional shape of the characteristic electrode sheet is smoothly connected to the rest of the characteristic electrode sheet, and each The shape of the outer peripheral edge of the electrode sheet is a closed curve.
  • the distinguishing mark of the characteristic electrode sheet is the shape of the electrode sheet
  • the shape of each electrode sheet in the plurality of electrode sheets is different, or the shape of each electrode sheet in the one electrode sheet group is The shapes of the electrode pads are all different.
  • the distinguishing mark of the characteristic electrode sheet is the position of the connection point of the electrode sheet relative to the side of the electrode sheet.
  • Each of the electrode sheets respectively includes an upper side and a lower side along the first direction. side, as well as the left side and right side along the second direction, and the distinguishing mark of the characteristic electrode sheet is the position of the connection point of the electrode sheet relative to the upper side and lower side of the electrode sheet, or, is The position of the connection point of the electrode sheet relative to the left and right sides of the electrode sheet.
  • the distance between the connection points of the plurality of characteristic electrode sheets along the second direction in one or more electrode sheet groups and the end surface of the stimulation segment gradually increases or decreases.
  • the distinguishing mark of the characteristic electrode sheet is the connection point shape of the electrode sheet or the shape of the connection point combination
  • the shape of the connection point combination is composed of the connection point positions in the connection point combination of the electrode sheet. shape.
  • connection lines are provided between the connection points of the connection point combination, and the shape of the connection point combination has directional marks for distinguishing multiple electrode sheets.
  • connection points in the connection point combination is connected to the electrode sheet lead,
  • the remaining connection points of the connection point combination are connected or not connected to the electrode sheet leads, and one or more of the remaining connection points of the connection point combination are metal sheets and are arranged on the flexible conductive soft plate back to the electrode sheet.
  • One side or embedded in the flexible conductive soft plate, the shape of the connection point of the metal sheet is the shape of the metal sheet, and the position of the connection point of the metal sheet is the position of the metal sheet.
  • connection point includes a via hole formed on the flexible conductive board and a conductive layer located in the via hole.
  • Each of the electrode sheets is connected to the corresponding electrode through the conductive layer in the via hole.
  • the chip leads are electrically connected.
  • the shape of the connection point is the radial cross-sectional shape of the via hole
  • the radial cross-sectional shape of the via hole is a rounded rectangle, a circle, an ellipse, a rounded triangle or a rounded corner. diamond.
  • the conductive layer is formed on the inner wall of the via hole, and the via hole after the conductive layer is formed is a hollow hole.
  • the inner wall of the via hole is a smooth inner wall.
  • the plurality of electrode sheets are distributed in an array at intervals, and the shape of each electrode sheet is the same.
  • the shape of the peripheral edge of each electrode sheet is a curve of a smooth outline, and the distinguishing marks of electrode sheets with different characteristics are Can be the same or different.
  • the segmented stimulation electrode includes 2-10 electrode sheet groups, the one electrode sheet group includes 2-10 electrode sheets, and the first direction and the second direction are perpendicular.
  • a piece-type stimulation electrode including an inner lining tube and a flexible conductive soft plate as described in any one of the above.
  • the inner lining tube has an outer wall for the flexible conductive soft plate to fit.
  • the flexible conductive soft plate has The stimulation section is wrapped around the outer wall of the lining tube, and the plurality of electrode sheets of the stimulation section are arranged on the outer side wall of the flexible conductive plate facing away from the lining tube;
  • the plurality of electrode sheets are divided into one or more circumferential electrode groups arranged at intervals along the axial direction of the lining tube, and each circumferential electrode group includes a plurality of electrode sheets arranged in the circumferential direction. .
  • the flexible conductive soft plate also includes a connecting section opposite to the stimulation section and an intermediate section located between the stimulation section and the connecting section.
  • the stimulation section and the connecting section of the flexible conductive soft plate are processed separately. into a cylindrical structure, and the middle section of the flexible conductive soft plate is processed into a cylindrical structure, a spiral structure or a structure formed by rolling the wavy flexible conductive soft plate.
  • a stimulation system includes a stimulator, a wire and a stimulation electrode.
  • the stimulator is connected to the stimulation electrode through a wire.
  • the stimulation electrode is the above-mentioned segmented stimulation electrode.
  • the beneficial effects of this application at least include:
  • the stimulation section of the flexible conductive soft plate provided by the embodiment of the present application extends along the first direction.
  • the electrode sheets for applying stimulation provided on the outer surface of the stimulation section are divided into multiple electrode sheet groups.
  • Each electrode sheet group includes a A plurality of electrode sheets arranged in the second direction, one or more electrode sheet groups are provided with characteristic electrode sheets, the characteristic electrode sheets have distinguishing marks, and the characteristic electrode sheets are used to distinguish the multiple electrodes of one electrode sheet group during imaging Separate areas.
  • the characteristic electrode sheet of the present application is used to apply electrical stimulation and also serves as a distinguishing feature during imaging to distinguish multiple electrode sheets of an electrode sheet group. It is easy to identify the electrode orientation and helps to reduce process steps and costs.
  • any one of the shape of the electrode sheet itself, the position of the connection points on the electrode sheet relative to the side of the electrode sheet, the shape of the connection points on the electrode sheet, and the combined shape of the connection points on the electrode sheet is used as the electrode.
  • the marking method of the tablet and the use of the process of forming thin film circuits of electrodes eliminate the need to set additional marks for differentiation on the stimulation electrodes, making it convenient for the operator to quickly mark and identify the electrode position, and accurately place the stimulation point of the stimulation electrode at the designated position. , reducing the requirements for the operator's ability to identify stimulation electrodes.
  • Figure 1 is a partial structural schematic diagram of the flexible conductive soft plate close to the stimulation section according to the embodiment of the present application;
  • Figure 2A is a cross-sectional view taken at A-A in Figure 1;
  • Figure 2B is another cross-sectional view at A-A in Figure 1;
  • Figure 3 is a partial schematic diagram of a flexible conductive board according to the first embodiment of the present application.
  • Figure 4 is a partial schematic diagram of another flexible conductive board according to the first embodiment of the present application.
  • Figure 5 is a partial schematic diagram of another flexible conductive board according to the first embodiment of the present application.
  • Figure 6 is a partial schematic diagram of another flexible conductive board according to the first embodiment of the present application.
  • Figure 7 is a partial schematic diagram of a flexible conductive board according to the second embodiment of the present application.
  • Figure 8 is a partial schematic diagram of yet another flexible conductive board according to the second embodiment of the present application.
  • Figure 9 is a partial schematic diagram of a flexible conductive board according to the third embodiment of the present application.
  • Figure 10 is a partial schematic diagram of yet another flexible conductive board according to the third embodiment of the present application.
  • Figure 11 is a partial schematic diagram of yet another flexible conductive board according to the third embodiment of the present application.
  • Figure 12 is a partial schematic diagram of yet another flexible conductive board according to the third embodiment of the present application.
  • Figure 13 is a partial schematic diagram of yet another flexible conductive board according to the third embodiment of the present application.
  • Figure 14 is a schematic flow chart of a method for manufacturing a flexible conductive board according to the fourth embodiment of the present application.
  • Figure 15 is a schematic structural diagram of the stimulation section of the segmented stimulation electrode according to the fifth embodiment of the present application.
  • Electrode sheet lead 11. Flexible base; 2. Electrode sheet; 21. Characteristic electrode sheet; 3. Flexible Conductive soft board; 4. Via hole; 41. Conductive layer; 5. Connecting wire; 6. First insulating layer; 7. Second insulating layer.
  • Example embodiments will now be described more fully with reference to the accompanying drawings.
  • Example embodiments may, however, be embodied in various forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the concepts of the example embodiments. To those skilled in the art.
  • the same reference numerals in the drawings represent the same or similar structures, and thus their repeated description will be omitted.
  • the implantable neurostimulation system (a type of neurostimulation system) mainly includes a stimulator implanted in the patient's body (i.e., an implantable neurostimulator, a type of neurostimulator) and a programmable controller installed outside the patient's body.
  • Relevant neuromodulation technology mainly involves implanting electrodes in specific parts of the body's tissues (i.e., target points) through stereotaxic surgery, and a stimulator implanted in the patient's body sends electrical pulses to the target point through the electrodes to regulate the corresponding neural structures. And the electrical activity and functions of the network, thereby improving symptoms and relieving pain.
  • the stimulator can be an implantable nerve electrical stimulation device, an implantable cardiac electrical stimulation system (also known as a pacemaker), an implantable drug delivery system (IDDS for short) and a lead transfer device. any of the connecting devices.
  • Implantable neuroelectric stimulation devices include, for example, Deep Brain Stimulation (DBS), Cortical Nerve Stimulation (CNS), and Spinal Cord. Stimulation, referred to as SCS), implanted sacral nerve electrical stimulation system (Sacral Nerve Stimulation, referred to as SNS), implanted vagus nerve electrical stimulation system (Vagus Nerve Stimulation, referred to as VNS), etc.
  • the stimulator may include an IPG and electrode module.
  • the electrode module may include electrode leads and may also include extension leads.
  • IPG implantable pulse generator, implantable pulse generator
  • the IPG may include a control module to receive program control instructions sent by the program controller.
  • IPG relies on sealed batteries and circuits to provide controllable electrical stimulation energy to tissues in the body. Through implanted electrode modules, it delivers one or two channels of controllable specific electrical stimulation to specific areas of tissue in the body.
  • the extension lead is used in conjunction with the IPG as a transmission medium for electrical stimulation signals to transmit the electrical stimulation signals generated by the IPG to the electrode leads.
  • Electrode leads deliver electrical stimulation to specific areas of tissue in the body through multiple electrode contacts.
  • the stimulator is designed to One or more electrode wires are provided on one side or both sides, and multiple electrode contacts are provided on the electrode wires.
  • the electrode contacts can be arranged evenly 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 (12 electrode contacts in total) in the circumferential direction of the electrode lead.
  • Electrode contacts may include stimulation contacts and/or acquisition contacts.
  • the electrode contacts may be in the shape of, for example, a sheet, a ring, a dot, or the like.
  • the stimulated internal tissue may be the patient's brain tissue, and the stimulated site may be a specific part of the brain tissue.
  • the stimulated parts are generally different, the number of stimulation contacts used (single source or multiple sources), one or more channels (single channel or multi-channel) specific electrical stimulation signals
  • the application and stimulation parameter data are also different.
  • the embodiments of this application do not limit the applicable disease types, which may be the disease types applicable to deep brain stimulation (DBS), spinal cord stimulation (SCS), pelvic stimulation, gastric stimulation, peripheral nerve stimulation, and functional electrical stimulation.
  • DBS diseases that DBS can be used to treat or manage
  • diseases include, but are not limited to: spastic diseases (eg, epilepsy), pain, migraine, mental illness (eg, major depressive disorder (MDD)), bipolar disorder, anxiety disorder, Post-traumatic stress disorder, mild depression, obsessive-compulsive disorder (OCD), behavioral disorders, mood disorders, memory disorders, mental status disorders, mobility disorders (e.g., essential tremor or Parkinson's disease), Huntington's disease, Alzheimer's disease Alzheimer's disease, drug addiction, autism or other neurological or psychiatric diseases and impairments.
  • spastic diseases eg, epilepsy
  • pain migraine
  • mental illness eg, major depressive disorder (MDD)
  • bipolar disorder e.g., anxiety disorder, Post-traumatic stress disorder, mild depression, obsessive-compulsive disorder (OCD)
  • OCD obsessive-compulsive disorder
  • behavioral disorders e.g., mood disorders, memory disorders, mental status
  • the program controller when the program controller 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 bioelectrical activity is used to collect electrophysiological signals, and the stimulation parameters of the electrical stimulation signal of the stimulator can be continuously adjusted through the collected electrophysiological signals.
  • Stimulation parameters can include: frequency (for example, the number of electrical stimulation pulse signals per unit time 1 s, the unit is Hz), pulse width (the duration of each pulse, the unit is ⁇ s), amplitude (generally expressed in voltage, that is, The intensity of each pulse, in 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 cyclic stimulation mode), physician control upper limit One or more of the upper and lower limits (the range that the doctor can adjust) and the upper and lower limits of the patient's control (the range that the patient can adjust independently). In some possible ways, various stimulation parameters of the stimulator can be adjusted in current mode or voltage mode.
  • the present application provides a flexible conductive soft plate 3.
  • the flexible conductive soft plate 3 has a stimulation section and extends along a first direction.
  • the outer surface of the stimulation section of the flexible conductive soft plate 3 is provided with a device for applying electrical stimulation.
  • There are a plurality of electrode sheets 2 each electrode sheet 2 is provided with a connection point for connecting the electrode sheet lead 1 , and the electrode sheet lead 1 is embedded in the flexible conductive soft plate 3 .
  • the first direction is, for example, the X direction shown in the figure
  • the second direction is, for example, the Y direction shown in the figure
  • the first direction and the second direction intersect, and the first direction and the second direction are preferably perpendicular, as shown in Fig. 4 and FIG. 13
  • the flexible conductive board 3 has the same or similar extension direction as the flexible conductive board 3 in FIG. 3 .
  • the plurality of electrode sheets 2 are divided into one or more electrode sheet groups.
  • Each electrode sheet group includes a plurality of electrode sheets 2 arranged along the second direction. In other words, the multiple electrode sheets 2 of each electrode sheet group are arranged along the same direction. , when the flexible conductive soft plate 3 is rolled into a cylindrical shape, the multiple electrode sheets 2 of each electrode sheet group pass through the same radial plane and form a circumferential electrode group.
  • Each circumferential electrode group includes A plurality of electrode sheets 2 are arranged.
  • One or more characteristic electrode sheets 21 are provided in one or more electrode sheet groups. The characteristic electrode sheets 21 have distinguishing marks. The characteristic electrode sheets 21 are used to distinguish multiple electrode sheets 2 of an electrode sheet group during imaging. Through upper and lower comparison, the multiple electrode pads 2 of each electrode pad group can be distinguished.
  • imaging is performed after the flexible conductive soft plate 3 is made into a piece-type stimulation electrode, and the piece-type stimulation electrode is implanted into the patient's brain. Imaging is performed inside tissues such as the body.
  • this application uses the characteristic electrode piece 21 as a mark to distinguish the electrode pieces 2 without setting additional marks.
  • the characteristic electrode sheet 21 is used to apply electrical stimulation. It also serves as a distinguishing feature during imaging to distinguish multiple electrode sheets 2 of an electrode sheet group, which facilitates the identification of electrode orientations and helps reduce process costs. steps and costs.
  • the above-mentioned flexible conductive soft plate 3 is rolled into a cylindrical shape and made into a segmented stimulation electrode.
  • the segmented stimulation electrode composed of the flexible conductive soft plate 3 with a characteristic electrode piece 21 is implanted in the patient's brain and other tissues.
  • the operator identifies the position of the characteristic electrode patch 21 to determine the position of all the electrode patches 2 of an electrode patch group in the patient's brain and other tissues, which facilitates the operator to quickly identify the electrode position and accurately place the stimulation electrode.
  • the stimulation point acts at a designated location, reducing the requirement for the operator's ability to identify stimulation electrodes.
  • the electrode sheet lead 1 is buried in the flexible conductive soft board 3 and is electrically connected to the electrode sheet 2 using connection points, which simplifies the connection method between the electrode sheet 2 and the electrode sheet lead 1, fully utilizes the structure of the flexible conductive soft board 3, and utilizes the flexibility
  • the circuit arrangement is relatively rich and flexible, and has a wide range of applications.
  • the connection point includes a via hole 4 formed on the flexible conductive soft board 3 and a conductive layer 41 located in the via hole 4.
  • Each electrode piece 2 is connected to the corresponding electrode through the conductive layer 41 in the via hole 4.
  • the electrode sheet lead 1 is electrically connected.
  • the stimulation signal on the flexible conductive board 3 is transmitted to the via hole 4, and is electrically connected through the conductive layer 41 in the via hole 4, and is finally transmitted to the electrode sheet 2 and releases electrical stimulation.
  • the flexible conductive board 3 includes: a flexible substrate 11 and a first insulating layer 6 located on the flexible substrate 11 , and the electrode lead 1 is provided on the flexible substrate 11 and located on the flexible substrate. Between 11 and the first insulating layer 6, a via hole 4 is formed on the first insulating layer 6, and the conductive layer 41 in the via hole 4 is electrically connected to the corresponding electrode sheet lead 1.
  • the flexible conductive soft plate 3 is made into a piece-type stimulation electrode, since there is no need to route wires within the micro-diameter of the piece-type stimulation electrode, more electrode lead wires 1 and electrode pieces 2 can be set on the piece-type stimulation electrode.
  • the line arrangement method is more abundant and flexible, and has a wide range of applications.
  • the flexible conductive board 3 includes: a flexible substrate 11, a first insulating layer 6 and a second insulating layer 7 located on the flexible substrate 11.
  • the flexible substrate 11 has opposite upper surfaces and On the lower surface, the first insulating layer 6 is provided on the upper surface of the flexible substrate 11 , and the second insulating layer 7 is provided on the lower surface of the flexible substrate 11 .
  • Part of the electrode sheet leads 1 is provided on the upper surface of the flexible substrate 11 and is located between the flexible substrate 11 and the first insulating layer 6 .
  • Part of the via hole 4 is formed on the first insulating layer 6 .
  • the conductive layer in the via hole 4 41 is electrically connected to the electrode sheet lead 1 corresponding to the upper surface of the flexible substrate 11; part of the electrode sheet lead 1 is provided on the lower surface of the flexible substrate 11 and is located between the flexible substrate 11 and the second insulating layer 7, and part of the via hole 4 Formed on the first insulating layer 6 and the flexible substrate 11 , the conductive layer 41 in the via hole 4 is electrically connected to the corresponding electrode sheet lead 1 on the lower surface of the flexible substrate 11 . Therefore, the number of electrode sheet leads 1 can be increased while the width of the flexible substrate 11 remains unchanged.
  • the flexible substrate 11 can be made of polymer materials such as polyimide and polyethylene terephthalate, and the material of the first insulating layer 6 and the second insulating layer 7 can be made of PDMS (polydimethylsiloxane).
  • connection point consists of a via hole 4 and a conductive layer 41 for connecting the electrode pad lead 1 and the electrode pad 2.
  • the structures of the connection points below and the connection points here may be the same and will not be described again.
  • the plurality of electrode sheets 2 in the second direction of the flexible conductive soft plate 3 are divided into an electrode sheet group, hereinafter referred to as the electrode sheet group.
  • the flexible conductive soft plate 3 is arranged extending along the first direction.
  • the plurality of electrode sheets 2 is a column of electrode sheets 2, and one or more characteristic electrode sheets 21 are provided in one or more electrode sheet groups.
  • the characteristic electrode sheets 21 are used to combine the multiple electrode sheets 2 of an electrode sheet group.
  • the distinguishing mark of the characteristic electrode sheet 21 is selected from any one or a combination of the following: the shape of the electrode sheet 2, the side position of the connection point of the electrode sheet 2 relative to the electrode sheet 2, the connection point of the electrode sheet 2
  • the shape, the shape of the connection point combination, the connection point combination includes at least two connection points located on the electrode sheet 2 .
  • the characteristic electrode sheet 21 in any electrode sheet group can be used as a distinguishing mark to distinguish all the electrode sheets 2 of an electrode sheet group.
  • the plurality of electrode sheets 2 are distributed in an array at intervals, and the shape of each electrode sheet 2 is the same or different.
  • the shape of the peripheral edge of each electrode sheet 2 is a smooth contour line.
  • the distinguishing marks of different characteristic electrode sheets 21 may be the same or different.
  • the flexible conductive soft plate 3 includes 2-10 electrode sheet groups, such as 3, 4, 5 or 6 electrode sheet groups, and one electrode sheet group includes 2-10 electrode sheets 2, such as 3, 4, 5 or 6 electrode pads2.
  • the number of electrode pads in an electrode set is maintained at 2 to 10, which can meet the stimulation needs of most nerve electrical stimulation.
  • the larger the number of electrode pads in an electrode pad group the more precise the stimulation that can be applied. For example, when an electrode When the number of pad groups reaches 10, multiple electrode pads 2 on the same stimulation electrode can accurately stimulate the corresponding points to be stimulated respectively, preventing one electrode pad 2 from stimulating multiple points to be stimulated, because the points to be stimulated need to be stimulated. Different strengths lead to poorer therapeutic effects.
  • the flexible conductive board 3 of this embodiment for example, referring to Figure 3, in the same electrode sheet group, there are two electrode sheets 2 with different shapes from the other electrode sheets 2, which are elliptical and rounded triangle respectively.
  • the electrode pads 2, or refer to Figure 4, the two electrode pads 2 located in different groups have different shapes.
  • the above-mentioned flexible conductive soft plate 3 is rolled into a cylindrical shape and made into a segmented stimulation electrode. After implanting the electrode pads 2, When stimulating electrodes in slices, under imaging technology, the operator can determine the orientation of all electrode patches 2 in an electrode patch group by looking for the two marked electrode patches 2 here, and then compare them up and down.
  • the multiple electrode pads 2 of each electrode pad group can be distinguished to facilitate identification by the operator, so that the stimulation point of the segmented stimulation electrode can be accurately applied to a designated position.
  • the distinguishing mark on the characteristic electrode sheet 21 is the shape of the electrode sheet 2
  • a directional shape is preferably formed on the characteristic electrode sheet 21, and the directional shape of the characteristic electrode sheet 21 is used to distinguish multiple electrode sheets 2. open.
  • the directional shape may be located on one edge or edges on opposite sides of the characteristic electrode sheet 21 .
  • the directional shape means that when the operator observes this type of shape, he can clearly and accurately identify the orientation of the electrode sheet 2 and determine the positions of multiple electrode sheets 2 in an electrode sheet group.
  • the directional shape on the characteristic electrode sheet 21 is, for example, formed by a wave shape, a sinusoidal curve, a semicircle, a rounded rectangle or a rounded triangle.
  • the directional shape of the characteristic electrode sheet 21 is consistent with the rest of the characteristic electrode sheet 21 . Partially smooth connection, And the shape of the outer peripheral edge of each electrode sheet 2 is a closed curve.
  • the smooth curve can ensure that there will be no concentration or spikes of the stimulation signal. Can reduce damage to tissue.
  • the electrode sheet 2 and the directional shape are made by one-piece molding technology during processing, and there is no need to additionally provide other materials as marks for the electrode sheet 2 .
  • the operator can identify the edge shape of the electrode sheet 2. Under the marking of the edge shape of the electrode sheet 2, the operator can clearly identify all the electrode sheets 2 of an electrode sheet group. The orientation makes it convenient for the operator to accurately place the stimulation electrode at the point to be stimulated.
  • the distinguishing mark of the characteristic electrode sheet 21 is the shape of the electrode sheet 2
  • the shape of each electrode sheet 2 in the plurality of electrode sheets 2 is different, or each electrode in the one electrode sheet group
  • the shapes of pieces 2 are all different.
  • the shapes of all the electrode pads 2 can be completely different. In this way, there is no need to distinguish the positions of each electrode pad 2 of other groups based on one electrode pad group.
  • the mark identifies the electrode orientation more easily.
  • each electrode piece 2 in an electrode piece group may have a different shape.
  • the distinguishing mark of the characteristic electrode sheet 21 is the position of the connection point of the electrode sheet 2 relative to the side of the electrode sheet 2.
  • Each of the electrode sheets 2 includes a line along the first The upper side and lower side in one direction, and the left side and right side along the second direction, the distinguishing marks of the characteristic electrode sheet 21 are the connection points of the electrode sheet 2 relative to the upper side of the electrode sheet 2 The position of the side and the lower side, or the position of the connection point of the electrode sheet 2 relative to the left side and right side of the electrode sheet 2 .
  • the above-mentioned flexible conductive soft plate 3 is rolled into a cylindrical shape and made into a segmented stimulation electrode.
  • the operator When implanting the segmented stimulation electrode, under the imaging equipment, the operator identifies the features on the segmented stimulation electrode.
  • the position of the connection point on the electrode sheet 21 serves as a distinguishing mark to determine the orientation of the segmented stimulation electrode, making it convenient for the operator to accurately act on the stimulation point of the segmented stimulation electrode at a designated position.
  • connection point of the first electrode sheet of the first group from top to bottom is located above the right side of the electrode sheet, and the connection point of the second electrode sheet group is The connection point of the last first electrode sheet is located on the lower left side of the electrode sheet.
  • the connection point will light up in white Appear in the form of dots, and the electrode pad 2 will appear in a gray sheet shape.
  • the relative position of the white bright spot in the gray graphic is the mark of the electrode pad 2.
  • the medical staff determines an electrode pad 2 by identifying the electrode pad 2 with different white bright spot positions. The positions of all electrode pads 2 in the electrode pad set facilitate the accurate stimulation points of the segmented stimulation electrodes at designated locations, reducing the operational requirements and difficulty of medical staff.
  • the distance between the connection points of the plurality of characteristic electrode sheets 21 along the second direction in one or more electrode sheet groups and the end surface of the stimulation section gradually increases or decreases, and the position of the connection point is the through hole.
  • the end face of the stimulation section refers to the end face of the stimulation section facing away from the connecting section.
  • the connection point combination includes at least two connection points located on the same electrode sheet 2, and the shape of the connection point combination is the shape composed of the connection point positions in the connection point combination of the electrode sheet 2 , the connection point combination shape can also be composed of multiple connection points with different shapes.
  • the above-mentioned flexible conductive soft plate 3 is rolled into a cylindrical shape and made into a segmented stimulation electrode.
  • the operator identifies the shape of the connection points on the electrode sheet 2, and uses the shape of the connection points or the combined shape of the connection points on the electrode sheet 2 as a distinguishing mark to identify the characteristic electrode sheet 21, thereby determining the electrode orientation, which is convenient for the operator Accurately apply the stimulation point of the segmented stimulation electrode to the designated location.
  • the shape of the connection point is the radial cross-sectional shape of the via hole 4, and the radial cross-sectional shape of the via hole 4 is a rounded rectangle, a circle, an ellipse, a rounded triangle or a rounded rhombus. Since the overall thickness of the flexible conductive board 3 is thin, the axial length of the via 4 will be relatively shorter. Under imaging technology, the visual importance brought by the axial length of the via 4 can be ignored. Without the influence of shadow, the shape of the via hole 4 on the flexible conductive board 3 can be clearly identified with the naked eye. Under the imaging device, the shape composed of the via hole 4 and the conductive layer 41 appears within the image range displayed by the electrode sheet 2. The operator only needs to first determine the graphic part of the electrode sheet 2, and then determine the process within the range of the electrode sheet 2. The radial cross-sectional shape of the hole 4 can determine the electrode orientation and has obvious distinction, which is convenient for operators to identify and distinguish.
  • the shapes of all the connection points on the segmented stimulation electrode are different, or the shapes of all the connection points of each electrode patch group on the segmented stimulation electrode are different.
  • the positions of all electrode sheets 2 of an electrode sheet group can be determined, and then other electrode sheet groups can be distinguished.
  • the shape of the connection point can also be used as a directional mark, for example, the connection point on the first electrode sheet 2 in the first group, the shape of the connection point is a triangle, one of the sharp corners of the triangle points to the same group in the horizontal direction
  • the operator can clearly identify the shape of the triangle and the other electrode piece 2 where the sharp corners of the triangle point, thereby identifying the orientation of the electrode, making it easier for the operator to accurately divide the points into
  • the stimulation point of the chip stimulation electrode acts at a designated location.
  • connection points in the above connection point combination can also be connected through connection wires 5 , where the material and structure of the connection wires 5 can be consistent with those of the electrode sheet leads 1 , and can also be arranged on the flexible substrate 11 .
  • the connection line 5 appears as a gray line under an X-ray machine. With the visual assistance of the gray line, it is convenient for the operator to easily identify the shape of the connection point combination on the characteristic electrode sheet 21, and then identify the electrode within the patient's tissue. The orientation makes it convenient for the operator to accurately apply the stimulation point of the segmented stimulation electrode to the designated position, accurately release the stimulation, and help the patient recover.
  • connection line between the two connection points of the first characteristic electrode sheet 21 in the first group is similar to a hypotenuse.
  • the hypotenuse has a certain directivity and points to an electrode sheet 2 on the right.
  • the personnel When operating When observing the imaging results, the personnel first find the characteristic electrode piece 21 with two connection points. Following the pointing direction of the combination of connection points, the position of the second electrode piece 2 in the same group can be quickly determined, making it easy to determine The orientation of all electrode pads 2 in the same group.
  • connection points on all electrode sheets 2 is two or more.
  • the combined shape of the connection points is used as a mark, and there are more ways of arrangement and combination.
  • connection points can be arranged and combined to meet a variety of use needs.
  • connection point combination can also be composed of multiple connection points with different shapes. In this case, there will be more types of connection point combinations, which can meet the needs of multiple applications on more types of segmented stimulation electrodes. need.
  • connection point in the connection point combination is connected to the electrode sheet lead 1, the remaining connection points of the connection point combination are connected to the electrode sheet lead 1 or not, and the connection point combination
  • One or more of the remaining connection points are metal sheets, for example, the metal sheets are copper sheets.
  • the shape of the connection point using the metal sheet is the shape of the metal sheet, and the position of the connection point using the metal sheet is the position of the metal sheet.
  • One or more metal sheets in the connection point combination can be placed on the side of the flexible conductive soft plate 3 away from the electrode sheet during processing, or the metal sheets can be buried in the flexible conductive soft plate 3 during processing.
  • connection point combination which serves as an identification mark of the electrode sheet and determines the orientation of the stimulation electrode.
  • metal sheets instead of via holes 4 and conductive layers 41 , the number of via holes 4 and conductive layers 41 can be reduced without affecting the electrical connection between the connection points and the electrode sheet leads 1 .
  • a conductive layer 41 is formed on the inner wall of the via hole 4 , and the via hole 4 after the conductive layer 41 is formed is a hollow hole.
  • the conductive layer 41 is used to electrically connect the electrode sheet leads 1 and the electrode sheet 2 on the flexible substrate 11, and is used to transmit stimulation signals.
  • the via hole 4 after forming the conductive layer 41 is set as a hollow hole, the shape and position of the via hole 4 will be more obvious under imaging equipment. For example, during X-ray imaging, the via hole 4 with a hollow hole structure will be white or nearly white. , the visual effect is more obvious, and it is more conducive to identifying the shape and position of the connection point.
  • the formed conductive layer 41 can also fill the via hole 4.
  • the corresponding conductive layer 41 has a larger cross-sectional area and a smaller resistance, so that the conductive layer 41 The electrical connection performance with the electrode sheet 2 and the electrode sheet lead 1 is better.
  • the inner wall of the via hole 4 is a smooth inner wall.
  • the inner wall of the via hole 4 maintains a smooth inner wall.
  • the via hole 4 with a smooth inner wall structure is more conducive to the adhesion of the conductive layer 41, which can ensure good electrical connection performance and ensure stable transmission. Stimulation signals provide good performance guarantees.
  • this embodiment provides a method for manufacturing a flexible conductive soft plate 3.
  • the flexible conductive soft plate 3 has a stimulation section and extends along a first direction, and the first direction and the second direction intersect.
  • the manufacturing method includes the following steps: step S1-step S3.
  • Step S1 Form a plurality of electrode sheet leads 1 on the flexible conductive board 3, and the electrode sheet leads 1 are embedded in the flexible conductive board 3.
  • the structure of the flexible conductive board 3 in step S1 can be realized through exposure, development, metal layer coating, and insulating layer coating.
  • step S1 includes: forming a plurality of electrode sheet leads 1 on the upper surface of the flexible substrate 11 and a first insulating layer 6 covering the plurality of electrode sheet leads 1 on the upper surface of the flexible substrate 11 .
  • step S1 includes: forming a dry film on the upper surface of the flexible substrate 11, forming a dry film
  • the method can be hot rolling, and the temperature of hot rolling can be 110°C; a mask is used to expose and develop the dry film on the flexible substrate 11, and a plurality of electrode sheet leads are formed on the flexible substrate 11
  • the pattern of 1 perform magnetron sputtering or vacuum evaporation on the upper surface of the flexible substrate 11, and form a metal base layer on the pattern of the electrode lead 1 of the flexible substrate 11.
  • the thickness of the metal base layer is, for example, 200nm, 400nm or 600nm; remove Dry film; thickening the metal base layer, the thickening method can be electroplating, to form the electrode lead 1 of the desired thickness.
  • the material of the electrode lead 1 can be copper, and the thickness can be 0.1 ⁇ m, 10 ⁇ m, 50 ⁇ m or 100 ⁇ m; in A first insulating layer 6 is formed on the flexible substrate 11.
  • the first insulating layer 6 covers the plurality of electrode sheet leads 1 on the upper surface of the flexible substrate 11.
  • a vacuum vapor deposition process or a coating process can be used to form a uniform layer on the upper surface of the flexible substrate 11. the first insulating layer 6.
  • the upper surface of the flexible substrate 11 may also be roughened. Through the roughening treatment, the bonding force between the flexible substrate 11 and the electrode sheet lead 1 can be improved.
  • the dry film can be a polymeric resin that reacts to ultraviolet rays. After being irradiated by ultraviolet rays, the dry film can undergo a polymerization reaction to form a stable substance attached to the flexible substrate 11, thereby achieving the function of blocking electroplating and etching.
  • the mask can be a film. Due to the use of the mask, the part with the image on the mask cannot transmit ultraviolet light. Therefore, the part of the dry film that is not exposed to ultraviolet light will not be able to produce polymerization.
  • the developer can be used to remove the non-polymerized part of the dry film to reveal the lines that need to be retained. Therefore, the circuit pattern produced through this step has the characteristics of being thin, straight and flat.
  • the method of performing magnetron sputtering or vacuum evaporation on the upper surface of the flexible substrate 11 may include: sequentially performing ultrasonic cleaning, hot air drying and surface plasma treatment on the dry film on the upper surface of the flexible substrate 11; Place it in the sputtering fixture or evaporation fixture for magnetron sputtering or vacuum evaporation.
  • step S1 includes: forming a plurality of electrode sheet leads 1 on the upper surface of the flexible substrate 11 and a first insulating layer 6 covering the plurality of electrode sheet leads 1 on the upper surface of the flexible substrate 11.
  • a plurality of electrode sheet leads 1 and a second insulating layer 7 covering the plurality of electrode sheet leads 1 on the lower surface of the flexible substrate 11 are formed on the lower surface of the flexible substrate 11 .
  • the first insulating layer 6 and the second insulating layer 7 respectively cover the electrode sheet leads 1 on both surfaces of the flexible substrate 11 .
  • step S1 includes: forming a dry film on the upper surface and lower surface of the flexible substrate 11.
  • the method of forming the dry film may be hot rolling, and the temperature of the hot rolling may be 110°C; using a mask to The dry film on the flexible substrate 11 is exposed and developed, and patterns of multiple electrode sheet leads 1 are formed on both surfaces of the flexible substrate 11; magnetron sputtering is performed on the upper and lower surfaces of the flexible substrate 11.
  • the thickness of the metal base layer is, for example, 200nm, 400nm or 600nm; removing the dry film; thickening the metal base layer on both surfaces , the thickening method can be electroplating, thereby forming the electrode sheet lead 1 of the desired thickness.
  • the material of the electrode sheet lead 1 can be copper, and the thickness can be 0.1 ⁇ m, 10 ⁇ m, 50 ⁇ m or 100 ⁇ m; forming a first first electrode lead 1 on the flexible substrate 11
  • a vacuum vapor deposition process or a coating process forms a uniform first insulating layer 6 and a second insulating layer 7 on the upper and lower surfaces of the flexible substrate 11 .
  • the remaining methods of this embodiment may be the same or similar to the above embodiment, and will not be described again here.
  • Step S2 Form multiple connection points on the flexible conductive board 3.
  • connection point preferably includes a via hole 4 formed on the flexible conductive board 3 and a conductive layer 41 located within the via hole 4 .
  • connection point corresponds to the position of the electrode lead 1 , where the connection point may be the via hole 4 and the conductive layer 41 located in the via hole 4 .
  • step S2 includes: forming a plurality of via holes 4 on the first insulating layer 6 and a conductive layer 41 located in the via holes 4 .
  • the via hole 4 can be formed on the first insulating layer 6 by drilling, for example, laser drilling.
  • the conductive layer 41 is formed in the via hole 4 by vacuum coating, and during the drilling, the via hole 4 is formed.
  • step S2 includes: forming a plurality of via holes 4 and a conductive layer 41 located in the via holes 4 on the flexible conductive soft board 3, and some of the via holes 4 are formed in the first
  • the conductive layer 41 on the insulating layer 6 and in the via hole 4 is electrically connected to the electrode lead 1 on the upper surface of the flexible substrate 11 .
  • a part of the via hole 4 is formed on the first insulating layer 6 and the flexible substrate 11 and in the via hole 4
  • the conductive layer 41 is electrically connected to the electrode lead 1 on the lower surface of the flexible substrate 11 .
  • the method of forming the via hole 4 and the conductive layer 41 in this embodiment may be the same as or similar to the above embodiment, and will not be described again here.
  • Step S3 Form a plurality of electrode sheets 2 for applying electrical stimulation on the outer surface of the stimulation section of the flexible conductive soft plate 3.
  • the plurality of electrode sheets 2 are divided into one or more electrode sheet groups.
  • Each electrode sheet group includes a plurality of electrode sheets 2 arranged along the second direction.
  • One or more characteristic electrode sheets are provided in one or more electrode sheet groups. 21.
  • the characteristic electrode sheet 21 has a distinguishing mark, and the characteristic electrode sheet 21 is used to distinguish a group of multiple electrode sheets 2 during imaging.
  • step S3 includes: forming a plurality of electrode sheets 2 on the surface of the first insulating layer 6 , each of the electrode sheets 2 passing through the conductive layer 41 in the via hole 4 and the corresponding electrode sheet lead. 1 electrical connection.
  • the plurality of electrode sheets 2 may be arranged at even intervals on the surface of the first insulating layer 6 .
  • Multiple electrode sheets 2 can be completed by 3D curved surface sputtering, and forming the conductive layer 41 in the via hole 4 can be performed in the same step as forming the electrode sheets.
  • the conductive layer 41 is formed on the inner wall of the via hole 4 , and the via hole 4 after the conductive layer 41 is formed is a hollow hole.
  • the visual effect of the via hole 4 of the hollow hole structure is more obvious, which is more conducive to identifying the shape and position of the connection point 4.
  • the inner wall of the via hole 4 is a smooth inner wall, which can ensure that the conductive layer 41 in the via hole 4 has good electrical connection performance, and provides good performance guarantee for stable transmission of stimulation signals.
  • the distinguishing mark of the characteristic electrode sheet 21 is selected from any one or a combination of the following: the shape of the electrode sheet 2, the side position of the connection point of the electrode sheet 2 relative to the electrode sheet 2, the shape of the connection point of the electrode sheet 2, the connection The shape of a point combination includes at least two connection points located on the electrode sheet 2 .
  • the shape of the connection point is the shape of the via hole 4
  • the shape of the connection point combination is a shape formed by the positions of the connection points in the connection point combination of the electrode sheet 2 .
  • connection point in the connection point combination is connected to the electrode sheet lead 1, the remaining connection points of the connection point combination are connected to the electrode sheet lead 1 or not, and the remaining connection points of the connection point combination are connected to the electrode sheet lead 1 or not.
  • connection points are metal sheets.
  • the metal sheets are, for example, copper sheets.
  • the shape of the connection point using the metal sheet is the shape of the metal sheet.
  • the position of the connection point using the metal sheet is the position of the metal sheet.
  • Step S2 may also include: using a metal sheet connection point to be arranged on a side of the flexible conductive board 3 facing away from the electrode sheet 2 or embedded in the flexible conductive board 3 .
  • One or more metal sheets in the connection point combination can be arranged on the side of the flexible conductive soft plate 3 away from the electrode sheet 2 during processing, or the metal sheets can be buried in the flexible conductive soft plate 3 during processing.
  • the operator Under the imaging equipment, the operator can directly observe that the metal sheet and the conductive layer 41 form a connection point combination, which serves as an identification mark of the electrode sheet 2 and determines the orientation of the stimulation electrode.
  • this embodiment provides a segmented stimulation electrode, including a lining tube (not shown) and the flexible conductive soft plate 3 of the above embodiment.
  • the stimulation section of the flexible conductive soft plate 3 is wrapped around On the outer wall of the lining tube, the lining tube can be made of a material that is not sensitive to thermal deformation, such as polyurethane.
  • the plurality of electrode sheets of the stimulation section are arranged on one side of the outer wall of the flexible conductive plate 3 facing away from the inner lining tube.
  • the electrode sheet 2 is correspondingly arranged on the outside to release electrical stimulation.
  • the plurality of electrode sheets 2 are divided into one or more circumferential electrode groups arranged at intervals along the axial direction of the lining tube, and each circumferential electrode group includes a plurality of electrode sheets 2 arranged in the circumferential direction.
  • each circumferential electrode group includes a plurality of electrode sheets 2 arranged in the circumferential direction.
  • the flexible conductive soft plate 3 also includes a connecting section opposite to the stimulation section and an intermediate section located between the stimulation section and the connecting section.
  • the stimulation section and the connecting section of the flexible conductive soft plate 3 are respectively processed into cylindrical structures.
  • the middle section of the flexible conductive soft board 3 is processed into a cylindrical structure, a spiral structure or a structure formed by rolling the wavy flexible conductive soft board 3 into a round shape.
  • the stimulation section and the connection section of the flexible conductive soft plate 3 are processed into cylinders with the same diameter, and a fixed lining tube is inserted in the middle of the cylinder, and the remaining middle sections are also wound and fixed on the outer wall of the lining tube.
  • the flexible conductive soft plate 3 is placed on the inner lining tube, which plays a role in shaping the shape of the flexible conductive soft plate 3.
  • the inner lining tube will The flexible conductive soft plate 3 is supported to form a smooth cylindrical shape, which is convenient for the operator to implant the flexible conductive soft plate 3 into the patient's tissue.
  • the flexible conductive soft plate 3 used uses the characteristic electrode piece 21 as a mark to distinguish the electrode piece 2. There is no need to set additional marks. After being made into a piece-type stimulation electrode, it can be operated when implanted in the patient's brain and other tissues.
  • the operator determines the position of all the electrode patches 2 of an electrode patch group in the patient's brain and other tissues, which facilitates the operator to quickly identify the electrode position and accurately activate the stimulation point of the stimulation electrode. At designated locations, reduce the operator's ability to identify stimulation electrodes.
  • This embodiment provides a stimulation system, including a stimulator, a wire and a stimulation electrode.
  • the stimulator (not shown in the figure) is connected to the stimulation electrode through a wire (not shown in the figure).
  • the stimulation electrode is the above-mentioned The fragmented stimulation electrode of the embodiment.
  • the stimulator When the stimulating electrode is accurately fixed at the point to be stimulated in the brain and other tissues using imaging technology, when working, the stimulator will output the stimulation signal and transmit it through the wire, and finally release the electrical stimulation to the patient's body through the electrode sheet 2 At the point of the brain to be stimulated, the preset stimulation signal circulates in the patient's brain, which helps to restore brain function and achieve treatment or rehabilitation by stimulating the patient's brain.
  • a stimulation system that uses segmented stimulation electrodes that use characteristic electrode pieces 21 as markers.
  • the operator When implanting the segmented stimulation electrodes in the patient's brain and other tissues, the operator identifies the position of the characteristic electrode pieces 21 to determine the location of the segmented stimulation electrodes.
  • the position of all the electrode pads 2 of an electrode pad group in the patient's brain and other tissues facilitates the operator to quickly identify the electrode position and accurately apply the stimulation points of the segmented stimulation electrode to the designated position, reducing the impact on the operator. Stimulating electrode identification ability requirements.

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Abstract

The present application discloses a flexible conductive flexible board, a split stimulation electrode, and a stimulation system. The flexible conductive flexible board has a stimulation section and extends in a first direction; the first direction intersects with a second direction; a plurality of electrode plates used for applying electrical stimulation are arranged on the outer surface of the stimulation section of the flexible conductive flexible board; each electrode plate is provided with a connecting point used for connecting an electrode plate lead; the electrode plate lead is embedded in the flexible conductive flexible board; the plurality of electrode plates are classified into one or more electrode plate groups; one or more characteristic electrode plates are arranged in the one or more electrode plate groups; the characteristic electrode plate is used for distinguishing a plurality of electrode plates of one electrode plate group during imaging. When the flexible conductive flexible board is manufactured into the split stimulation electrode for implantation, an operator can conveniently and quickly identify an electrode orientation; in addition, the connecting mode between the electrode plates and the electrode plate leads is simplified, and when the flexible conductive flexible board is used to manufacture the stimulation electrode, circuit arrangements are rich and flexible, and the application range is wide.

Description

柔性导电软板、分片式刺激电极和刺激系统Flexible conductive plates, segmented stimulation electrodes and stimulation systems
本申请要求于2022年3月30日提交的申请号为202210334061.6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。This application claims priority to the Chinese patent with application number 202210334061.6, which was submitted on March 30, 2022. The above Chinese patent is incorporated by reference in full.
技术领域Technical field
本申请涉及刺激电极技术领域,例如涉及一种柔性导电软板、分片式刺激电极和刺激系统。This application relates to the technical field of stimulation electrodes, for example, to a flexible conductive soft plate, a segmented stimulation electrode and a stimulation system.
背景技术Background technique
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,成像技术如磁共振成像(MRI,Magnetic Resonance Imaging)、计算机断层摄影(CT,Computed Tomography)、X射线、荧光成像以及立体成像。For deep brain stimulation therapy (DBS, Deep Brain Stimulation), which involves delivering electrical stimulation to neural structures in specific areas of the brain to excite or inhibit cell activity, it can effectively treat chronic pain, Parkinson's disease, idiopathic diseases, etc. Movement disorders such as tremors, epilepsy, and psychiatric conditions such as depression and obsessive-compulsive disorder. Specifically, the stimulating electrode used to apply electrical stimulation acts on the patient's head and stimulates a designated part of the brain to treat the patient's brain damage. At the same time, the other end of the stimulating electrode is connected to the neurostimulator through an electrode lead. Currently, in order to accurately implant electrodes at desired locations in the brain and avoid side effects on other parts of the brain, electrode leads are usually relatively accurately implanted at desired locations in the brain using various imaging technologies, such as magnetic imaging. Resonance imaging (MRI, Magnetic Resonance Imaging), computed tomography (CT, Computed Tomography), X-ray, fluorescence imaging and three-dimensional imaging.
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。In most applications, it is desirable to precisely place and orient stimulation electrodes within a patient (eg, the patient's brain) to deliver electrical stimulation to the intended site and avoid side effects. In some applications, it is desirable to position stimulation electrodes to deliver stimulation to very small target sites without stimulating adjacent brain tissue; if stimulation is not delivered precisely to the desired target site, efficacy may be reduced and adjacent areas Unnecessary excessive stimulation; therefore, clinical expectations will continue to improve the ability to accurately place and orient stimulation electrodes.
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。The Chinese patent with announcement number CN104703653B discloses the implantation of directional wires guided by microelectrode recording. The patent provides a method for implanting the wires into the brain tissue of the patient, in which the wires include radial holes on the distal end of the wires. Segmented electrode set. The method includes performing multiple microelectrode recordings through multiple separate recording tracks in brain tissue; generating a three-dimensional map of the brain structure based on the microelectrode recordings; positioning a diagram of radially segmented electrodes on the map of the brain structure to generate leads Graphical depiction of desired depth and desired radial orientation in brain tissue; and implantation of leads into brain tissue according to desired depth and desired radial orientation middle. The device used to determine the radial orientation of the wire includes a radial directional ruler and an indicator indicating which electrode is in contact with the ruler. In order to position the electrode, the patent still uses an additional radial directional ruler and electrode, Therefore, the position of the electrode can be deduced, which has certain limitations.
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。Chinese patent publication number CN112292176A, which discloses an implantable medical lead indicator, provides an electrode at a distal portion of the lead, the electrode being configured to monitor a target site or provide therapy to the target site. The lead may include a visible indicator visible to the naked eye of a clinician at a middle portion of the lead, the visible indicator being configured to indicate when the electrode of the lead is properly longitudinal and Radially aligned to monitor or treat the target site. The clinician may insert the lead into the patient by using an introducer sheath inserted into the patient to a predetermined depth and subsequently by directing the indicator into the introducer sheath. port to align the distal portion of the lead. This patent still has certain limitations by setting an additional indicator on the lead wire to determine the orientation of the electrode during use.
相关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。Related technologies usually identify the electrode position by setting additional marks on the stimulation electrode, and determine the position and direction of the electrode through the correspondence between the predefined mark direction and the electrode stimulation sheet. Usually, this method requires doctors to have strong logical judgment ability. , no mistakes are allowed in the process, the requirements for doctors’ experience are too high, and the limitations are large.
因此,现有的刺激电极仍需要改进。Therefore, existing stimulation electrodes still need improvement.
发明内容Contents of the invention
本申请提供了解决上述问题的一种柔性导电软板、分片式刺激电极和刺激系统。This application provides a flexible conductive soft plate, a segmented stimulation electrode and a stimulation system that solve the above problems.
本申请的目的采用以下技术方案实现:The purpose of this application is achieved using the following technical solutions:
一种柔性导电软板,所述柔性导电软板具有刺激段并沿第一方向延伸,第一方向和第二方向交叉,所述柔性导电软板的刺激段的外表面上设置有用于施加电刺激的多个电极片,每个所述电极片上分别设置有用于连接电极片引线的连接点,所述电极片引线埋设于所述柔性导电软板内;A flexible conductive soft plate. The flexible conductive soft plate has a stimulation section and extends along a first direction. The first direction and the second direction intersect. The outer surface of the stimulation section of the flexible conductive soft plate is provided with a stimulating section for applying electricity. A plurality of electrode sheets for stimulation, each electrode sheet is provided with a connection point for connecting the lead of the electrode sheet, and the lead of the electrode sheet is embedded in the flexible conductive soft plate;
所述多个电极片划分为一个或多个电极片组,每个电极片组包括沿第二方向排列的多个电极片,一个或多个所述电极片组中设置有一个或多个特征电极片,所述特征电极片具有区分标记,所述特征电极片用于在成像时将一个电极片组的多个电极片区分开。 The plurality of electrode sheets are divided into one or more electrode sheet groups. Each electrode sheet group includes a plurality of electrode sheets arranged along the second direction. One or more of the electrode sheet groups are provided with one or more features. Electrode sheets, the characteristic electrode sheets have distinguishing marks, and the characteristic electrode sheets are used to distinguish multiple electrode sheets of an electrode sheet group during imaging.
在一些可能的方式中,所述特征电极片的区分标记选自以下任意一种或组合:In some possible ways, the distinguishing mark of the characteristic electrode sheet is selected from any one or combination of the following:
电极片的形状;The shape of the electrode pad;
电极片的连接点相对于该电极片的侧边位置;The connection point of the electrode piece is positioned relative to the side of the electrode piece;
电极片的连接点形状;The shape of the connection points of the electrode pads;
连接点组合的形状,所述连接点组合包括位于所述电极片上的至少两个连接点。The shape of a connection point combination, the connection point combination includes at least two connection points located on the electrode sheet.
在一些可能的方式中,所述特征电极片的区分标记为电极片的形状时,所述特征电极片上形成有指向性形状,所述特征电极片的指向性形状用于将多个电极片区分开。In some possible ways, when the distinguishing mark of the characteristic electrode sheet is the shape of the electrode sheet, a directional shape is formed on the characteristic electrode sheet, and the directional shape of the characteristic electrode sheet is used to distinguish multiple electrode sheets. .
在一些可能的方式中,所述特征电极片的指向性形状位于所述特征电极片的一侧边缘或相对两侧的边缘;In some possible ways, the directional shape of the characteristic electrode sheet is located on one edge of one side or edges of opposite sides of the characteristic electrode sheet;
所述特征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,所述特征电极片的指向性形状与特征电极片其余部分圆滑连接,且每个电极片的外周边缘的形状是闭合的曲线。The directional shape of the characteristic electrode sheet is formed by a wave shape, a sinusoidal curve, a semicircle, a rounded rectangle or a rounded triangle. The directional shape of the characteristic electrode sheet is smoothly connected to the rest of the characteristic electrode sheet, and each The shape of the outer peripheral edge of the electrode sheet is a closed curve.
在一些可能的方式中,所述特征电极片的区分标记为电极片的形状时,所述多个电极片中每个电极片的形状均不相同,或者,所述一个电极片组中的每个电极片的形状均不相同。In some possible ways, when the distinguishing mark of the characteristic electrode sheet is the shape of the electrode sheet, the shape of each electrode sheet in the plurality of electrode sheets is different, or the shape of each electrode sheet in the one electrode sheet group is The shapes of the electrode pads are all different.
在一些可能的方式中,所述特征电极片的区分标记为电极片的连接点相对于该电极片的侧边位置时,每个所述电极片分别包括沿第一方向的上侧边和下侧边,以及沿第二方向的左侧边和右侧边,所述特征电极片的区分标记为电极片的连接点相对于该电极片的上侧边和下侧边的位置,或者,为电极片的连接点相对于该电极片的左侧边和右侧边的位置。In some possible ways, the distinguishing mark of the characteristic electrode sheet is the position of the connection point of the electrode sheet relative to the side of the electrode sheet. Each of the electrode sheets respectively includes an upper side and a lower side along the first direction. side, as well as the left side and right side along the second direction, and the distinguishing mark of the characteristic electrode sheet is the position of the connection point of the electrode sheet relative to the upper side and lower side of the electrode sheet, or, is The position of the connection point of the electrode sheet relative to the left and right sides of the electrode sheet.
在一些可能的方式中,一个或多个电极片组中沿第二方向的多个特征电极片的连接点与刺激段端面的距离逐渐增大或减小。In some possible ways, the distance between the connection points of the plurality of characteristic electrode sheets along the second direction in one or more electrode sheet groups and the end surface of the stimulation segment gradually increases or decreases.
在一些可能的方式中,所述特征电极片的区分标记为电极片的连接点形状或连接点组合的形状时,所述连接点组合的形状为电极片的连接点组合中连接点位置组成的形状。In some possible ways, when the distinguishing mark of the characteristic electrode sheet is the connection point shape of the electrode sheet or the shape of the connection point combination, the shape of the connection point combination is composed of the connection point positions in the connection point combination of the electrode sheet. shape.
在一些可能的方式中,所述连接点组合的连接点之间设置有连接线,所述连接点组合的形状具有用于将多个电极片区分开的指向性标记。In some possible ways, connection lines are provided between the connection points of the connection point combination, and the shape of the connection point combination has directional marks for distinguishing multiple electrode sheets.
在一些可能的方式中,所述连接点组合中的一个连接点与电极片引线连接, 所述连接点组合的其余连接点与电极片引线连接或不连接,且所述连接点组合的其余连接点中的一个或多个为金属片并设置在所述柔性导电软板背向电极片的一侧或埋设于所述柔性导电软板内,采用金属片的连接点的形状为金属片的形状,采用金属片的连接点的位置为金属片的位置。In some possible ways, one of the connection points in the connection point combination is connected to the electrode sheet lead, The remaining connection points of the connection point combination are connected or not connected to the electrode sheet leads, and one or more of the remaining connection points of the connection point combination are metal sheets and are arranged on the flexible conductive soft plate back to the electrode sheet. One side or embedded in the flexible conductive soft plate, the shape of the connection point of the metal sheet is the shape of the metal sheet, and the position of the connection point of the metal sheet is the position of the metal sheet.
在一些可能的方式中,所述连接点包括形成在所述柔性导电软板上的过孔以及位于过孔内的导电层,每个所述电极片通过过孔内的导电层与对应的电极片引线电连接。In some possible ways, the connection point includes a via hole formed on the flexible conductive board and a conductive layer located in the via hole. Each of the electrode sheets is connected to the corresponding electrode through the conductive layer in the via hole. The chip leads are electrically connected.
在一些可能的方式中,所述连接点的形状为所述过孔的径向截面形状,所述过孔的径向截面形状为圆角矩形、圆形、椭圆形、圆角三角形或圆角菱形。In some possible ways, the shape of the connection point is the radial cross-sectional shape of the via hole, and the radial cross-sectional shape of the via hole is a rounded rectangle, a circle, an ellipse, a rounded triangle or a rounded corner. diamond.
在一些可能的方式中,所述导电层形成在所述过孔的内壁上,形成导电层后的所述过孔为空心孔。In some possible ways, the conductive layer is formed on the inner wall of the via hole, and the via hole after the conductive layer is formed is a hollow hole.
在一些可能的方式中,所述过孔的内壁为圆滑内壁。In some possible ways, the inner wall of the via hole is a smooth inner wall.
在一些可能的方式中,所述多个电极片呈阵列间隔分布,且每个电极片的形状相同,每个电极片的外周边缘的形状是圆滑轮廓线的曲线,不同特征电极片的区分标记可以相同或不同。In some possible ways, the plurality of electrode sheets are distributed in an array at intervals, and the shape of each electrode sheet is the same. The shape of the peripheral edge of each electrode sheet is a curve of a smooth outline, and the distinguishing marks of electrode sheets with different characteristics are Can be the same or different.
在一些可能的方式中,所述分片式刺激电极包括2-10个电极片组,所述一个电极片组包括2-10个电极片,所述第一方向和第二方向垂直。In some possible ways, the segmented stimulation electrode includes 2-10 electrode sheet groups, the one electrode sheet group includes 2-10 electrode sheets, and the first direction and the second direction are perpendicular.
一种分片式刺激电极,包括内衬管和上述任意一项所述的柔性导电软板,所述内衬管具有用于柔性导电软板贴合的外侧壁,所述柔性导电软板的刺激段环绕包覆在所述内衬管的所述外侧壁上,所述刺激段的多个电极片排布在所述柔性导电软板的背向内衬管的一侧外侧壁上;A piece-type stimulation electrode, including an inner lining tube and a flexible conductive soft plate as described in any one of the above. The inner lining tube has an outer wall for the flexible conductive soft plate to fit. The flexible conductive soft plate has The stimulation section is wrapped around the outer wall of the lining tube, and the plurality of electrode sheets of the stimulation section are arranged on the outer side wall of the flexible conductive plate facing away from the lining tube;
所述多个电极片划分为沿所述内衬管轴向间隔排布的一个或多个周向电极组,每个周向电极组包括沿周向排列的多个电极片。。The plurality of electrode sheets are divided into one or more circumferential electrode groups arranged at intervals along the axial direction of the lining tube, and each circumferential electrode group includes a plurality of electrode sheets arranged in the circumferential direction. .
在一些可能的方式中,所述柔性导电软板还包括与刺激段相对的连接段和位于刺激段和连接段之间的中间段,所述柔性导电软板的刺激段和连接段分别被加工成圆筒状结构,所述柔性导电软板的中间段被加工成圆筒状结构、螺旋状结构或波浪形的柔性导电软板经卷圆后形成的结构。In some possible ways, the flexible conductive soft plate also includes a connecting section opposite to the stimulation section and an intermediate section located between the stimulation section and the connecting section. The stimulation section and the connecting section of the flexible conductive soft plate are processed separately. into a cylindrical structure, and the middle section of the flexible conductive soft plate is processed into a cylindrical structure, a spiral structure or a structure formed by rolling the wavy flexible conductive soft plate.
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。A stimulation system includes a stimulator, a wire and a stimulation electrode. The stimulator is connected to the stimulation electrode through a wire. The stimulation electrode is the above-mentioned segmented stimulation electrode.
与相关技术相比,本申请的有益效果至少包括: Compared with related technologies, the beneficial effects of this application at least include:
本申请实施例提供的柔性导电软板的刺激段沿第一方向延伸,刺激段的外表面上设置的用于施加刺激的电极片被划分成多个电极片组,每个电极片组包括沿第二方向排列的多个电极片,一个或多个电极片组中设置有特征电极片,特征电极片具有区分标记,所述特征电极片用于在成像时将一个电极片组的多个电极片区分开。与额外设置标记来识别电极方位的情况相比,本申请的特征电极片,用于施加电刺激的同时,其本身还作为成像时的区别特征将一个电极片组的多个电极片区分开来,便于识别电极方位,有利于降低工艺步骤和成本。The stimulation section of the flexible conductive soft plate provided by the embodiment of the present application extends along the first direction. The electrode sheets for applying stimulation provided on the outer surface of the stimulation section are divided into multiple electrode sheet groups. Each electrode sheet group includes a A plurality of electrode sheets arranged in the second direction, one or more electrode sheet groups are provided with characteristic electrode sheets, the characteristic electrode sheets have distinguishing marks, and the characteristic electrode sheets are used to distinguish the multiple electrodes of one electrode sheet group during imaging Separate areas. Compared with the situation where additional marks are set to identify the electrode orientation, the characteristic electrode sheet of the present application is used to apply electrical stimulation and also serves as a distinguishing feature during imaging to distinguish multiple electrode sheets of an electrode sheet group. It is easy to identify the electrode orientation and helps to reduce process steps and costs.
可选方案中,以电极片本身的形状、电极片上的连接点相对该电极片上的侧边位置、电极片的连接点的形状、电极片上的连接点的组合形状,其中的任意一种作为电极片的标记方式,并利用电极成型薄膜电路的工艺,无需额外在刺激电极上设置用于区分的标记,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,降低对操作人员的刺激电极识别能力要求。In the alternative, any one of the shape of the electrode sheet itself, the position of the connection points on the electrode sheet relative to the side of the electrode sheet, the shape of the connection points on the electrode sheet, and the combined shape of the connection points on the electrode sheet is used as the electrode. The marking method of the tablet and the use of the process of forming thin film circuits of electrodes eliminate the need to set additional marks for differentiation on the stimulation electrodes, making it convenient for the operator to quickly mark and identify the electrode position, and accurately place the stimulation point of the stimulation electrode at the designated position. , reducing the requirements for the operator's ability to identify stimulation electrodes.
附图说明Description of drawings
图1是本申请实施例的柔性导电软板靠近刺激段的部分结构示意图;Figure 1 is a partial structural schematic diagram of the flexible conductive soft plate close to the stimulation section according to the embodiment of the present application;
图2A是图1中A-A处的一种剖视图;Figure 2A is a cross-sectional view taken at A-A in Figure 1;
图2B是图1中A-A处的另一种剖视图;Figure 2B is another cross-sectional view at A-A in Figure 1;
图3是本申请第一实施例的一种柔性导电软板的局部示意图;Figure 3 is a partial schematic diagram of a flexible conductive board according to the first embodiment of the present application;
图4是本申请第一实施例的另一种柔性导电软板的局部示意图;Figure 4 is a partial schematic diagram of another flexible conductive board according to the first embodiment of the present application;
图5是本申请第一实施例的又一种柔性导电软板的局部示意图;Figure 5 is a partial schematic diagram of another flexible conductive board according to the first embodiment of the present application;
图6是本申请第一实施例的又一种柔性导电软板的局部示意图;Figure 6 is a partial schematic diagram of another flexible conductive board according to the first embodiment of the present application;
图7是本申请第二实施例的一种柔性导电软板的局部示意图;Figure 7 is a partial schematic diagram of a flexible conductive board according to the second embodiment of the present application;
图8是本申请第二实施例的再一种柔性导电软板的局部示意图;Figure 8 is a partial schematic diagram of yet another flexible conductive board according to the second embodiment of the present application;
图9是本申请第三实施例的一种柔性导电软板的局部示意图;Figure 9 is a partial schematic diagram of a flexible conductive board according to the third embodiment of the present application;
图10是本申请第三实施例的再一种柔性导电软板的局部示意图;Figure 10 is a partial schematic diagram of yet another flexible conductive board according to the third embodiment of the present application;
图11是本申请第三实施例的再一种柔性导电软板的局部示意图;Figure 11 is a partial schematic diagram of yet another flexible conductive board according to the third embodiment of the present application;
图12是本申请第三实施例的再一种柔性导电软板的局部示意图;Figure 12 is a partial schematic diagram of yet another flexible conductive board according to the third embodiment of the present application;
图13是本申请第三实施例的再一种柔性导电软板的局部示意图;Figure 13 is a partial schematic diagram of yet another flexible conductive board according to the third embodiment of the present application;
图14是本申请第四实施例的柔性导电软板制作方法的流程示意图;Figure 14 is a schematic flow chart of a method for manufacturing a flexible conductive board according to the fourth embodiment of the present application;
图15是本申请第五实施例的分片式刺激电极的刺激段的结构示意图。Figure 15 is a schematic structural diagram of the stimulation section of the segmented stimulation electrode according to the fifth embodiment of the present application.
图中:1、电极片引线;11、柔性基底;2、电极片;21、特征电极片;3、柔性 导电软板;4、过孔;41、导电层;5、连接线;6、第一绝缘层;7、第二绝缘层。In the picture: 1. Electrode sheet lead; 11. Flexible base; 2. Electrode sheet; 21. Characteristic electrode sheet; 3. Flexible Conductive soft board; 4. Via hole; 41. Conductive layer; 5. Connecting wire; 6. First insulating layer; 7. Second insulating layer.
具体实施方式Detailed ways
现在将参考附图更全面地描述示例实施方式。然而,示例实施方式能够以多种形式实施,且不应被理解为限于在此阐述的实施方式;相反,提供这些实施方式使得本申请更全面和完整,并将示例实施方式的构思全面地传达给本领域的技术人员。在图中相同的附图标记表示相同或类似的结构,因而将省略对它们的重复描述。Example embodiments will now be described more fully with reference to the accompanying drawings. Example embodiments may, however, be embodied in various forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the concepts of the example embodiments. To those skilled in the art. The same reference numerals in the drawings represent the same or similar structures, and thus their repeated description will be omitted.
本申请中所描述的表达位置与方向的词,均是以附图为例进行的说明,但根据需要也可以做出改变,所做改变均包含在本申请保护范围内。The words expressing position and direction described in this application are all explained by taking the accompanying drawings as examples, but they can be changed as needed, and all changes are included in the protection scope of this application.
下面,首先对本申请实施例的其中一个应用领域(即植入式神经刺激器)进行简单说明。Below, one of the application fields of the embodiments of the present application (namely, the implantable neurostimulator) will be briefly described.
植入式神经刺激系统(一种神经刺激系统)主要包括植入患者体内的刺激器(即植入式神经刺激器,一种神经刺激器)以及设置于患者体外的程控器。相关的神经调控技术主要是通过立体定向手术在生物体的组织的特定部位(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 Delivery 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 Stimu lation,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 Stimulation,简称VNS)等。The implantable neurostimulation system (a type of neurostimulation system) mainly includes a stimulator implanted in the patient's body (i.e., an implantable neurostimulator, a type of neurostimulator) and a programmable controller installed outside the patient's body. Relevant neuromodulation technology mainly involves implanting electrodes in specific parts of the body's tissues (i.e., target points) through stereotaxic surgery, and a stimulator implanted in the patient's body sends electrical pulses to the target point through the electrodes to regulate the corresponding neural structures. And the electrical activity and functions of the network, thereby improving symptoms and relieving pain. Among them, the stimulator can be an implantable nerve electrical stimulation device, an implantable cardiac electrical stimulation system (also known as a pacemaker), an implantable drug delivery system (IDDS for short) and a lead transfer device. any of the connecting devices. Implantable neuroelectric stimulation devices include, for example, Deep Brain Stimulation (DBS), Cortical Nerve Stimulation (CNS), and Spinal Cord. Stimulation, referred to as SCS), implanted sacral nerve electrical stimulation system (Sacral Nerve Stimulation, referred to as SNS), implanted vagus nerve electrical stimulation system (Vagus Nerve Stimulation, referred to as VNS), etc.
刺激器可以包括IPG和电极模块。电极模块可以包括电极导线,还可以包括延伸导线。IPG(implantable pulse generator,植入式脉冲发生器)设置于患者体内,IPG可以包括控制模块,接收程控器发送的程控指令。IPG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,通过植入的电极模块,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。电极导线通过多个电极触点,向体内组织的特定区域递送电刺激。可以理解为,刺激器设 置有单侧或双侧的一路或多路电极导线,电极导线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)排列在电极导线的周向上。电极触点可以包括刺激触点和/或采集触点。电极触点例如可以采用片状、环状、点状等形状。The stimulator may include an IPG and electrode module. The electrode module may include electrode leads and may also include extension leads. IPG (implantable pulse generator, implantable pulse generator) is installed in the patient's body. The IPG may include a control module to receive program control instructions sent by the program controller. IPG relies on sealed batteries and circuits to provide controllable electrical stimulation energy to tissues in the body. Through implanted electrode modules, it delivers one or two channels of controllable specific electrical stimulation to specific areas of tissue in the body. The extension lead is used in conjunction with the IPG as a transmission medium for electrical stimulation signals to transmit the electrical stimulation signals generated by the IPG to the electrode leads. Electrode leads deliver electrical stimulation to specific areas of tissue in the body through multiple electrode contacts. It can be understood that the stimulator is designed to One or more electrode wires are provided on one side or both sides, and multiple electrode contacts are provided on the electrode wires. The electrode contacts can be arranged evenly or non-uniformly in the circumferential direction of the electrode wires. As an example, the electrode contacts may be arranged in an array of 4 rows and 3 columns (12 electrode contacts in total) in the circumferential direction of the electrode lead. Electrode contacts may include stimulation contacts and/or acquisition contacts. The electrode contacts may be in the shape of, for example, a sheet, a ring, a dot, or the like.
在一些可能的方式中,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。In some possible ways, the stimulated internal tissue may be the patient's brain tissue, and the stimulated site may be a specific part of the brain tissue. When patients have different types of diseases, the stimulated parts are generally different, the number of stimulation contacts used (single source or multiple sources), one or more channels (single channel or multi-channel) specific electrical stimulation signals The application and stimulation parameter data are also different. The embodiments of this application do not limit the applicable disease types, which may be the disease types applicable to deep brain stimulation (DBS), spinal cord stimulation (SCS), pelvic stimulation, gastric stimulation, peripheral nerve stimulation, and functional electrical stimulation. Among them, the types of diseases that DBS can be used to treat or manage include, but are not limited to: spastic diseases (eg, epilepsy), pain, migraine, mental illness (eg, major depressive disorder (MDD)), bipolar disorder, anxiety disorder, Post-traumatic stress disorder, mild depression, obsessive-compulsive disorder (OCD), behavioral disorders, mood disorders, memory disorders, mental status disorders, mobility disorders (e.g., essential tremor or Parkinson's disease), Huntington's disease, Alzheimer's disease Alzheimer's disease, drug addiction, autism or other neurological or psychiatric diseases and impairments.
本申请实施例中,程控器和刺激器建立程控连接时,可以利用程控器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。In the embodiment of the present application, when the program controller and the stimulator establish a program-controlled connection, the program controller 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 bioelectrical activity is used to collect electrophysiological signals, and the stimulation parameters of the electrical stimulation signal of the stimulator can be continuously adjusted through the collected electrophysiological signals.
刺激参数可以包括: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)中的一种或多种。在一些可能的方式中,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。Stimulation parameters can include: frequency (for example, the number of electrical stimulation pulse signals per unit time 1 s, the unit is Hz), pulse width (the duration of each pulse, the unit is μs), amplitude (generally expressed in voltage, that is, The intensity of each pulse, in 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 cyclic stimulation mode), physician control upper limit One or more of the upper and lower limits (the range that the doctor can adjust) and the upper and lower limits of the patient's control (the range that the patient can adjust independently). In some possible ways, various stimulation parameters of the stimulator can be adjusted in current mode or voltage mode.
参照图1,本申请提供一种柔性导电软板3,柔性导电软板3具有刺激段并沿第一方向延伸,柔性导电软板3的刺激段的外表面上设置有用于施加电刺激的 多个电极片2,每个电极片2上分别设置有用于连接电极片引线1的连接点,电极片引线1埋设于柔性导电软板3内。Referring to Figure 1 , the present application provides a flexible conductive soft plate 3. The flexible conductive soft plate 3 has a stimulation section and extends along a first direction. The outer surface of the stimulation section of the flexible conductive soft plate 3 is provided with a device for applying electrical stimulation. There are a plurality of electrode sheets 2 , each electrode sheet 2 is provided with a connection point for connecting the electrode sheet lead 1 , and the electrode sheet lead 1 is embedded in the flexible conductive soft plate 3 .
参照图1和3,第一方向例如是图中所示X方向,第二方向例如是图中所示Y方向,第一方向和第二方向交叉,第一方向和第二方向优选垂直,图4和图13中,柔性导电软板3具有与图3中柔性导电软板3相同或相似的延伸方向。Referring to Figures 1 and 3, the first direction is, for example, the X direction shown in the figure, the second direction is, for example, the Y direction shown in the figure, the first direction and the second direction intersect, and the first direction and the second direction are preferably perpendicular, as shown in Fig. 4 and FIG. 13 , the flexible conductive board 3 has the same or similar extension direction as the flexible conductive board 3 in FIG. 3 .
多个电极片2划分为一个或多个电极片组,每个电极片组包括沿第二方向排列的多个电极片2,换言之,每个电极片组的多个电极片2沿同一方向排列,柔性导电软板3卷圆为圆筒状时,每个电极片组的多个电极片2穿过同一径向平面,并形成一个周向电极组,每个周向电极组包括沿周向排列的多个电极片2。一个或多个电极片组中设置有一个或多个特征电极片21,特征电极片21具有区分标记,特征电极片21用于在成像时将一个电极片组的多个电极片2区分开,通过上下对照,可以将每个电极片组的多个电极片2区分开,成像例如是在将柔性导电软板3制作成分片式刺激电极后,并将分片式刺激电极植入患者的脑部等组织内时进行成像。与现有的在刺激电极上额外设置标记来识别电极方位相比,本申请利用特征电极片21作为标记进行电极片2的区分,无需额外设置标记,与额外设置标记来识别电极方位的情况相比,本申请的特征电极片21用于施加电刺激的同时,其本身还作为成像时的区别特征将一个电极片组的多个电极片2区分开来,便于识别电极方位,有利于降低工艺步骤和成本。将上述柔性导电软板3卷圆为圆筒状并制成分片式刺激电极,具有特征电极片21的柔性导电软板3组成的分片式刺激电极在植入在患者的脑部等组织内时,操作人员通过识别特征电极片21的位置,从而确定一个电极片组的所有电极片2在患者脑部等组织内的位置,方便操作人员快速识别出电极方位,并准确的将刺激电极的刺激点作用在指定位置,降低对操作人员的刺激电极识别能力要求。The plurality of electrode sheets 2 are divided into one or more electrode sheet groups. Each electrode sheet group includes a plurality of electrode sheets 2 arranged along the second direction. In other words, the multiple electrode sheets 2 of each electrode sheet group are arranged along the same direction. , when the flexible conductive soft plate 3 is rolled into a cylindrical shape, the multiple electrode sheets 2 of each electrode sheet group pass through the same radial plane and form a circumferential electrode group. Each circumferential electrode group includes A plurality of electrode sheets 2 are arranged. One or more characteristic electrode sheets 21 are provided in one or more electrode sheet groups. The characteristic electrode sheets 21 have distinguishing marks. The characteristic electrode sheets 21 are used to distinguish multiple electrode sheets 2 of an electrode sheet group during imaging. Through upper and lower comparison, the multiple electrode pads 2 of each electrode pad group can be distinguished. For example, imaging is performed after the flexible conductive soft plate 3 is made into a piece-type stimulation electrode, and the piece-type stimulation electrode is implanted into the patient's brain. Imaging is performed inside tissues such as the body. Compared with the existing method of setting additional marks on the stimulation electrode to identify the electrode orientation, this application uses the characteristic electrode piece 21 as a mark to distinguish the electrode pieces 2 without setting additional marks. Compared with the situation where additional marks are set to identify the electrode orientation, Compared with the present application, the characteristic electrode sheet 21 is used to apply electrical stimulation. It also serves as a distinguishing feature during imaging to distinguish multiple electrode sheets 2 of an electrode sheet group, which facilitates the identification of electrode orientations and helps reduce process costs. steps and costs. The above-mentioned flexible conductive soft plate 3 is rolled into a cylindrical shape and made into a segmented stimulation electrode. The segmented stimulation electrode composed of the flexible conductive soft plate 3 with a characteristic electrode piece 21 is implanted in the patient's brain and other tissues. During the operation, the operator identifies the position of the characteristic electrode patch 21 to determine the position of all the electrode patches 2 of an electrode patch group in the patient's brain and other tissues, which facilitates the operator to quickly identify the electrode position and accurately place the stimulation electrode. The stimulation point acts at a designated location, reducing the requirement for the operator's ability to identify stimulation electrodes.
将电极片引线1埋设于柔性导电软板3内并采用连接点电连接电极片2,简化了电极片2和电极片引线1的连接方式,充分利用柔性导电软板3的自身结构,利用柔性导电软板3制作刺激电极时,线路排布方式较为丰富和灵活,适用范围广。The electrode sheet lead 1 is buried in the flexible conductive soft board 3 and is electrically connected to the electrode sheet 2 using connection points, which simplifies the connection method between the electrode sheet 2 and the electrode sheet lead 1, fully utilizes the structure of the flexible conductive soft board 3, and utilizes the flexibility When the conductive soft plate 3 is used to make stimulation electrodes, the circuit arrangement is relatively rich and flexible, and has a wide range of applications.
在一种实施例中,连接点包括形成在柔性导电软板3上的过孔4以及位于过孔4内的导电层41,每个电极片2通过过孔4内的导电层41与对应的电极片引线1电连接。在工作时,柔性导电软板3上的刺激信号经过电极片引线1传递至 过孔4,并通过过孔4内的导电层41电连接最终传递给电极片2并释放电刺激。In one embodiment, the connection point includes a via hole 4 formed on the flexible conductive soft board 3 and a conductive layer 41 located in the via hole 4. Each electrode piece 2 is connected to the corresponding electrode through the conductive layer 41 in the via hole 4. The electrode sheet lead 1 is electrically connected. When working, the stimulation signal on the flexible conductive board 3 is transmitted to the via hole 4, and is electrically connected through the conductive layer 41 in the via hole 4, and is finally transmitted to the electrode sheet 2 and releases electrical stimulation.
在一种实施例中,参照图2A,柔性导电软板3包括:柔性基底11和位于柔性基底11上的第一绝缘层6,电极片引线1设置在所述柔性基底11上并位于柔性基底11和第一绝缘层6之间,过孔4形成在第一绝缘层6上,过孔4内的导电层41与对应的电极片引线1电连接。将柔性导电软板3制作成分片式刺激电极时,由于无需在分片式刺激电极的微细管径内走线,分片式刺激电极上可以设置更多的电极片引线1和电极片2,线路排布方式更加丰富和灵活,适用范围广。In one embodiment, referring to FIG. 2A , the flexible conductive board 3 includes: a flexible substrate 11 and a first insulating layer 6 located on the flexible substrate 11 , and the electrode lead 1 is provided on the flexible substrate 11 and located on the flexible substrate. Between 11 and the first insulating layer 6, a via hole 4 is formed on the first insulating layer 6, and the conductive layer 41 in the via hole 4 is electrically connected to the corresponding electrode sheet lead 1. When the flexible conductive soft plate 3 is made into a piece-type stimulation electrode, since there is no need to route wires within the micro-diameter of the piece-type stimulation electrode, more electrode lead wires 1 and electrode pieces 2 can be set on the piece-type stimulation electrode. The line arrangement method is more abundant and flexible, and has a wide range of applications.
在另一种实施例中,参照图2B,柔性导电软板3包括:柔性基底11、位于柔性基底11上的第一绝缘层6和第二绝缘层7,柔性基底11具有相对的上表面和下表面,第一绝缘层6设置在柔性基底11的上表面,第二绝缘层7设置在柔性基底11的下表面。部分电极片引线1设置在所述柔性基底11的上表面并位于柔性基底11和第一绝缘层6之间,部分过孔4形成在第一绝缘层6上,该过孔4内的导电层41与柔性基底11的上表面对应的电极片引线1电连接;部分电极片引线1设置在所述柔性基底11的下表面并位于柔性基底11和第二绝缘层7之间,部分过孔4形成在第一绝缘层6和柔性基底11上,该过孔4内的导电层41与柔性基底11的下表面对应的电极片引线1电连接。由此可以在柔性基底11的宽度不变情况下,增加电极片引线1的数量。柔性基底11可以选用聚酰亚胺、聚对苯二甲酸乙二醇酯等高分子材料,第一绝缘层6和第二绝缘层7的材料可以选用PDMS(聚二甲基硅氧烷)。In another embodiment, referring to Figure 2B, the flexible conductive board 3 includes: a flexible substrate 11, a first insulating layer 6 and a second insulating layer 7 located on the flexible substrate 11. The flexible substrate 11 has opposite upper surfaces and On the lower surface, the first insulating layer 6 is provided on the upper surface of the flexible substrate 11 , and the second insulating layer 7 is provided on the lower surface of the flexible substrate 11 . Part of the electrode sheet leads 1 is provided on the upper surface of the flexible substrate 11 and is located between the flexible substrate 11 and the first insulating layer 6 . Part of the via hole 4 is formed on the first insulating layer 6 . The conductive layer in the via hole 4 41 is electrically connected to the electrode sheet lead 1 corresponding to the upper surface of the flexible substrate 11; part of the electrode sheet lead 1 is provided on the lower surface of the flexible substrate 11 and is located between the flexible substrate 11 and the second insulating layer 7, and part of the via hole 4 Formed on the first insulating layer 6 and the flexible substrate 11 , the conductive layer 41 in the via hole 4 is electrically connected to the corresponding electrode sheet lead 1 on the lower surface of the flexible substrate 11 . Therefore, the number of electrode sheet leads 1 can be increased while the width of the flexible substrate 11 remains unchanged. The flexible substrate 11 can be made of polymer materials such as polyimide and polyethylene terephthalate, and the material of the first insulating layer 6 and the second insulating layer 7 can be made of PDMS (polydimethylsiloxane).
参照图1、图2A和2B,连接点由过孔4和导电层41组成,用于连接电极片引线1和电极片2。下文的连接点和此处的连接点结构可以相同,不再赘述。Referring to Figures 1, 2A and 2B, the connection point consists of a via hole 4 and a conductive layer 41 for connecting the electrode pad lead 1 and the electrode pad 2. The structures of the connection points below and the connection points here may be the same and will not be described again.
为了方便理解和描述,将柔性导电软板3的第二方向上的多个电极片2划分为一个电极片组,以下简称电极片组,柔性导电软板3上,沿着第一方向延伸排列的多个电极片2为一列电极片2,一个或多个电极片组中设置有一个或多个特征电极片21,所述特征电极片21用于将一个电极片组的多个电极片2区分开,所述特征电极片21的区分标记选自以下任意一种或组合:电极片2的形状、电极片2的连接点相对于该电极片2的侧边位置、电极片2的连接点形状、连接点组合的形状,所述连接点组合包括位于所述电极片2上的至少两个连接点。柔性导电软板3上分布有多个电极片组,任意一个电极片组中的特征电极片21都能作为区分标记,用来区分一个电极片组所有的电极片2,通过采用以上区分标记 对特征电极片21进行标记,可以根据情况满足多种标记需要,适用范围广泛。In order to facilitate understanding and description, the plurality of electrode sheets 2 in the second direction of the flexible conductive soft plate 3 are divided into an electrode sheet group, hereinafter referred to as the electrode sheet group. The flexible conductive soft plate 3 is arranged extending along the first direction. The plurality of electrode sheets 2 is a column of electrode sheets 2, and one or more characteristic electrode sheets 21 are provided in one or more electrode sheet groups. The characteristic electrode sheets 21 are used to combine the multiple electrode sheets 2 of an electrode sheet group. To distinguish, the distinguishing mark of the characteristic electrode sheet 21 is selected from any one or a combination of the following: the shape of the electrode sheet 2, the side position of the connection point of the electrode sheet 2 relative to the electrode sheet 2, the connection point of the electrode sheet 2 The shape, the shape of the connection point combination, the connection point combination includes at least two connection points located on the electrode sheet 2 . There are multiple electrode sheet groups distributed on the flexible conductive soft plate 3. The characteristic electrode sheet 21 in any electrode sheet group can be used as a distinguishing mark to distinguish all the electrode sheets 2 of an electrode sheet group. By using the above distinguishing mark Marking the characteristic electrode sheet 21 can meet various marking needs according to the situation, and has a wide range of applications.
在柔性导电软板3的刺激段上,所述多个电极片2呈阵列间隔分布,且每个电极片2的形状相同或不同,每个电极片2的外周边缘的形状是圆滑轮廓线,不同特征电极片21的区分标记可以相同或不同。当电极片2的外周边缘是圆滑轮廓线时,当刺激电极在植入大脑等组织中时,电极片2施加刺激时,圆滑的曲线可以保证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。On the stimulation section of the flexible conductive plate 3, the plurality of electrode sheets 2 are distributed in an array at intervals, and the shape of each electrode sheet 2 is the same or different. The shape of the peripheral edge of each electrode sheet 2 is a smooth contour line. The distinguishing marks of different characteristic electrode sheets 21 may be the same or different. When the outer peripheral edge of the electrode sheet 2 is a smooth contour line, when the stimulation electrode is implanted in the brain and other tissues, and the electrode sheet 2 applies stimulation, the smooth curve can ensure that there will be no stimulation signal concentration or spikes, and the stimulation can Reduce damage to tissue.
所述柔性导电软板3包括2-10个电极片组,例如包括3个、4个、5个或6个电极片组,所述一个电极片组包括2-10个电极片2,例如包括3个、4个、5个或6个电极片2。刺激电极展开后,一个电极片组的数量保持在2个至10个,能够满足大多数神经电刺激的刺激需要,一个电极片组的数量越多,能够施加的刺激越精确,例如当一个电极片组的数量达到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。The flexible conductive soft plate 3 includes 2-10 electrode sheet groups, such as 3, 4, 5 or 6 electrode sheet groups, and one electrode sheet group includes 2-10 electrode sheets 2, such as 3, 4, 5 or 6 electrode pads2. After the stimulating electrodes are deployed, the number of electrode pads in an electrode set is maintained at 2 to 10, which can meet the stimulation needs of most nerve electrical stimulation. The larger the number of electrode pads in an electrode pad group, the more precise the stimulation that can be applied. For example, when an electrode When the number of pad groups reaches 10, multiple electrode pads 2 on the same stimulation electrode can accurately stimulate the corresponding points to be stimulated respectively, preventing one electrode pad 2 from stimulating multiple points to be stimulated, because the points to be stimulated need to be stimulated. Different strengths lead to poorer therapeutic effects.
第一实施例First embodiment
本实施例的柔性导电软板3中,例如参照图3,在同一个电极片组中,有两个电极片2的形状与其余电极片2的形状不同,分别是椭圆形和圆角三角形的电极片2,或参照图4,分别位于不同组中的两个电极片2的形状不同,将上述柔性导电软板3卷圆为圆筒状并制成分片式刺激电极,在植入该分片式刺激电极时,在成像技术下,操作人员通过观察寻找此处的两个带有标记的电极片2,即可确定一个电极片组中所有电极片2的方位,再通过上下对照,可以将每个电极片组的多个电极片2区分开,方便操作人员识别,从而准确的将分片式刺激电极的刺激点作用在指定位置。In the flexible conductive board 3 of this embodiment, for example, referring to Figure 3, in the same electrode sheet group, there are two electrode sheets 2 with different shapes from the other electrode sheets 2, which are elliptical and rounded triangle respectively. The electrode pads 2, or refer to Figure 4, the two electrode pads 2 located in different groups have different shapes. The above-mentioned flexible conductive soft plate 3 is rolled into a cylindrical shape and made into a segmented stimulation electrode. After implanting the electrode pads 2, When stimulating electrodes in slices, under imaging technology, the operator can determine the orientation of all electrode patches 2 in an electrode patch group by looking for the two marked electrode patches 2 here, and then compare them up and down. The multiple electrode pads 2 of each electrode pad group can be distinguished to facilitate identification by the operator, so that the stimulation point of the segmented stimulation electrode can be accurately applied to a designated position.
当特征电极片21上的区分标记为电极片2的形状时,所述特征电极片21上优选形成有指向性形状,所述特征电极片21的指向性形状用于将多个电极片2区分开。When the distinguishing mark on the characteristic electrode sheet 21 is the shape of the electrode sheet 2, a directional shape is preferably formed on the characteristic electrode sheet 21, and the directional shape of the characteristic electrode sheet 21 is used to distinguish multiple electrode sheets 2. open.
指向性形状可以是位于所述特征电极片21的一侧边缘或相对两侧的边缘。指向性形状简单来讲,就是操作人员观察到该类形状时,能够清晰准确的辨认出电极片2的方位,并确定一个电极片组中多个电极片2的位置。所述特征电极片21上的指向性形状,例如是由波浪形、正弦曲线、半圆形、圆角矩形或圆角三角形形成,所述特征电极片21的指向性形状与特征电极片21其余部分圆滑连接, 且每个电极片2的外周边缘的形状是闭合的曲线。当电极片2的外周边缘和指向性形状是圆滑的曲线时,当刺激电极在植入脑等组织中时,电极片2施加刺激时,圆滑的曲线可以保证不会出现刺激信号集中和尖峰,能够减少对组织的损伤。The directional shape may be located on one edge or edges on opposite sides of the characteristic electrode sheet 21 . Simply speaking, the directional shape means that when the operator observes this type of shape, he can clearly and accurately identify the orientation of the electrode sheet 2 and determine the positions of multiple electrode sheets 2 in an electrode sheet group. The directional shape on the characteristic electrode sheet 21 is, for example, formed by a wave shape, a sinusoidal curve, a semicircle, a rounded rectangle or a rounded triangle. The directional shape of the characteristic electrode sheet 21 is consistent with the rest of the characteristic electrode sheet 21 . Partially smooth connection, And the shape of the outer peripheral edge of each electrode sheet 2 is a closed curve. When the peripheral edge and directivity shape of the electrode sheet 2 are rounded curves, when the stimulation electrode is implanted in tissues such as the brain and the electrode sheet 2 applies stimulation, the smooth curve can ensure that there will be no concentration or spikes of the stimulation signal. Can reduce damage to tissue.
参照图5和图6为例,电极片2和指向性形状在加工时,通过一体成型的技术制成,无需额外设置其他材料作为电极片2的标记。而在使用此类指向性形状时,在成像技术下,操作人员识别电极片2的边缘形状,在电极片2的边缘形状的标记下,能够清楚的识别一个电极片组的所有电极片2的方位,方便操作人员将刺激电极准确的放置在待刺激点处。Referring to FIGS. 5 and 6 as an example, the electrode sheet 2 and the directional shape are made by one-piece molding technology during processing, and there is no need to additionally provide other materials as marks for the electrode sheet 2 . When using such a directional shape, under imaging technology, the operator can identify the edge shape of the electrode sheet 2. Under the marking of the edge shape of the electrode sheet 2, the operator can clearly identify all the electrode sheets 2 of an electrode sheet group. The orientation makes it convenient for the operator to accurately place the stimulation electrode at the point to be stimulated.
当所述特征电极片21的区分标记为电极片2的形状时,所述多个电极片2中每个电极片2的形状均不相同,或者,所述一个电极片组中的每个电极片2的形状均不相同。同一个分片式刺激电极上,所有的电极片2的形状可以完全不同,这样不用根据一个电极片组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,也可以是一个电极片组中的每个电极片2的形状均不相同,观察时只需要确定唯一一组形状不同的电极片2,就可以方便地区分开一个电极片组中的每个电极片2,再通过上下对照,根据区分开的一个电极片组确定其他组的各个电极片2的位置。When the distinguishing mark of the characteristic electrode sheet 21 is the shape of the electrode sheet 2, the shape of each electrode sheet 2 in the plurality of electrode sheets 2 is different, or each electrode in the one electrode sheet group The shapes of pieces 2 are all different. On the same segmented stimulation electrode, the shapes of all the electrode pads 2 can be completely different. In this way, there is no need to distinguish the positions of each electrode pad 2 of other groups based on one electrode pad group. Under imaging technology, the mark identifies the electrode orientation more easily. Conveniently, alternatively, each electrode piece 2 in an electrode piece group may have a different shape. When observing, you only need to identify the only group of electrode pieces 2 with different shapes, and you can easily distinguish the electrode pieces in an electrode piece group. of each electrode sheet 2, and then through upper and lower comparison, determine the position of each electrode sheet 2 of the other groups according to the distinguished electrode sheet group.
第二实施例Second embodiment
本实施例的柔性导电软板3中,所述特征电极片21的区分标记为电极片2的连接点相对于该电极片2的侧边位置时,每个所述电极片2分别包括沿第一方向的上侧边和下侧边,以及沿第二方向的左侧边和右侧边,所述特征电极片21的区分标记为电极片2的连接点相对于该电极片2的上侧边和下侧边的位置,或者,为电极片2的连接点相对于该电极片2的左侧边和右侧边的位置。将上述柔性导电软板3卷圆为圆筒状并制成分片式刺激电极,在植入该分片式刺激电极时,在成像设备下,操作人员通过识别分片式刺激电极上的特征电极片21上的连接点位置,作为区分标记,即可确定分片式刺激电极的方位,方便操作人员,准确地将分片式刺激电极的刺激点作用在指定位置。In the flexible conductive board 3 of this embodiment, the distinguishing mark of the characteristic electrode sheet 21 is the position of the connection point of the electrode sheet 2 relative to the side of the electrode sheet 2. Each of the electrode sheets 2 includes a line along the first The upper side and lower side in one direction, and the left side and right side along the second direction, the distinguishing marks of the characteristic electrode sheet 21 are the connection points of the electrode sheet 2 relative to the upper side of the electrode sheet 2 The position of the side and the lower side, or the position of the connection point of the electrode sheet 2 relative to the left side and right side of the electrode sheet 2 . The above-mentioned flexible conductive soft plate 3 is rolled into a cylindrical shape and made into a segmented stimulation electrode. When implanting the segmented stimulation electrode, under the imaging equipment, the operator identifies the features on the segmented stimulation electrode. The position of the connection point on the electrode sheet 21 serves as a distinguishing mark to determine the orientation of the segmented stimulation electrode, making it convenient for the operator to accurately act on the stimulation point of the segmented stimulation electrode at a designated position.
如图7所示,分片式刺激电极的展开图中,从上到下中的第一组的第一个电极片的连接点位于该电极片的右侧上方,第二个电极片组中的最后第一个电极片的连接点位于该电极片的左下侧,在一种实施例中,当将带有此种电极片2的分片式刺激电极植入在患者的脑部等组织中,打开X光机,连接点将会以白色亮 点的形式出现,而电极片2将会呈灰色片状图形,白色的亮点在灰色图形中的相对位置,就是电极片2的标记,医护人员通过识别白色亮点位置不同的电极片2,确定一个电极片组中所有电极片2的位置,方便将准确的将分片式刺激电极的刺激点作用在指定位置,降低医护人员的操作要求和难度。As shown in Figure 7, in the expanded view of the segmented stimulation electrode, the connection point of the first electrode sheet of the first group from top to bottom is located above the right side of the electrode sheet, and the connection point of the second electrode sheet group is The connection point of the last first electrode sheet is located on the lower left side of the electrode sheet. In one embodiment, when the segmented stimulation electrode with such electrode sheet 2 is implanted in the patient's brain and other tissues , turn on the X-ray machine, the connection point will light up in white Appear in the form of dots, and the electrode pad 2 will appear in a gray sheet shape. The relative position of the white bright spot in the gray graphic is the mark of the electrode pad 2. The medical staff determines an electrode pad 2 by identifying the electrode pad 2 with different white bright spot positions. The positions of all electrode pads 2 in the electrode pad set facilitate the accurate stimulation points of the segmented stimulation electrodes at designated locations, reducing the operational requirements and difficulty of medical staff.
优选的,一个或多个电极片组中沿第二方向的多个特征电极片21的连接点与刺激段端面的距离逐渐增大或减小,所述连接点的位置即为所述过孔4的位置,刺激段端面是指刺激段背向连接段的端面。例如参照图8,当一个电极片组上的多个电极片2的连接点的位置沿第二方向呈阶梯状分布时,操作人员在成像设备下,旋转分片式刺激电极,只需观察该一个电极片组上的连接点位置就能将该电极片组上的多个电极片2区分开,进而区分其他电极片组上的多个电极片2,该同一个电极片组上的连接点在电极片2上的位置变化有规律,且识别度较高,方便操作人员识别出具有标记的电极片2,从而确定电极的方位。Preferably, the distance between the connection points of the plurality of characteristic electrode sheets 21 along the second direction in one or more electrode sheet groups and the end surface of the stimulation section gradually increases or decreases, and the position of the connection point is the through hole. At the position of 4, the end face of the stimulation section refers to the end face of the stimulation section facing away from the connecting section. For example, referring to Figure 8, when the positions of the connection points of multiple electrode sheets 2 on an electrode sheet group are distributed in a ladder-like manner along the second direction, the operator rotates the segmented stimulation electrode under the imaging device and only needs to observe the The position of the connection point on an electrode sheet group can distinguish multiple electrode sheets 2 on the electrode sheet group, and further distinguish multiple electrode sheets 2 on other electrode sheet groups. The connection point on the same electrode sheet group The position on the electrode sheet 2 changes regularly and has a high degree of recognition, which facilitates the operator to identify the marked electrode sheet 2 and thereby determine the orientation of the electrode.
第三实施例Third embodiment
本实施例的柔性导电软板3中,参照图10和图11,所述特征电极片21的区分标记为电极片2的连接点形状或连接点组合的形状时,所述连接点的形状即为所述过孔4的形状,所述连接点组合包括位于同一所述电极片2上的至少两个连接点,连接点组合的形状为电极片2的连接点组合中连接点位置组成的形状,连接点组合形状也可是由多个形状不同的连接点组成,将上述柔性导电软板3卷圆为圆筒状并制成分片式刺激电极,在植入该分片式刺激电极时,在成像技术下,操作人员识别电极片2上的连接点的形状,通过电极片2上连接点的形状或连接点组合形状作为区分标记来识别特征电极片21,从而确定电极方位,方便操作人员准确的将分片式刺激电极的刺激点作用在指定位置。In the flexible conductive board 3 of this embodiment, referring to Figures 10 and 11, when the distinguishing mark of the characteristic electrode sheet 21 is the shape of the connection point or the shape of the combination of connection points of the electrode sheet 2, the shape of the connection point is is the shape of the via hole 4, the connection point combination includes at least two connection points located on the same electrode sheet 2, and the shape of the connection point combination is the shape composed of the connection point positions in the connection point combination of the electrode sheet 2 , the connection point combination shape can also be composed of multiple connection points with different shapes. The above-mentioned flexible conductive soft plate 3 is rolled into a cylindrical shape and made into a segmented stimulation electrode. When the segmented stimulation electrode is implanted, Under the imaging technology, the operator identifies the shape of the connection points on the electrode sheet 2, and uses the shape of the connection points or the combined shape of the connection points on the electrode sheet 2 as a distinguishing mark to identify the characteristic electrode sheet 21, thereby determining the electrode orientation, which is convenient for the operator Accurately apply the stimulation point of the segmented stimulation electrode to the designated location.
所述连接点的形状为所述过孔4的径向截面形状,所述过孔4的径向截面形状为圆角矩形、圆形、椭圆形、圆角三角形或圆角菱形。由于在制作此种柔性导电软板3时的整体厚度较薄,因此过孔4的轴向长度将会相对更短,在成像技术下,能够忽略过孔4的轴向长度带来的视觉重影影响,通过肉眼就能够清晰的识别出柔性导电软板3上过孔4的形状。在成像设备下,过孔4及导电层41组成的形状出现在电极片2显示的图象范围内,操作人员只需首先确定电极片2的图形部分,然后在电极片2的范围内确定过孔4的径向截面形状即可确定电极方位,具有较明显的区分性,方便操作人员识别并区分。 The shape of the connection point is the radial cross-sectional shape of the via hole 4, and the radial cross-sectional shape of the via hole 4 is a rounded rectangle, a circle, an ellipse, a rounded triangle or a rounded rhombus. Since the overall thickness of the flexible conductive board 3 is thin, the axial length of the via 4 will be relatively shorter. Under imaging technology, the visual importance brought by the axial length of the via 4 can be ignored. Without the influence of shadow, the shape of the via hole 4 on the flexible conductive board 3 can be clearly identified with the naked eye. Under the imaging device, the shape composed of the via hole 4 and the conductive layer 41 appears within the image range displayed by the electrode sheet 2. The operator only needs to first determine the graphic part of the electrode sheet 2, and then determine the process within the range of the electrode sheet 2. The radial cross-sectional shape of the hole 4 can determine the electrode orientation and has obvious distinction, which is convenient for operators to identify and distinguish.
分片式刺激电极上的所有连接点的形状均不相同,或分片式刺激电极上的每一个电极片组的所有连接点的形状均不相同,操作人员观察到此时的电极片2时,根据预先定义好的特征电极片21和位于该特征电极片21上连接点的形状,一一对应的关系,即能确定一个电极片组的所有电极片2的位置,进而区分其他电极片组上的多个电极片2,并方便操作人员将电极片2精准的设置在待刺激点。The shapes of all the connection points on the segmented stimulation electrode are different, or the shapes of all the connection points of each electrode patch group on the segmented stimulation electrode are different. When the operator observes the electrode patch 2 at this time , according to the one-to-one correspondence between the predefined characteristic electrode sheet 21 and the shape of the connection point located on the characteristic electrode sheet 21, the positions of all electrode sheets 2 of an electrode sheet group can be determined, and then other electrode sheet groups can be distinguished. There are multiple electrode pads 2 on the device, and it is convenient for the operator to accurately set the electrode pads 2 at the point to be stimulated.
参照图10,连接点的形状也可以作为指向性标记,例如,第一组中第一个电极片2上的连接点,连接点的形状是三角形,三角形的一个尖角指向水平方向上同组的另一个电极片2,操作人员在成像设备辅助下,可以清晰的识别出三角形的形状,以及三角形的尖角指向的另一个电极片2,从而识别电极的方位,方便操作人员准确的将分片式刺激电极的刺激点作用在指定位置。Referring to Figure 10, the shape of the connection point can also be used as a directional mark, for example, the connection point on the first electrode sheet 2 in the first group, the shape of the connection point is a triangle, one of the sharp corners of the triangle points to the same group in the horizontal direction With the assistance of the imaging equipment, the operator can clearly identify the shape of the triangle and the other electrode piece 2 where the sharp corners of the triangle point, thereby identifying the orientation of the electrode, making it easier for the operator to accurately divide the points into The stimulation point of the chip stimulation electrode acts at a designated location.
较优的,上述连接点组合中的多个连接点之间还可以通过连接线5连接,其中连接线5的材料以及结构和电极片引线1可以一致,并且也可以设置在柔性基底11上。连接线5例如在X光机下,呈现出灰色的线条,在灰色线条的视觉辅助下,便于操作人员轻松识别该特征电极片21上的连接点组合的形状,进而识别出电极在患者组织内的方位,从而方便操作人员准确地将分片式刺激电极的刺激点作用在指定位置,准确的释放刺激,帮助患者康复。Preferably, multiple connection points in the above connection point combination can also be connected through connection wires 5 , where the material and structure of the connection wires 5 can be consistent with those of the electrode sheet leads 1 , and can also be arranged on the flexible substrate 11 . For example, the connection line 5 appears as a gray line under an X-ray machine. With the visual assistance of the gray line, it is convenient for the operator to easily identify the shape of the connection point combination on the characteristic electrode sheet 21, and then identify the electrode within the patient's tissue. The orientation makes it convenient for the operator to accurately apply the stimulation point of the segmented stimulation electrode to the designated position, accurately release the stimulation, and help the patient recover.
参照图11,第一组中的第一个特征电极片21的两个连接点的连线类似于一条斜边,该斜边具有一定的指向性,指向右侧的一个电极片2,当操作人员观察成像结果时,先找到带有两个连接点的特征电极片21,顺着连接点组合的指向方向很快可以确定同组中的第二个电极片2的位置,从而很容易的确定同组所有电极片2的方位。Referring to Figure 11, the connection line between the two connection points of the first characteristic electrode sheet 21 in the first group is similar to a hypotenuse. The hypotenuse has a certain directivity and points to an electrode sheet 2 on the right. When operating When observing the imaging results, the personnel first find the characteristic electrode piece 21 with two connection points. Following the pointing direction of the combination of connection points, the position of the second electrode piece 2 in the same group can be quickly determined, making it easy to determine The orientation of all electrode pads 2 in the same group.
参照图12,所有电极片2上的连接点数量均为两个及以上,以连接点的组合形状作为标记,具有更多种排列组合的方式,当分片式刺激电极上的电极片2数量足够多,或,不同种类的分片式刺激电极数量庞大时,可以排列组合出更多种类的连接点组合,满足多种使用需求。Referring to Figure 12, the number of connection points on all electrode sheets 2 is two or more. The combined shape of the connection points is used as a mark, and there are more ways of arrangement and combination. When the number of electrode sheets 2 on the segmented stimulation electrode is sufficient When there are many, or when there are a large number of different types of segmented stimulation electrodes, more types of connection point combinations can be arranged and combined to meet a variety of use needs.
参照图13,其中连接点组合的形状也可以由多个形状不同的连接点组成,此时连接点组合的种类将会更多,满足应用在更多种类的分片式刺激电极上的多种需求。Referring to Figure 13, the shape of the connection point combination can also be composed of multiple connection points with different shapes. In this case, there will be more types of connection point combinations, which can meet the needs of multiple applications on more types of segmented stimulation electrodes. need.
在一个实施例中,所述连接点组合中的一个连接点与电极片引线1连接,所述连接点组合的其余连接点与电极片引线1连接或不连接,且所述连接点组合的 其余连接点中的一个或多个为金属片,金属片例如为铜片,采用金属片的连接点的形状为金属片的形状,采用金属片的连接点的位置为金属片的位置。其中连接点组合中的其中一个或多个金属片可以在加工时设置在柔性导电软板3的远离电极片的一侧,或者在加工时将金属片埋设在柔性导电软板3内,在成像设备下,操作人员可以直接观测出,金属片和导电层41形成连接点组合,作为电极片的识别标记,对刺激电极的方位进行确定。通过采用金属片代替过孔4和导电层41,可以减少设置过孔4和导电层41,且不影响连接点与电极片引线1的电连接。In one embodiment, one connection point in the connection point combination is connected to the electrode sheet lead 1, the remaining connection points of the connection point combination are connected to the electrode sheet lead 1 or not, and the connection point combination One or more of the remaining connection points are metal sheets, for example, the metal sheets are copper sheets. The shape of the connection point using the metal sheet is the shape of the metal sheet, and the position of the connection point using the metal sheet is the position of the metal sheet. One or more metal sheets in the connection point combination can be placed on the side of the flexible conductive soft plate 3 away from the electrode sheet during processing, or the metal sheets can be buried in the flexible conductive soft plate 3 during processing. Under the equipment, the operator can directly observe that the metal sheet and the conductive layer 41 form a connection point combination, which serves as an identification mark of the electrode sheet and determines the orientation of the stimulation electrode. By using metal sheets instead of via holes 4 and conductive layers 41 , the number of via holes 4 and conductive layers 41 can be reduced without affecting the electrical connection between the connection points and the electrode sheet leads 1 .
参照图2所示,导电层41形成在过孔4的内壁上,形成导电层41后的所述过孔4为空心孔。导电层41用于电连接柔性基底11上的电极片引线1和电极片2,用于传递刺激信号。当形成导电层41后的过孔4设置为空心孔时,在成像设备下,过孔4的形状和位置更加明显,例如是X光成像时,空心孔结构的过孔4为白色或近似白色,视觉效果更加明显,更有利于识别连接点的形状和位置。Referring to FIG. 2 , a conductive layer 41 is formed on the inner wall of the via hole 4 , and the via hole 4 after the conductive layer 41 is formed is a hollow hole. The conductive layer 41 is used to electrically connect the electrode sheet leads 1 and the electrode sheet 2 on the flexible substrate 11, and is used to transmit stimulation signals. When the via hole 4 after forming the conductive layer 41 is set as a hollow hole, the shape and position of the via hole 4 will be more obvious under imaging equipment. For example, during X-ray imaging, the via hole 4 with a hollow hole structure will be white or nearly white. , the visual effect is more obvious, and it is more conducive to identifying the shape and position of the connection point.
需要说明的是,在另一些实施例中,形成的导电层41还可以填充满所述过孔4,相应的导电层41的截面积较大,导电层41的电阻较小,使得导电层41与电极片2和电极片引线1的电连接性能更佳。It should be noted that in other embodiments, the formed conductive layer 41 can also fill the via hole 4. The corresponding conductive layer 41 has a larger cross-sectional area and a smaller resistance, so that the conductive layer 41 The electrical connection performance with the electrode sheet 2 and the electrode sheet lead 1 is better.
较佳地,所述过孔4的内壁为圆滑内壁。过孔4的内壁保持圆滑的内壁,相比于过孔4内具有狭缝的结构,圆滑内壁结构的过孔4更有利于导电层41的附着,可以保证良好的电连接性能,为稳定传递刺激信号提供良好的性能保障。Preferably, the inner wall of the via hole 4 is a smooth inner wall. The inner wall of the via hole 4 maintains a smooth inner wall. Compared with the structure of the via hole 4 with a slit, the via hole 4 with a smooth inner wall structure is more conducive to the adhesion of the conductive layer 41, which can ensure good electrical connection performance and ensure stable transmission. Stimulation signals provide good performance guarantees.
第四实施例Fourth embodiment
参照图1-3和图14,本实施例提供了一种柔性导电软板3的制作方法,所述柔性导电软板3具有刺激段并沿第一方向延伸,第一方向和第二方向交叉,所述制作方法包括以下步骤:步骤S1-步骤S3。Referring to Figures 1-3 and 14, this embodiment provides a method for manufacturing a flexible conductive soft plate 3. The flexible conductive soft plate 3 has a stimulation section and extends along a first direction, and the first direction and the second direction intersect. , the manufacturing method includes the following steps: step S1-step S3.
步骤S1:在柔性导电软板3上形成多个电极片引线1,所述电极片引线1埋设于所述柔性导电软板3内。Step S1: Form a plurality of electrode sheet leads 1 on the flexible conductive board 3, and the electrode sheet leads 1 are embedded in the flexible conductive board 3.
步骤S1中柔性导电软板3的结构可以通过曝光、显影、金属层镀膜、绝缘层镀膜实现。The structure of the flexible conductive board 3 in step S1 can be realized through exposure, development, metal layer coating, and insulating layer coating.
在一具体实施例中,步骤S1包括:在柔性基底11的上表面形成多个电极片引线1和覆盖柔性基底11上表面的多个电极片引线1的第一绝缘层6。In a specific embodiment, step S1 includes: forming a plurality of electrode sheet leads 1 on the upper surface of the flexible substrate 11 and a first insulating layer 6 covering the plurality of electrode sheet leads 1 on the upper surface of the flexible substrate 11 .
具体地,步骤S1包括:在所述柔性基底11的上表面形成干膜,形成干膜的 方式可以是热辊压,热辊压的温度可以是110℃;利用掩膜板对所述柔性基底11上的干膜进行曝光、显影处理,在所述柔性基底11上形成多个电极片引线1的图案;在柔性基底11的上表面进行磁控溅射或真空蒸镀,在柔性基底11的电极片引线1的图案上形成金属基层,金属基层的厚度例如是200nm、400nm或600nm;去除干膜;对金属基层进行增厚,增厚方式可以是电镀,从而形成期望厚度的电极片引线1,电极片引线1的材料可以是铜,厚度可以是0.1μm、10μm、50μm或者100μm;在所述柔性基底11上形成第一绝缘层6,第一绝缘层6覆盖柔性基底11上表面的多个电极片引线1,可以采用真空气相沉积工艺或涂布工艺在柔性基底11上表面形成均匀的第一绝缘层6。Specifically, step S1 includes: forming a dry film on the upper surface of the flexible substrate 11, forming a dry film The method can be hot rolling, and the temperature of hot rolling can be 110°C; a mask is used to expose and develop the dry film on the flexible substrate 11, and a plurality of electrode sheet leads are formed on the flexible substrate 11 The pattern of 1; perform magnetron sputtering or vacuum evaporation on the upper surface of the flexible substrate 11, and form a metal base layer on the pattern of the electrode lead 1 of the flexible substrate 11. The thickness of the metal base layer is, for example, 200nm, 400nm or 600nm; remove Dry film; thickening the metal base layer, the thickening method can be electroplating, to form the electrode lead 1 of the desired thickness. The material of the electrode lead 1 can be copper, and the thickness can be 0.1μm, 10μm, 50μm or 100μm; in A first insulating layer 6 is formed on the flexible substrate 11. The first insulating layer 6 covers the plurality of electrode sheet leads 1 on the upper surface of the flexible substrate 11. A vacuum vapor deposition process or a coating process can be used to form a uniform layer on the upper surface of the flexible substrate 11. the first insulating layer 6.
在柔性基底11的上表面形成干膜之前,还可以对所述柔性基底11的上表面进行粗糙化处理,通过粗糙化处理,能够提高柔性基底11与电极片引线1的结合力。Before forming a dry film on the upper surface of the flexible substrate 11 , the upper surface of the flexible substrate 11 may also be roughened. Through the roughening treatment, the bonding force between the flexible substrate 11 and the electrode sheet lead 1 can be improved.
干膜可以是一种对紫外线反应的聚合性树脂,干膜通过紫外线的照射后能够发生聚合反应形成一种稳定的物质附着于柔性基底11,从而达到阻挡电镀和蚀刻的功能。掩膜板可以是菲林片,由于掩膜板的使用,掩膜板上有图像的部分无法透射紫外线,因此,干膜上未被紫外线照射的部分将无法产生聚合作用。可以利用显影液将未产生聚合的干膜部分去除,将需要保留的线路显现出来,由此,通过该步骤制作出来的线路图案具有细直平整的特性。The dry film can be a polymeric resin that reacts to ultraviolet rays. After being irradiated by ultraviolet rays, the dry film can undergo a polymerization reaction to form a stable substance attached to the flexible substrate 11, thereby achieving the function of blocking electroplating and etching. The mask can be a film. Due to the use of the mask, the part with the image on the mask cannot transmit ultraviolet light. Therefore, the part of the dry film that is not exposed to ultraviolet light will not be able to produce polymerization. The developer can be used to remove the non-polymerized part of the dry film to reveal the lines that need to be retained. Therefore, the circuit pattern produced through this step has the characteristics of being thin, straight and flat.
在所述柔性基底11的上表面进行磁控溅射或真空蒸镀的方法可以包括:对柔性基底11的上表面的干膜依次进行超声清洗、热风烘干和表面等离子处理;将柔性基底11放置于溅射夹具中或蒸镀夹具中,进行磁控溅射或真空蒸镀。The method of performing magnetron sputtering or vacuum evaporation on the upper surface of the flexible substrate 11 may include: sequentially performing ultrasonic cleaning, hot air drying and surface plasma treatment on the dry film on the upper surface of the flexible substrate 11; Place it in the sputtering fixture or evaporation fixture for magnetron sputtering or vacuum evaporation.
在另一具体实施例中,步骤S1包括:在柔性基底11的上表面形成多个电极片引线1和覆盖柔性基底11上表面的多个电极片引线1的第一绝缘层6,在柔性基底11的下表面形成多个电极片引线1和覆盖柔性基底11下表面的多个电极片引线1的第二绝缘层7。所述第一绝缘层6和第二绝缘层7分别覆盖在柔性基底11两个表面的电极片引线1上。In another specific embodiment, step S1 includes: forming a plurality of electrode sheet leads 1 on the upper surface of the flexible substrate 11 and a first insulating layer 6 covering the plurality of electrode sheet leads 1 on the upper surface of the flexible substrate 11. A plurality of electrode sheet leads 1 and a second insulating layer 7 covering the plurality of electrode sheet leads 1 on the lower surface of the flexible substrate 11 are formed on the lower surface of the flexible substrate 11 . The first insulating layer 6 and the second insulating layer 7 respectively cover the electrode sheet leads 1 on both surfaces of the flexible substrate 11 .
具体地,步骤S1包括:在所述柔性基底11的上表面和下表面形成干膜,形成干膜的方式可以是热辊压,热辊压的温度可以是110℃;利用掩膜板对所述柔性基底11上的干膜进行曝光、显影处理,在所述柔性基底11的两个表面分别形成多个电极片引线1的图案;在柔性基底11的上表面和下表面进行磁控溅射或 真空蒸镀,在柔性基底11两个表面的电极片引线1的图案上形成金属基层,金属基层的厚度例如是200nm、400nm或600nm;去除干膜;对两个表面上的金属基层进行增厚,增厚方式可以是电镀,从而形成期望厚度的电极片引线1,电极片引线1的材料可以是铜,厚度可以是0.1μm、10μm、50μm或者100μm;在所述柔性基底11上形成第一绝缘层6和第二绝缘层7,第一绝缘层6覆盖柔性基底11上表面的多个电极片引线1,第二绝缘层7覆盖柔性基底11下表面的多个电极片引线1,可以采用真空气相沉积工艺或涂布工艺在柔性基底11上表面和下表面形成均匀的第一绝缘层6和第二绝缘层7。本实施例的其余方法可以与上述实施例相同或相似,在此不予赘述。Specifically, step S1 includes: forming a dry film on the upper surface and lower surface of the flexible substrate 11. The method of forming the dry film may be hot rolling, and the temperature of the hot rolling may be 110°C; using a mask to The dry film on the flexible substrate 11 is exposed and developed, and patterns of multiple electrode sheet leads 1 are formed on both surfaces of the flexible substrate 11; magnetron sputtering is performed on the upper and lower surfaces of the flexible substrate 11. or Vacuum evaporation, forming a metal base layer on the pattern of the electrode lead 1 on both surfaces of the flexible substrate 11, the thickness of the metal base layer is, for example, 200nm, 400nm or 600nm; removing the dry film; thickening the metal base layer on both surfaces , the thickening method can be electroplating, thereby forming the electrode sheet lead 1 of the desired thickness. The material of the electrode sheet lead 1 can be copper, and the thickness can be 0.1 μm, 10 μm, 50 μm or 100 μm; forming a first first electrode lead 1 on the flexible substrate 11 The insulating layer 6 and the second insulating layer 7, the first insulating layer 6 covers the plurality of electrode sheet leads 1 on the upper surface of the flexible substrate 11, and the second insulating layer 7 covers the multiple electrode sheet leads 1 on the lower surface of the flexible substrate 11, can be used A vacuum vapor deposition process or a coating process forms a uniform first insulating layer 6 and a second insulating layer 7 on the upper and lower surfaces of the flexible substrate 11 . The remaining methods of this embodiment may be the same or similar to the above embodiment, and will not be described again here.
步骤S2:在柔性导电软板3上形成多个连接点。Step S2: Form multiple connection points on the flexible conductive board 3.
所述连接点优选包括形成在所述柔性导电软板3上的过孔4以及位于过孔4内的导电层41。The connection point preferably includes a via hole 4 formed on the flexible conductive board 3 and a conductive layer 41 located within the via hole 4 .
连接点的形成位置和电极片引线1的位置对应,其中连接点可以是过孔4以及位于过孔4内的导电层41。The formation position of the connection point corresponds to the position of the electrode lead 1 , where the connection point may be the via hole 4 and the conductive layer 41 located in the via hole 4 .
参照图2A,在一具体实施例中,步骤S2包括:在所述第一绝缘层6上形成多个过孔4和位于过孔4内的导电层41。在第一绝缘层6上可以通过打孔形成过孔4,打孔例如是激光打孔,形成过孔4后,再通过真空镀膜方式在过孔4内形成导电层41,并且在打孔的过程中,需要将过孔4的位置和电极片引线1的位置进行对应,保证过孔4内的导电层41电连接电极片引线1。Referring to FIG. 2A , in a specific embodiment, step S2 includes: forming a plurality of via holes 4 on the first insulating layer 6 and a conductive layer 41 located in the via holes 4 . The via hole 4 can be formed on the first insulating layer 6 by drilling, for example, laser drilling. After the via hole 4 is formed, the conductive layer 41 is formed in the via hole 4 by vacuum coating, and during the drilling, the via hole 4 is formed. During the process, it is necessary to match the position of the via hole 4 with the position of the electrode sheet lead 1 to ensure that the conductive layer 41 in the via hole 4 is electrically connected to the electrode sheet lead 1.
参照图2B,在另一具体实施例中,步骤S2包括:在所述柔性导电软板3上形成多个过孔4以及位于过孔4内的导电层41,部分过孔4形成在第一绝缘层6上且该过孔4内的导电层41与柔性基底11上表面的电极片引线1电连接,部分过孔4形成在第一绝缘层6和柔性基底11上且该过孔4内的导电层41与柔性基底11下表面的电极片引线1电连接。本实施例形成过孔4和导电层41的方式可以与上述实施例相同或相似,在此不予赘述。Referring to Figure 2B, in another specific embodiment, step S2 includes: forming a plurality of via holes 4 and a conductive layer 41 located in the via holes 4 on the flexible conductive soft board 3, and some of the via holes 4 are formed in the first The conductive layer 41 on the insulating layer 6 and in the via hole 4 is electrically connected to the electrode lead 1 on the upper surface of the flexible substrate 11 . A part of the via hole 4 is formed on the first insulating layer 6 and the flexible substrate 11 and in the via hole 4 The conductive layer 41 is electrically connected to the electrode lead 1 on the lower surface of the flexible substrate 11 . The method of forming the via hole 4 and the conductive layer 41 in this embodiment may be the same as or similar to the above embodiment, and will not be described again here.
步骤S3:在所述柔性导电软板3的刺激段的外表面上形成用于施加电刺激的多个电极片2。多个电极片2划分为一个或多个电极片组,每个电极片组包括沿第二方向排列的多个电极片2,一个或多个电极片组中设置有一个或多个特征电极片21,所述特征电极片21具有区分标记,所述特征电极片21用于在成像时将一组的多个电极片2区分开。 Step S3: Form a plurality of electrode sheets 2 for applying electrical stimulation on the outer surface of the stimulation section of the flexible conductive soft plate 3. The plurality of electrode sheets 2 are divided into one or more electrode sheet groups. Each electrode sheet group includes a plurality of electrode sheets 2 arranged along the second direction. One or more characteristic electrode sheets are provided in one or more electrode sheet groups. 21. The characteristic electrode sheet 21 has a distinguishing mark, and the characteristic electrode sheet 21 is used to distinguish a group of multiple electrode sheets 2 during imaging.
在一具体实施例中,步骤S3包括:在所述第一绝缘层6的表面形成多个电极片2,每个所述电极片2通过过孔4内的导电层41与对应的电极片引线1电连接。多个电极片2在第一绝缘层6的表面可以按照均匀间隔分布的形式设置。多个电极片2可以通过3D曲面溅射完成,形成过孔4内的导电层41可以与形成电极片在同一步骤中进行。In a specific embodiment, step S3 includes: forming a plurality of electrode sheets 2 on the surface of the first insulating layer 6 , each of the electrode sheets 2 passing through the conductive layer 41 in the via hole 4 and the corresponding electrode sheet lead. 1 electrical connection. The plurality of electrode sheets 2 may be arranged at even intervals on the surface of the first insulating layer 6 . Multiple electrode sheets 2 can be completed by 3D curved surface sputtering, and forming the conductive layer 41 in the via hole 4 can be performed in the same step as forming the electrode sheets.
在一个实施例中,所述导电层41形成在所述过孔4的内壁上,形成导电层41后的所述过孔4为空心孔。上述结构在成像时,空心孔结构的过孔4的视觉效果更加明显,更有利于识别连接点4的形状和位置。In one embodiment, the conductive layer 41 is formed on the inner wall of the via hole 4 , and the via hole 4 after the conductive layer 41 is formed is a hollow hole. When the above structure is imaged, the visual effect of the via hole 4 of the hollow hole structure is more obvious, which is more conducive to identifying the shape and position of the connection point 4.
其中较优的,所述过孔4的内壁为圆滑内壁,可以保证过孔4内的导电层41具有良好的电连接性能,为稳定传递刺激信号提供良好的性能保障。Preferably, the inner wall of the via hole 4 is a smooth inner wall, which can ensure that the conductive layer 41 in the via hole 4 has good electrical connection performance, and provides good performance guarantee for stable transmission of stimulation signals.
其中,特征电极片21的区分标记选自以下任意一种或组合:电极片2的形状、电极片2的连接点相对于该电极片2的侧边位置、电极片2的连接点形状、连接点组合的形状,所述连接点组合包括位于所述电极片2上的至少两个连接点。Among them, the distinguishing mark of the characteristic electrode sheet 21 is selected from any one or a combination of the following: the shape of the electrode sheet 2, the side position of the connection point of the electrode sheet 2 relative to the electrode sheet 2, the shape of the connection point of the electrode sheet 2, the connection The shape of a point combination includes at least two connection points located on the electrode sheet 2 .
在一个实施例中,参照图10和11,特征电极片21的区分标记为电极片2的连接点形状或连接点组合的形状时,所述连接点的形状为所述过孔4的形状,所述连接点组合的形状为电极片2的连接点组合中连接点位置组成的形状。In one embodiment, referring to Figures 10 and 11, when the distinguishing mark of the characteristic electrode sheet 21 is the connection point shape or the shape of the connection point combination of the electrode sheet 2, the shape of the connection point is the shape of the via hole 4, The shape of the connection point combination is a shape formed by the positions of the connection points in the connection point combination of the electrode sheet 2 .
在一个实施例中,所述连接点组合中的一个连接点与电极片引线1连接,所述连接点组合的其余连接点与电极片引线1连接或不连接,且所述连接点组合的其余连接点中的一个或多个为金属片,金属片例如为铜片,采用金属片的连接点的形状为金属片的形状,采用金属片的连接点的位置为金属片的位置。In one embodiment, one connection point in the connection point combination is connected to the electrode sheet lead 1, the remaining connection points of the connection point combination are connected to the electrode sheet lead 1 or not, and the remaining connection points of the connection point combination are connected to the electrode sheet lead 1 or not. One or more of the connection points are metal sheets. The metal sheets are, for example, copper sheets. The shape of the connection point using the metal sheet is the shape of the metal sheet. The position of the connection point using the metal sheet is the position of the metal sheet.
步骤S2还可以包括:采用金属片的连接点设置在所述柔性导电软板3背向电极片2的一侧或埋设于所述柔性导电软板3内。其中连接点组合中的其中一个或多个金属片可以在加工时设置在柔性导电软板3的远离电极片2的一侧,或者在加工时将金属片埋设在柔性导电软板3内,在成像设备下,操作人员可以直接观测出,金属片和导电层41形成连接点组合,作为电极片2的识别标记,对刺激电极的方位进行确定。Step S2 may also include: using a metal sheet connection point to be arranged on a side of the flexible conductive board 3 facing away from the electrode sheet 2 or embedded in the flexible conductive board 3 . One or more metal sheets in the connection point combination can be arranged on the side of the flexible conductive soft plate 3 away from the electrode sheet 2 during processing, or the metal sheets can be buried in the flexible conductive soft plate 3 during processing. Under the imaging equipment, the operator can directly observe that the metal sheet and the conductive layer 41 form a connection point combination, which serves as an identification mark of the electrode sheet 2 and determines the orientation of the stimulation electrode.
第五实施例Fifth embodiment
参照图15,本实施例提供了一种分片式刺激电极,包括内衬管(未示出)和上述实施例的柔性导电软板3,所述柔性导电软板3的刺激段环绕包覆在所述内衬管的所述外侧壁上,内衬管可以选用热形变不敏感的材质,例如聚氨酯,所 述刺激段的多个电极片排布在所述柔性导电软板3的背向内衬管的一侧外侧壁上。当柔性导电软板3固定在内衬管上时,电极片2对应设置在外侧用来释放电刺激。所述多个电极片2划分为沿所述内衬管轴向间隔排布的一个或多个周向电极组,每个周向电极组包括沿周向排列的多个电极片2。分片式刺激电极上的多个周向排布的电极片2,在植入待刺激点处时,操作人员通过识别特征电极片21从而确定所有电极片2的方位。在内衬管的同一轴向位置上,设置有多个同组且周向分布的电极片2,刺激电极上的多个轴向位置都具有多个电极片2,在工作时能够对待刺激点精准的释放多种电刺激。Referring to Figure 15, this embodiment provides a segmented stimulation electrode, including a lining tube (not shown) and the flexible conductive soft plate 3 of the above embodiment. The stimulation section of the flexible conductive soft plate 3 is wrapped around On the outer wall of the lining tube, the lining tube can be made of a material that is not sensitive to thermal deformation, such as polyurethane. The plurality of electrode sheets of the stimulation section are arranged on one side of the outer wall of the flexible conductive plate 3 facing away from the inner lining tube. When the flexible conductive plate 3 is fixed on the inner lining tube, the electrode sheet 2 is correspondingly arranged on the outside to release electrical stimulation. The plurality of electrode sheets 2 are divided into one or more circumferential electrode groups arranged at intervals along the axial direction of the lining tube, and each circumferential electrode group includes a plurality of electrode sheets 2 arranged in the circumferential direction. When implanting a plurality of circumferentially arranged electrode pieces 2 on the segmented stimulation electrode at the point to be stimulated, the operator determines the orientation of all the electrode pieces 2 by identifying the characteristic electrode pieces 21. At the same axial position of the inner lining tube, there are multiple electrode pads 2 of the same group and circumferentially distributed. Multiple electrode pads 2 are provided at multiple axial positions on the stimulation electrode, so that the stimulation point can be treated during operation. Accurately release a variety of electrical stimulation.
所述柔性导电软板3还包括与刺激段相对的连接段和位于刺激段和连接段之间的中间段,所述柔性导电软板3的刺激段和连接段分别被加工成圆筒状结构,所述柔性导电软板3的中间段被加工成圆筒状结构、螺旋状结构或波浪形的柔性导电软板3经卷圆后形成的结构。柔性导电软板3的刺激段和连接段均被加工成直径相同的圆筒状,并在圆筒中间插入固定内衬管,其余的中间段也被缠绕固定在内衬管的外侧壁上。The flexible conductive soft plate 3 also includes a connecting section opposite to the stimulation section and an intermediate section located between the stimulation section and the connecting section. The stimulation section and the connecting section of the flexible conductive soft plate 3 are respectively processed into cylindrical structures. , the middle section of the flexible conductive soft board 3 is processed into a cylindrical structure, a spiral structure or a structure formed by rolling the wavy flexible conductive soft board 3 into a round shape. The stimulation section and the connection section of the flexible conductive soft plate 3 are processed into cylinders with the same diameter, and a fixed lining tube is inserted in the middle of the cylinder, and the remaining middle sections are also wound and fixed on the outer wall of the lining tube.
将柔性导电软板3套设在内衬管上,对柔性导电软板3起到形状定型的作用,将分片式刺激电极植入在患者的脑部等组织内时,例如内衬管将柔性导电软板3支撑形成光滑的圆筒状,方便操作人员将柔性导电软板3植入患者组织内。采用的柔性导电软板3,利用特征电极片21作为标记进行电极片2的区分,无需额外设置标记,制成分片式刺激电极后,在植入在患者的脑部等组织内时,操作人员通过识别特征电极片21的位置,从而确定一个电极片组的所有电极片2在患者脑部等组织内的位置,方便操作人员快速识别出电极方位,并准确的将刺激电极的刺激点作用在指定位置,降低对操作人员的刺激电极识别能力要求。The flexible conductive soft plate 3 is placed on the inner lining tube, which plays a role in shaping the shape of the flexible conductive soft plate 3. When the segmented stimulation electrode is implanted in the patient's brain and other tissues, for example, the inner lining tube will The flexible conductive soft plate 3 is supported to form a smooth cylindrical shape, which is convenient for the operator to implant the flexible conductive soft plate 3 into the patient's tissue. The flexible conductive soft plate 3 used uses the characteristic electrode piece 21 as a mark to distinguish the electrode piece 2. There is no need to set additional marks. After being made into a piece-type stimulation electrode, it can be operated when implanted in the patient's brain and other tissues. By identifying the position of the characteristic electrode patch 21, the operator determines the position of all the electrode patches 2 of an electrode patch group in the patient's brain and other tissues, which facilitates the operator to quickly identify the electrode position and accurately activate the stimulation point of the stimulation electrode. At designated locations, reduce the operator's ability to identify stimulation electrodes.
第六实施例Sixth embodiment
本实施例提供一种刺激系统,包括刺激器、导线和刺激电极,所述刺激器(图中未示出)通过导线(图中未示出)连接所述刺激电极,所述刺激电极是上述实施例的分片式刺激电极。This embodiment provides a stimulation system, including a stimulator, a wire and a stimulation electrode. The stimulator (not shown in the figure) is connected to the stimulation electrode through a wire (not shown in the figure). The stimulation electrode is the above-mentioned The fragmented stimulation electrode of the embodiment.
当刺激电极在成像技术下完成在脑部等组织的待刺激点精准固定后,在工作时,刺激器将会输出刺激信号,并通过导线输送,最终在通过电极片2将电刺激释放患者的脑部待刺激点处,预先设定的刺激信号在患者的脑部循环刺激,有助于通过刺激患者的脑部,帮助恢复脑部的功能,实现治疗或康复。 When the stimulating electrode is accurately fixed at the point to be stimulated in the brain and other tissues using imaging technology, when working, the stimulator will output the stimulation signal and transmit it through the wire, and finally release the electrical stimulation to the patient's body through the electrode sheet 2 At the point of the brain to be stimulated, the preset stimulation signal circulates in the patient's brain, which helps to restore brain function and achieve treatment or rehabilitation by stimulating the patient's brain.
采用利用特征电极片21作为标记的分片式刺激电极的刺激系统,在将分片式刺激电极植入在患者的脑部等组织内时,操作人员通过识别特征电极片21的位置,从而确定一个电极片组的所有电极片2在患者脑部等组织内的位置,方便操作人员快速识别出电极方位,并准确的将分片式刺激电极的刺激点作用在指定位置,降低对操作人员的刺激电极识别能力要求。 A stimulation system that uses segmented stimulation electrodes that use characteristic electrode pieces 21 as markers. When implanting the segmented stimulation electrodes in the patient's brain and other tissues, the operator identifies the position of the characteristic electrode pieces 21 to determine the location of the segmented stimulation electrodes. The position of all the electrode pads 2 of an electrode pad group in the patient's brain and other tissues facilitates the operator to quickly identify the electrode position and accurately apply the stimulation points of the segmented stimulation electrode to the designated position, reducing the impact on the operator. Stimulating electrode identification ability requirements.

Claims (18)

  1. 一种柔性导电软板,所述柔性导电软板具有刺激段并沿第一方向延伸,第一方向和第二方向交叉,所述柔性导电软板的刺激段的外表面上设置有用于施加电刺激的多个电极片,每个所述电极片上分别设置有用于连接电极片引线的连接点,所述电极片引线埋设于所述柔性导电软板内;A flexible conductive soft plate. The flexible conductive soft plate has a stimulation section and extends along a first direction. The first direction and the second direction intersect. The outer surface of the stimulation section of the flexible conductive soft plate is provided with a stimulating section for applying electricity. A plurality of electrode sheets for stimulation, each electrode sheet is provided with a connection point for connecting the lead of the electrode sheet, and the lead of the electrode sheet is embedded in the flexible conductive soft plate;
    所述多个电极片划分为一个或多个电极片组,每个所述电极片组包括沿第二方向排列的多个电极片,一个或多个所述电极片组中设置有一个或多个特征电极片,所述特征电极片具有区分标记,所述特征电极片用于在成像时将一个电极片组的多个电极片区分开。The plurality of electrode sheets are divided into one or more electrode sheet groups, each of the electrode sheet groups includes a plurality of electrode sheets arranged along the second direction, and one or more electrode sheet groups are provided with one or more electrode sheets. A characteristic electrode piece has a distinguishing mark, and the characteristic electrode piece is used to distinguish multiple electrode pieces of an electrode piece group during imaging.
  2. 根据权利要求1所述的柔性导电软板,其中,所述特征电极片的区分标记选自以下任意一种或组合:The flexible conductive board according to claim 1, wherein the distinguishing mark of the characteristic electrode sheet is selected from any one or combination of the following:
    电极片的形状;The shape of the electrode pad;
    电极片的连接点相对于该电极片的侧边位置;The connection point of the electrode piece is positioned relative to the side of the electrode piece;
    电极片的连接点形状;The shape of the connection points of the electrode pads;
    连接点组合的形状,所述连接点组合包括位于所述电极片上的至少两个连接点。The shape of a connection point combination, the connection point combination includes at least two connection points located on the electrode sheet.
  3. 根据权利要求2所述的柔性导电软板,其中,所述特征电极片的区分标记为电极片的形状时,所述特征电极片上形成有指向性形状,所述特征电极片的指向性形状用于将多个电极片区分开。The flexible conductive board according to claim 2, wherein when the distinguishing mark of the characteristic electrode sheet is the shape of the electrode sheet, a directional shape is formed on the characteristic electrode sheet, and the directional shape of the characteristic electrode sheet is represented by To separate multiple electrode pads.
  4. 根据权利要求3所述的柔性导电软板,其中,所述特征电极片的指向性形状位于所述特征电极片的一侧边缘或相对两侧的边缘;The flexible conductive board according to claim 3, wherein the directional shape of the characteristic electrode sheet is located at one edge of one side or edges of opposite sides of the characteristic electrode sheet;
    所述特征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,所述特征电极片的指向性形状与特征电极片其余部分圆滑连接,且每个电极片的外周边缘的形状是闭合的曲线。The directional shape of the characteristic electrode sheet is formed by a wave shape, a sinusoidal curve, a semicircle, a rounded rectangle or a rounded triangle. The directional shape of the characteristic electrode sheet is smoothly connected to the rest of the characteristic electrode sheet, and each The shape of the outer peripheral edge of the electrode sheet is a closed curve.
  5. 根据权利要求2所述的柔性导电软板,其中,所述特征电极片的区分标记为电极片的形状时,所述多个电极片中每个电极片的形状均不相同,或者,所述一个电极片组中的每个电极片的形状均不相同。The flexible conductive board according to claim 2, wherein when the distinguishing mark of the characteristic electrode piece is the shape of the electrode piece, the shape of each electrode piece in the plurality of electrode pieces is different, or the shape of the electrode piece is different. Each electrode piece in an electrode piece set has a different shape.
  6. 根据权利要求1所述的柔性导电软板,其中,所述特征电极片的区分标记为电极片的连接点相对于该电极片的侧边位置时,每个所述电极片分别包括沿第一方向的上侧边和下侧边,以及沿第二方向的左侧边和右侧边,所述特征电极 片的区分标记为电极片的连接点相对于该电极片的上侧边和下侧边的位置,或者,为电极片的连接点相对于该电极片的左侧边和右侧边的位置。The flexible conductive board according to claim 1, wherein the distinguishing mark of the characteristic electrode sheet is the position of the connection point of the electrode sheet relative to the side of the electrode sheet, and each of the electrode sheets respectively includes a line along the first the upper and lower sides along the second direction, and the left and right sides along the second direction, the characteristic electrode The distinguishing mark of the electrode sheet is the position of the connection point of the electrode sheet relative to the upper and lower sides of the electrode sheet, or the position of the connection point of the electrode sheet relative to the left side and right side of the electrode sheet.
  7. 根据权利要求6所述的柔性导电软板,其中,一个或多个电极片组中沿第二方向的多个特征电极片的连接点与刺激段端面的距离逐渐增大或减小。The flexible conductive board according to claim 6, wherein the distance between the connection points of the plurality of characteristic electrode sheets along the second direction in the one or more electrode sheet groups and the end surface of the stimulation section gradually increases or decreases.
  8. 根据权利要求2所述的柔性导电软板,其中,所述特征电极片的区分标记为电极片的连接点形状或连接点组合的形状时,所述连接点组合的形状为电极片的连接点组合中连接点位置组成的形状。The flexible conductive board according to claim 2, wherein when the distinguishing mark of the characteristic electrode sheet is the connection point shape of the electrode sheet or the shape of the connection point combination, the shape of the connection point combination is the connection point of the electrode sheet. A shape formed by the locations of connected points in the composition.
  9. 根据权利要求8所述的柔性导电软板,其中,所述连接点组合的连接点之间设置有连接线,所述连接点组合的形状具有用于将多个电极片区分开的指向性标记。The flexible conductive board according to claim 8, wherein connection lines are provided between the connection points of the connection point combination, and the shape of the connection point combination has directional marks for distinguishing a plurality of electrode sheets.
  10. 根据权利要求8所述的柔性导电软板,其中,所述连接点组合中的一个连接点与电极片引线连接,所述连接点组合的其余连接点与电极片引线连接或不连接,且所述连接点组合的其余连接点中的一个或多个为金属片并设置在所述柔性导电软板背向电极片的一侧或埋设于所述柔性导电软板内,采用金属片的连接点的形状为金属片的形状,采用金属片的连接点的位置为金属片的位置。The flexible conductive board according to claim 8, wherein one connection point in the connection point combination is connected to the electrode sheet lead, the remaining connection points of the connection point combination are connected to the electrode sheet lead or not, and the One or more of the remaining connection points of the connection point combination are metal sheets and are arranged on the side of the flexible conductive soft plate facing away from the electrode sheet or are embedded in the flexible conductive soft plate. The connection points of the metal sheets are used. The shape is the shape of the metal piece, and the position of the connection point of the metal piece is the position of the metal piece.
  11. 根据权利要求1所述的柔性导电软板,其中,所述连接点包括形成在所述柔性导电软板上的过孔以及位于过孔内的导电层,每个所述电极片通过过孔内的导电层与对应的电极片引线电连接。The flexible conductive board according to claim 1, wherein the connection points include via holes formed on the flexible conductive board and a conductive layer located in the via holes, and each of the electrode sheets passes through the via holes. The conductive layer is electrically connected to the corresponding electrode sheet lead.
  12. 根据权利要求11所述的柔性导电软板,其中,所述连接点的形状为所述过孔的径向截面形状,所述过孔的径向截面形状为圆角矩形、圆形、椭圆形、圆角三角形或圆角菱形。The flexible conductive board according to claim 11, wherein the shape of the connection point is the radial cross-sectional shape of the via hole, and the radial cross-sectional shape of the via hole is a rounded rectangle, a circle, or an ellipse. , rounded triangle or rounded rhombus.
  13. 根据权利要求11所述的柔性导电软板,其中,所述导电层形成在所述过孔的内壁上,形成导电层后的所述过孔为空心孔。The flexible conductive board according to claim 11, wherein the conductive layer is formed on the inner wall of the via hole, and the via hole after the conductive layer is formed is a hollow hole.
  14. 根据权利要求1所述的柔性导电软板,其中,所述多个电极片呈阵列间隔分布,且每个电极片的形状相同或不同,每个电极片的外周边缘的形状是圆滑轮廓线,不同特征电极片的区分标记相同或不同。The flexible conductive board according to claim 1, wherein the plurality of electrode sheets are distributed at intervals in an array, and the shape of each electrode sheet is the same or different, and the shape of the outer peripheral edge of each electrode sheet is a smooth contour line, The distinguishing marks of electrode pieces with different characteristics are the same or different.
  15. 根据权利要求1所述的柔性导电软板,其中,所述柔性导电软板包括2-10个电极片组,所述一个电极片组包括2-10个电极片,所述第一方向和第二方向垂直。The flexible conductive board according to claim 1, wherein the flexible conductive board includes 2-10 electrode sheet groups, and one electrode sheet group includes 2-10 electrode sheets, and the first direction and the first electrode sheet group include 2-10 electrode sheet groups. Two directions are vertical.
  16. 一种分片式刺激电极,包括: A segmented stimulation electrode, including:
    内衬管,所述内衬管具有用于柔性导电软板贴合的外侧壁;A lining tube, the lining tube has an outer side wall for the flexible conductive soft board to fit;
    如权利要求1至15任意一项所述的柔性导电软板,所述柔性导电软板的刺激段环绕包覆在所述内衬管的所述外侧壁上,所述刺激段的多个电极片排布在所述柔性导电软板的背向内衬管的一侧外侧壁上;The flexible conductive plate according to any one of claims 1 to 15, the stimulation section of the flexible conductive plate is wrapped around the outer wall of the lining tube, and the plurality of electrodes of the stimulation section The sheets are arranged on one side of the outer wall of the flexible conductive soft plate facing away from the lining tube;
    所述多个电极片划分为沿所述内衬管轴向间隔排布的一个或多个周向电极组,每个周向电极组包括沿周向排列的多个电极片。The plurality of electrode sheets are divided into one or more circumferential electrode groups arranged at intervals along the axial direction of the lining tube, and each circumferential electrode group includes a plurality of electrode sheets arranged in the circumferential direction.
  17. 如权利要求16所述的分片式刺激电极,其中,所述柔性导电软板还包括与刺激段相对的连接段和位于刺激段和连接段之间的中间段,所述柔性导电软板的刺激段和连接段分别被加工成圆筒状结构,所述柔性导电软板的中间段被加工成圆筒状结构、螺旋状结构或波浪形的柔性导电软板经卷圆后形成的结构。The segmented stimulation electrode according to claim 16, wherein the flexible conductive soft plate further includes a connecting section opposite to the stimulating section and an intermediate section located between the stimulating section and the connecting section. The stimulation section and the connecting section are respectively processed into cylindrical structures, and the middle section of the flexible conductive soft plate is processed into a cylindrical structure, a spiral structure or a structure formed by rolling the wavy flexible conductive soft plate.
  18. 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,所述刺激电极是权利要求16或17所述的分片式刺激电极。 A stimulation system includes a stimulator, a wire and a stimulation electrode. The stimulator is connected to the stimulation electrode through a wire. The stimulation electrode is the segmented stimulation electrode described in claim 16 or 17.
PCT/CN2023/080278 2022-03-30 2023-03-08 Flexible conductive flexible board, split stimulation electrode, and stimulation system WO2023185408A1 (en)

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