Electrode lead, stimulation system, and method for identifying orientation of electrode plate
Patent Information
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- SCENERAY
- Filing Date
- 2025-09-18
- Publication Date
- 2026-06-25
Smart Images
Figure CN2025122197_25062026_PF_FP_ABST
Abstract
Description
An electrode lead, a stimulation system, and a method for identifying the orientation of electrode pads.
[0001] This application claims priority to Chinese Patent Application No. 202411855417.6, filed on December 16, 2024, and Chinese Patent Application No. 202423108221.9, filed on December 16, 2024, the entire contents of which are incorporated herein by reference. Technical Field
[0002] This application relates to the field of medical product technology, such as an electrode lead, a stimulation system, and a method for identifying the orientation of electrode pads. Background Technology
[0003] Deep brain stimulation (DBS) is an invasive neuromodulation technique. This technique involves implanting stimulating electrodes into specific neural structures in the brain using stereotactic surgery, and then implanting a neurostimulator to connect to the electrodes. The DBS delivers adjustable and controllable weak electrical pulses, thereby altering the electrical activity and function of brain neural circuits and networks to control and improve patient symptoms.
[0004] Traditional DBS electrodes have circular metal contacts for stimulation output, and the entire electrode is rotationally symmetrical at any angle without a specific orientation. Newer DBS electrode designs allow the original circular metal contacts to be divided into multiple segments, typically three equal parts. These electrodes support independent control of the stimulation output parameters of one or more segments, thereby achieving stimulation of brain tissue in a specific direction; hence, they are called "directional electrodes."
[0005] However, once the DBS electrode is implanted in the human body, it is impossible to obtain the angle information of the stimulation end of the electrode wire, making it inconvenient to control the segmented contact points in a specific direction.
[0006] Therefore, there is an urgent need for an electrode lead, a stimulation system, and a method for identifying the orientation of the electrode pads to solve the aforementioned problems. Summary of the Invention
[0007] This application provides an electrode lead, a stimulation system, and a method for identifying the orientation of electrode pads. The orientation information of the electrode pads can be obtained through both X-ray imaging and CT technology, which improves the success rate of surgery, enhances the convenience of operation, reduces surgical costs for patients, and reduces the number of radiological examinations for patients.
[0008] The following technical solution is adopted in this application:
[0009] In a first aspect, an electrode wire is provided, the electrode wire including a stimulation section, a connecting section and an intermediate section connecting the stimulation section and the connecting section, the stimulation section being provided with a plurality of electrode plates arranged circumferentially with insulating intervals, the stimulation section also being provided with a development marking assembly, the development marking assembly being provided with a first marking part and a second marking part connected to each other along the axial direction of the electrode wire, the first marking part being provided with at least one through marking hole, through which the angle of the development marking assembly can be marked in the X-ray development image of the development marking assembly;
[0010] The second marking portion includes two display films extending axially along the electrode wire. The two display films are arc-shaped and are spaced apart circumferentially. A first notch is provided between the ends of the two display films that are close to each other circumferentially, and a second notch is provided between the ends of the two display films that are opposite to each other circumferentially. The first notch is smaller than the second notch.
[0011] Secondly, a stimulation system is provided, comprising an implantable pulse generator and the electrode wires described above, wherein the stimulation segment of the electrode wires is configured to be implanted in the brain, and the connection segment of the electrode wires is electrically connected to the implantable pulse generator.
[0012] Thirdly, a method for identifying the orientation of electrode pads is provided, applied to the electrode wires described above. The method for identifying the orientation of electrode pads includes an X-ray image recognition method, which includes:
[0013] The stimulation segment of the electrode wire is rotated to obtain X-ray imaging images of the imaging marker assembly in multiple directions as reference images;
[0014] Acquire a preset X-ray imaging image of the stimulation segment of the electrode wire in its working state;
[0015] The preset X-ray imaging image is compared with the reference image, and the orientation of the electrode sheet is determined according to the radiation image corresponding to the marked hole in the preset X-ray imaging image.
[0016] Fourthly, a method for identifying the orientation of electrode pads is provided, applied to the electrode wires described above. The method for identifying the orientation of electrode pads includes a CT image-based identification method, which includes:
[0017] Acquire CT images of the stimulation segment of the electrode leads;
[0018] Select a preset section CT image of a preset position section in the CT image, wherein the preset position section contains only two images;
[0019] The preset cross-sectional CT image includes two first bright line regions and two second bright line regions. The brightness of the first bright line regions is greater than that of the second bright line regions. The position between the two first bright line regions corresponds to the first gap between the two imaging films. The orientation of the electrode pads is determined based on the first gap between the two imaging films. Attached Figure Description
[0020] Figure 1 is a schematic diagram of the structure of the electrode wire provided in Embodiment 1 of this application;
[0021] Figure 2 is a partial structural diagram of the stimulation segment of the electrode wire provided in Embodiment 1 of this application;
[0022] Figure 3 is a schematic diagram of the developing label component provided in Embodiment 1 of this application;
[0023] Figure 4 is a partial structural schematic diagram of the electrode wire provided in Embodiment 1 of this application;
[0024] Figure 5 shows X-ray images of the developing marking component provided in Embodiment 1 of this application from different angles;
[0025] Figure 6 is a schematic diagram of the preset position section located at point XX in Figure 3;
[0026] Figure 7 is a schematic diagram of a preset cross-sectional CT image provided in Embodiment 1 of this application;
[0027] Figure 8 is a schematic diagram of the technical principle 1 of the X-ray hardening effect artifact provided in Embodiment 1 of this application;
[0028] Figure 9 is a schematic diagram of the technical principle 2 of the X-ray hardening effect artifact provided in Embodiment 1 of this application;
[0029] Figure 10 is a schematic diagram combining the principle 1 and the technical principle 2 of the ray hardening effect artifact technology provided in Embodiment 1 of this application;
[0030] Figure 11 is a flowchart of the X-ray image recognition method provided in Embodiment 1 of this application;
[0031] Figure 12 is a flowchart of the CT image recognition method provided in Embodiment 1 of this application;
[0032] Figure 13 is a schematic diagram of the stimulation segment of the electrode wire provided in Embodiment 2 of this application.
[0033] The diagram is marked as follows: 10, Electrode lead; 101, Stimulation section; 1011, Support; 10111, Protrusion; 102, Connecting section; 103, Middle section; 201, Dark stripe; 202, Bright stripe; 1, Developing marking assembly; 11, First marking part; 111, Marking hole; 112, Extension piece part; 113, Fixing ring; 1131, Slot; 12, Second marking part; 121, Developing film; 122, First notch; 123, Second notch; 2, Directional electrode assembly; 21, Indicating electrode piece; 3, Stimulation ring; 41, First bright line area; 42, Second bright line area; 5, First axis. Detailed Implementation
[0034] The present application will now be described in detail with reference to the accompanying drawings and embodiments. In the description of this application, unless otherwise expressly specified and limited, the terms "connected," "linked," and "fixed" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.
[0035] In this application, unless otherwise expressly specified and limited, "above" or "below" the second feature can include direct contact between the first and second features, or contact between the first and second features through another feature between them. Furthermore, "above," "over," and "on top" of the second feature includes the first feature being directly above or diagonally above the second feature, or simply indicates that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature includes the first feature being directly below or diagonally below the second feature, or simply indicates that the first feature is at a lower horizontal level than the second feature.
[0036] In the description of this embodiment, the terms "upper," "lower," "left," and "right," etc., refer to the orientation or positional relationship shown in the accompanying drawings. They are used only for ease of description and simplification of operation, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this application. In addition, the terms "first" and "second" are used only for distinction in description and have no special meaning.
[0037] Example 1
[0038] The technical field and related terms of the embodiments of this application are briefly described below.
[0039] Implantable medical systems include implantable neurostimulation systems, implantable cardiac stimulation systems (also known as pacemakers), implantable drug delivery systems (IDDS), and lead transfer systems. Examples of implantable neurostimulation systems include deep brain stimulation (DBS), cortical nerve stimulation (CNS), spinal cord stimulation (SCS), sacral nerve stimulation (SNS), and vagus nerve stimulation (VNS).
[0040] Implantable neurostimulation systems consist of a stimulator implanted in the patient's body (i.e., an implantable neurostimulator) and a programmed device placed outside the patient's body. In other words, the stimulator is a medical device, or medical devices include stimulators. Related neuromodulation techniques primarily involve stereotactic surgery to implant electrodes (e.g., electrode wires) at specific sites (target points) in the body's tissues. Discharge pulses are then delivered through these electrodes to the target points, modulating the electrical activity and function of corresponding neural structures and networks, thereby improving symptoms and alleviating pain.
[0041] As an example, a DBS includes an IPG (Implantable Pulse Generator), extension leads, and electrode leads. The IPG (i.e., the stimulator) is connected to the electrode leads via the extension leads. The IPG is implanted in the patient's body, for example, in the chest or other internal locations.
[0042] As another example, DBS includes an IPG and electrode leads, with the IPG directly connected to the electrode leads. The IPG is implanted in the patient's head, for example, by creating a groove in the patient's skull and then placing the IPG in the groove. In this case, the IPG may not protrude from the outer surface of the skull, or it may protrude partially from the outer surface of the skull.
[0043] In this system, the IPG responds to programmed commands sent by a programmable device, relying on sealed batteries and circuits to provide controllable electrical stimulation therapy (or electrical stimulation energy) to tissues within the body. The IPG delivers one or more controllable specific electrical stimuli to specific areas of tissues within the body via electrode leads.
[0044] In some embodiments, the extension wire is used in conjunction with the IPG as a medium for transmitting electrical stimulation, thereby transmitting the electrical stimulation generated by the IPG to the electrode wire.
[0045] In some embodiments, electrical stimulation can be delivered in the form of a pulsed signal or a non-pulsed signal. For example, electrical stimulation can be delivered as a signal with various waveform shapes, frequencies, and amplitudes. Therefore, non-pulsed signal electrical stimulation can be a continuous signal, which can have a sinusoidal waveform or other continuous waveforms.
[0046] After receiving electrical stimulation from the IPG or extension leads, the electrode leads deliver the stimulation to specific areas of tissue within the body via multiple electrode contacts. The stimulator may have one or more electrode leads on one or both sides, with multiple electrode contacts on each lead. These contacts may be evenly or non-uniformly arranged circumferentially on the electrode leads. As an example, the electrode contacts may be arranged in a 4x3 array (a total of 12 contacts) circumferentially on the electrode leads. The electrode contacts may include stimulating electrode contacts and / or collecting electrode contacts. The electrode contacts may be in shapes such as sheet-like, ring-like, or dot-like.
[0047] In some embodiments, the stimulated tissue may be the patient's brain tissue, and the stimulated site may be a specific location within the brain tissue. Generally, the stimulated site differs depending on the patient's disease type, and the number of stimulation contacts (single-source or multi-source), the application of one or more specific electrical stimulation pathways (single-channel or multi-channel), and the stimulation parameters (values) also vary.
[0048] This application does not limit the applicable disease types, but can be any disease type applicable to deep brain stimulation (DBS), spinal cord stimulation (SCS), sacral nerve stimulation, gastric stimulation, peripheral nerve stimulation, or functional electrical stimulation. Among these, DBS can be used to treat or manage diseases including, but not limited to: spastic disorders (e.g., epilepsy), pain, migraines, mental illnesses (e.g., major depressive disorder (MDD)), bipolar disorder, anxiety disorders, post-traumatic stress disorder, mild depression, obsessive-compulsive disorder (OCD), behavioral disorders, mood disorders, memory disorders, mental state disorders, mobility 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 impairments.
[0049] In this embodiment of the application, when the programmable device and the stimulator establish a programmable connection, the programmable device can be used to adjust at least one stimulation parameter of the stimulator (or at least one stimulation parameter of the pulse generator, different stimulation parameters correspond to different electrical stimuli). Alternatively, the stimulator can sense the patient's electrophysiological activity to collect electrophysiological signals, and the collected electrophysiological signals can be used to continue to adjust the stimulation parameters of the stimulator to achieve closed-loop control (or adaptive adjustment) of the stimulation parameters.
[0050] 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).
[0051] In some embodiments, the stimulation parameters of the stimulator can be adjusted in current mode or voltage mode.
[0052] 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.).
[0053] As shown in Figures 1-4 and 6, 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 arranged circumferentially with insulating intervals. The stimulation section 101 is also provided with a development marking assembly 1, which 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 11. 1. The angle of the developing marking component 1 can be marked in the X-ray developing image of the developing marking component 1 through the marking hole 111; the second marking part 12 includes two developing films 121 extending along the axial direction of the electrode wire 10. The two developing films 121 are arc-shaped and are spaced apart in the circumferential direction. A first notch 122 is provided between the two ends of the two developing films 121 that are close to each other in the circumferential direction, and a second notch 123 is provided between the two ends of the two developing films 121 that are far apart in the circumferential direction. The first notch 122 is smaller than the second notch 123.
[0054] Before the electrode lead 10 is implanted into the human body, the stimulation segment 101 of the electrode lead 10 is rotated, and X-ray imaging images of the imaging marker component 1 in multiple directions are obtained as reference images. Then, the electrode lead 10 is implanted into the human body, and a preset X-ray imaging image of the stimulation segment 101 of the electrode lead 10 in working state is obtained. The preset X-ray imaging image is compared with the reference image, and the angle of the imaging marker component 1 can be marked in the preset X-ray imaging image of the imaging marker component 1 through the marking hole 111. Furthermore, the position of the electrode sheet of the stimulation segment 101 of the electrode lead 10 relative to the imaging marker component 1 is relatively fixed. When the angle of the imaging marker component 1 is known, the orientation of the electrode sheet can be obtained, which facilitates the subsequent operation of the operator to control the operation of the electrode sheet in a specific direction during the treatment process, improves the convenience of operation, and increases the success rate of the surgery.
[0055] When a CT image of the stimulation segment 101 of the electrode lead 10 is obtained using CT technology, a preset cross-sectional CT image of a preset position section is selected in the CT image. The preset position section contains only two imaging films 121. Since the first notch 122 of the two imaging films 121 is smaller than the second notch 123, as shown in Figure 7, the preset cross-sectional CT image presented by the two imaging films 121 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 the brightness of the second bright line region 42. The position between the two first bright line regions 41 corresponds to the first notch 122 between the two imaging films 121, thereby obtaining the rotation angle of the imaging marker component 1. Since the position of the electrode sheet of the stimulation segment 101 of the electrode lead 10 relative to the imaging marker component 1 is fixed, the orientation of all electrode sheets is determined according to the electrode sheet corresponding to the first notch 122 between the two imaging films 121. This also facilitates the subsequent operation of the operator to control the operation of the electrode sheet in a specific direction during the treatment process, improves the convenience of operation, and increases the success rate of the surgery.
[0056] In this embodiment, the imaging marker component 1 set by the electrode wire 10 can obtain the orientation information of the electrode sheet through both X-ray imaging technology and CT technology, thereby improving the success rate of surgery, improving the convenience of operation, reducing the surgical cost for patients, and reducing the number of radiological examinations for patients.
[0057] In this embodiment, the first marking part 11 and the second marking part 12 are integrally formed; or the first marking part 11 and the second marking part 12 are disposed on the stimulation section 101 with an insulating gap along the axial direction of the stimulation section 101.
[0058] Optionally, the two ends of the marking hole 111 along the circumferential direction are asymmetrical. Since the two ends of the marking hole 111 of the developing marking assembly 1 are asymmetrical along the circumferential direction, the radiographic images of the marking hole 111 at different angles are different, and this is used as a reference to distinguish the rotation angle of the developing marking corresponding to each X-ray developing image.
[0059] In this embodiment, the projection of the marking hole 111 is a triangular hole, with the first apex of the triangle located at one end of the marking hole 111 along the circumference, and the straight side inside the triangle opposite to the first apex located at the other end of the marking hole 111 along the circumference. In other embodiments, the shape of the marking hole 111 can be polygonal. This polygon can be a regular polygon, such as a square, rectangle, or regular pentagon, or it can be an irregular polygon. In the radiographic image, when the developing marking component 1 rotates with the electrode wire 10, the marking hole 111 can form different shapes, each shape corresponding to a unique orientation, thereby accurately identifying the orientation of the electrode sheet.
[0060] In other embodiments, there may be two marking holes 111, which are arranged circumferentially at intervals along the stimulation segment 101. The two marking holes 111 have different shapes, so that the angle of the developing marking component 1 can be marked in the X-ray developing image of the developing marking component 1 through the marking holes 111.
[0061] Optionally, the two imaging films 121 extend to different lengths along the axial direction of the electrode wire 10. When acquiring X-ray images using X-ray imaging technology, the two imaging films 121 exhibit different shapes in X-ray images at different angles, and each shape corresponds to a unique orientation, thereby assisting in determining and identifying the orientation of the electrode sheet.
[0062] Optionally, referring to Figure 3, the first marking portion 11 includes an extension portion 112 extending axially along the electrode wire 10, with a marking hole 111 passing through the extension portion 112. The extension portion 112 is an open annular shape, and its width gradually increases or decreases from its first end to its second end. In this embodiment, the first end of the extension portion 112 is the end closest to the two display films 121, and its width gradually increases from its first end to its second end. When acquiring X-ray images using X-ray imaging technology, the extension portion 112 presents different shapes in X-ray images at different angles, and each shape corresponds to a unique orientation, thereby assisting in determining and identifying the orientation of the electrode films.
[0063] Alternatively, the circumferential curvature of the extension portion 112 is less than 240° to ensure that the extension portion 112 will produce different images in the radiographic imaging when the electrode wire 10 is rotated to different angles.
[0064] In this embodiment, as shown in Figures 3 and 4, both ends of the extension sheet 112 along the axial direction of the electrode wire 10 are provided with fixing rings 113. The fixing rings 113 can be sleeved and connected to the stimulation section 101, thereby realizing that the imaging marking assembly 1 is fixed on the stimulation section 101 of the electrode wire 10, and the second marking part 12 is connected to a fixing ring 113.
[0065] Optionally, the fixing ring 113 has a slot 1131 that engages with the stimulation segment 101. In this embodiment, the stimulation segment 101 is provided with a bracket 1011, and the fixing ring 113 is sleeved on the bracket 1011. The bracket 1011 is provided with a protrusion 10111, which is embedded in the slot 1131 to prevent the fixing ring 113 from rotating relative to the stimulation segment 101 and to improve the structural stability.
[0066] For example, as shown in FIG2, the stimulation segment 101 is further provided with a directional electrode assembly 2, which includes a plurality of electrode sheets arranged with insulating intervals along the circumference. Optionally, the plurality of electrode sheets include an indicator electrode sheet 21, which is located on a first axis 5 with the first notch 122, and the first axis 5 extends along the axial direction of the stimulation segment 101 (i.e., the axial direction of the electrode wire 10); and / or the indicator electrode sheet 21 is located on the first axis 5 with the marking hole 111. In this embodiment, the indicator electrode sheet 21, the first notch 122 and the marking hole 111 are all located on the first axis 5. After obtaining the angle information of the imaging marking assembly 1, the orientation of the indicator electrode sheet 21 can be indirectly obtained, and thus the orientation of all electrode sheets can be obtained.
[0067] In this embodiment, the stimulation segment 101 is provided with two stimulation rings 3 and two directional electrode assemblies 2. Each directional electrode assembly 2 includes three electrode plates arranged circumferentially with insulating spacing. The stimulation segment 101 of the electrode wire 10 is provided with one stimulation ring 3, two directional electrode assemblies 2, another stimulation ring 3, and a imaging marking assembly 1 arranged sequentially and at intervals along the axial direction, forming a 1-3-3-1 type 8-contact electrode wire 10. In other embodiments, the number of directional electrode assemblies 2 and the number of electrode plates within the directional electrode assembly 2 can be adaptively selected according to requirements, all of which are within the protection scope of this embodiment.
[0068] This embodiment also provides a method for identifying the orientation of an electrode sheet, applied to the electrode wire 10 described above. The method for identifying the orientation of the electrode sheet includes an X-ray image recognition method, as shown in FIG11, which includes S11-S13.
[0069] S11. Rotate the stimulation segment 101 of the electrode wire 10 to obtain X-ray imaging images of the imaging marker assembly 1 in multiple directions as reference images.
[0070] Before surgery, X-ray images of the imaging marker assembly 1 from multiple directions are acquired outside the human body as reference images. In this embodiment, as shown in Figure 5, X-ray images of the imaging marker assembly 1 at 0°, 90°, 180°, and 270° can be selected as reference images. The initial position is taken when the indicator electrode 21 faces the treatment target. At this time, the angle of the imaging marker assembly 1 is set to 0°, and the first notch 122 between the marker hole 111 and the two display films 121 both face the treatment target. In this embodiment, the radiographic image formed by the marker hole 111 is hereinafter referred to as the hole image, the radiographic image formed by the extension 112 is hereinafter referred to as the first background image, the radiographic image formed by the two display films 121 is hereinafter referred to as the second background image, and the radiographic images of the fixing ring 113 are all rectangular. The changes in the X-ray imaging images are as follows:
[0071] When the developing marker assembly 1 is at 0°, the field of view is directly facing the first notch 122 between the extension film 112, the marker hole 111 and the two developing films 121. At this time, the X-ray irradiation produces the leftmost image in Figure 5. The hole image is a triangle with the tip pointing to the right, the first bottom image is wider at the top and narrower at the bottom, and the second bottom image is two rectangles that are shorter on the left and longer on the right.
[0072] When the developing mark assembly 1 is at 90°, the first bottom image is a right-angled triangle with the longer right-angled side of the right-angled triangle on the left side. The left side of the first bottom image is flush with the left side of the fixing ring 113. The hole image is a notch on the longer right-angled side of the right-angled triangle of the first bottom image. The second bottom image is a rectangle with increased width.
[0073] When the developing marker component 1 is at 180°, the X-ray developing image with the developing marker component 1 at 0° is symmetrical, the aperture image is a triangle with the tip pointing to the left, the first bottom image is wider at the top and narrower at the bottom, and the second bottom image is two rectangles with the left side longer than the right side.
[0074] When the developing mark assembly 1 is at 270°, the X-ray developing image at 90° with the developing mark assembly 1 is symmetrical. The first base image is a right-angled triangle with the long right-angled side of the right triangle on the right side. The right side of the first base image is flush with the right side of the fixing ring 113. The hole image is a notch on the long right-angled side of the right triangle of the first base image. The second base image is a rectangle with increased width.
[0075] S12. Obtain a preset X-ray imaging image of the stimulation segment 101 of the electrode lead 10 when it is in working state.
[0076] After the stimulation segment 101 of the electrode wire 10 is implanted into the human body, a preset X-ray imaging image of the stimulation segment 101 of the electrode wire 10 implanted in the human body is obtained.
[0077] S13. Compare the preset X-ray imaging image with the reference image, and determine the orientation of the electrode sheet according to the radiation image corresponding to the marked hole 111 in the preset X-ray imaging image.
[0078] 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.
[0079] This embodiment also provides a method for identifying the orientation of electrode pads, applied to the electrode wire 10 described above. The method for identifying the orientation of electrode pads includes a CT image recognition method, as shown in Figure 12, which includes steps S21-S23.
[0080] S21. Obtain a CT image of the stimulation segment 101 of the electrode lead 10.
[0081] After the surgery, CT images of the stimulation segment 101 of the electrode lead 10 implanted in the human body are obtained.
[0082] S22. Select the preset section CT image of the preset position section in the CT image, as shown in Figure 6. The preset position section contains only two images 121.
[0083] S23. As shown in Figure 7, 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.
[0084] 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.
[0085] This CT image recognition method allows operators to intuitively identify the angle and position of electrode pads, improving operational convenience and application success rate.
[0086] It is important to note that the basic principle of CT scanning is to use an X-ray beam to scan a layer of the human body of a specific thickness. When X-rays penetrate the human body, the intensity of the radiation received by the detector varies due to the different absorption rates of different tissues. These varying radiation signals are converted into electrical signals, then into digital signals via an analog-to-digital converter, and finally input into a computer for processing. An X-ray beam consists of individual photons with a specific energy range. When the beam passes through an object, it becomes "harder," producing metallic artifacts. This effect is called beam hardening artifact: dark bands or stripes appearing between dense objects in an image. Beam hardening artifacts produce dark stripes 201 between two film pieces 121. They can also produce dark stripes 201 along the long axis of a single film piece 121; therefore, bright stripes 202 are adjacent to dark stripes 201. Therefore, this embodiment utilizes the beam hardening artifact principle to generate directional artifacts to indicate the intermediate position of the first notch 122.
[0087] For example, as shown in Figure 8, using technical principle 1, the X-ray hardening effect artifact will produce dark stripes 201 between two high-attenuation objects (such as metal), i.e., film 121.
[0088] As shown in Figure 9, using technical principle 2, the X-ray hardening effect artifact will produce dark stripes 201 along the long axis of a single high-attenuation object (such as metal), i.e., film 121.
[0089] The above technical principles 1 and 2 combine to produce X-ray hardening artifacts. Another problem causing stripe artifacts is the Compton scattering effect. Scattering causes X-ray photons to change direction and energy. Therefore, as shown in Figures 7 and 10, the bright stripes and dark stripes 201 are not completely symmetrical, and their brightness and darkness are also different. Therefore, in the CT image, the two brightest first bright line regions 41 and the darkest stripe 201 in the middle provide the directional indication function of the first notch 122.
[0090] Optionally, the arc angle of at least one display film 121 is X, 10°≤X≤170°; and / or the arc angle of the first notch 122 is Y, 10°≤Y<160°. This ensures 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 partitions are distinct, thereby improving the recognition accuracy of the middle region between the two first bright line regions 41.
[0091] This embodiment also provides a stimulation system, including an implantable pulse generator and the aforementioned electrode wire 10. The stimulation section 101 of the electrode wire 10 is configured to be implanted in the brain, and the connection section 102 of the electrode wire 10 is electrically connected to the implantable pulse generator.
[0092] Optionally, the stimulation system also includes an extension lead, through which the implantable pulse generator is electrically connected to the electrode lead 10.
[0093] Example 2
[0094] As shown in Figure 13, 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. Only 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.
[0095] 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.
[0096] Note that the above are merely optional embodiments and technical principles applied 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 more 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 conductor (10), the electrode conductor (10) 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 directional electrode assembly (2), the directional electrode assembly (2) includes a plurality of electrode plates arranged with insulating intervals 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) connected to each other along the axial direction of the electrode conductor (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 axially along the electrode wire (10). The two display films (121) are arc-shaped and are spaced apart circumferentially. A first notch (122) is provided between the ends of the two display films (121) that are close to each other circumferentially, and a second notch (123) is provided between the ends of the two display films (121) that are opposite to each other circumferentially. The first notch (122) is smaller than the second notch (123).
2. The electrode wire according to claim 1, wherein, The marking hole (111) has an asymmetrical structure at both ends along the circumferential direction.
3. The electrode wire according to claim 1, wherein, The projection of the marking hole (111) is a triangular hole, with the first apex of the triangular hole located at one end of the marking hole (111) along the circumference, and the straight side of the triangular hole opposite to the first apex located at the other end of the marking hole (111) along the circumference.
4. The electrode wire according to claim 1, wherein, The first marking part (11) and the second marking part (12) are integrally formed; or The first marking portion (11) and the second marking portion (12) are disposed on the stimulation segment (101) with an axial insulating gap.
5. The electrode wire according to claim 1, wherein, The two display films (121) extend for different lengths along the axial direction of the electrode wire (10).
6. The electrode wire according to claim 4, wherein, The plurality of electrode pads include an indicator electrode pad (21), the indicator electrode pad (21) satisfying one of the following: The indicator electrode (21) and the first notch (122) are located on the first axis (5), which extends axially along the stimulation segment (101); The indicator electrode (21) and the marking hole (111) are located on the first axis (5), which extends axially along the stimulation segment (101).
7. The electrode wire according to claim 1, wherein, The first marking portion (11) includes an extension portion (112) extending along the axial direction of the electrode wire, and the marking hole (111) is disposed through the extension portion (112); the extension portion (112) is an open ring, and the width of the extension portion (112) gradually increases or decreases from the first end of the extension portion (112) to the second end of the extension portion (112).
8. The electrode wire according to claim 7, wherein, The circumferential curvature of the extension portion (112) is less than 240°.
9. The electrode wire according to claim 7, wherein, The extension portion (112) is provided with a retaining ring (113) at both ends along the axial direction of the electrode wire. The retaining ring (113) can be sleeved and connected to the stimulation segment (101). The second marking portion (12) is connected to one of the retaining rings (113).
10. The electrode wire according to claim 9, wherein, The fixing ring (113) has a slot (1131) that engages with the stimulation segment (101).
11. The electrode wire according to claim 1, wherein, The arc angle of at least one of the two display films (121) is X, where 10°≤X≤170°.
12. The electrode wire according to claim 1 or 11, wherein, The arc angle of the first notch (122) is Y, where 10°≤Y<160°.
13. A stimulation system comprising an implantable pulse generator and an electrode lead (10) as claimed in any one of claims 1-12, wherein a stimulation segment (101) of the electrode lead (10) is configured to be implanted in the brain, and a connecting segment (102) of the electrode lead (10) is electrically connected to the implantable pulse generator.
14. The stimulation system according to claim 13 further includes an extension wire, wherein the implantable pulse generator is electrically connected to the electrode wire (10) via the extension wire.
15. A method for identifying the orientation of an electrode pad, applied to the electrode wire (10) according to any one of claims 1-12, the method for identifying the orientation of the electrode pad comprising an X-ray image recognition method, the X-ray image recognition method comprising: Rotate the stimulation segment (101) of the electrode wire (10) to obtain X-ray imaging images of the imaging marker assembly (1) in multiple directions as reference images; Acquire a preset X-ray imaging image of the stimulation segment (101) of the electrode wire (10) in working state; The preset X-ray imaging image is compared with the reference image, and the orientation of the electrode sheet is determined according to the radiation image corresponding to the marking hole (111) in the preset X-ray imaging image.
16. A method for identifying the orientation of an electrode pad, applied to the electrode lead (10) according to any one of claims 1-12, the method for identifying the orientation of the electrode pad comprising a CT image-based identification method, the CT image-based identification method comprising: Acquire CT images of the stimulation segment (101) of the electrode lead (10); Select a preset section CT image of a preset position section in the CT image, wherein the preset position section contains only two of the imaging films (121); 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) between the two display films (121).