Electrode wire and stimulation system

Abstract

The utility model relates to the technical field of medical products, and discloses an electrode wire and a stimulation system. The stimulation section of the electrode wire is provided with a developing identification assembly, the developing identification assembly is provided with a first identification part and a second identification part which are connected with each other in the axial direction of the electrode wire, and the first identification part is provided with at least one through identification hole. The angle of the development identification assembly can be identified in the X-ray development image of the development identification assembly through the identification hole; the second identification part comprises two arc-shaped display sheets extending in the axial direction of the electrode wire, the two display sheets are arranged at intervals in the circumferential direction, a first notch is formed between the ends, close to each other, of the two display sheets in the circumferential direction, and a second notch is formed between the ends, away from each other, of the two display sheets in the circumferential direction. The first gap is smaller than the second gap. Through the X-ray imaging technology and the CT technology, the orientation information of the electrode plate can be obtained through naked eyes, and the operation convenience is improved.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical products, in particular to an electrode lead and a stimulation system. BACKGROUND

[0002] Deep brain stimulation (DBS) is an invasive neural modulation technology. Through stereotactic surgery, the technology implants a stimulation electrode in a specific neural structure of the human brain and implants a neurostimulator in the human body to connect the electrode, and emits a weak electric pulse that can be adjusted and controlled to change the electrical activity and function of the brain neural circuit and network, so as to control and improve the symptoms of patients.

[0003] The stimulation output metal contact of the traditional DBS electrode is a circular ring, and the whole electrode is rotationally symmetrical at any angle and has no specific orientation. The current new type of DBS electrode design allows the original circular ring-shaped stimulation output metal contact to be split into multiple pieces, usually three equal pieces. These electrodes support independent regulation of the stimulation output parameters of one piece or multiple pieces, thereby realizing stimulation of specific directional brain tissue, and are therefore called "directional electrodes".

[0004] However, after the DBS electrode is implanted in the human body, the angle information of the stimulation end of the electrode lead cannot be obtained, so it is inconvenient to control a specific directional piece.

[0005] Therefore, there is an urgent need for an electrode lead and a stimulation system to solve the above problems. CONTENT OF THE INVENTION

[0006] Based on the above, the purpose of the present application is to provide an electrode lead and a stimulation system, which can obtain the orientation information of the electrode piece through X-ray imaging technology and CT technology, improve the success rate of surgery, improve the convenience of operation, reduce the cost of surgery for patients, and at the same time reduce the number of radioactive examinations for patients.

[0007] To achieve the above purpose, the technical scheme adopted by the present application is as follows:

[0008] In a first aspect, an electrode lead is provided, which comprises a stimulation section, a connecting section, and an intermediate section connecting the stimulation section and the connecting section, and the stimulation section is provided with a plurality of electrode pieces arranged in a circumferential direction and insulated and spaced apart, characterized in that the stimulation section is further provided with a developing mark assembly, the developing mark assembly is provided with a first mark part and a second mark part connected to each other in the axial direction of the electrode lead, the first mark part is provided with at least one mark hole penetrating through, and the angle of the developing mark assembly can be identified in the X-ray developing image of the developing mark assembly through the mark hole.

[0009] The second identification part comprises two films extending along the axial direction of the electrode lead wire, the two films are arc-shaped, the two films are arranged at intervals along the circumferential direction, a first gap is arranged between the ends of the two films that are close to each other along the circumferential direction, and a second gap is arranged between the ends of the two films that are away from each other along the circumferential direction, and the first gap is smaller than the second gap.

[0010] As a preferred technical solution of the electrode lead wire, the two ends of the identification hole along the circumferential direction are asymmetric structures.

[0011] As a preferred technical solution of the electrode lead wire, the projection of the identification hole is a triangular hole, the first acute angle of the triangular hole is located at one end of the identification hole along the circumferential direction, and the straight edge opposite to the first acute angle in the triangular hole is located at the other end of the identification hole along the circumferential direction.

[0012] As a preferred technical solution of the electrode lead wire, the first identification part and the second identification part are integrally formed; or

[0013] The first identification part and the second identification part are insulated and arranged on the stimulation section at intervals along the axial direction of the stimulation section.

[0014] As a preferred technical solution of the electrode lead wire, the lengths of the two films extending along the axial direction of the electrode lead wire are different.

[0015] As a preferred technical solution of the electrode lead wire, one indicating electrode sheet is arranged in the plurality of electrode sheets, the indicating electrode sheet is located on a first axis together with the first gap, the first axis extends along the axial direction of the stimulation section; and / or the indicating electrode sheet is located on the first axis together with the identification hole.

[0016] As a preferred technical solution of the electrode lead wire, the first identification part comprises an extension sheet part extending along the axial direction of the electrode lead wire, and the identification hole is arranged through the extension sheet part; the extension sheet part is in the form of an unsealed ring, and the width of the extension sheet part gradually increases or decreases from the first end of the extension sheet part to the second end of the extension sheet part.

[0017] As a preferred technical solution of the electrode lead wire, the circumferential arc of the extension sheet part is less than 240°.

[0018] As a preferred technical solution of the electrode lead wire, the two ends of the extension sheet part along the axial direction of the electrode lead wire are provided with fixing rings, the fixing rings can be sleeved and connected to the stimulation section, and the second identification part is connected to one of the fixing rings.

[0019] As a preferred technical solution of the electrode lead wire, the fixing ring has a clamping groove, and the clamping groove is clamped with the stimulation section.

[0020] As a preferred technical solution of the electrode lead, at least one of the film has an arc angle X, 10°≤X≤170°; and / or

[0021] The arc angle of the first gap is Y, 10°≤Y<160°.

[0022] In a second aspect, a stimulation system is provided, comprising an implantable pulse generator and the electrode lead of any one of the above, the stimulation section of the electrode lead is configured to be implanted in the brain, and the connection section of the electrode lead is electrically connected to the implantable pulse generator.

[0023] As a preferred technical solution of the stimulation system, the stimulation system further comprises an extension lead, and the implantable pulse generator is electrically connected to the electrode lead through the extension lead.

[0024] The beneficial effects of the present application are:

[0025] The electrode lead and the stimulation system provided by the present application are as follows: before the electrode lead is implanted into the human body, the stimulation section of the electrode lead is rotated, and X-ray developing images of the developing marker assembly in multiple directions are obtained as reference images; then the electrode lead is implanted into the human body, and a preset X-ray developing image of the stimulation section of the electrode lead in a working state is obtained; the preset X-ray developing image is compared with the reference image, and the angle of the developing marker assembly can be identified in the preset X-ray developing image of the developing marker assembly through the identification hole; in addition, the position of the electrode sheet of the stimulation section of the electrode lead relative to the developing marker assembly is relatively fixed, when the angle of the developing marker assembly is known, the direction of the electrode sheet can be obtained, which is convenient for subsequent operating personnel to control the electrode sheet in a specific direction in the subsequent treatment process, improves the operation convenience, and improves the success rate of the operation.

[0026] When the CT image of the stimulation section of the electrode lead is obtained by the CT technology, a preset cross-sectional CT image of a preset position cross section in the CT image is selected, and the preset position cross section only contains two films; since the first gap of the two films is smaller than the second gap, the preset cross-sectional CT image presented by the two films includes two first bright line regions and two second bright line regions, the brightness of the first bright line region is greater than the brightness of the second bright line region, and the position between the two first bright line regions corresponds to the first gap between the two films, and then the rotation angle of the developing marker assembly is obtained; since the position of the electrode sheet of the stimulation section of the electrode lead relative to the developing marker assembly is relatively fixed, the direction of the electrode sheet is determined according to the first gap between the two films, which is also convenient for subsequent operating personnel to control the electrode sheet in a specific direction in the subsequent treatment process, improves the operation convenience, and improves the success rate of the operation.

[0027] The application can obtain the orientation information of the electrode sheet through naked eyes by X-ray imaging technology and CT technology through the developing mark component arranged by the electrode lead wire, improve the operation convenience, reduce the patient operation cost, and reduce the number of patient radioactive examination. BRIEF DESCRIPTION OF DRAWINGS

[0028] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the drawings needed to be used in the description of the embodiments of the present application will be briefly introduced. Obviously, the drawings in the following description are only some embodiments of the present application, and other drawings can be obtained by the person skilled in the art without creative labor on the basis of the contents of the embodiments of the present application and the drawings.

[0029] Figure 1 is a structural schematic diagram of the electrode lead wire provided by the first embodiment of the present application;

[0030] Figure 2 is a partial structural schematic diagram of the stimulating section of the electrode lead wire provided by the first embodiment of the present application;

[0031] Figure 3 is a structural schematic diagram of the developing mark component provided by the first embodiment of the present application;

[0032] Figure 4 is a partial structural schematic diagram of the electrode lead wire provided by the first embodiment of the present application;

[0033] Figure 5 is an X-ray developing image of the developing mark component at different angles provided by the first embodiment of the present application;

[0034] Figure 6 is a schematic diagram of the preset position cross section located at X-X in Figure 3 ;

[0035] Figure 7 is a schematic diagram of the preset cross section CT image provided by the first embodiment of the present application;

[0036] Figure 8 is a schematic diagram of the technical principle 1 of the ray hardening effect artifact provided by the first embodiment of the present application;

[0037] Figure 9 is a schematic diagram of the technical principle 2 of the ray hardening effect artifact provided by the first embodiment of the present application;

[0038] Figure 10 is a schematic diagram of the combination of the technical principle 1 and the technical principle 2 of the ray hardening effect artifact provided by the first embodiment of the present application;

[0039] Figure 11 is a flowchart of the X-ray image recognition method provided by the first embodiment of the present application;

[0040] Figure 12 is a flow chart of a CT image recognition method provided by an embodiment of the present application;

[0041] Figure 13 is a structural schematic diagram of a stimulation section of an electrode lead provided by an embodiment two of the present application.

[0042] The figure is marked as follows:

[0043] 10, electrode lead; 101, stimulation section; 1011, support; 10111, protrusion; 102, connecting section; 103, intermediate section; 201, dark stripe; 202, bright stripe;

[0044] 1, developing mark component; 11, first mark part; 111, mark hole; 112, extension piece part; 113, fixing ring; 1131, clamping groove; 12, second mark part; 121, developing film; 122, first gap; 123, second gap; 2, direction electrode component; 21, indicating electrode piece; 3, stimulation ring; 41, first bright line area; 42, second bright line area;

[0045] 5, first axis. DETAILED DESCRIPTION

[0046] The present application will be further described in detail below in conjunction with the accompanying drawings and embodiments. It can be understood that the specific embodiments described herein are only used to explain the present application, but not to limit the present application. In addition, it should be noted that, for the convenience of description, only the parts related to the present application are shown in the drawings, but not all the structures.

[0047] In the description of the present application, unless otherwise explicitly specified and limited, the terms "connected", "connected", "fixed" should be understood broadly, for example, it can be fixedly connected, or it can be detachably connected, or it can be integrated; it can be mechanically connected, or it can be electrically connected; it can be directly connected, or it can be indirectly connected through an intermediate medium; it can be the internal communication of two elements or the interaction relationship between two elements. For those skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances.

[0048] In the present application, unless specifically defined and limited otherwise, the first feature "on" or "under" the second feature can include that the first and second features are in direct contact, or that the first and second features are not in direct contact but are in contact through another feature between them. Moreover, the first feature "on", "above" and "over" the second feature includes that the first feature is directly above and obliquely above the second feature, or only indicates that the first feature is higher than the second feature in horizontal height. The first feature "under", "below" and "under" the second feature includes that the first feature is directly below and obliquely below the second feature, or only indicates that the first feature is lower than the second feature in horizontal height.

[0049] In the description of the present embodiment, the terms "upper", "lower", "left", "right", and the like, orientation or position relationship are based on the orientation or position relationship shown in the drawings, and are only for the convenience of description and simplification of operation, and do not indicate or imply that the device or element referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as a limitation on the present application. In addition, the terms "first" and "second" are only used to distinguish in description, and have no special meaning.

[0050] Embodiment one

[0051] The technical field and related terms of the embodiments of the present application are briefly described below.

[0052] Implantable medical systems include implantable neurostimulation systems, implantable cardiac electrical stimulation systems (also known as cardiac pacemakers), implantable drug delivery systems (IDDS) and lead extension systems, etc. Implantable neurostimulation systems are, for example, deep brain stimulation systems (DBS), implantable cortical nerve stimulation systems (CNS), implantable spinal cord stimulation systems (SCS), implantable sacral nerve stimulation systems (SNS), implantable vagus nerve stimulation systems (VNS), etc.

[0053] An implantable neurostimulation system includes an implantable neurostimulator (i.e., an implantable neurostimulation device) implanted in a patient and a programming device disposed outside the patient. That is, the implantable neurostimulator is a medical device, or, stated differently, the medical device includes the implantable neurostimulator. The related neuromodulation technology is mainly through stereotactic surgery to implant electrodes (electrodes are, for example, in the form of electrode leads) at a specific site (i.e., a target site) of the patient's tissue, and deliver electrical pulses to the target site through the electrodes to modulate the electrical activity of the corresponding neural structures and networks and their functions, thereby improving symptoms and relieving pain.

[0054] As an example, DBS includes an IPG (Implantable Pulse Generator), an extension lead, and an electrode lead, with the IPG connected to the extension lead and the electrode lead. The IPG is implanted in the patient, for example, in the front of the patient's chest or other body part.

[0055] As another example, DBS includes an IPG and an electrode lead, with the IPG directly connected to the electrode lead. The IPG is implanted in the patient's head, for example, by slotting the patient's skull and then installing the IPG in the slot of the skull, in which case the IPG can not protrude out of the outer surface of the skull or can partially protrude out of the outer surface of the skull.

[0056] The IPG provides controllable electrical stimulation therapy (or, stated differently, electrical stimulation energy) to the tissue in the body in response to programming instructions sent by the programming device, relying on a sealed battery and circuitry. The IPG delivers one or more controllable specific electrical stimulations to a specific area of the tissue in the body through the electrode lead.

[0057] In some embodiments, the extension lead is used in conjunction with the IPG as a transmission medium for electrical stimulation, delivering electrical stimulation generated by the IPG to the electrode lead.

[0058] In some embodiments, electrical stimulation can be delivered in the form of a pulsed signal or in the form of a non-pulsed signal. For example, electrical stimulation can be delivered as a signal with various waveform shapes, frequencies, and amplitudes. Thus, electrical stimulation in the form of a non-pulsed signal can be a continuous signal, which can have a sinusoidal waveform or other continuous waveform.

[0059] The electrode lead delivers electrical stimulation to a specific region of the body tissue through a plurality of electrode contacts after receiving the electrical stimulation transmitted by the IPG or the extension lead. The stimulator is provided with one or more electrode leads, for example, on one side or on both sides, and the electrode leads are provided with a plurality of electrode contacts which can be arranged uniformly or non-uniformly in the circumferential direction of the electrode lead. As an example, the electrode contacts can be arranged in an array of 4 rows and 3 columns (a total of 12 electrode contacts) in the circumferential direction of the electrode lead. The electrode contacts can include stimulation electrode contacts and / or collection electrode contacts. The electrode contacts can have a shape such as a sheet, a ring, a dot, etc.

[0060] In some embodiments, the body tissue to be stimulated can be brain tissue of the patient, and the site to be stimulated can be a specific site of the brain tissue. The site to be stimulated is generally different when the type of disease of the patient is different, and the number of stimulation contacts (single source or multiple sources) used, the use of one or more specific electrical stimulations (single channel or multiple channels), and the stimulation parameters (values) are also different.

[0061] The embodiments of the present application are not limited to the type of disease to be treated, and can be used for deep brain stimulation (DBS), spinal cord stimulation (SCS), sacral nerve stimulation, gastric stimulation, peripheral nerve stimulation, functional electrical stimulation, etc. The types of diseases that can be treated or managed by DBS include, but are not limited to, convulsive diseases (e.g., epilepsy), pain, migraine, mental diseases (e.g., major depressive disorder (MDD)), bipolar disorder, anxiety disorder, post-traumatic stress disorder, dysthymia, obsessive-compulsive disorder (OCD), behavioral disorders, emotional disorders, memory disorders, mental state disorders, movement disorders (e.g., essential tremor or Parkinson's disease), Huntington's disease, Alzheimer's disease, drug addiction, autism, or other neurological or psychiatric diseases and injuries.

[0062] In the embodiments of the present application, when the programming device and the stimulator establish a programming connection, the programming device can adjust one or more stimulation parameters of the stimulator (or one or more stimulation parameters of the pulse generator, different stimulation parameters correspond to different electrical stimulation), or the stimulator can sense the electrical physiological activity of the patient to collect an electrical physiological signal, and the stimulation parameters of the stimulator can be continuously adjusted based on the collected electrical physiological signal to achieve closed-loop control (or adaptive adjustment) of the stimulation parameters.

[0063] Stimulation parameters may include at least one of the following: electrode contact identification for delivering electrical stimulation (e.g., electrode contact #2 and electrode contact #3), frequency (e.g., the number of electrical stimulation pulse signals per second, in Hz), pulse width (duration of each pulse, in μs), amplitude (generally expressed as voltage, i.e., the intensity of each pulse, in V), timing (e.g., continuous or bursty, bursty refers to discontinuous timing behavior composed of multiple processes), stimulation mode (including one or more of current mode, voltage mode, timed stimulation mode, and cyclic stimulation mode), physician control upper and lower limits (the range that the physician can adjust), and patient control upper and lower limits (the range that the patient can adjust independently).

[0064] In some embodiments, the stimulation parameters of the stimulator can be adjusted in current mode or voltage mode.

[0065] Programmable devices can include physician-controlled devices (i.e., devices used by physicians) and / or patient-controlled devices (i.e., devices used by patients). Physician-controlled devices are, for example, smart terminal devices such as tablets, laptops, desktop computers, and mobile phones equipped with programming software. Patient-controlled devices are, for example, smart terminal devices such as tablets, laptops, desktop computers, and mobile phones equipped with programming software; patient-controlled devices can also be other electronic devices with programming functions (e.g., chargers with programming functions, electrophysiological acquisition devices, etc.).

[0066] like Figures 1-4 As shown, this embodiment provides an electrode wire 10, which includes a stimulation section 101, a connecting section 102, and an intermediate section 103 connecting the stimulation section 101 and the connecting section 102. The stimulation section 101 is provided with a plurality of electrode plates that are insulated and spaced apart along the circumferential direction. The stimulation section 101 is also provided with a development marking assembly 1. The development marking assembly 1 is provided with a first marking part 11 and a second marking part 12 that are interconnected along the axial direction of the electrode wire 10. The first marking part 11 is provided with at least one through marking hole 111, through which the angle of the development marking assembly 1 can be marked in the X-ray development image of the development marking assembly 1. The second marking part 12 includes two display films 121 extending along the axial direction of the electrode wire 10. The two display films 121 are arc-shaped and are spaced apart along the circumferential direction. A first notch 122 is provided between the two display films 121 that are close to each other along the circumferential direction, and a second notch 123 is provided between the two display films 121 that are far apart along the circumferential direction. The first notch 122 is smaller than the second notch 123.

[0067] Before the electrode lead 10 is implanted into the human body, the stimulating section 101 of the electrode lead 10 is rotated, and X-ray imaging of the developing identification component 1 in multiple directions is obtained as a reference image; then the electrode lead 10 is implanted into the human body, and a preset X-ray imaging of the stimulating section 101 of the electrode lead 10 in the working state is obtained; the preset X-ray imaging is compared with the reference image, and the angle of the developing identification component 1 in the preset X-ray imaging of the developing identification component 1 can be identified through the identification hole 111; in addition, the position of the electrode sheet of the stimulating section 101 of the electrode lead 10 relative to the developing identification component 1 is relatively fixed, when the angle of the developing identification component 1 is known, the direction of the electrode sheet can be obtained, which is convenient for subsequent operators to control the electrode sheet in a specific direction in the subsequent treatment process, improves the operation convenience, and improves the success rate of the operation.

[0068] When the CT image of the stimulating section 101 of the electrode lead 10 is obtained by the CT technology, a preset cross-sectional CT image of a preset position cross section in the CT image is selected, and the preset position cross section only includes two developing sheets 121; since the first gap 122 of the two developing sheets 121 is smaller than the second gap 123, the preset cross-sectional CT image presented by the two developing sheets 121 includes two first bright line areas 41 and two second bright line areas 42, the brightness of the first bright line area 41 is greater than the brightness of the second bright line area 42, and the position between the two first bright line areas 41 corresponds to the first gap 122 between the two developing sheets 121; since the position of the electrode sheet of the stimulating section 101 of the electrode lead 10 relative to the developing identification component 1 is relatively fixed, the direction of all the electrode sheets is determined according to the electrode sheet corresponding to the first gap 122 between the two developing sheets 121, which is also convenient for subsequent operators to control the electrode sheet in a specific direction in the subsequent treatment process, improves the operation convenience, and improves the success rate of the operation.

[0069] In the embodiment, the developing identification component 1 provided by the electrode lead 10 can obtain the direction information of the electrode sheet through the X-ray imaging technology and the CT technology, improve the success rate of the operation, improve the operation convenience, reduce the operation cost of the patient, and reduce the number of radioactive examinations of the patient.

[0070] In the embodiment, the first identification part 11 and the second identification part 12 are integrally formed; or the first identification part 11 and the second identification part 12 are insulatively and separately arranged on the stimulating section 101 along the axial direction of the stimulating section 101.

[0071] Preferably, the two ends of the identification hole 111 in the circumferential direction are asymmetric structures. Since the two ends of the identification hole 111 of the developing identification component 1 in the circumferential direction are asymmetric structures, the radiographic images of the identification hole 111 in different angles are different, so as to distinguish the rotating angles of the developing identification components corresponding to each X-ray imaging by taking the radiographic images as a reference.

[0072] In the embodiment, the projection of the identification hole 111 is a triangular hole, a first acute angle of the triangular hole is located at one end of the identification hole 111 in the circumferential direction, and a straight side of the triangular hole opposite to the first acute angle is located at the other end of the identification hole 111 in the circumferential direction. In other embodiments, the shape of the identification hole 111 can be a polygon, which can be a regular polygon such as a square, a rectangle, a regular pentagon, etc., or an irregular polygon. When the radiographic identification assembly 1 rotates with the electrode lead 10, the identification hole 111 can form different shapes in the radiographic image, each shape corresponding to a unique orientation, thereby accurately identifying the orientation of the electrode sheet.

[0073] In other embodiments, the identification hole 111 can also be two, the two identification holes 111 are arranged at intervals along the circumferential direction of the stimulation section 101, and the shapes of the two identification holes 111 are different, so that the identification hole 111 can identify the angle of the radiographic identification assembly 1 in the X-ray radiographic image of the radiographic identification assembly 1.

[0074] Preferably, the lengths of the two developing films 121 extending in the axial direction of the electrode lead 10 are different. When the X-ray radiographic image is obtained by X-ray imaging technology, the two developing films 121 present different shapes in X-ray radiographic images of different angles, and each shape also corresponds to a unique orientation, thereby assisting in judging and identifying the orientation of the electrode sheet.

[0075] Further preferably, the first identification part 11 includes an extension film part 112 extending in the axial direction of the electrode lead 10, and the identification hole 111 is arranged through the extension film part 112; the extension film part 112 is an unclosed ring, and the width of the extension film part 112 gradually increases or decreases from the first end of the extension film part 112 to the second end of the extension film part 112. In the embodiment, the first end of the extension film part 112 is close to one end of the two developing films 121, and the width of the extension film part 112 gradually decreases from the first end of the extension film part 112 to the second end of the extension film part 112. When the X-ray radiographic image is obtained by X-ray imaging technology, the extension film part 112 presents different shapes in X-ray radiographic images of different angles, and each shape also corresponds to a unique orientation, thereby assisting in judging and identifying the orientation of the electrode sheet.

[0076] As preferably, the circumferential arc of the extension film part 112 is less than 240°, so as to ensure that the extension film part 112 will develop different images in the radiographic image when the electrode lead 10 rotates to different angles.

[0077] In the embodiment, as Figure 3 and Figure 4As shown, the extension piece 112 is provided with a fixing ring 113 at both ends along the axial direction of the electrode lead 10, and the fixing ring 113 can be sleeved and connected to the stimulation section 101, so that the radiographic identification assembly 1 is fixed to the stimulation section 101 of the electrode lead 10, and the second identification part 12 is connected to one of the fixing rings 113.

[0078] Preferably, the fixing ring 113 has a clamping groove 1131 which is clamped with the stimulation section 101. In this embodiment, the stimulation section 101 is provided with a support 1011, the fixing ring 113 is sleeved on the support 1011, the support 1011 is provided with a protrusion 10111, and the protrusion 10111 is embedded in the clamping groove 1131 to prevent the fixing ring 113 from rotating relative to the stimulation section 101, thereby improving the structural stability.

[0079] Further, as shown in the figure, Figure 2 The stimulation section 101 is also provided with a directional electrode assembly 2, which includes a plurality of electrode pieces arranged in a circumferential direction and insulated from each other. Preferably, one of the plurality of electrode pieces is an indicator electrode piece 21, the indicator electrode piece 21 and the first notch 122 are located on a first axis 5, and the first axis 5 extends along the axial direction of the stimulation section 101; and / or the indicator electrode piece 21 and the identification hole 111 are located on the first axis 5. In this embodiment, the indicator electrode piece 21, the first notch 122 and the identification hole 111 are all located on the first axis 5, so that after obtaining the angle information of the radiographic identification assembly 1, the direction of the indicator electrode piece 21 can be indirectly obtained, and then the directions of all the electrode pieces can be obtained.

[0080] In this embodiment, the stimulation section 101 is provided with two stimulation rings 3 and two directional electrode assemblies 2, each directional electrode assembly 2 includes three electrode pieces arranged in a circumferential direction and insulated from each other, and the stimulation section 101 of the electrode lead 10 is sequentially and spacedly provided with one stimulation ring 3, two directional electrode assemblies 2, another stimulation ring 3 and the radiographic identification assembly 1 along the axial direction, forming an electrode lead 10 with 1-3-3-1 type 8 contacts. In other embodiments, the number of directional electrode assemblies 2 and the number of electrode pieces in the directional electrode assembly 2 can be adaptively selected according to requirements, which are all within the protection scope of this embodiment.

[0081] This embodiment also provides a method for identifying the direction of the electrode piece, which is applied to the above-mentioned electrode lead 10, and includes an X-ray image-based identification method, as shown in the figure, Figure 11 The X-ray image-based identification method includes the following steps:

[0082] S11, rotate the stimulation section 101 of the electrode lead 10 to obtain X-ray radiographic images of the radiographic identification assembly 1 in multiple directions as reference images; before the operation, X-ray radiographic images of the radiographic identification assembly 1 in multiple directions are obtained outside the human body as reference images. In this embodiment, as shown in the figure,Figure 5 As shown in the figure, the X-ray developing images of the developing mark assembly 1 at 0°, 90°, 180° and 270° can be selected as the reference images, wherein the initial position is when the electrode sheet 21 is directed to the treatment target, at this time, the angle of the developing mark assembly 1 is set to 0°, and the first gap 122 between the mark hole 111 and the two developing sheets 121 are all directed to the treatment target. In this embodiment, the radiation image formed by the mark hole 111 is referred to as the hole image, the radiation image formed by the extension sheet part 112 is referred to as the first bottom image, the radiation image formed by the two developing sheets 121 is referred to as the second bottom image, and the radiation image of the fixed ring 113 is a rectangle. The changes of the X-ray developing images are as follows:

[0083] When the developing mark assembly 1 is at 0°, the first gap 122 of the extension sheet part 112, the mark hole 111 and the two developing sheets 121 are directly opposite, at this time, the hole image is a triangle with the tip pointing to the right, the first bottom image is wide at the top and narrow at the bottom, and the second bottom image is two rectangles with the left side shorter than the right side;

[0084] When the developing mark assembly 1 is at 90°, the first bottom image is in the shape of a right triangle, the long straight angle side of the right triangle is located on the left side, the left side of the first bottom image is flush with the left side of the fixed ring 113, the hole image is a gap on the long straight angle side of the right triangle of the first bottom image, and the second bottom image is a rectangle with increased width;

[0085] When the developing mark assembly 1 is at 180°, the X-ray developing image is a symmetrical structure with the X-ray developing image when the developing mark assembly 1 is at 0°, the hole image is a triangle with the tip pointing to the left, the first bottom image is wide at the top and narrow at the bottom, and the second bottom image is two rectangles with the left side longer than the right side;

[0086] When the developing mark assembly 1 is at 270°, the X-ray developing image is a symmetrical structure with the X-ray developing image when the developing mark assembly 1 is at 90°, the first bottom image is in the shape of a right triangle, the long straight angle side of the right triangle is located on the right side, the right side of the first bottom image is flush with the right side of the fixed ring 113, the hole image is a gap on the long straight angle side of the right triangle of the first bottom image, and the second bottom image is a rectangle with increased width.

[0087] S12, obtaining a preset X-ray developing image of the stimulation section 101 of the electrode lead 10 in the working state; after the stimulation section 101 of the electrode lead 10 is implanted into the human body, a preset X-ray developing image of the stimulation section 101 of the electrode lead 10 implanted in the human body is obtained.

[0088] S13, comparing the preset X-ray developing image with the reference image, and determining the direction of the electrode sheet according to the radiation image corresponding to the mark hole 111 in the preset X-ray developing image.

[0089] This embodiment obtains the angle information of the developing marking component 1 by comparing a preset X-ray developing image with X-ray developing images at 0°, 90°, 180°, and 270° in the reference image, thereby determining the orientation of the electrode sheet. For example, the position of the marking hole 111 and the first notch 122 between the two developing films 121 in the developing marking component 1 are on the same side as the orientation of the indicating electrode sheet 21. Therefore, the orientation of the indicating electrode sheet 21 is determined based on the orientation of the marking hole 111 and the first notch 122 in the developing marking component 1. Since the position of the electrode sheet is relatively fixed with the position of the indicating electrode sheet 21, the orientation of all electrode sheets can be derived.

[0090] Furthermore, this embodiment also provides a method for identifying the orientation of electrode pads, applied to the aforementioned electrode wire 10. The method for identifying the orientation of electrode pads includes a CT image-based identification method, such as... Figure 12 As shown, the CT image recognition method includes the following steps:

[0091] S21. Obtain a CT image of the stimulation segment 101 of the electrode lead 10; after surgery, obtain a CT image of the stimulation segment 101 of the electrode lead 10 implanted in the human body.

[0092] S22. Select a preset section CT image of a preset location section from the CT images, such as... Figure 6 As shown, the preset position section contains only two display films 121;

[0093] S23, such as Figure 7 As shown, the preset cross-sectional CT image includes two first bright line regions 41 and two second bright line regions 42. The brightness of the first bright line region 41 is greater than that of the second bright line region 42. The position between the two first bright line regions 41 corresponds to the first gap 122 between the two display films 121. The orientation of the electrode sheet is determined according to the first gap 122 of the two display films 121.

[0094] For example, in this embodiment, the orientation electrode assembly 2 includes three electrode pieces, one of which is an indicator electrode piece 21. The indicator electrode piece 21 is located on the same side as the first notch 122. The orientation of the indicator electrode piece 21 is determined according to the orientation of the first notch 122 in the developing marking assembly 1. The positions of the electrode pieces and the indicator electrode piece 21 are relatively fixed. Therefore, the orientation of all electrode pieces can be derived.

[0095] This CT image recognition method allows operators to intuitively identify the angle and position of electrode pads, improving operational convenience and application success rate.

[0096] It should be noted that the basic principle of CT scanning is to scan the layer of a certain thickness of the human body by using the X-ray beam. When X-rays penetrate the human body, the intensity of the rays received by the detector will change due to the different absorption of X-rays by different tissues. These changing ray signals are converted into electrical signals and converted into digital signals by an analog / digital converter, and then input into a computer for processing. The X-ray beam is composed of single photons with a certain energy range. When the beam passes through an object, it becomes "harder", producing a metal artifact, and this effect is called a beam hardening artifact: that is, dark bands or stripes appear between dense objects in the image. The beam hardening artifact can produce dark stripes 201 between the two films 121. They can also produce dark stripes 201 along the long axis of a single film 121, so the bright stripes 202 are adjacent to the dark stripes 201. Therefore, the present embodiment utilizes the principle of the beam hardening artifact to produce a directional artifact for indicating the middle position of the first gap 122.

[0097] For example, as shown in Figure 8 , using technical principle 1, the beam hardening artifact produces dark stripes 201 between two high-attenuation objects (such as metal), i.e. films 121.

[0098] As shown in Figure 9 , using technical principle 2, the beam hardening artifact produces dark stripes 201 along the long axis of a single high-attenuation object (such as metal), i.e. film 121.

[0099] The beam hardening artifact is produced by combining the above technical principle 1 and technical principle 2. Another problem that causes strip artifacts is the Compton scattering effect. Scattering can cause X-ray photons to change direction and energy, so as shown in Figure 7 and Figure 10 , the bright and dark stripes 201 are not completely symmetrical, and the brightness and darkness are different, so in the CT actual image; that is, the two brightest first bright line regions 41 and the darkest middle stripe 201 provide a directional indication function of the first gap 122.

[0100] Preferably, the arc angle of at least one film 121 is X, 10°≤X≤170°; and / or the arc angle of the first gap 122 is Y, 10°≤Y<160°. To ensure that the first bright line region 41, the second bright line region 42 and the dark stripe 201 in the preset cross-sectional CT image are clear and the partition is obvious, the identification accuracy of the middle region of the two first bright line regions 41 is improved.

[0101] This embodiment also provides a stimulation system, including an implantable pulse generator and the aforementioned electrode wire 10. The stimulation segment 101 of the electrode wire 10 is used for implantation in the brain, and the connection segment 102 of the electrode wire 10 is electrically connected to the implantable pulse generator.

[0102] Preferably, the stimulation system further includes an extension wire, through which the implantable pulse generator is electrically connected to the electrode wire 10.

[0103] Example 2

[0104] like Figure 13 As shown, this embodiment provides an electrode wire 10, and the structure of the electrode wire 10 provided in this embodiment is basically the same as that in Embodiment 1, except that the structure of the stimulation segment 101 of the electrode wire 10 is partially different. This embodiment will not describe the structure that is the same as that in Embodiment 1.

[0105] In this embodiment, the stimulation section 101 of the electrode wire 10 is provided with four directional electrode assemblies 2. The four directional electrode assemblies 2 are insulated and spaced apart along the axial direction of the electrode wire 10, forming a 3-3-3-3 type 12-contact electrode wire 10. By identifying the orientation of the electrode pieces, the angle and position of the indicator electrode piece 21 within one directional electrode assembly 2 can be obtained, thus determining the angle and position of any electrode piece. In other embodiments, the number of directional electrode assemblies 2 can be adaptively selected according to requirements, all within the scope of protection of this embodiment.

[0106] Note that the above are merely preferred embodiments and the technical principles employed in this application. Those skilled in the art will understand that this application is not limited to the specific embodiments described herein, and various obvious changes, readjustments, and substitutions can be made without departing from the scope of protection of this application. Therefore, although this application has been described in detail through the above embodiments, this application is not limited to the above embodiments, and may include many other equivalent embodiments without departing from the concept of this application, the scope of which is determined by the scope of the appended claims.

Claims

1. An electrode lead comprising a stimulation segment (101), a connecting segment (102) and an intermediate segment (103) connecting the stimulation segment (101) and the connecting segment (102), the stimulation segment (101) being provided with a directional electrode assembly (2) comprising a plurality of electrode segments arranged in circumferential insulation intervals, characterized in that, The stimulation section (101) is also provided with a developing identification assembly (1), which is provided with a first identification part (11) and a second identification part (12) connected with each other in the axial direction of the electrode lead wire, the first identification part (11) is provided with at least one identification hole (111) penetrating through, and the angle of the developing identification assembly (1) can be identified in the X-ray developing image of the developing identification assembly (1) through the identification hole (111); The second identification part (12) comprises two developing films (121) extending in the axial direction of the electrode lead wire, the two developing films (121) are arc-shaped, the two developing films (121) are arranged in a circumferential direction and spaced apart, a first gap (122) is arranged between the ends of the two developing films (121) close to each other in the circumferential direction, and a second gap (123) is arranged between the ends of the two developing films (121) away from each other in the circumferential direction, and the first gap (122) is smaller than the second gap (123).

2. The electrode lead of claim 1, wherein The two ends of the identification hole (111) in the circumferential direction are asymmetric structures.

3. The electrode lead of claim 1, wherein, The projection of the identification hole (111) is a triangular hole, the first acute angle of the triangular hole is located at one end of the identification hole (111) in the circumferential direction, and the straight edge opposite to the first acute angle in the triangular hole is located at the other end of the identification hole (111) in the circumferential direction.

4. The electrode lead of claim 1, wherein, The first identification part (11) and the second identification part (12) are integrally formed; or The first identification part (11) and the second identification part (12) are insulated and spaced apart on the stimulation section (101) in the axial direction of the stimulation section (101).

5. The electrode lead of claim 1, wherein, The lengths of the two developing films (121) extending in the axial direction of the electrode lead wire are different.

6. The electrode lead of claim 4, wherein, A plurality of electrode pieces are provided with an indicating electrode piece (21), the indicating electrode piece (21) is located on a first axis (5) with the first gap (122), the first axis (5) extends in the axial direction of the stimulation section (101); and / or the indicating electrode piece (21) is located on the first axis (5) with the identification hole (111).

7. The electrode lead of claim 1, wherein, The first identification part (11) comprises an extension piece part (112) extending in the axial direction of the electrode lead wire, and the identification hole (111) is arranged penetratingly on the extension piece part (112); the extension piece part (112) is in an unsealed ring shape, and the width of the extension piece part (112) gradually increases or decreases from a first end of the extension piece part (112) to a second end of the extension piece part (112).

8. The electrode lead of claim 7, wherein, The circumferential arc of the extension piece part (112) is less than 240°.

9. The electrode lead of claim 7, wherein, Both ends of the extension piece part (112) in the axial direction of the electrode lead wire are provided with a fixing ring (113), the fixing ring (113) can be sleeved and connected to the stimulation section (101), and the second identification part (12) is connected to one of the fixing rings (113).

10. The electrode lead of claim 9, wherein, The fixing ring (113) has a clamping groove (1131) which is clamped with the stimulation section (101).

11. The electrode lead of claim 1, wherein, at least one of the film (121) has an arc angle X, 10°≤X≤170°; and / or the first gap (122) has an arc angle Y, 10°≤Y<160°.

12. A stimulation system comprising an implantable pulse generator and an electrode lead according to any one of claims 1-11, the stimulation segment (101) of the electrode lead being configured for implantation in the brain, the connection segment (102) of the electrode lead being configured for electrical connection to the implantable pulse generator.

13. The stimulation system of claim 12, wherein, The stimulation system further comprises an extension lead, the implantable pulse generator being electrically connected to the electrode lead via the extension lead.

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