WO2023185408A1

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

Info

Publication number: WO2023185408A1
Application number: PCT/CN2023/080278
Authority: WO
Inventors: 姜传江; 朱为然
Original assignee: 苏州景昱医疗器械有限公司
Priority date: 2022-03-30
Filing date: 2023-03-08
Publication date: 2023-10-05
Also published as: CN114712705A

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

Flexible conductive plates, segmented stimulation electrodes and stimulation systems

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.

Technical field

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.

Background technique

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.

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. 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.

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.

Therefore, existing stimulation electrodes still need improvement.

Contents of the invention

This application provides a flexible conductive soft plate, a segmented stimulation electrode and a stimulation system that solve the above problems.

The purpose of this application is achieved using the following technical solutions:

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;

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.

In some possible ways, the distinguishing mark of the characteristic electrode sheet is selected from any one or combination of the following:

The shape of the electrode pad;

The connection point of the electrode piece is positioned relative to the side of the electrode piece;

The shape of the connection points of the electrode pads;

The shape of a connection point combination, the connection point combination includes at least two connection points located on the electrode sheet.

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. .

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;

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

In some possible ways, the inner wall of the via hole is a smooth inner wall.

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.

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.

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. .

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.

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.

Compared with related technologies, 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. 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.

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.

Description of drawings

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.

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.

Detailed ways

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 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.

Below, one of the application fields of the embodiments of the present application (namely, the implantable neurostimulator) will be briefly described.

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.

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.

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.

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.

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.

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 .

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 .

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.

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.

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.

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.

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).

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.

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.

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.

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.

First embodiment

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.

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.

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.

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.

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.

Second embodiment

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.

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.

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.

Third embodiment

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.

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. 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.

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.

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.

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.

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.

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.

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 .

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.

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.

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.

Fourth embodiment

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.

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.

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 .

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.

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.

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.

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 .

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.

Step S2: Form multiple connection points on the flexible conductive board 3.

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 .

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 .

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.

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.

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.

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.

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.

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.

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 .

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 .

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.

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.

Fifth embodiment

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.

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. 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.

Sixth embodiment

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.

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. 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

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;

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.
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:

The shape of the electrode pad;

The connection point of the electrode piece is positioned relative to the side of the electrode piece;

The shape of the connection points of the electrode pads;

The shape of a connection point combination, the connection point combination includes at least two connection points located on the electrode sheet.
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.
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;

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 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
A segmented stimulation electrode, including:

A lining tube, the lining tube has an outer side wall for the flexible conductive soft board to fit;

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;

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 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.
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.