Lead for deep brain stimulation, stimulation apparatus, and use of stimulation apparatus

Abstract

A lead for deep brain stimulation, a stimulation apparatus, and the use of the apparatus. The lead is configured to stimulate two or more intracerebral functional targets. The lead is directionally implanted into the brain, passing through or being inserted into the two or more intracerebral functional targets to apply joint electrical stimulation to the two or more intracerebral functional targets. The lead comprises a stimulation section (1), wherein the stimulation section (1) is provided with a lead contact combination (4) arranged in the length direction of the stimulation section (1), the lead contact combination (4) comprises at least two lead contact groups (41), the at least two lead contact groups (41) respectively correspond to different intracerebral functional targets, each lead contact group (41) comprises at least one lead contact (10), at least one lead contact (10) in the same lead contact group (41) can output the same electrical stimulation parameter combination, and electrical stimulation parameter combinations output by different lead contact groups (41) are different.

Description

Electrode for deep brain stimulation, stimulation device and use of a stimulation device

[0001] This application claims priority to the Chinese patent application No. 202411515356.9, filed on October 29, 2024, with the Chinese Patent Office, the content of which is incorporated herein by reference in its entirety. TECHNICAL FIELD

[0002] The present application relates to the technical field of medical devices, for example to an electrode for deep brain stimulation, a stimulation device and use of a stimulation device. BACKGROUND

[0003] A deep brain stimulation device (DBS) is a medical device for electrically stimulating specific regions of the brain. A DBS device usually includes an implantable pulse generator (IPG) and an electrode (Lead), the implantable pulse generator is implanted in the patient's body and delivers the generated electrical stimulation signal to the specific region implanted in the patient's brain through the electrode, to regulate the neural activity of the specific brain region.

[0004] In a DBS surgery, different intracerebral functional targets are closely related to their respective brain functions. For example, the subthalamic nucleus (STN) is usually used as the main target for Parkinson's disease patients, and is directly related to motor control and muscle tone regulation; the globus pallidus internus (GPi) is also commonly used for the treatment of Parkinson's disease and dystonia, and mainly acts on the regulation of muscle tone and action initiation.

[0005] In order to effectively treat complex conditions such as mental and movement disorder diseases, it is usually necessary to stimulate multiple intracerebral functional targets simultaneously. To achieve this treatment purpose, a DBS device usually relies on multiple independent electrodes to stimulate different functional targets, which increases the complexity of implantation surgery and head trauma of the patient, and increases the patient's burden of diagnosis and treatment. In addition, the coordination problem between multiple independent electrodes can affect the overall stimulation effect, resulting in inaccurate stimulation or insufficient coverage of functional targets. SUMMARY

[0006] The present application provides an electrode for deep brain stimulation, a stimulation device and use of a stimulation device. Through the present application, the electrode can pass through or insert multiple intracerebral functional targets when implanted in the brain, and simultaneously implement electrical stimulation on multiple targets, thereby improving the accuracy of stimulation and treatment effect.

[0007] This application provides an electrode for deep brain stimulation, configured to stimulate two or more functional targets in the brain. When the electrode is implanted into the brain, it passes through or inserts into two or more functional targets to jointly stimulate them. The electrode includes a stimulation segment with electrode contact combinations arranged along its length. Each electrode contact combination includes at least two groups of electrode contacts, each corresponding to a different functional target in the brain. Each group of electrode contacts includes at least one electrode contact, and at least one electrode contact within the same group can output the same combination of electrical stimulation parameters. Different groups of electrode contacts output different combinations of electrical stimulation parameters. The total length of the electrode contact combination is X, where X ≥ 12 mm. The total number of electrode contacts in the combination is n, where n ≥ 5.

[0008] This application also provides a stimulation device, including a pulse generator and electrodes as described above, the electrodes being electrically connected to the pulse generator, the pulse generator being configured to output different combinations of electrical stimulation parameters to at least two groups of electrode contacts in the electrode contact combination.

[0009] This application also provides a use of the above-mentioned stimulation device, which is configured to treat mental illnesses and movement disorders. Attached Figure Description

[0010] Figure 1 is a schematic diagram of the deep brain stimulation method implemented in the embodiments of this application;

[0011] Figure 2 is a schematic diagram of the structure of an electrode provided in an embodiment of this application;

[0012] Figure 3 is a schematic diagram of another electrode provided in an embodiment of this application;

[0013] Figure 4 is a partial exploded view of the electrodes in an embodiment of this application;

[0014] Figure 5 is a schematic diagram of the deep brain stimulation method implemented in Example 1.

[0015] In the diagram: 1000, nucleus accumbens; 2000, anterior limb of internal capsule; 100, electrode; 200, extension lead; 300, pulse generator; 10, electrode contact; 101, electrode pad; 1, stimulation segment; 2, intermediate segment; 3, connecting segment; 4, electrode contact assembly; 41, electrode contact group; 42, additional electrode contact; 43, cortical electrode contact. Detailed Implementation

[0016] 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.

[0017] In the description of this application, unless otherwise 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. The meaning of the above terms in this application can be understood according to the actual situation.

[0018] In this application, unless otherwise 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 first feature is at a higher horizontal level than 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 first feature is at a lower horizontal level than the second feature.

[0019] In the description of this embodiment, the terms "upper," "lower," "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.

[0020] As mentioned earlier, to improve the treatment efficacy for complex conditions such as mental illnesses and movement disorders, two or more independent electrodes are typically used to electrically stimulate different functional targets in the brain (i.e., areas in the brain with specific functions that participate in regulating certain neural processes or behaviors, such as individual neural nuclei or neural tracts). Although this design can stimulate multiple functional targets in the brain, it is highly complex to operate. In particular, during surgery, the precise implantation and adjustment of the position of each electrode is required, increasing the difficulty and time of the operation. In addition, the implantation of multiple electrodes also increases the risk of surgical trauma and potential complications. Furthermore, since each electrode can only target one functional target in the brain, the synchronous control of multiple electrodes is also one of the challenges of the surgery, which may lead to inaccurate stimulation or insufficient coverage of functional targets in the brain.

[0021] Studies of human brain anatomy have revealed that many important functional targets within the brain can lie on the same straight line in a specially selected cross-section. This anatomical feature provides a new approach to electrode design: by using a single electrode, multiple target brain functional points can be combined and precisely stimulated within a directionally selected linear minimally invasive channel. Compared to surgical methods using two or more independent electrodes, this method simplifies the surgical procedure, reduces the risk of trauma during electrode implantation, and improves the efficiency and effectiveness of electrical stimulation, while still achieving simultaneous electrical stimulation of different brain functional targets.

[0022] This application aims to provide a stimulation device for achieving deep brain stimulation based on the above-mentioned concept. As shown in Figure 1, the device includes a pulse generator 300 and an electrode 100, with the pulse generator 300 electrically connected to the electrode 100. In this embodiment, the pulse generator 300 can be any type of IPG, and the pulse generator 300 can be implanted in the patient's body, such as in the chest, brain, or other internal sites.

[0023] For example, when implanting the pulse generator 300 into a patient's brain, the patient's skull needs to be pre-grooved before the pulse generator 300 is installed in the skull groove. The pulse generator 300 can be completely embedded inside the skull or partially protrude from the skull surface.

[0024] When the pulse generator 300 is implanted subcutaneously in the patient's chest or other locations far from the head, the length of the electrode 100 may not be sufficient to directly connect to the pulse generator 300. Therefore, as shown in Figure 1, an extension wire 200 can be used to connect the electrode 100 and the pulse generator 300 in series. That is, the extension wire 200 serves as the electrical stimulation transmission medium, effectively transmitting the electrical stimulation generated by the pulse generator 300 to the electrode 100. The pulse generator 300 responds to programmed instructions sent by a programmable device, providing controllable electrical stimulation therapy to the body's tissues through a sealed battery and circuitry.

[0025] Based on treatment needs, the first step is to determine the combination of brain functional targets to be electrically stimulated (i.e., two or more brain functional targets requiring simultaneous electrical stimulation, hereinafter referred to as target combinations). Different combinations of electrical stimulation parameters are then set for each of these determined brain functional targets (hereinafter referred to as targets). This is because the anatomical location, functional characteristics, and responses to electrical stimulation of these target combinations in the brain differ, leading to variations in the required electrical stimulation parameters. Furthermore, the electrical stimulation targets of different targets may address different conditions, influencing the selection of electrical stimulation parameters. Even for the same target, the electrical stimulation parameters need to be adjusted accordingly due to individual patient differences. Therefore, the combinations of electrical stimulation parameters need to be adjusted individually to ensure optimal treatment results.

[0026] Secondly, in order to achieve simultaneous electrical stimulation of multiple targets, the design and arrangement of electrodes 100 also require the rational planning of the configuration of electrode contact combination 4 based on the anatomical characteristics and functional requirements of the targets, including parameters such as the number of electrode contacts, contact spacing, and length of a single contact.

[0027] Next, preoperative medical imaging techniques (such as magnetic resonance imaging (MRI) or computed tomography (CT)) are used to determine the insertion path of electrode 100 to ensure that electrode 100 can accurately reach and pass through these target points. In Figure 1, an example shows two target points (labeled 1000 and 2000), representing the nucleus accumbens (NAc) and the anterior limb of the internal capsule (ALIC), respectively.

[0028] Finally, when electrode 100 is implanted into the patient's brain, it will sequentially pass through target point 1000 and target point 2000. Pulse generator 300 generates electrical stimulation signals based on electrical stimulation parameter combinations set for these target points 1000 and 2000 respectively, and delivers the corresponding electrical stimulation parameter combinations to target points 1000 and 2000 respectively through electrode contact combinations 4 provided on electrode 100, achieving combined electrical stimulation of multiple target points. Pulse generator 300 is configured to output different electrical stimulation parameter combinations to at least two electrode contact groups 41 in electrode contact combinations 4.

[0029] For example, the above-described combination of electrical stimulation parameters may include one or more of the following parameters:

[0030] Frequency, such as the number of electrical stimulation pulses per second, is measured in Hz.

[0031] Pulse width, the duration of each pulse, in μs;

[0032] Amplitude, usually expressed as voltage or current, is the intensity of each pulse, measured in V or I.

[0033] Timing can be either continuous or clustered, with clustered behavior referring to non-continuous temporal behavior consisting of multiple processes.

[0034] Stimulation modes include one or more of the following: current mode, voltage mode, timed stimulation mode, and cyclic stimulation mode;

[0035] The doctor's control limits are the upper and lower limits (the range that the doctor can adjust) and the patient's control limits are the upper and lower limits (the range that the patient can adjust independently).

[0036] The selection of the target site and its electrical stimulation parameter combination will be discussed in a later section. The construction of the electrode 100 used in this embodiment will be described below.

[0037] Please refer to Figure 2. One end of the electrode 100 (left end of Figure 2) is defined as the distal end, which is deep into the brain; the other end (right end of Figure 2) is defined as the proximal end, which is usually located outside or near the outside of the body.

[0038] The portion of electrode 100 near its distal end is defined as the Stimulation Segment 1, which contains multiple electrode contacts 10 configured to directly contact and stimulate the target site. The portion of electrode 100 near its proximal end is defined as the Connector Segment 3, which is typically connected to the pulse generator 300 or a connecting device (such as an extension wire 200 or cable). The Connector Segment 3 also contains multiple electrode contacts 10 configured to transmit the electrical signal generated by the pulse generator 300 to the distal Stimulation Segment 1.

[0039] Between stimulation segment 1 and connecting segment 3, there is usually a section without stimulation function, called intermediate segment 2. Intermediate segment 2 mainly provides mechanical support and ensures the stability of electrode 100 so that stimulation segment 1 can be accurately positioned in the target area.

[0040] For ease of understanding and differentiation, please refer to Figures 2 and 3. These electrode contacts 10 can be divided and defined according to their functions:

[0041] On the one hand, since all the electrode contacts 10 arranged on the stimulation segment 1 are configured to provide electrical stimulation to two or more target points, and these electrode contacts 10 exert different stimulation effects on different target points, these electrode contacts 10 are defined as electrode contact combinations 4. Based on the correspondence with multiple target points to be stimulated, the electrode contact combination 4 includes at least two electrode contact groups 41, and at least one electrode contact 10 within each electrode contact group 41 is capable of outputting the same combination of electrical stimulation parameters. Since at least two electrode contact groups 41 correspond to different target points, the combinations of electrical stimulation parameters output by the electrode contacts 10 within different electrode contact groups 41 are different to adapt to the stimulation needs of different target points, thereby achieving the best therapeutic effect.

[0042] On the other hand, the multiple electrode contacts 10 arranged on the connecting section 3 are all configured to connect to the pulse generator 300 or a connecting device (the extension wire 200 shown in Figure 1), so these electrode contacts 10 can be defined as connection points. In the connecting section 3, each electrode contact 10 is independently connected to the pulse generator 300, and each electrode contact 10 in the connecting section 3 corresponds to the electrode contact 10 of the stimulation section 1, so that there is a one-to-one electrical connection between the electrode contact 10 of the stimulation section 1 and the electrode contact 10 of the connecting section 3. For example, a metal wire built into the electrode 100 is used for connection, so that each electrode contact 10 of the stimulation section 1 can be individually electrically connected to the pulse generator 300, ensuring that the combination of electrical stimulation parameters output by the electrode contact 10 of each stimulation section 1 can be independently controlled. By independently adjusting different stimulation contact groups 41, precise electrical stimulation parameters can be provided for different target points, thereby improving the therapeutic effect. As shown in Figure 3, for example, the electrode contact assembly 4 can include two electrode contact groups 41, and each electrode contact group 41 can include four electrode contacts 10.

[0043] The total length of the electrode contact assembly 4 needs to be selected based on the location distribution of different target points in the brain. Since the target points in most combined stimulations are not spatially close together but distributed across different brain regions, the length of the electrode 100 must be long enough to span these regions to ensure coverage of these different target points. The stimulation segment 1 of a conventional electrode 100 is relatively short and typically only acts on one target point, failing to achieve simultaneous coverage of multiple target points. Therefore, in this embodiment, the total length of the electrode contact assembly 4 is extended to 12 mm or longer to ensure effective coverage of multiple target points when the electrode 100 is inserted into the brain, and to ensure that these target points are covered independently and separately, thereby reducing interference between electric fields, improving the stimulation accuracy of each target point, and ultimately enhancing the therapeutic effect.

[0044] In this embodiment, the total length of the electrode contact assembly 4 is denoted as X, and the range of X is 12mm≤X≤70mm. For example, X can be 12mm, 19mm, 21.8mm, 22.1mm, 22.5mm, 26mm, 32.5mm or 70mm, etc. The listed values ​​are not limited, and other unlisted values ​​within this range are also applicable.

[0045] Furthermore, to meet the need for joint stimulation of two or more target points, in this embodiment, the total number of electrode contacts 10 included in the electrode contact assembly 4 is denoted as n, where n ≥ 5. Simultaneously, appropriately increasing the number of electrode contacts 10 in the electrode contact assembly 4 also helps improve the accuracy of electrical stimulation. Increasing the number of electrode contacts 10 provides more options for electrical stimulation positions, thereby allowing for more precise alignment with the target point. That is, within the same size, the more electrode contacts 10 there are, and the smaller the spacing between the electrode contacts 10, the more optimal electrode contacts 10 can be selected as stimulation points.

[0046] When stimulating multiple targets simultaneously, the design and selection of the total length X of the electrode contact assembly 4 and the number n of its constituent electrode contacts 10 are crucial for achieving high-precision brain electrical stimulation. The design described above ensures that at least one complete electrode contact 10 is used for stimulation within each target, and that these electrode contacts 10 create sufficient surface area to release a specific combination of stimulation parameters that generate an electric field within the brain that significantly influences the location and size of the target in the lesion area. Exemplarily, each target is stimulated by 1 to 6 electrode contacts 10.

[0047] Therefore, by corresponding different electrode contact groups 41 to different target points, independent and combined stimulation of multiple target points can be achieved. This not only improves the precision of stimulation but also avoids potential interference between different target points, ensuring that each target point receives the most suitable electrical stimulation parameters for its treatment. By independently corresponding different electrode contact groups 41 to different target points and adjusting the output of multiple groups of electrical stimulation parameters, high-precision deep brain stimulation can be achieved, thereby reducing the risk of unnecessary stimulation of non-target areas and reducing side effects such as language disorders and memory problems.

[0048] Generally, different diseases require electrical stimulation targeting different numbers of points. For example, some complex neurological diseases may require simultaneous action on multiple points with a wide coverage area, thus necessitating a larger number of electrode contacts 10 to ensure adequate coverage of each target. Furthermore, in clinical practice, the size, shape, and location of lesions vary among patients, therefore the number of electrode contacts 10 needs to be flexible enough to adapt to different patients' pathological conditions and surgical errors. Different electrode contact groups 41 can be individually adjusted for different targets.

[0049] Therefore, in one embodiment, the number n of electrode contacts 10 included in the electrode contact assembly 4 is in the range of 5 ≤ n ≤ 24. For example, n can be 5, 6, 8, 10, 12, 16, 20, 22, and 24, etc. The listed values ​​are not limiting, and other values ​​not listed within this range are also applicable. The flexibility of this range design mainly considers that under the current technological level, n ≤ 24 can meet millimeter-level precision control, ensure treatment effect and multi-target coverage, and adapt to individual differences in cases.

[0050] n can be selected as 5 ≤ ​​n ≤ 12. Based on practicality and cost-effectiveness considerations in clinical applications, a design with 5 to 12 electrode contacts 10 ensures sufficient coverage of target points while maintaining the accuracy of stimulation at each target point. Within this range, the number of electrode contacts 10 provides sufficient surface area for electrical stimulation while effectively controlling the electric field range and avoiding interference with adjacent unrelated areas. A larger number of electrode contacts 10 increases the complexity of the electrode 100 structure and the difficulty of operation, while a design with 5 to 12 electrode contacts 10 ensures therapeutic efficacy while maintaining a relatively simple structure, facilitating surgical manipulation and adjustment. Furthermore, more electrode contacts 10 mean higher manufacturing costs and technical requirements, while a contact number between 5 and 12 strikes a reasonable balance between technical difficulty and cost, making it suitable for widespread clinical applications.

[0051] In this embodiment, the length of the electrode contact 10 is denoted as L, and L≥1mm. Considering that an excessively long electrode contact 10 may cause side effects to the patient during treatment, the selectable range for the length of the electrode contact 10 is 1mm≤L≤3mm. For example, L can be 1mm, 1.5mm, 2mm, 2.5mm or 3mm, but is not limited to the listed values. Other lengths within this range are also applicable.

[0052] Multiple electrode contacts 10 may have the same or different lengths, but they can be designed to be the same length to simplify the design and manufacturing process of the electrode 100. Using electrode contacts 10 of the same length can reduce potential interference caused by uneven electric field distribution, while ensuring that each electrode contact 10 stimulates the same volume area in the brain, thereby improving the repeatability and reliability of the treatment effect.

[0053] Please refer to Figure 3. In this embodiment, the distance between any two adjacent electrode contacts 10 is denoted as P, and P ≥ 0.5 mm. Values ​​include, for example, 0.5 mm, 1 mm, 1.5 mm, 2 mm, 3 mm, or 4 mm. By reasonably setting the contact distance P, independent coverage of different target points can be ensured, and side effects that may be caused by excessive concentrated stimulation can be avoided. Similar to the selection of the length L of the electrode contact 10, the distance P between adjacent electrode contacts 10 can be the same or not exactly the same.

[0054] Electrode configuration example:

[0055] Example 1: When n=8, the length L of each electrode contact 10 is ≥1.5mm, and the distance P between adjacent electrode contacts 10 is ≥0.5mm;

[0056] Example 2: When n = 12, the length L of each electrode contact 10 is ≥ 1.5 mm, and the distance P between adjacent electrode contacts 10 is ≥ 0.5 mm.

[0057] As mentioned earlier, the selection of target combinations should depend on the patient's specific condition and treatment needs. Different target combinations typically involve different electrode configurations, such as the number n, length L, and spacing P of the electrode contacts 10 in the electrode contact combination 4 on the corresponding electrode 100. Therefore, to meet diverse stimulation needs, it is necessary to develop multiple electrode models. However, this approach may result in a large number of electrode models and high production costs in practical applications, which is not conducive to clinical promotion and large-scale production.

[0058] To address this issue, the electrode configurations required for different target combinations can be accumulated and analyzed to identify one or more target combinations with similar electrode configurations. The electrode configuration requirements for these target combinations are then summarized and comprehensively analyzed. Based on these results, an electrode configuration that can meet the stimulation needs of these target combinations is determined. This method can significantly reduce the number of electrode models required, satisfying the stimulation needs of multiple target combinations with a small number of electrode specifications, thus making it more suitable for large-scale production and clinical applications.

[0059] Building upon this foundation, a sufficient number of electrode contacts 10 can be designed and arranged on the electrode 100, and at least one of the length L and spacing P of these electrode contacts 10 can be standardized to optimize electrode design, reduce production requirements, and improve clinical applicability. To ensure that the stimulation needs of multiple targets can be met in practical applications, the electrode contacts 10 can be precisely selected intraoperatively. For example, through intraoperative image analysis, the most suitable electrode contacts 10 can be selected from the standardized electrode contact combinations 4 of the electrode 100 and configured to stimulate the corresponding target, thereby ensuring that each target can be effectively stimulated by at least one complete electrode contact 10. This method not only helps to simplify the production process but also optimizes the clinical application effect of the electrode 100, ultimately achieving dual optimization of production and clinical needs.

[0060] Electrode configuration example:

[0061] Example 3: n = 8, the length L of each electrode contact is 1.5 mm, and the distance P between adjacent electrode contacts is ≥ 0.5 mm;

[0062] Example 4: n = 12, the length L of each electrode contact is 1.5 mm, and the distance P between adjacent electrode contacts is ≥ 0.5 mm;

[0063] Example 5: n = 12, the length L of each electrode contact is 1.5 mm, and the distance P between adjacent electrode contacts is 0.5 mm.

[0064] Example 6: n = 24, the length L of each electrode contact is 1.0 mm, and the distance P between adjacent electrode contacts is 0.5 mm.

[0065] The discussion of the length L of the electrode contact 10, the spacing P between adjacent electrode contacts 10, and the number n of electrode contacts 10 involved in the above electrode configuration is limited to the configuration of the electrode contact combination 4 on the stimulation segment 1 and does not constitute a limitation on the electrode contacts 10 on the connection segment 3.

[0066] Referring to Figure 3, the electrode contact assembly 4 may further include at least one additional electrode contact 42 located proximally to all electrode contact groups 41. During brain electrical stimulation, the electric field extends from the deep brain region towards the cortex. To prevent excessive stimulation of the cerebral cortex, the additional electrode contact 42 can be set to a positive electrode to form an electric field and cut off the stimulation area, preventing the charge generated by the electrode contact group 41 from diffusing into the cortex and reducing patient discomfort. In this embodiment, there is one additional electrode contact 42, arranged in a ring.

[0067] The length of the additional electrode contact 42 is denoted as L. a For example, L a The length L of the electrode contact 10 is greater than or equal to that of the electrode contact 10. For example, in an optional embodiment, L ≤ 2 mm. a ≥2mm, for example, value is L a =3mm. Under the same voltage conditions, the longer the length of the auxiliary electrode contact 42, the lower the current density. Thus, by increasing the length of the auxiliary electrode contact 42, patient discomfort caused by excessive current density can be avoided.

[0068] Furthermore, the number of additional electrode contacts 42 can be set to two or more, and the spacing between adjacent additional electrode contacts 42 can be from 0.5 mm to 4 mm. The spacing can be 0.5 mm, 1.5 mm, 2 mm, 3 mm, or 4 mm, but is not limited to the listed values; other values ​​within this range are also applicable. This embodiment uses 2 mm as an example for illustration. This design ensures that the additional electrode contacts 42 have sufficient contact area to form a current loop and cut off the stimulation area.

[0069] For example, the distance between the additional electrode contact 42 and the adjacent electrode contact 10 is greater than or equal to the distance between any two adjacent electrode contacts 10. This is because the greater the distance between the additional electrode contact 42 and the adjacent electrode contact 10, the less interference it causes with the effective stimulation range of the electrode contact 10. If the additional electrode contact 42 is too close to the electrode contact 10, the additional electrode contact 42, as the positive electrode, may compress the electric field range of the electrode contact 10. For example, when the additional electrode contact 42 is located immediately above the electrode contact 10, it will compress the circular electric field formed by the electrode contact 10 into an elliptical shape, which may affect the effectiveness and accuracy of the stimulation.

[0070] Please refer to Figure 3. In this embodiment, the distance between the additional electrode contact 42 and the distal end of the stimulation segment 1 of the electrode is denoted as Y, where 14mm ≤ Y ≤ 70mm. This ensures that during brain electrical stimulation, the additional electrode contact 42 can be located in a non-target region of the brain, such as white or gray matter. Electrophysiological signals from the brain are acquired through the additional electrode contact 42, and the electrical stimulation parameters are adjusted based on the acquired signals to achieve closed-loop control (or adaptive adjustment) of the electrical stimulation parameters, thereby improving the treatment effect for complex diseases. For example, Y can be 14mm, 22mm, 34mm, 48mm, 60mm, or 70mm, but is not limited to the listed values; other values ​​within this range are also applicable.

[0071] As shown in Figure 3, in this embodiment, the electrode contact assembly 4 further includes at least one cortical electrode contact 43, which is located proximal to the additional electrode contact 42. During brain electrical stimulation, the cortical electrode contact 43 is located in the cerebral cortex. The cortical electrode contact 43 not only collects electrophysiological signals from the cortical region, which can be configured to correct electrical stimulation parameters in deep brain regions, but also modulates neural activity in the cortical region, enhancing the overall therapeutic effect.

[0072] As mentioned above, in this embodiment, at least two electrode contact groups 41 are configured to output different combinations of electrical stimulation parameters to ensure that the corresponding target points receive appropriate electrical stimulation. However, the electric fields formed by adjacent electrode contact groups 41 may superimpose, leading to instability or inaccuracy in the electrical stimulation effect, thereby triggering unintended therapeutic effects and physiological responses.

[0073] To address the aforementioned issues, in one exemplary embodiment, at least one independent electrode contact 10 (i.e., the electrode contact 10 does not belong to any electrode contact group 41) may be provided between adjacent electrode contact groups 41. During brain electrical stimulation, this independent electrode contact 10 serves as a positive electrode, acting as a neutral electrode or a reference electrode. The presence of the independent electrode contact 10 effectively isolates the electric fields generated by adjacent electrode contact groups 41, preventing mutual interference or superposition of electric fields, and ensuring that the electric field generated by each group of contacts acts independently on the target area specified by the independent electrode contact 10.

[0074] As an alternative or supplementary measure, the spacing between adjacent electrode contact groups 41 can be set to be greater than 0.5 mm, such as 1 mm or 2 mm. The spacing is determined according to the range of the electric field generated by the adjacent electrode contact groups 41, so as to avoid problems caused by mutual interference or superposition of electric fields. Within this spacing, it is optional to not set electrode contacts 10, or to set electrode contacts 10, but it is not necessary to deliver electrical stimulation parameters to these electrode contacts 10.

[0075] As shown in Figure 4, considering that the implantation position of electrode 100 during surgery may not only deviate from the expected position in depth but also may deviate laterally, theoretically, different target points can be stimulated by selecting different electrode contacts 10. However, this cannot solve the problem of lateral deviation in the implantation position of electrode 100, causing the electric field to act on non-treatment areas and triggering side effects. As shown in Figure 4, at least one electrode contact 10 in at least one electrode contact combination 4 can be set in a segmented form. The segmented electrode contact 10 includes Z electrode pieces 101 spaced circumferentially along electrode 100, where Z≥3. Each electrode piece 101 is individually connected to pulse generator 300, so that the electrical stimulation parameters of each electrode piece 101 can be adjusted individually. By controlling the delivery of electrical stimulation only to the electrode pieces 101 pointing to the target point and not to the electrode pieces 101 deviating from the target point, side effects can be effectively avoided. At the same time, this design can also improve the stimulation density and precision of specific sites, thereby enhancing the treatment effect of complex diseases.

[0076] Z can be 3, 6, or 12, but is not limited to the listed values; other unlisted values ​​within this range are also applicable. In this embodiment, three electrode sheets 101 are used as an example.

[0077] This application provides an electrode for deep brain stimulation, wherein the electrode is configured to stimulate two or more functional targets in the brain.

[0078] When the electrode is implanted into the brain, it passes through or is inserted into two or more functional targets in the brain to provide combined electrical stimulation to multiple functional targets in the brain.

[0079] The electrode includes a stimulation segment 1, on which an electrode contact assembly 4 is arranged along the length direction of the stimulation segment 1. The electrode contact assembly 4 includes at least two electrode contact groups 41, which correspond to different functional targets in the brain. Each electrode contact group 41 includes at least one electrode contact 10. At least one electrode contact 10 in the same electrode contact group 41 can output the same combination of electrical stimulation parameters. Different electrode contact groups 41 output different combinations of electrical stimulation parameters.

[0080] The total length of electrode contact assembly 4 is X, where X ≥ 12 mm;

[0081] The total number of electrode contacts 10 included in electrode contact assembly 4 is n, where n≥5.

[0082] In one or more embodiments, each electrode contact group 41 acts on a functional target in the brain, and each functional target in the brain is stimulated by at least one electrode contact 10.

[0083] In one or more embodiments, 5 ≤ n ≤ 24.

[0084] In one or more embodiments, 5 ≤ n ≤ 12.

[0085] In one or more embodiments, n is 5, 6, 8, 10, or 12.

[0086] In one or more embodiments, the length of the electrode contact 10 is L, where L ≥ 1 mm, and at least one electrode contact 10 may have the same or different lengths.

[0087] In one or more embodiments, 1mm ≤ L ≤ 3mm.

[0088] In one or more embodiments, the distance between two adjacent electrode contacts 10 is P, where P ≥ 0.5 mm, and the distance between any two adjacent electrode contacts 10 may be the same or not exactly the same.

[0089] In one or more embodiments, n = 8, the length L of each electrode contact 10 is ≥ 1.5 mm, and the distance between any two adjacent electrode contacts 10 is P, where P ≥ 0.5 mm.

[0090] In one or more embodiments, n = 8, the length L of each electrode contact 10 is 1.5 mm, and the distance between any two adjacent electrode contacts 10 is P, where P ≥ 0.5 mm.

[0091] In one or more embodiments, n = 12, the length of each electrode contact 10 is L, L ≥ 1.5 mm, and the distance P between any two adjacent electrode contacts 10 is ≥ 0.5 mm.

[0092] In one or more embodiments, n = 12, the length L of each electrode contact 10 is 1.5 mm, and the distance P between any two adjacent electrode contacts 10 is ≥ 0.5 mm.

[0093] In one or more embodiments, the electrode contact assembly 4 further includes at least one additional electrode contact 42 located on the proximal side of all electrode contact assemblies 41, which serves as a positive electrode when the brain is electrically stimulated.

[0094] In one or more embodiments, the length of the additional electrode contact 42 is greater than or equal to the length of each electrode contact 10.

[0095] In one or more embodiments, the length of the additional electrode contact 42 is L. a L a ≥2mm.

[0096] In one or more embodiments, the distance between the additional electrode contact 42 and the adjacent electrode contact 10 is greater than or equal to the distance between any two adjacent electrode contacts 10.

[0097] In one or more embodiments, the distance between the additional electrode contact 42 and the distal end of the stimulation segment 1 is Y, where 14mm ≤ Y ≤ 70mm.

[0098] In one or more embodiments, the number of additional electrode contacts 42 is two or more.

[0099] In one or more embodiments, when the brain is electrically stimulated, the additional electrode contact 42 can be placed in a non-functional target region within the brain.

[0100] In one or more embodiments, the electrode contact assembly 4 further includes at least one cortical electrode contact 43 located proximal to the additional electrode contact 42, wherein the cortical electrode contact 43 is located in the cerebral cortex when the brain is electrically stimulated.

[0101] In one or more embodiments, at least one independent electrode contact 10 is provided between adjacent electrode contact groups 41, which serves as the positive electrode when the brain is electrically stimulated.

[0102] In one or more embodiments, the spacing between adjacent electrode contact groups 41 is greater than 0.5 mm.

[0103] In one or more embodiments, each functional target in the brain is stimulated by 1 to 6 electrode contacts 10.

[0104] In one or more embodiments, two or more intracranial functional targets are:

[0105] The anterior limb of the internal capsule (ALIC) and the nucleus accumbens (NAc); or

[0106] The posterior subthalamic region (PSA) and the ventral intermediate nucleus (Vim) of the thalamus; or

[0107] Subthalamic nucleus (STN) and substantia nigra (SN); or

[0108] Subthalamic nucleus (STN), substantia nigra (SN), and caudal zone of indeterminate shape (Czi); or

[0109] Hippo from the seahorse and Amyotrophic lateral fossa (Amg); or

[0110] The infrakal cingulates return to Cg25 and the anterior cingulates return to ACC; or

[0111] BNST of the end-stretch bed and ALIC of the anterior limb of the internal capsule; or

[0112] ventral internal capsule (VC) / ventral striatum (VS); or

[0113] The nucleus accumbens (NAc) and the supralateral part of the medial forebrain tract (slMFB); or

[0114] CM-parafascicular nucleus complex pf in the central nucleus of the thalamus; or

[0115] Anterior thalamic nucleus (ANT) and mammillary thalamic tract (MTT); or

[0116] Subthalamic nucleus (STN) and substantia nigra reticularis (SNr); or

[0117] Medial globus pallidus GPi and subthalamic nucleus STN; or

[0118] The medial globus pallidus GPi and the substantia nigra reticularis SNr; or

[0119] The ventral intermediate nucleus (Vim) of the thalamus and the subthalamic nucleus (STN).

[0120] In one or more embodiments, when electrical stimulation is simultaneously applied to the anterior limb of the internal capsule ALIC2000 and the nucleus accumbens NAc1000, the electrode contact assembly 4 covers a total length L of the anterior limb of the internal capsule ALIC2000 and the nucleus accumbens NAc1000. t 7.5mm≤L t ≤32mm.

[0121] In one or more embodiments, when electrical stimulation is applied simultaneously to the anterior limb of the internal capsule ALIC2000 and the nucleus accumbens NAc1000, at least one independent electrode contact 10 is provided at the junction of the anterior limb of the internal capsule ALIC2000 and the nucleus accumbens NAc1000 or between the two, and the electrode contact 10 serves as the positive electrode.

[0122] In one or more embodiments, at least one electrode contact 10 in at least one electrode contact assembly 4 is arranged in a segmented manner.

[0123] In one or more embodiments, the electrode contacts 10 arranged in segments include Z electrode pieces 101 arranged circumferentially around the electrode, where Z ≥ 3.

[0124] For example, a microelectrode is disposed between two adjacent electrode sheets 101.

[0125] This application aims to achieve precise combined stimulation of multiple brain functional targets using a single electrode. The electrode has at least two independent electrode contact groups, spaced apart from each other, and is independently electrically connected to a pulse generator. This allows each contact group to simultaneously cover different brain functional targets, and the electrical stimulation parameters, such as pulse frequency, width, and intensity, can be independently set according to treatment needs. This design not only improves the accuracy of multi-target stimulation but also simplifies the implantation process and reduces surgical risks. In practical applications, doctors can accurately implant the electrode into the target brain region through a pre-set implantation path and precisely control the electrical stimulation of different contact groups using the pulse generator. This is suitable for the treatment of various mental illnesses and movement disorders.

[0126] Based on in-depth research into human brain anatomy, this application has discovered that many important brain functional targets can lie on the same straight line in a specific selected cross-section. This anatomical feature inspired an innovative electrode design scheme, which uses a single electrode within a directionally selected channel to jointly stimulate multiple target brain functional points. Compared with traditional designs, this design has the following advantages:

[0127] 1. Simplified surgical procedure: By using a single electrode to cover multiple target points, the complex operation of using multiple independent electrodes is avoided, reducing the complexity of the surgery and the head trauma to the patient.

[0128] 2. Reduced trauma risk: By reducing the number of implanted electrodes, the patient's head wound area is reduced, which helps to reduce the risks during the implantation process and alleviate the patient's recovery stress.

[0129] 3. Improve the efficiency and effectiveness of electrical stimulation: A single electrode can achieve precise stimulation of multiple brain functional targets within a single surgical channel, effectively reducing mutual interference between electrodes, thereby improving the accuracy of electrical stimulation and the therapeutic effect.

[0130] 4. Independent stimulation of multiple targets: This application enables the electrode contacts in different electrode contact groups on a single electrode to independently correspond to different functional targets in the brain, and adjust the electrical stimulation parameters according to the needs of each target, thereby optimizing the treatment effect and reducing the occurrence of side effects.

[0131] 5. Reduce patient burden: By reducing the number of implanted electrodes and optimizing surgical pathways, the medical burden on patients can be reduced.

[0132] In summary, this application not only simplifies the surgical procedure but also significantly improves the electrical stimulation effect of multifunctional targets, making deep brain stimulation therapy more efficient and safer in the treatment of mental illnesses and movement disorders.

[0133] The present application will now be described in conjunction with embodiments:

[0134] Example 1

[0135] Please refer to Figure 5. This embodiment relates to the treatment of mental disorders, such as obsessive-compulsive disorder, based on the aforementioned stimulation device and combined stimulation of functional targets in the brain. The selected targets are the nucleus accumbens (NAc1000) and the anterior limb of the internal capsule (ALIC2000). These targets play important roles in the brain and are closely related to the aforementioned diseases. By simultaneously stimulating these two targets, comprehensive regulation of the affected area can be achieved, improving the therapeutic effect.

[0136] Based on the fact that the electrodes penetrate the anterior limb of the internal capsule ALIC2000 and the nucleus accumbens NAc1000, the length X of the electrode contact assembly 4, the length L of the electrode contact 10, the spacing P of the electrode contact 10, and the number n of the electrode contact 10 are designed and selected as follows in this embodiment to ensure coverage of the target point while improving the accuracy of stimulation.

[0137] The length X of electrode contact assembly 4: Based on the anatomical structure of the anterior limb of the internal capsule (ALIC2000) and the nucleus accumbens (NAc1000), X = 15 mm is selected to ensure that the electrode contact assembly simultaneously covers and penetrates the key areas of these two target points. The total length L of electrode contact assembly 4 covering the anterior limb of the internal capsule (ALIC2000) and the nucleus accumbens (NAc1000) is calculated. t With a diameter greater than 7.5 mm, the electrode contact 10 has sufficient coverage within both target points, thereby effectively releasing electrical stimulation parameters and forming a sufficient electric field to affect the lesion area.

[0138] The electrode contact assembly 4 has 8 electrode contacts 10, each with a length L of 1.0 mm and a spacing P of 1.0 mm between adjacent electrode contacts 10. This configuration provides sufficient contact density within a total length of 15 mm to improve the alignment accuracy between the electrode 100 and the target, thereby enhancing the therapeutic effect.

[0139] The selection criteria for the length X of electrode contact assembly 4, the number n of electrode contacts 10, the length L of electrode contacts 10, and the spacing P of electrode contacts 10 are as follows:

[0140] Based on the penetration of the electrodes along their length, the size of the electrode penetration in the anterior limb of the internal capsule ALIC2000 is 18–27 mm, with an optimal stimulation range of 12–18 mm; the size of the electrode penetration in the nucleus accumbens NAc1000 is D, where 1 mm < D ≤ 7.5 mm, and the maximum distance the electrode is allowed to be exposed after passing through the nucleus accumbens is 4 mm. At the same time, the minimum distance between the electrode contact group 41 and the distal end of the electrode (length of the electrode head insulator) is 1.5 mm.

[0141] When X ≤ 70 mm, electrode contact assembly 4 will be located below the cerebral cortex. When X is between 12 mm and 70 mm, electrode contact assembly 4 will be located entirely below the cerebral cortex and can simultaneously penetrate the anterior limb of the internal capsule (ALIC2000) and the nucleus accumbens (NAc1000).

[0142] When X is between 12mm and 32mm, it ensures that the electrode contact assembly 4 completely passes through the anterior limb of the internal capsule ALIC2000 and the nucleus accumbens NAc1000, covering the electrical stimulation area of ​​these two target points, thereby improving the effect of electrical stimulation of the anterior limb of the internal capsule ALIC2000 and the nucleus accumbens NAc1000.

[0143] Therefore, when X = 15 mm, the electrode contact assembly 4 can be ensured to extend beyond the nucleus accumbens (NAc1000) and into the anterior limb of the internal capsule (ALIC2000). When X = 15 mm, the electrode contact assembly 4 can cover the total length L within the anterior limb of the internal capsule (ALIC2000) and the nucleus accumbens (NAc1000). t The electrode contact assembly is 10mm long, ensuring that the electrode contact assembly 4 simultaneously penetrates the anterior limb of the internal capsule ALIC2000 and the nucleus accumbens NAc1000, and maintains a certain length inside these two target points.

[0144] When using electrodes 100 of different lengths and considering individual differences among patients, when simultaneously performing combined electrical stimulation on the anterior limb of the internal capsule ALIC2000 and the nucleus accumbens NAc1000, the electrode contact combination 4 covers a total length L of the anterior limb of the internal capsule ALIC2000 and the nucleus accumbens NAc1000. t It ranges from 7.5mm to 32mm.

[0145] At least one independent electrode contact 10 is provided at the junction of the anterior limb of the internal capsule ALIC2000 and the nucleus accumbens NAc1000 or between the two (considering individual differences), and this electrode contact 10 serves as the positive electrode.

[0146] Furthermore, in this embodiment, the electrode 100 also includes one or both of the following: an additional electrode contact 42 and a skin electrode contact 43. Correspondingly, the length X of the electrode contact combination 4 should be selected to meet the following conditions:

[0147] When setting the additional electrode contact 42: X should be greater than or equal to 15mm to ensure effective coverage of the target area; for example, if an additional electrode contact 42 is set with a length of 3mm and a distance of 3mm between the additional electrode contact 42 and the adjacent electrode contact 10, then n = 9 and X = 21mm.

[0148] When setting cortical electrode contact 43: X should be greater than or equal to 50 mm to accommodate deeper brain targets while ensuring safe positioning throughout the entire cerebral cortex. For example, when X = 70 mm, an additional electrode contact 42 and a cortical electrode contact 43 can be set together, in which case n = 10.

[0149] During the surgical procedure, electrode 100 is gradually inserted to the predetermined target point through test stimulation. When electrode 100 reaches the target point, the doctor can adjust the electrical stimulation parameter combination of the two electrode contact groups 41 based on real-time feedback to ensure that both the internal capsule anterior limb ALIC2000 and the nucleus accumbens NAc1000 achieve the best therapeutic effect.

[0150] During treatment, to ensure effective stimulation of the ALIC2000 anterior limb of the internal capsule and the NAc1000 nucleus accumbens, the following combinations of electrical stimulation parameters were set:

[0151] NAc1000 voltmeter core: voltage 3.5V, frequency 130Hz, pulse width 130μS.

[0152] ALIC2000 for the anterior limb of the internal capsule: voltage 3.2V, frequency 150Hz, pulse width 180μS.

[0153] This setup ensures that the anterior limb of the internal capsule (ALIC2000) and the nucleus accumbens (NAc1000) can be effectively stimulated simultaneously, improving the treatment efficacy for mental illnesses.

[0154] In this application, "joint stimulation" refers to the combined stimulation of the nucleus accumbens 10 and the anterior limb of the internal capsule 2000 by the electrode contact 10 within a period of 1 second or longer, meaning that an effective electric field stimulation is generated at each target point. Of course, within a shorter time period (e.g., 15 milliseconds), the electrical stimulation of the two target points by the electrode contact 10 can be understood as independent, synchronous, or alternating. While alternating stimulation can be understood as "intermittent" within a very short time period, the overall effect can still simultaneously influence both target points.

[0155] Example 2

[0156] This embodiment, also based on the aforementioned stimulation device, performs combined electrical stimulation on functional targets in the brain, primarily for addiction, obsessive-compulsive disorder, and depression. The selected targets in this embodiment are still the anterior limb of the internal capsule (ALIC) and the nucleus accumbens (NAc). By simultaneously stimulating these two targets, the aim is to comprehensively regulate the affected area.

[0157] Unlike Example 1, in this example, the length and spacing of the electrode contacts are differentiated based on the anatomical characteristics of the anterior limb ALIC of the internal capsule and the nucleus accumbens (NAc). Each electrode contact in the electrode contact group corresponding to the NAC has a length of 1.5 mm and a contact spacing of 1 mm, with a total of 4 electrode contacts in this group. Conversely, each electrode contact in the electrode contact group corresponding to the anterior limb ALIC has a length of 2 mm and a contact spacing of 2 mm, with a total of 8 electrode contacts in this group. The total number of electrode contacts in the electrode contact combination is n = 12. The spacing between the two electrode contact groups is 1 mm, and the length X of the electrode contact combination is 27 mm.

[0158] This differentiated design helps to directly match the anatomical structure and functional needs of different target points, thereby improving the precision and therapeutic effect of electrical stimulation. The total length and number of electrodes can be adjusted according to actual needs to ensure effective coverage and stimulation of the target area. Furthermore, the combination of electrical stimulation parameters used during treatment still needs to be fine-tuned based on real-time feedback to achieve the best therapeutic effect.

[0159] Example 3

[0160] This embodiment relates to the treatment of movement disorders, such as Parkinson's disease, based on the aforementioned stimulation device and combined stimulation of functional targets in the brain. The selected targets are the ventral intermediate nucleus of the thalamus (Vim) and the subthalamic nucleus (STN), which play important roles in the brain and are closely related to the aforementioned diseases. Through electrical stimulation of these targets, comprehensive regulation of the affected area can be achieved, improving the therapeutic effect.

[0161] Based on the fact that the electrodes penetrate the ventral intermediate nucleus (Vim) and the subthalamic nucleus (STN), the length X of the electrode contact assembly 4, the length L of the electrode contact, the spacing P of the electrode contact, and the number n of the electrode contacts in this embodiment are designed and selected as follows to ensure coverage of the target point while improving the accuracy of stimulation.

[0162] The length X of the electrode contact assembly: Based on the anatomical structure of the target ventral intermediate nucleus (Vim) and the subthalamic nucleus (STN), X = 24 mm is chosen to ensure that the electrode contact assembly simultaneously covers and penetrates the key areas of the target Vim and STN. The total length L of the electrode contact assembly covering the target ventral intermediate nucleus (Vim) and the subthalamic nucleus (STN) is then determined. t The electrode is 18.7 mm in diameter, ensuring that the electrode contacts have sufficient coverage within the target area, the ventral intermediate nucleus (Vim) of the thalamus and the subthalamic nucleus (STN), thereby effectively releasing electrical stimulation parameters and forming a sufficient electric field to affect the lesion area.

[0163] The number of electrode contacts, n, in the electrode contact assembly is set to n = 10. The length L of each electrode contact is 1.5 mm, and the spacing P between adjacent electrode contacts is 1 mm. This setup provides sufficient contact density within a total length of 24 mm to improve the accuracy of electrode-target alignment, thereby enhancing the therapeutic effect.

[0164] The selection criteria for the length X of the electrode contact assembly, the number n of electrode contacts, the length L of the electrode contacts, and the spacing P of the electrode contacts are as follows:

[0165] Based on the penetration of the electrodes along their length, the ventral intermediate nucleus (Vim) of the thalamus is penetrated by the electrodes by approximately 5.8 mm, the subthalamic nucleus (STN) by approximately 5.5 mm, and the distance between the ventral intermediate nucleus (Vim) and the subthalamic nucleus (STN) is approximately 7.4 mm. Therefore, selecting electrode leads with the following parameters—electrode contact combination length X = 24 mm, number of electrode contacts n = 10, electrode contact length L = 1.5 mm, and electrode contact spacing P = 1 mm—can meet the above requirements for treating Parkinson's disease.

[0166] In addition, the stimulation device provided in this application can also stimulate the combination of brain functional targets shown in Examples 4 to 16 below to treat the corresponding indications.

[0167] Example 4

[0168] This embodiment provides a deep brain stimulation method based on dual-target combined stimulation, primarily for the treatment of movement disorders such as Parkinson's disease and essential tremor. This embodiment selects the posterior subthalamic area (PSA) and the ventral intermediate nucleus (Vim) of the thalamus as the combined stimulation target combination. These targets play a crucial role in regulating motor function and controlling tremor.

[0169] To cover these target points and achieve optimal therapeutic effects, the electrode contact combination is configured as follows in this embodiment:

[0170] Number of electrode contacts n: Select n = 8 electrode contacts to provide sufficient target coverage and precise stimulation control.

[0171] The length L of each electrode contact is 1.5 mm to ensure sufficient electric field distribution in the target area.

[0172] Electrode contact spacing P: The spacing between adjacent electrode contacts is 1.0 mm to ensure that the distribution of electrode contacts can effectively cover the target area while avoiding mutual interference.

[0173] With this design, the electrodes can generate an effective electric field within the PSA and Vim target sites, inhibiting abnormal neural activity in patients with Parkinson's disease and essential tremor, and improving symptom control.

[0174] Example 5

[0175] In this embodiment, the target stimulation combination is the subthalamic nucleus (STN) and substantia nigra (SN), primarily used for the treatment of Parkinson's disease. The STN and SN are important nuclei closely related to motor control and have a significant impact on the pathological mechanisms of Parkinson's disease.

[0176] Therefore, the electrode configuration in this embodiment is as follows:

[0177] Number of electrode contacts n: Choose n=6 to reduce stimulation of surrounding non-target areas while covering the target area.

[0178] Electrode contact length L: Each electrode contact is 1.5mm long to ensure coverage of the critical areas of STN and SN.

[0179] Electrode contact spacing P: The spacing between adjacent electrode contacts is 0.5mm, providing higher stimulation precision and effect.

[0180] This design allows for the establishment of an effective electric field within the STN and SN, thereby suppressing Parkinson's disease symptoms.

[0181] Example 6

[0182] This embodiment provides a multi-target combined stimulation method for the treatment of Parkinson's disease. The selected targets include the subthalamic nucleus (STN), substantia nigra (SN), and caudal zona incerta (Czi). Combined stimulation of these targets can enhance the control of Parkinson's disease, especially in terms of motor control.

[0183] The electrode configuration is as follows:

[0184] Number of electrode contacts n: Select n = 8 contacts to ensure that an effective electric field is generated in multiple target areas.

[0185] Electrode contact length L: Each electrode contact is 1.5 mm long, covering the entire target area.

[0186] Electrode contact spacing P: The spacing between adjacent electrode contacts is 0.5 mm to improve the accuracy of stimulation and therapeutic effect.

[0187] This design can simultaneously stimulate the STN, SN, and Czi, significantly improving motor symptoms in Parkinson's disease patients.

[0188] Example 7

[0189] This embodiment targets the hippocampus (Hippo) and amygdala (Amg) as combined stimulation sites for the treatment of epilepsy and panic attacks. These two targets play important roles in the regulation of emotion and memory and are closely related to the pathogenesis of epilepsy and panic attacks.

[0190] The electrode configuration is as follows:

[0191] Number of electrode contacts n: Choose n=8 to ensure sufficient target coverage.

[0192] The length L of the electrode contact: Each electrode contact is 1.5 mm long, covering the target area.

[0193] Electrode contact spacing P: The spacing between adjacent electrode contacts is 1.5 mm to optimize the electric field distribution and reduce stimulation of non-target areas.

[0194] This design can effectively control epileptic seizures and panic attacks.

[0195] Example 8

[0196] This embodiment targets the subgenual cingulate gyrus (Cg25) and the anterior cingulate cortex (ACC) as combined stimulation points for the treatment of mental illnesses such as obsessive-compulsive disorder, depression, and schizophrenia. Cg25 and ACC play crucial roles in emotional processing and decision-making, and have a significant impact on the pathological mechanisms of the aforementioned mental illnesses.

[0197] The electrode configuration is as follows:

[0198] Number of electrode contacts n: Choose n=8 to provide sufficient target coverage and stimulation control.

[0199] Electrode contact length L: Each electrode contact is 1.5 mm long to cover the target area.

[0200] Electrode contact spacing P: The spacing between adjacent electrode contacts is 1.5 mm to ensure precise stimulation control and optimized treatment results.

[0201] This design can effectively improve the symptoms of patients with obsessive-compulsive disorder, depression, and schizophrenia.

[0202] Example 9

[0203] This embodiment targets the bed nucleus of the stria terminalis (BNST) and the auricular alicoid ligament (ALIC) of the internal capsule as a combined stimulation target combination for the treatment of mental disorders such as addiction (including gambling addiction, alcohol addiction, drug addiction, etc.) and obsessive-compulsive disorder. The BNST and ALIC play important roles in emotion regulation and reward circuits, and are key targets for the treatment of addiction and obsessive-compulsive disorder.

[0204] The electrode configuration is as follows:

[0205] Number of electrode contacts n: Select n = 8 electrode contacts to ensure sufficient target coverage and provide precise stimulation.

[0206] The length L of the electrode contact: Each electrode contact is 1.5 mm long to cover the target area and achieve effective electric field distribution.

[0207] Electrode contact spacing P: The spacing between adjacent contacts is 1.0 mm to ensure precise arrangement of electrode contacts and enhance stimulation effect.

[0208] With this design, the electrodes can generate an effective electric field within the BNST and ALIC target sites, improving patients' addiction and obsessive-compulsive symptoms.

[0209] Example 10

[0210] In this embodiment, the stimulation target combination is the ventral capsule / ventral striatum (VC / VS), primarily used to treat mental illnesses such as obsessive-compulsive disorder, depression, addiction, autism (autism spectrum disorder), anorexia nervosa, and bipolar disorder. The VC / VS plays an important role in emotion regulation and reward systems.

[0211] The electrode configuration is as follows:

[0212] Number of electrode contacts n: Select n=8 to cover the target area and provide sufficient stimulation control.

[0213] Electrode contact length L: Each electrode contact is 1.5mm long to ensure full coverage of the VC / VS area.

[0214] Electrode contact spacing P: The spacing between adjacent contacts is 1.5mm to optimize the electric field distribution and avoid non-targeted stimulation of surrounding tissues.

[0215] This design can significantly improve patients' mental symptoms, especially for symptoms related to mood disorders.

[0216] Example 11

[0217] This embodiment targets the nucleus accumbens (NAc) and the superolateral medial forebrain bundle (slMFB) as combined stimulation sites for the treatment of obsessive-compulsive disorder and bipolar disorder. The NAc and slMFB are important components of the reward circuit and have a direct impact on the control of emotions and behavior.

[0218] The electrode configuration is as follows:

[0219] Number of electrode contacts n: Select n = 8 contacts to ensure sufficient coverage area and precise control of target activity.

[0220] Electrode contact length L: Each electrode contact is 1.5 mm long to fully cover the NAc and slMFB areas.

[0221] Electrode contact spacing P: The spacing between adjacent contacts is 1.0 mm to ensure precise stimulation and reduce off-target effects.

[0222] This design can effectively regulate patients' emotional and behavioral responses, and alleviate symptoms of obsessive-compulsive disorder and bipolar disorder.

[0223] Example 12

[0224] This embodiment aims to treat disorders of consciousness through combined stimulation of two targets. The selected target combination is the centromedian-parafascicular nuclei complex (CM-pf) of the thalamus, which plays a key role in the regulation of consciousness and arousal.

[0225] The electrode configuration is as follows:

[0226] Number of electrode contacts n: Select n = 5 contacts to cover the target area and reduce interference from stimulation to surrounding non-target areas. Of these, 4 are the main electrode contacts and 1 is the auxiliary electrode contact.

[0227] Electrode contact length L: Each electrode contact is 1.5 mm long to ensure that the electrode covers the critical portion of the CM-pf area. Additional electrode contact length L a It is 3mm.

[0228] Electrode contact spacing P: The spacing between adjacent contacts is 1.5mm, providing a uniform electric field distribution and improving the stimulation effect.

[0229] This electrode design helps enhance the patient's arousal and promotes the recovery of consciousness.

[0230] Example 13

[0231] This embodiment, targeting the treatment of epilepsy, selected the anterior nucleus of thalamus (ANT) and the mammaryothalamic tract (MTT) as combined stimulation targets. ANT and MTT play important roles in memory circuits and epileptic seizures.

[0232] The electrode configuration is as follows:

[0233] Number of electrode contacts n: Select n = 6 contacts to cover the critical areas of ANT and MTT. Among them, the number of electrode contacts is 4, and the number of auxiliary electrode contacts is 2.

[0234] Electrode contact length L: Each electrode contact is 1.5 mm long to provide adequate electric field coverage. Additional electrode contact length L a It is 2mm.

[0235] Electrode contact spacing P: The spacing between adjacent contacts is 1.0 mm to ensure that the electrode arrangement can achieve precise stimulation.

[0236] This design can effectively reduce the frequency and severity of epileptic seizures.

[0237] Example 14

[0238] This embodiment, targeting the treatment of Parkinson's disease, selected the subthalamic nucleus (STN) and the substantia nigra pars reticulata (Snr) as targets for combined stimulation. These two targets play important roles in motor control and tremor modulation.

[0239] The electrode configuration is as follows:

[0240] Number of electrode contacts n: Select n = 8 contacts to ensure sufficient target coverage area.

[0241] Electrode contact length L: Each electrode contact is 1.5 mm long, covering the STN and Snr regions.

[0242] Electrode contact spacing P: The spacing between adjacent contacts is 0.5 mm to improve stimulation accuracy.

[0243] This electrode design can significantly improve motor symptoms in Parkinson's disease patients, especially in controlling tremors.

[0244] Example 15

[0245] This embodiment targets the globus pallidus internus (GPi) and the subthalamic nucleus (STN) for combined stimulation in the treatment of movement disorders. These targets play an important role in regulating motor function and inhibiting involuntary movements.

[0246] The electrode configuration is as follows:

[0247] Number of electrode contacts n: Select n = 8 contacts to cover the critical areas of GPi and STN.

[0248] Electrode contact length L: Each electrode contact is 1.5 mm long to ensure coverage of the stimulation area.

[0249] Electrode contact spacing P: The spacing between adjacent contacts is 1.5mm, providing a uniform electric field distribution and avoiding the influence on the surrounding non-target area.

[0250] This design can significantly improve motor function in patients with Parkinson's disease, dystonia, spasmodic torticollis, essential tremor, and Meige syndrome.

[0251] Example 16

[0252] This embodiment aims to treat Parkinson's disease, dystonia, and spasmodic torticollis by combining stimulation of the medial globus pallidus (GPi) and substantia nigra reticularis (SNr). GPi and SNR play key roles in regulating motor function and muscle tone, and their combined stimulation helps improve symptoms of related diseases.

[0253] The electrode configuration is as follows:

[0254] Number of electrode contacts n: Select n = 12 contacts to ensure broad coverage of the target area and achieve the best treatment effect.

[0255] Electrode contact length L: Each electrode contact is 1.5mm long, fully covering the key areas of GPi and SNR, enhancing the electrical stimulation effect.

[0256] Electrode contact spacing P: The spacing between adjacent contacts is 1.0 mm to ensure the accuracy of electrical stimulation and reduce adverse effects on surrounding tissues.

[0257] This design can effectively alleviate motor symptoms in Parkinson's disease patients and improve the condition of patients with dystonia and spasmodic torticollis, thereby improving their quality of life.

[0258] Example 17

[0259] This embodiment provides an application of the above-described stimulation device for treating mental illnesses and movement disorders. The mental illnesses include addiction, obsessive-compulsive disorder, autism spectrum disorder, depression, schizophrenia, bipolar disorder, and anorexia nervosa. The movement disorders include Parkinson's disease, essential tremor, dystonia, spasmodic torticollis, and Meige syndrome.

[0260] Example 18

[0261] This embodiment provides a deep brain stimulation method for treating mental illnesses and movement disorders, the method comprising the following steps:

[0262] Select at least two functional targets in the brain, which are located at different positions on the same straight line; and set different combinations of electrical stimulation parameters according to the treatment needs of the at least two functional targets in the brain.

[0263] Multiple electrode contact groups are set at the distal end of the electrodes, and each electrode contact group corresponds to a functional target point in the brain.

[0264] Preoperative medical imaging is used to determine the insertion path of the electrode, and a single electrode is inserted into the patient's brain along a predetermined channel, so that the electrode passes through or is inserted into at least two functional target points in the brain.

[0265] The pulse generator delivers a preset combination of electrical stimulation parameters to the functional targets in the brain through the electrode contact group to jointly stimulate at least two functional targets in the brain.

[0266] In the process of determining the electrode insertion path through preoperative medical imaging, an implantation path that avoids major blood vessels and sensitive dermal areas can be selected based on the preoperative medical imaging. Among the possible implantation paths, the one with the largest coverage area of ​​the target area is selected first to reduce treatment risks and meet treatment requirements.

[0267] The aforementioned electrode implantation path can be a linear path, which allows functional target points in the brain to be distributed along the axis of the electrode after implantation. This not only simplifies electrode design and implantation process and reduces surgical trauma, but also ensures precise stimulation of multiple target points and improves treatment efficacy.

[0268] In some implementations, the electrode implantation path can also be a non-linear path to avoid specific brain structures. Non-linear path design can improve surgical flexibility, avoid important brain structures, and reduce surgical risks.

[0269] The aforementioned combinations of electrical stimulation parameters (such as at least one of the frequency, pulse width, amplitude, timing, stimulation mode, physician control limits, and patient control limits mentioned above) can be customized according to individual patient differences. Personalized electrical stimulation parameters can improve treatment effectiveness and patient tolerance, and reduce side effects.

[0270] In addition, at least one additional electrode contact can be provided on the proximal side of the electrode contact group, with the additional electrode contact serving as the positive electrode. When the brain is electrically stimulated, the additional electrode contact can effectively form a current loop in the brain, limiting the diffusion of the stimulation electric field to non-target areas, reducing the impact on surrounding healthy brain tissue, and improving the accuracy and safety of electrical stimulation.

[0271] Optionally, at least one cortical electrode contact can be set on the proximal side of the electrode contact group. During the operation, the electrophysiological signal feedback obtained from the cortical electrode contact can monitor the patient's neural activity in real time, and dynamically adjust the electrical stimulation parameters according to the monitoring results to achieve closed-loop control, optimize the electrical stimulation parameters in real time, and improve the accuracy and effect of treatment.

[0272] In summary, this application aims to achieve combined, simultaneous, and precise stimulation of multiple brain functional targets using a single electrode. The electrode design of the device provides multiple independent electrode contact groups, each consisting of several independent electrode contacts, each electrically connected independently to a pulse generator.

[0273] In the electrode design, multiple electrode contacts within each electrode contact group are arranged along the electrode axis, with at least two electrode contact groups spaced apart to ensure that different contact groups can respectively cover different intracranial functional targets. Each electrode contact group can be independently controlled, allowing for targeted electrical stimulation of the corresponding intracranial functional target. The number and distribution of electrode contacts can be configured according to clinical needs to cover the required intracranial functional targets and achieve optimal therapeutic effects.

[0274] To achieve high-precision stimulation of intracranial functional targets, the electrode design in this embodiment allows different electrode contact groups to act on different targets simultaneously without interference. The electrical stimulation parameters of each electrode contact group, such as pulse frequency, pulse width, and current intensity, can be independently adjusted via a pulse generator. This design ensures precise control of multiple intracranial functional targets and reduces the complexity of the surgical procedure.

[0275] During use, surgeons can implant electrodes into specific areas of the patient's brain through pre-designed implantation paths, ensuring that at least two contact groups accurately cover the target points. The pulse generator can output corresponding stimulation signals to the electrode contacts in different contact groups according to the parameters set by the surgeon, thereby achieving effective treatment of multiple functional targets in the brain.

[0276] This single-electrode design effectively simplifies the surgical procedure for multi-target electrical stimulation, reduces surgical risks, and improves the precision and effectiveness of electrical stimulation.

Claims

1. An electrode for deep brain stimulation, wherein, The electrodes are configured to stimulate two or more functional targets in the brain. In response to the targeted implantation of the electrode into the brain, the electrode passes through or is inserted into two or more functional targets in the brain to jointly apply electrical stimulation to the two or more functional targets in the brain. The electrode includes a stimulation segment (1), and an electrode contact assembly (4) arranged along the length direction of the stimulation segment (1) is provided on the stimulation segment (1). The electrode contact assembly (4) includes at least two electrode contact groups (41), and the at least two electrode contact groups (41) correspond to different functional targets in the brain. Each electrode contact group (41) includes at least one electrode contact (10). At least one electrode contact (10) in the same electrode contact group (41) can output the same combination of electrical stimulation parameters. Different electrode contact groups (41) output different combinations of electrical stimulation parameters. The total length of the electrode contact assembly (4) is X, where X ≥ 12 mm; The electrode contact assembly (4) contains a total of n electrode contacts (10), where n ≥ 5.

2. The electrode according to claim 1, wherein, Each electrode contact group (41) acts on a functional target in the brain, and each functional target in the brain is stimulated by at least one electrode contact (10).

3. The electrode according to claim 1, wherein, 5≤n≤24。 4. The electrode according to claim 3, wherein, 5≤n≤12。 5. The electrode according to claim 3, wherein, n can be 5, 6, 8, 10, or 12.

6. The electrode according to claim 1, wherein, The length of the electrode contact (10) is L, L≥1mm, and at least one electrode contact (10) has the same or different lengths.

7. The electrode according to claim 6, wherein, 1mm≤L≤3mm.

8. The electrode according to claim 1, wherein, The distance between two adjacent electrode contacts (10) is P, P≥0.5mm, and the distance between any two adjacent electrode contacts (10) may be the same or not exactly the same.

9. The electrode according to claim 1, wherein, n = 8, the length L of each electrode contact (10) is ≥ 1.5 mm, and the distance between each two adjacent electrode contacts (10) is P, P ≥ 0.5 mm.

10. The electrode according to claim 1, wherein, n = 8, the length L of each electrode contact (10) is 1.5 mm, and the distance between each two adjacent electrode contacts (10) is P, P ≥ 0.5 mm.

11. The electrode according to claim 1, wherein, n = 12, the length of each electrode contact (10) is L, L ≥ 1.5 mm, and the distance between each two adjacent electrode contacts (10) is P ≥ 0.5 mm.

12. The electrode according to claim 1, wherein, n = 12, the length L of each electrode contact (10) is 1.5 mm, and the distance P between any two adjacent electrode contacts (10) is ≥ 0.5 mm.

13. The electrode according to claim 1, wherein, The electrode contact assembly (4) further includes at least one additional electrode contact (42) located on the proximal side of all electrode contact assemblies (41) and serving as a positive electrode in response to electrical stimulation of the brain.

14. The electrode according to claim 13, wherein, The length of the additional electrode contact (42) is greater than or equal to the length of each electrode contact (10).

15. The electrode according to claim 13, wherein, The length of the additional electrode contact (42) is L a L a ≥2mm.

16. The electrode according to claim 13, wherein, The distance between the additional electrode contact (42) and its adjacent electrode contact (10) is greater than or equal to the distance between any two adjacent electrode contacts (10).

17. The electrode according to claim 13, wherein, The distance between the additional electrode contact (42) and the distal end of the stimulation segment (1) is Y, 14mm≤Y≤70mm.

18. The electrode according to claim 13, wherein, The number of the additional electrode contacts (42) is two or more.

19. The electrode according to claim 13, wherein, In response to electrical stimulation of the brain, the additional electrode contacts (42) can be placed in a non-functional target area within the brain.

20. The electrode according to claim 13, wherein, The electrode contact assembly (4) further includes at least one cortical electrode contact (43) located proximal to the at least one additional electrode contact (42) in response to electrical stimulation of the brain, wherein the at least one cortical electrode contact (43) is located in the cerebral cortex.

21. The electrode according to claim 1, wherein, At least one independent electrode contact (10) is provided between adjacent electrode contact groups (41), and the electrode contact (10) serves as a positive electrode in response to electrical stimulation of the brain.

22. The electrode according to claim 1, wherein, The spacing between adjacent electrode contact groups (41) is greater than 0.5 mm.

23. The electrode according to claim 1, wherein, Each functional target point in the brain is stimulated by 1 to 6 electrode contacts (10).

24. The electrode according to claim 1, wherein, The two or more brain functional targets are: The anterior limb of the internal capsule (ALIC) and the nucleus accumbens (NAc); or The posterior subthalamic region (PSA) and the ventral intermediate nucleus (Vim) of the thalamus; or Subthalamic nucleus (STN) and substantia nigra (SN); or Subthalamic nucleus (STN), substantia nigra (SN), and caudal zone of indeterminate shape (Czi); or Hippo from the seahorse and Amyotrophic lateral fossa (Amg); or The infrakal cingulates return to Cg25 and the anterior cingulates return to ACC; or BNST of the end-stretch bed and ALIC of the anterior limb of the internal capsule; or ventral internal capsule (VC) / ventral striatum (VS); or The nucleus accumbens (NAc) and the supralateral part of the medial forebrain tract (slMFB); or CM-parafascicular nucleus complex pf in the central nucleus of the thalamus; or Anterior thalamic nucleus (ANT) and mammillary thalamic tract (MTT); or Subthalamic nucleus (STN) and substantia nigra reticularis (SNr); or Medial globus pallidus GPi and subthalamic nucleus STN; or The medial globus pallidus GPi and the substantia nigra reticularis SNr; or The ventral intermediate nucleus (Vim) of the thalamus and the subthalamic nucleus (STN).

25. The electrode according to claim 24, wherein, In response to simultaneous electrical stimulation of the anterior limb of the internal capsule ALIC (2000) and the nucleus accumbens NAc (1000), the electrode contact assembly (4) covers a total length L of the anterior limb of the internal capsule ALIC (2000) and the nucleus accumbens NAc (1000). t Where 7.5mm≤L t ≤32mm.

26. The electrode according to claim 24, wherein, In response to simultaneous electrical stimulation of the anterior limb of the internal capsule ALIC (2000) and the nucleus accumbens NAc (1000), at least one independent electrode contact (10) is provided at the junction of the anterior limb of the internal capsule ALIC (2000) and the nucleus accumbens NAc (1000) or between the two, and the electrode contact (10) serves as the positive electrode.

27. The electrode according to claim 1, wherein, At least one electrode contact (10) in at least one of the electrode contact assemblies (4) is arranged in a segmented manner.

28. The electrode according to claim 27, wherein, The electrode contacts (10) arranged in a segmented manner include Z electrode pieces (101) arranged circumferentially around the electrode, wherein Z≥3.

29. A stimulation device comprising a pulse generator (300) and an electrode (100) as claimed in any one of claims 1 to 28, the electrode (100) being electrically connected to the pulse generator (300), the pulse generator (300) being configured to output different combinations of electrical stimulation parameters to at least two electrode contact groups (41) in the electrode contact assembly (4).

30. The stimulation device according to claim 29, wherein, The stimulation device also includes an extension wire (200), and the electrode (100), the extension wire (200), and the pulse generator (300) are electrically connected in sequence.

31. Use of the stimulation device as described in claim 29 or 30, wherein, The stimulation device is configured to treat mental illnesses and movement disorders.

32. Use of the stimulation device according to claim 31, wherein, The mental illnesses mentioned include addiction, obsessive-compulsive disorder, autism spectrum disorder, depression, schizophrenia, bipolar disorder, or anorexia nervosa; The movement disorders mentioned include Parkinson's disease, essential tremor, dystonia, spasmodic torticollis, or Meige syndrome.

Images