Electrode lead and method for identifying orientation of electrode plate

Abstract

Provided are an electrode lead and a method for identifying the orientation of an electrode plate. The electrode lead (10) comprises a stimulation end (101), a connection end (102), and an intermediate section (103) connecting the stimulation end (101) and the connection end (102). The stimulation end (101) is provided with at least one first direction electrode assembly (1), and the first direction electrode assembly (1) comprises a first electrode plate (11), a second electrode plate (12), and a third electrode plate (13) that are insulated and spaced apart from each other in the circumferential direction. The length of the first electrode plate (11) in the axial direction of the electrode lead (10) is less than the length of the second electrode plate (12) and the length of the third electrode plate (13).

Description

Methods for identifying electrode wire orientation and electrode plate orientation

[0001] This application claims priority to Chinese Patent Application No. 202411864440.1, filed on December 16, 2024, and Chinese Patent Application No. 202423120401.9, 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 wire and a method for identifying the orientation of electrode sheets. 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 of the segmented contact points or distinguish the types of the three segmented contacts, thus making it inconvenient to control the segmented contacts in a specific direction. Summary of the Invention

[0006] This application provides an electrode wire and a method for identifying the orientation of electrode sheets, which facilitates the control of electrode sheets in a specific direction, optimizes product structure, reduces the amount of metal used in the electrode wire, and saves costs.

[0007] This application provides an electrode wire, which includes a stimulation end, a connection end, and an intermediate section connecting the stimulation end and the connection end. The stimulation end is provided with at least one first-direction electrode assembly. Each first-direction electrode assembly includes a first electrode plate, a second electrode plate, and a third electrode plate that are circumferentially insulated and spaced apart. The length of the first electrode plate in the axial direction of the electrode wire is less than the lengths of the second electrode plate and the third electrode plate in the axial direction of the electrode wire.

[0008] In one embodiment, the arc angle of the second electrode is X1, 10°≤X1≤170°; the arc angle of the third electrode is X2, 10°≤X2≤170°; or

[0009] The second electrode and the third electrode have a first arc-shaped notch at their closest points to each other, the arc angle of the first arc-shaped notch being Y, where 10° ≤ Y < 160°; or

[0010] The arc angle of the second electrode plate (12) is X1, 10°≤X1≤170°; the arc angle of the third electrode plate (13) is X2, 10°≤X2≤170°; a first arc-shaped notch is provided at one end of the second electrode plate (12) and the third electrode plate (13) that are close to each other, and the arc angle of the first arc-shaped notch is Y, 10°≤Y<160°.

[0011] In one embodiment, the number of the first electrode sheets is multiple.

[0012] In one embodiment, the end faces of the first electrode sheet, the second electrode sheet, and the third electrode sheet are flush.

[0013] In one embodiment, the second electrode sheet and the third electrode sheet have the same length in the axial direction of the electrode wire.

[0014] In one embodiment, the length of the second electrode sheet is greater than the length of the third electrode sheet in the axial direction of the electrode wire.

[0015] In one embodiment, the stimulation end of the electrode wire further includes at least one stimulation ring, which is spaced apart from the first direction electrode assembly in the axial direction of the electrode wire.

[0016] In one embodiment, the stimulation end of the electrode wire is further provided with at least one second-direction electrode assembly, each second-direction electrode assembly including at least three fourth electrode plates, the at least three fourth electrode plates being arranged with circumferential insulation intervals along the second-direction electrode assembly.

[0017] In one embodiment, the stimulation end of the electrode wire is provided with two stimulation rings, and the stimulation end of the electrode wire is provided with one stimulation ring, a first direction electrode assembly, a second direction electrode assembly and another stimulation ring in sequence at intervals along the axial direction of the electrode wire.

[0018] In one embodiment, the stimulation end of the electrode wire is further provided with three second-direction electrode assemblies, and the first-direction electrode assemblies and the three second-direction electrode assemblies are arranged sequentially at intervals along the axial direction of the stimulation end of the electrode wire.

[0019] In one embodiment, the stimulation end of the electrode wire is provided with two first-direction electrode assemblies and two stimulation rings. The stimulation end of the electrode wire is provided with one stimulation ring, one first-direction electrode assembly, another first-direction electrode assembly, and another stimulation ring at intervals along the axial direction of the electrode wire. The first electrode plates of the two first-direction electrode assemblies are located on the same side.

[0020] In one embodiment, the stimulation end of the electrode wire is provided with four first-direction electrode assemblies, which are insulated and spaced apart along the axial direction of the electrode wire.

[0021] This application provides a method for identifying the orientation of an electrode sheet, applied to the electrode wires described in any of the above solutions. The method for identifying the orientation of the electrode sheet includes:

[0022] Acquire CT images of the stimulation end of the electrode leads;

[0023] A preset cross-section CT image is selected from the preset position cross-section of the CT image. The preset position cross-section only includes the second electrode and the third electrode. The preset cross-section 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 middle position of the two first bright line regions corresponds to the middle position of the second electrode and the third electrode.

[0024] The angles and positions of the first, second, and third electrode plates are determined based on the midpoint between the second and third electrode plates. Attached Figure Description

[0025] Figure 1 is a schematic diagram of the structure of the electrode wire provided in Embodiment 1 of this application;

[0026] Figure 2 is a schematic diagram of the structure of the first directional electrode assembly provided in Embodiment 1 of this application;

[0027] Figure 3 is a schematic diagram of the preset position section located at BB in Figure 2;

[0028] Figure 4 is a schematic diagram of a preset cross-sectional CT image provided in Embodiment 1 of this application;

[0029] Figure 5 is a schematic diagram of the structure of the stimulation end of the electrode wire provided in Embodiment 1 of this application;

[0030] Figure 6 is a flowchart of the method for identifying the orientation of electrode sheets provided in Embodiment 1 of this application;

[0031] Figure 7 is a schematic diagram of the technical principle 1 of the ray hardening effect artifact provided in Embodiment 1 of this application;

[0032] Figure 8 is a schematic diagram of the technical principle 2 of the ray hardening effect artifact provided in Embodiment 1 of this application;

[0033] Figure 9 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;

[0034] Figure 10 is a schematic diagram of the structure of the first directional electrode assembly of this application, which includes two first electrode sheets;

[0035] Figure 11 is a schematic diagram of the structure of the stimulation end of the electrode wire provided in Embodiment 2 of this application;

[0036] Figure 12 is a schematic diagram of the structure of the stimulation end of the electrode wire provided in Embodiment 3 of this application;

[0037] Figure 13 is a schematic diagram of the structure of the stimulation end of the electrode wire provided in Embodiment 4 of this application;

[0038] Figure 14 is a schematic diagram of the structure of the stimulation end of the electrode wire provided in Embodiment 5 of this application.

[0039] The diagram is labeled as follows: 10, electrode lead; 101, stimulation end; 102, connection end; 103, middle section; 20, high attenuation object; 201, dark stripe; 202, bright stripe; 1, first direction electrode assembly; 11, first electrode plate; 12, second electrode plate; 13, third electrode plate; 2, stimulation ring; 3, second direction electrode assembly; 31, fourth electrode plate; 41, first bright line area; 42, second bright line area. Detailed Implementation

[0040] The present application will now be described in conjunction with the accompanying drawings and embodiments. The embodiments described herein are merely illustrative and not intended to limit the scope of the application. For ease of description, only the parts relevant to the present application are shown in the drawings, not the entire structure.

[0041] 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 meaning of the above terms in this application according to the circumstances.

[0042] 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 directly above or diagonally above the second feature, or simply indicates that the horizontal height of the first feature is higher than the horizontal height of the second feature. "Below," "below," and "under" the second feature includes the first feature directly below or diagonally below the second feature, or simply indicates that the horizontal height of the first feature is lower than the horizontal height of the second feature.

[0043] 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.

[0044] Example 1

[0045] The technical field and related terms of the embodiments of this application are briefly described below.

[0046] 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).

[0047] 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.

[0048] As an example, DBS includes an implantable pulse generator (IPG), extension leads, and electrode leads, with the IPG 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 location.

[0049] 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.

[0050] IPGs respond to programmed commands sent by a programmable device, using sealed batteries and circuitry to deliver controllable electrical stimulation (or electrical stimulation energy) to tissues within the body. IPGs deliver one or more controllable electrical stimuli to specific areas of tissues via electrode leads.

[0051] 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.

[0052] 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.

[0053] 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.

[0054] 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.

[0055] 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. 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 disorders and impairments.

[0056] 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 one or more stimulation parameters of the stimulator (or one or more stimulation parameters of the pulse generator, with different stimulation parameters corresponding 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 adjusting the stimulation parameters of the stimulator to achieve closed-loop control (or adaptive adjustment) of the stimulation parameters.

[0057] 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).

[0058] In some embodiments, multiple stimulation parameters of the stimulator can be adjusted in current mode or voltage mode.

[0059] 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.).

[0060] As shown in Figures 1 and 2, this embodiment provides an electrode wire 10, which includes a stimulation end 101, a connecting end 102, and an intermediate section 103 connecting the stimulation end 101 and the connecting end 102. The stimulation end 101 is provided with at least one first-direction electrode assembly 1, which includes a first electrode sheet 11, a second electrode sheet 12, and a third electrode sheet 13 arranged circumferentially with insulating intervals. The length of the first electrode sheet 11 in the axial direction of the electrode wire 10 is less than the lengths of the second electrode sheet 12 and the third electrode sheet 13 in the axial direction of the electrode wire. In this embodiment, the stimulation end 101 of the electrode wire 10 is provided with a support, and the first-direction electrode assembly 1 is mounted on the support.

[0061] As shown in Figures 1-4, computed tomography (CT) images of the stimulation end 101 of the electrode lead 10 implanted in the human body are acquired after surgery; metal artifacts are removed from the CT images to obtain a preset cross-sectional CT image; a preset cross-sectional CT image of a preset position is selected from the CT images, and the preset position cross-section only includes the second electrode 12 and the third electrode 13; as shown in Figure 3, the preset position cross-section only includes the second electrode 12 and the third electrode 13; by analyzing the preset cross-sectional CT image, as shown in Figure 4, 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 middle position of the two first bright line regions 41 corresponds to the middle position of the second electrode 12 and the third electrode 13. Since the relative positions of the first electrode 11, the second electrode 12 and the third electrode 13 are fixed, the angles and positions of the first electrode 11, the second electrode 12 and the third electrode 13 are determined according to the middle position of the second electrode 12 and the third electrode 13. After the electrode wire 10 is implanted in the human body, the angles and positions of the first electrode plate 11, the second electrode plate 12 and the third electrode plate 13 in the first direction electrode assembly 1 can be obtained through CT images. This makes it easy to control the operation of the electrode plate in a specific direction, and no additional direction markings are needed to determine the contact rotation direction, thus optimizing the product structure. At the same time, it can reduce the amount of metal used in the electrode wire 10 and save costs.

[0062] In this embodiment, the end faces of the first electrode plate 11, the second electrode plate 12, and the third electrode plate 13 are flush. Therefore, the area of ​​the notch formed between the other end of the first electrode plate 11 and the second electrode plate 12 and the third electrode plate 13 is increased, the range of the preset position cross-section is increased, and the efficiency of acquiring the cross-sectional image of the preset position cross-section is improved.

[0063] As shown in Figure 5, the stimulation end 101 of the electrode wire 10 also includes at least one stimulation ring 2, which is spaced apart from the first direction electrode assembly 1 in the axial direction of the electrode wire 10.

[0064] In this embodiment, the stimulation end 101 of the electrode wire 10 is provided with two first-direction electrode assemblies 1 and two stimulation rings 2. The stimulation end 101 of the electrode wire 10 is sequentially provided with one stimulation ring 2, one first-direction electrode assembly 1, another first-direction electrode assembly 1, and another stimulation ring 2 at intervals along the axial direction, forming a 1-3-3-1 type 8-contact electrode wire 10. The first electrode plates 11 of the two first-direction electrode assemblies 1 are located on the same side. Since the positions of the first electrode plates 11 and the second electrode plates 12 within the two first-direction electrode assemblies 1 are fixed, obtaining the angle and position of the first electrode plate 11 within one first-direction electrode assembly 1 allows obtaining the angle and position of any electrode plate. In other embodiments, the number of first-direction electrode assemblies 1 can be adaptively selected according to requirements, all within the scope of protection of this embodiment.

[0065] In this embodiment, the second electrode sheet 12 and the third electrode sheet 13 of the two first direction electrode assemblies 1 have the same length in the axial direction of the electrode wire 10.

[0066] As shown in Figure 6, this embodiment also provides a method for identifying the orientation of electrode sheets, applied to the electrode wire 10 described above. The method for identifying the orientation of electrode sheets includes the following steps:

[0067] S1. Obtain a CT image of the stimulation end 101 of the electrode lead 10; during surgery, a CT image of the electrode lead 10 implanted in the human body can be obtained.

[0068] S2. Select the preset section CT image of the preset position section in the CT image, as shown in Figure 3. The preset position section only includes the second electrode 12 and the third electrode 13.

[0069] As shown in Figure 4, 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 middle position of the two first bright line regions 41 corresponds to the middle position of the second electrode plate 12 and the third electrode plate 13.

[0070] S3. Determine the angle and position of the first electrode 11, the second electrode 12, and the third electrode 13 based on the midpoint position of the second electrode 12 and the third electrode 13.

[0071] For example, in this embodiment, there is one first electrode plate 11. Since the relative angles and positions of the first electrode plate 11, the second electrode plate 12, and the third electrode plate 13 are fixed, and the included angle between adjacent electrode plates among the first electrode plate 11, the second electrode plate 12, and the third electrode plate 13 is 120°, the middle position of the two first bright line regions 41 rotated 180° is the position of the first electrode plate 11, and the middle position of the two first bright line regions 41 rotated 60° left and right are the positions of the second electrode plate 12 and the third electrode plate 13, respectively.

[0072] In other embodiments, there are multiple first electrode plates 11. As shown in FIG10, taking two first electrode plates 11 as an example, the included angle between adjacent electrode plates is 90°. Therefore, the middle positions of the two first bright line regions 41 rotated 135° left and right are the positions of the two first electrode plates 11, and the middle positions of the two first bright line regions 41 rotated 45° left and right are the positions of the second electrode plate 12 and the third electrode plate 13.

[0073] By using this method of identifying the orientation of the electrode plates, operators can intuitively identify the angles and positions of the first electrode plate 11, the second electrode plate 12, and the third electrode plate 13, thereby improving operational convenience and increasing the success rate of application.

[0074] 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 high-attenuation objects 20 (such as metal). They can also produce dark stripes 201 along the long axis of a single high-attenuation object 20; therefore, bright stripes 202 are adjacent to dark stripes 201. Therefore, this embodiment utilizes the beam hardening artifact principle to generate directional artifacts for indicating the position of electrode pads.

[0075] For example, as shown in Figure 7, using technical principle 1, the ray hardening effect artifact will produce dark stripes 201 between two high-attenuation objects 20 (such as metal).

[0076] As shown in Figure 8, 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 20.

[0077] The above technical principles 1 and 2 combine to produce X-ray hardening artifacts. Another problem causing the stripe artifacts is the Compton scattering effect. Scattering causes X-ray photons to change direction and energy. Therefore, as shown in Figures 4 and 9, the bright stripes and dark stripes 201 are not perfectly symmetrical, and their brightness and darkness are also different. Therefore, in the CT images, the two brightest first bright line regions 41 and the darkest stripe in the middle provide the directional indication function of the first electrode plate 11.

[0078] Optionally, the arc angle of the second electrode 12 is X1, 10°≤X1≤170°; the arc angle of the third electrode 13 is X2, 10°≤X2≤170°; and / or a first arc-shaped notch is provided at one end of the second electrode 12 and the third electrode 13 that are close to each other, the arc angle of the first arc-shaped notch is Y, 10°≤Y<160°, so as to ensure that the first bright line area 41, the second bright line area 42 and the dark stripe 201 in the preset cross-section CT image are clear and the partitions are obvious, thereby improving the recognition accuracy of the middle area of ​​the two first bright line areas 41.

[0079] Example 2

[0080] As shown in Figure 11, 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 end 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.

[0081] In this embodiment, the stimulation end 101 of the electrode wire 10 is provided with four first-direction electrode assemblies 1. The four first-direction electrode assemblies 1 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. The first electrode plates 11 of two first-direction electrode assemblies 1 are located on the same side. By obtaining the angle and position of the first electrode plate 11 within a first-direction electrode assembly 1, the angle and position of any electrode plate can be obtained. In other embodiments, the number of first-direction electrode assemblies 1 can be adaptively selected according to requirements, all of which are within the protection scope of this embodiment.

[0082] Example 3

[0083] As shown in Figure 12, 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 end 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.

[0084] In this embodiment, the stimulation end 101 of the electrode wire 10 is provided with two stimulation rings 2. Along the axial direction, the stimulation end 101 of the electrode wire 10 is sequentially provided with one stimulation ring 2, one first-direction electrode assembly 1, another first-direction electrode assembly 1, and another stimulation ring 2, forming a 1-3-3-1 type 8-contact electrode wire 10. In this embodiment, the second electrode piece 12 and the third electrode piece 13 of one first-direction electrode assembly 1 have equal lengths in the axial direction of the electrode wire 10. In the axial direction of the electrode wire 10, the length of the second electrode piece 12 of the other first-direction electrode assembly 1 is greater than the length of the third electrode piece 13.

[0085] Example 4

[0086] 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, except that the structure of the stimulation end 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.

[0087] The stimulation end 101 of the electrode wire 10 is also provided with at least one second-direction electrode assembly 3. The second-direction electrode assembly 3 includes at least three fourth electrode plates 31, which are arranged with circumferential insulation at intervals. In this embodiment, the second-direction electrode 3 includes three fourth electrode plates 31. Since the relative positions of the electrode plates in the first-direction electrode assembly 1 and the second-direction electrode assembly 3 are fixed, the angle and position of the first electrode plate 11 in the first-direction electrode assembly 1 can be obtained to determine the angle and position of any electrode plate on the electrode wire 10.

[0088] In this embodiment, the stimulation end 101 of the electrode wire 10 is provided with two stimulation rings 2. The stimulation end 101 of the electrode wire 10 is provided with one stimulation ring 2, a first direction electrode assembly 1, a second direction electrode assembly 3 and another stimulation ring 2 in sequence along the axial direction, forming a 1-3-3-1 type 8-contact electrode wire 10.

[0089] In this embodiment, the length of the fourth electrode piece 31 is the same as the length of the second electrode piece 12. In other embodiments, the number of the first directional electrode assembly 1 and the second directional electrode assembly 3 can be adaptively selected according to requirements, and the length of the fourth electrode piece 31 can be adaptively selected according to requirements. When there are multiple second directional electrode assemblies 3, the lengths of the fourth electrode pieces 31 of the multiple second directional electrode assemblies 3 can be the same or different, all of which are within the protection scope of this embodiment.

[0090] Example 5

[0091] As shown in Figure 14, 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 end 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.

[0092] In this embodiment, the stimulation end 101 of the electrode wire 10 is provided with three second-direction electrode assemblies 3. The first-direction electrode assembly 1 and the three second-direction electrode assemblies 3 are arranged sequentially and spaced apart along the axial direction of the stimulation end 101 of the electrode wire 10, forming a 3-3-3-3 type 12-contact electrode wire 10. In other embodiments, the number of first-direction electrode assemblies 1 and second-direction electrode assemblies 3 can be adaptively selected according to needs, all of which are within the protection scope of this embodiment.

[0093] Example 6

[0094] This embodiment provides an implantable neurostimulation system, including an extension lead, an implantable pulse generator, and an electrode lead 10 of any of the above embodiments. One end of the extension lead is electrically connected to the electrode lead 10, and the other end is electrically connected to the implantable pulse generator.

Claims

1. An electrode wire, comprising a stimulation end (101), a connection end (102), and an intermediate section (103) connecting the stimulation end (101) and the connection end (102), wherein the stimulation end (101) is provided with at least one first-direction electrode assembly (1), each first-direction electrode assembly (1) comprising a first electrode sheet (11), a second electrode sheet (12), and a third electrode sheet (13) disposed circumferentially and insulatedly, wherein the length of the first electrode sheet (11) in the axial direction of the electrode wire is less than the lengths of the second electrode sheet (12) and the third electrode sheet (13) in the axial direction of the electrode wire.

2. The electrode lead of claim 1, wherein, The arc angle of the second electrode (12) is X1, 10°≤X1≤170°; the arc angle of the third electrode (13) is X2, 10°≤X2≤170°; or The second electrode plate (12) and the third electrode plate (13) are provided with a first arc-shaped notch at their respective ends, the arc angle of the first arc-shaped notch being Y, 10°≤Y<160°; or The arc angle of the second electrode plate (12) is X1, 10°≤X1≤170°; the arc angle of the third electrode plate (13) is X2, 10°≤X2≤170°; a first arc-shaped notch is provided at one end of the second electrode plate (12) and the third electrode plate (13) that are close to each other, and the arc angle of the first arc-shaped notch is Y, 10°≤Y<160°.

3. The electrode lead of claim 1, wherein, The number of the first electrode sheet (11) is multiple.

4. The electrode lead of claim 1, wherein, The end faces of the first electrode plate (11), the second electrode plate (12) and the third electrode plate (13) are flush.

5. The electrode lead of claim 1, wherein, The second electrode plate (12) and the third electrode plate (13) have the same length in the axial direction of the electrode wire.

6. The electrode lead of claim 1, wherein, The length of the second electrode piece (12) is greater than the length of the third electrode piece (13) in the axial direction of the electrode wire.

7. The electrode lead of claim 1, wherein, The stimulation end (101) of the electrode wire further includes at least one stimulation ring (2), which is spaced apart from the first direction electrode assembly (1) in the axial direction of the electrode wire.

8. The electrode lead of claim 1, wherein, The stimulation end (101) of the electrode wire is also provided with at least one second direction electrode assembly (3), each second direction electrode assembly (3) includes at least three fourth electrode pieces (31), and the at least three fourth electrode pieces (31) are arranged with circumferential insulation intervals along the second direction electrode assembly (3).

9. The electrode lead of claim 8, wherein, The stimulation end (101) of the electrode wire is provided with two stimulation rings (2). The stimulation end (101) of the electrode wire is provided with one stimulation ring (2), the first direction electrode assembly (1), the second direction electrode assembly (3) and the other stimulation ring (2) in sequence at intervals along the axial direction of the electrode wire.

10. The electrode lead of claim 8, wherein, The stimulation end (101) of the electrode wire is also provided with three second-direction electrode assemblies (3), and the first-direction electrode assembly (1) and the three second-direction electrode assemblies (3) are arranged sequentially at intervals along the axial direction of the stimulation end (101) of the electrode wire.

11. The electrode lead of claim 1, wherein, The stimulation end (101) of the electrode wire is provided with two first direction electrode assemblies (1) and two stimulation rings (2). The stimulation end (101) of the electrode wire is provided with one stimulation ring (2), one first direction electrode assembly (1), another first direction electrode assembly (1) and another stimulation ring (2) in sequence at intervals along the axial direction of the electrode wire. The first electrode plates (11) of the two first direction electrode assemblies (1) are located on the same side.

12. The electrode lead of claim 1, wherein, The stimulation end (101) of the electrode wire is provided with four first-direction electrode assemblies (1), and the four first-direction electrode assemblies (1) are insulated and spaced apart along the axial direction of the electrode wire.

13. A method for identifying the orientation of an electrode sheet, applied to the electrode wire according to any one of claims 1-12, the method for identifying the orientation of the electrode sheet comprising: Acquire computed tomography (CT) images of the stimulation end (101) of the electrode lead; A preset cross-section CT image is selected from the preset position cross-section of the CT image. The preset position cross-section only includes the second electrode (12) and the third electrode (13). The preset cross-section 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 middle position of the two first bright line regions (41) corresponds to the middle position of the second electrode (12) and the third electrode (13). The angles and positions of the first electrode plate (11), the second electrode plate (12), and the third electrode plate (13) are determined based on the midpoint between the second electrode plate (12) and the third electrode plate (13).

Images