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

Abstract

The present invention belongs to the field of deep brain stimulation, and discloses an electrode for deep brain stimulation, a stimulation device and the use of the device. The present invention aims to achieve precise joint stimulation of multiple functional targets in the brain through a single electrode. The electrode is provided with at least two independent electrode contact groups, and each contact group is arranged at intervals, and through independent electrical connection with a pulse generator, each contact group can simultaneously cover different functional targets in the brain, and 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 actual applications, doctors can accurately implant electrodes into the target brain area through a preset implantation path, and perform precise electrical stimulation control on different contact groups through a pulse generator, which is suitable for the treatment of a variety of mental illnesses and movement disorders.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an electrode for deep brain stimulation, a stimulation device and a use of the stimulation device. Background Art

[0002] Deep Brain Stimulation (DBS) is a medical device used to electrically stimulate specific areas of the brain. DBS devices usually include 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 a specific area of ​​the patient's brain through the electrode to regulate the neural activity of the specific brain area.

[0003] In DBS surgery, different functional targets in the brain are closely related to their respective brain functions. For example, the subthalamic nucleus (STN) is usually the main target for Parkinson's disease patients, which is directly related to motor control and muscle tension regulation; the globus pallidus internus (GPi) is also commonly used in the treatment of Parkinson's disease and dystonia, and its main function is to regulate muscle tension and movement initiation.

[0004] In order to effectively treat complex diseases such as mental illness and movement disorders, it is usually necessary to perform synchronous electrical stimulation on multiple functional targets in the brain. To achieve such treatment goals, existing DBS devices usually rely on multiple independent electrodes to stimulate different functional targets separately, which increases the complexity of implantation surgery and head trauma of patients, and increases the diagnosis and treatment burden on patients. In addition, coordination problems between multiple independent electrodes may affect the overall stimulation effect, resulting in inaccurate stimulation or insufficient coverage of functional targets.

[0005] Therefore, solving the above problems is of great significance to the further development of DBS technology. Summary of the invention

[0006] In order to overcome the above-mentioned defects in the prior art, the present invention provides an electrode for deep brain stimulation, a stimulation device and a use of the stimulation device. Through the present invention, the electrode can pass through or be inserted into multiple functional targets in the brain when being implanted in a targeted manner in the brain, and electrically stimulate each target at the same time, thereby improving the accuracy of the stimulation and the therapeutic effect.

[0007] To achieve this object, the present invention adopts the following technical solutions:

[0008] An electrode for deep brain stimulation, the electrode is used for stimulating two or more functional targets in the brain; when the electrode is implanted in the brain in a direction, the electrode passes through or is inserted into two or more functional targets in the brain to simultaneously implement electrical stimulation on each functional target in the brain; the electrode includes a stimulation segment, and the stimulation segment is provided with an electrode contact combination arranged along the length direction of the stimulation segment, the electrode contact combination includes at least two electrode contact groups, each electrode contact group corresponds to a different functional target in the brain, each electrode contact group includes at least one electrode contact, each electrode contact in the same electrode contact group can output the same electrical stimulation parameter combination, and different electrode contact groups output different electrical stimulation parameter combinations; the total length of the electrode contact combination is X, X≥12mm; the total number of electrode contacts contained in the electrode contact combination is n, n≥5.

[0009] Preferably, each of the electrode contact groups acts on a functional target point in the brain, and each of the functional target points in the brain is stimulated by at least one electrode contact.

[0010] Preferably, 5≤n≤24.

[0011] Preferably, 5≤n≤12.

[0012] Preferably, n is 5 or 6 or 8 or 10 or 12.

[0013] Preferably, the length of the electrode contact is L, L≥1 mm, and the lengths of the electrode contacts are the same or different.

[0014] Preferably, 1mm≤L≤3mm.

[0015] Preferably, the distance between two adjacent electrode contacts is P, where P≥0.5 mm, and the distance between every two adjacent electrode contacts is the same or different.

[0016] Preferably, n=8, the length of each electrode contact L≥1.5 mm, and the distance between each two adjacent electrode contacts is P, where P≥0.5 mm.

[0017] Preferably, n=8, the length L of each electrode contact is 1.5 mm, and the distance between every two adjacent electrode contacts is P, where P≥0.5 mm.

[0018] Preferably, n=12, the length of each electrode contact is L, L≥1.5 mm, and the distance between each two adjacent electrode contacts is P≥0.5 mm.

[0019] Preferably, n=12, the length L of each electrode contact is 1.5 mm, and the distance P between every two adjacent electrode contacts is ≥0.5 mm.

[0020] Preferably, the electrode contact combination further comprises at least one additional electrode contact, which is located at the proximal side of all the electrode contact groups, and serves as a positive electrode when the brain is electrically stimulated.

[0021] Preferably, the length of the additional electrode contact is greater than or equal to the length of each of the electrode contacts.

[0022] Preferably, the length of the additional electrode contact is L a , L a ≥2mm.

[0023] Preferably, the distance between the additional electrode contact and the electrode contact immediately adjacent thereto is greater than or equal to the distance between any two adjacent electrode contacts.

[0024] Preferably, the distance between the additional electrode contact and the distal end of the stimulation segment is Y, 14mm≤Y≤70mm.

[0025] Preferably, the number of the additional electrode contacts is two or more.

[0026] Preferably, when electrically stimulating the brain, the additional electrode contacts can be placed in non-functional target areas within the brain.

[0027] Preferably, the electrode contact combination further includes at least one cortical electrode contact, which is located on the proximal side of the additional electrode contact, and when the brain is electrically stimulated, the cortical electrode contact is located in the cerebral cortex.

[0028] Preferably, at least one independent electrode contact is provided between adjacent electrode contact groups, and when the brain is electrically stimulated, the electrode contact serves as a positive electrode.

[0029] Preferably, the spacing between adjacent electrode contact groups is greater than 0.5 mm.

[0030] Preferably, each functional target point in the brain is stimulated by 1-6 electrode contacts.

[0031] Preferably, the two or more brain functional targets are:

[0032] Anterior limb of internal capsule (ALIC) and nucleus accumbens (NAc); or

[0033] The posterior subthalamic area PSA and the ventral intermediate thalamic nucleus Vim; or,

[0034] Subthalamic nucleus (STN) and substantia nigra (SN); or

[0035] Subthalamic nucleus STN, substantia nigra SN and caudal zona incerta Czi; or,

[0036] Hippocampus and Amg; or

[0037] Subgenual cingulate gyrus Cg25 and anterior cingulate gyrus ACC; or,

[0038] Bed nucleus of the stria terminalis (BNST) and anterior limb of the internal capsule (ALIC); or

[0039] VC / VS; or

[0040] NAc and slMFB; or

[0041] CM-parafascicular nucleus complex of the thalamus; or,

[0042] anterior thalamic nucleus ANT and mamithalamic tract MTT; or,

[0043] Subthalamic nucleus (STN) and substantia nigra pars reticulata (SNr); or

[0044] GPi and STN; or

[0045] Globus pallidus internus (GPi) and substantia nigra pars reticulata (SNr); or,

[0046] The ventral intermediate thalamic nucleus Vim and the subthalamic nucleus STN.

[0047] Preferably, when the anterior limb of the internal capsule ALIC and the nucleus accumbens NAc are electrically stimulated simultaneously, the electrode contact combination covers a total length of L in the anterior limb of the internal capsule ALIC and the nucleus accumbens NAc. t , 7.5mm≤L t ≤32mm.

[0048] Preferably, when the anterior limb of the internal capsule ALIC and the nucleus accumbens NAc are electrically stimulated simultaneously, at least one independent electrode contact is provided at the junction of the anterior limb of the internal capsule ALIC and the nucleus accumbens NAc or between the two, and the electrode contact serves as the positive electrode.

[0049] Preferably, at least one electrode contact in at least one of the electrode contact assemblies is arranged in a sliced ​​form.

[0050] Preferably, the electrode contacts arranged in segments include Z electrode segments arranged at intervals in the circumferential direction of the electrode, and Z≥3.

[0051] Preferably, a microelectrode is arranged between two adjacent electrode sheets.

[0052] A stimulation device comprises a pulse generator and the electrode as described above, wherein the electrode is electrically connected to the pulse generator, and the pulse generator is used to output different electrical stimulation parameter combinations to each of the electrode contact groups in the electrode contact combination.

[0053] Preferably, the stimulation device further comprises an extension wire, and the electrode, the extension wire and the pulse generator are electrically connected in sequence.

[0054] The use of the above-mentioned stimulation device is to treat mental diseases and movement disorders.

[0055] Preferably, the mental illness includes addiction, obsessive-compulsive disorder, autism spectrum disorder, depression, schizophrenia, bipolar disorder, and anorexia nervosa;

[0056] The movement disorders include Parkinson's disease, essential tremor, dystonia, spasmodic torticollis, and Meige's syndrome.

[0057] Beneficial effects of the present invention:

[0058] This application is based on an in-depth study of human brain anatomy, and found that many important brain functional targets can be located on the same straight line on a specific selected section. This anatomical feature inspired an innovative electrode design scheme, which is to use a single electrode in a directionally selected channel to jointly stimulate multiple target brain functional targets. Compared with the traditional design, this design has the following benefits:

[0059] 1. Simplify surgical operations: Covering multiple targets with a single electrode avoids the complicated operation of using multiple independent electrodes, reduces the complexity of surgery and patient head trauma.

[0060] 2. Reduce the risk of trauma: Since the number of implanted electrodes is reduced, the trauma surface on the patient's head is reduced, which helps to reduce the risk during the implantation process and alleviates the patient's recovery pressure.

[0061] 3. Improve the efficiency and effect of electrical stimulation: A single electrode can achieve precise stimulation of multiple functional targets in the brain within one surgical channel, effectively reducing mutual interference between electrodes, thereby improving the accuracy and therapeutic effect of electrical stimulation.

[0062] 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 adjusts the electrical stimulation parameters according to the needs of each target, thereby optimizing the treatment effect and reducing the occurrence of side effects.

[0063] 5. Reduce patient burden: By reducing the number of implanted electrodes and optimizing the surgical pathway, the medical burden on patients can be reduced.

[0064] In summary, the present application is not only simpler in surgical operation, but also significantly improves the electrical stimulation effect of multifunctional targets, making deep brain stimulation therapy more efficient and safe in the treatment of mental illnesses and movement disorders. BRIEF DESCRIPTION OF THE DRAWINGS

[0065] Figure 1 is a schematic diagram of a method for implementing deep brain stimulation in an embodiment of the present invention;

[0066] Figure 2 is one of the structural schematic diagrams of the electrode in the embodiment of the present invention;

[0067] Figure 3 This is the second schematic diagram of the structure of the electrode in the embodiment of the present invention;

[0068] Figure 4 is a partial exploded view of an electrode in an embodiment of the present invention;

[0069] Figure 5 Schematic diagram of the deep brain stimulation method implemented in Example 1.

[0070] In the figure:

[0071] 1000, nucleus accumbens; 2000, anterior limb of internal capsule;

[0072] 100, electrode; 200, extension wire; 300, pulse generator;

[0073] 10. electrode contact; 101. electrode sheet;

[0074] 1. Stimulation segment; 2. Middle segment; 3. Connection segment;

[0075] 4. Electrode contact combination; 41. Electrode contact group; 42. Additional electrode contact; 43. Cortical electrode contact. DETAILED DESCRIPTION

[0076] The present invention will be further described in detail below in conjunction with the accompanying drawings and embodiments. It is to be understood that the specific embodiments described herein are only used to explain the present invention, rather than to limit the present invention. It is also necessary to explain that, for ease of description, only the parts related to the present invention, rather than all structures, are shown in the accompanying drawings.

[0077] In the description of the present invention, unless otherwise clearly specified and limited, the terms "connected", "connected", and "fixed" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0078] In the present invention, unless otherwise clearly specified and limited, a first feature being "above" or "below" a second feature may include that the first and second features are in direct contact, or may include that the first and second features are not in direct contact but are in contact through another feature between them. Moreover, a first feature being "above", "above" and "above" a second feature includes that the first feature is directly above and obliquely above the second feature, or simply indicates that the first feature is higher in level than the second feature. A first feature being "below", "below" and "below" a second feature includes that the first feature is directly below and obliquely below the second feature, or simply indicates that the first feature is lower in level than the second feature.

[0079] In the description of this embodiment, the terms "upper", "lower", "right", etc., directions or positional relationships are based on the directions or positional relationships shown in the drawings, and are only for the convenience of description and simplification of operation, rather than indicating or implying that the device or element referred to must have a specific direction, be constructed and operated in a specific direction, and therefore cannot be understood as limiting the present invention. In addition, the terms "first" and "second" are only used to distinguish in the description and have no special meaning.

[0080] As mentioned above, in the prior art, in order to improve the treatment effect of complex diseases such as mental illnesses and movement disorders, two or more independent electrodes are usually used to electrically stimulate different functional targets in the brain (i.e., areas in the brain that have specific functions and are involved in regulating certain neural processes or behaviors, such as independent neural nuclei or neural conduction bundles). Although this design can achieve stimulation of multiple functional targets in the brain, its operation is relatively complex. In particular, during surgery, the position of each electrode needs to be accurately implanted and adjusted, which increases the difficulty and time of the operation. In addition, the implantation of multiple electrodes also increases the risk of surgical trauma and potential complications, and since each electrode can only target one functional target in the brain, the synchronous regulation of multiple electrodes has also become one of the difficulties of the operation, which may lead to inaccurate stimulation or insufficient coverage of functional targets in the brain.

[0081] Based on the study of human brain anatomy, it was found that many important functional targets in the brain can be located on the same straight line on specially selected sections. This anatomical feature provides a new idea for electrode design, that is, by using a single electrode, multiple target functional targets in the brain can be combined and precisely stimulated in a directionally selected linear minimally invasive channel. Compared with surgical methods using two or more independent electrodes, this method can simplify surgical operations, reduce the risk of trauma during electrode implantation, and improve the efficiency and effectiveness of electrical stimulation while achieving simultaneous electrical stimulation of different functional targets in the brain.

[0082] The present application is intended to provide a stimulation device for achieving deep brain stimulation based on the above ideas, such as Figure 1 As shown, the device includes a pulse generator 300 and an electrode 100, and the pulse generator 300 is electrically connected to the electrode 100. Specifically, the pulse generator 300 in this embodiment can be any implantable pulse generator (IPG) in the prior art, and the pulse generator 300 can be implanted in the patient's body, such as the chest, brain or other parts of the body.

[0083] For example, when the pulse generator 300 is implanted into the patient's brain, the patient's skull needs to be grooved in advance, and then the pulse generator 300 is installed in the skull groove. It should be noted that the pulse generator 300 can be completely embedded in the skull or partially protrude from the skull surface.

[0084] When the pulse generator 300 is implanted in a location far from the head, such as the subcutaneous portion of the patient's chest, the length of the electrode 100 may not be sufficient to directly connect to the pulse generator 300. Figure 1 Generally, the electrode 100 is connected in series with the pulse generator 300 using an extension wire 200. That is, the electrical stimulation generated by the pulse generator 300 is effectively transmitted to the electrode 100 through the extension wire 200 as an electrical stimulation transmission medium. The pulse generator 300 responds to the program control instructions sent by the program control device and provides controllable electrical stimulation therapy to the tissue in the body through a sealed battery and circuit.

[0085] Based on the treatment needs, first of all, it is necessary to determine the combination of functional targets in the brain that need to be electrically stimulated (that is, two or more functional targets in the brain that need to be electrically stimulated at the same time, hereinafter referred to as the target combination), and set different combinations of electrical stimulation parameters according to these determined functional targets in the brain (hereinafter referred to as targets). This is because the electrical stimulation parameter combinations corresponding to these targets have differences in anatomical positions, functional characteristics, and responses to electrical stimulation in the brain, resulting in different required electrical stimulation parameters. At the same time, the electrical stimulation targets of different targets may be used to treat different diseases, further affecting the selection of electrical stimulation parameters. Even for the same target, the electrical stimulation parameters need to be adjusted accordingly due to individual differences among patients. Therefore, the electrical stimulation parameter combinations need to be adjusted separately to ensure the best treatment effect.

[0086] Secondly, in order to achieve simultaneous electrical stimulation of multiple targets, during the design and arrangement of the electrode 100, it is also necessary to rationally plan the configuration of the electrode contact combination 4 based on the anatomical characteristics and functional requirements of the target, including but not limited to parameters such as the number of electrode contacts, contact spacing, and the length of a single contact.

[0087] Next, the insertion path of the electrode 100 is determined by preoperative medical imaging means (such as MRI or CT) to ensure that the electrode 100 can accurately reach and pass through these target points. Figure 1 In the example, two targets are shown (labeled 1000 and 2000), representing the Nucleus Accumbens (NAc) and the Anterior Limb of the Internal Capsule (ALIC), respectively.

[0088] Finally, when the electrode 100 is implanted in the patient's brain, the electrode 100 will sequentially pass through the target points 1000 and 2000. The pulse generator 300 generates electrical stimulation signals according to the electrical stimulation parameter combinations set for the target points 1000 and 2000, and delivers the corresponding electrical stimulation parameter combinations to the target points 1000 and 2000 through the electrode contact combination 4 set on the electrode 100, thereby achieving joint electrical stimulation of each target point.

[0089] Exemplarily, the above-mentioned electrical stimulation parameter combination may include one or more of the following parameters:

[0090] Frequency, such as the number of electrical stimulation pulse signals per second, in Hz;

[0091] Pulse width, the duration of each pulse, in μs;

[0092] Amplitude, usually expressed as voltage or current, that is, the strength of each pulse, with the unit of V or I;

[0093] Timing, for example, can be continuous or burst mode, where the burst mode refers to non-continuous timing behavior consisting of multiple processes;

[0094] Stimulation mode, including one or more of current mode, voltage mode, timed stimulation mode and cyclic stimulation mode;

[0095] The doctor controls the upper and lower limits (the range that the doctor can adjust) and the patient controls the upper and lower limits (the range that the patient can adjust independently).

[0096] The specific selection of the target point and its combination of electrical stimulation parameters will be discussed in detail in the following sections. The structure of the electrode 100 used in this embodiment will be first introduced below.

[0097] See also Figure 2 , one end of the electrode 100 ( Figure 2 The left end is defined as the distal end, which is deep in the brain; the other end ( Figure 2 The right end is defined as the proximal end, which is usually located outside the body or close to the outside of the body.

[0098] The portion of the electrode 100 near the distal end is defined as the stimulation segment 1, which includes a plurality of electrode contacts 10 for directly contacting and stimulating the target point. The portion of the electrode 100 near the proximal end is defined as the connection segment 3, which is usually connected to the pulse generator 300 or a connection device (such as an extension wire 200 or a cable). The connection segment 3 also includes a plurality of electrode contacts 10 for transmitting the electrical signal generated by the pulse generator 300 to the stimulation segment 1 at the distal end.

[0099] Between the stimulation segment 1 and the connection segment 3, there is usually a section without stimulation function, which is called the intermediate segment 2. The intermediate segment 2 mainly provides mechanical support and ensures the stability of the electrode 100 so that the stimulation segment 1 can be accurately positioned in the target area.

[0100] For easier understanding and distinction, please refer to Figure 2 and Figure 3 , these electrode contacts 10 can be divided and defined according to their functions:

[0101] On the one hand, since all the electrode contacts 10 arranged on the stimulation segment 1 are used to implement electrical stimulation on two or more target points, and these electrode contacts 10 play different stimulation effects on different target points, these electrode contacts 10 are specifically defined as an electrode contact combination 4. Further, according to the corresponding relationship with each target point to be stimulated, the electrode contact combination 4 includes at least two electrode contact groups 41, and each electrode contact 10 in each electrode contact group 41 can output the same combination of electrical stimulation parameters. Since each electrode contact group 41 corresponds to a different target point, the electrode contacts 10 in different electrode contact groups 41 output different combinations of electrical stimulation parameters to meet the stimulation requirements of different target points, thereby achieving the best treatment effect.

[0102] On the other hand, the plurality of electrode contacts 10 arranged on the connection section 3 are used to connect to the pulse generator 300 or the connection device (such as Figure 1 ), so these electrode contacts 10 can be defined as connecting contacts. Specifically, in the connecting segment 3, each electrode contact 10 of the connecting segment 3 is independently connected to the pulse generator 300, and each electrode contact 10 in the connecting segment 3 is arranged corresponding to the electrode contact 10 of the stimulation segment 1, so that the electrode contact 10 of the stimulation segment 1 is electrically connected to the electrode contact 10 of the connecting segment 3 in a one-to-one correspondence, for example, a metal wire built into the electrode 100 is used for connection, so that the electrode contact 10 of each stimulation segment 1 can be electrically connected to the pulse generator 300 separately, ensuring that the output electrical stimulation parameter combination of the electrode contact 10 of each stimulation segment 1 can be independently controlled. By independently regulating different stimulation contact groups 41, accurate electrical stimulation parameters can be provided for different targets, thereby improving the treatment effect. As Figure 3 As shown in the example, the electrode contact assembly 4 may include two electrode contact groups 41 , and each electrode contact group 41 may include four electrode contacts 10 .

[0103] It should be pointed out that the total length of the electrode contact combination 4 needs to be selected according to the position distribution of different targets in the brain. Since the targets in most combined stimulations are not closely arranged in space, but are distributed in different brain regions, in order to ensure coverage of these different targets, the length of the electrode 100 must be long enough to span these regions. The stimulation segment 1 of the traditional electrode 100 is relatively short and can usually only act on one target, and it is impossible to achieve simultaneous coverage of multiple targets. Therefore, in this embodiment, the total length of the electrode contact combination 4 is extended to 12 mm or longer to ensure that multiple targets can be effectively covered when the electrode 100 is inserted into the brain, and to ensure that these targets can be covered independently and separately, thereby reducing interference between electric fields, improving the stimulation accuracy of each target, and thus improving the treatment effect.

[0104] In this embodiment, the total length of the electrode contact assembly 4 is denoted as X, and the range of X is 12 mm ≤ X ≤ 70 mm. For example, X can be 12 mm, 19 mm, 21.8 mm, 22.1 mm, 22.5 mm, 26 mm, 32.5 mm or 70 mm, etc. The listed values ​​do not constitute a limitation, and other unlisted values ​​within the range are also applicable.

[0105] In addition, in order to meet the need for joint stimulation of more than two target points, in this embodiment, the total number of electrode contacts 10 included in the electrode contact combination 4 is recorded as n, n ≥ 5. At the same time, appropriately increasing the number of electrode contacts 10 in the electrode contact combination 4 also helps to improve the accuracy of electrical stimulation. Increasing the number of electrode contacts 10 can provide more electrical stimulation position options, thereby more accurately aligning the target point. That is, within the same size, the more electrode contacts 10 there are, the smaller the spacing between the electrode contacts 10, and the best electrode contacts 10 can be selected as stimulation points accordingly.

[0106] In particular, when it comes to joint stimulation of multiple targets, the combined design and selection of the total length X of the electrode contact assembly 4 and the number n of electrode contacts 10 it contains are particularly critical for achieving high-precision brain electrical stimulation. The above design ensures that there is at least one complete electrode contact 10 for stimulation in each target, and that sufficient surface area is formed by these electrode contacts 10 to release a specific combination of stimulation parameters, so that these parameters form an electric field in the brain that can significantly affect the position and size of the target in the lesion area. Preferably, each target is stimulated by 1 to 6 electrode contacts 10.

[0107] Thus, by making different electrode contact groups 41 correspond to different targets, independent and joint stimulation of multiple targets can be achieved. This not only improves the accuracy of stimulation, but also avoids possible interference between different targets, ensuring that each target can obtain the most suitable electrical stimulation parameters for its treatment. By making different electrode contact groups 41 correspond to different targets independently and adjusting the output of electrical stimulation parameters of each group, 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 barriers, memory problems, etc.

[0108] Generally speaking, different diseases require electrical stimulation of different numbers of targets. For example, some complex neurological diseases may require acting on multiple targets at the same time, with a wide coverage range, so more electrode contacts 10 are needed to ensure that each target is fully covered. In addition, in clinical practice, the lesion areas of different patients vary in size, shape and position, so the number of electrode contacts 10 needs to have a certain degree of flexibility so that it can adapt to the pathological conditions and surgical errors of different patients, and different electrode contact groups 41 can be personalized for different targets.

[0109] Therefore, in a preferred embodiment, the number n of the 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 ​​do not constitute a limitation, and other values ​​not listed in the range are also applicable. The flexibility of the range design mainly considers that under the conditions of the existing process level, n≤24 can meet the millimeter-level precision control, ensure the treatment effect and multi-target coverage, and adapt to the individual differences of the cases.

[0110] More preferably, n is further selected as 5≤n≤12. Based on practical and economic considerations in clinical applications, the design of 5 to 12 electrode contacts 10 can ensure the accuracy of stimulation of each target while ensuring that enough targets are covered. The number of electrode contacts 10 within this range can not only provide sufficient surface area to release electrical stimulation, but also effectively control the range of the electric field to avoid interference with adjacent unrelated areas. A large number of electrode contacts 10 will increase the complexity of the structure of the electrode 100 and the difficulty of operation, while the design of 5 to 12 contacts ensures the efficacy while keeping the structure of the electrode 100 relatively simple, which is convenient for surgeons to operate and adjust. In addition, more electrode contacts 10 mean higher manufacturing costs and technical requirements, while the number of contacts between 5 and 12 achieves a reasonable balance between technical difficulty and cost, which is suitable for a wide range of clinical applications.

[0111] In this embodiment, the length of the electrode contact 10 is recorded as L, and L≥1mm. Considering that the length of the electrode contact 10 is too long, it will cause side effects to the patient during treatment. Therefore, the preferred range of 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.

[0112] It should be noted that the lengths of the electrode contacts 10 may be the same or different, but are preferably designed to be the same length to simplify the design and manufacturing process of the electrode 100. The use of 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.

[0113] Please continue reading Figure 3In this embodiment, the spacing between each two adjacent electrode contacts 10 is recorded as P, and P ≥ 0.5 mm, and the specific value is, for example, 0.5 mm, 1 mm, 1.5 mm, 2 mm, 3 mm or 4 mm. By reasonably setting the contact spacing P, it is possible to ensure independent coverage of different targets and avoid side effects that may be caused by excessive concentrated stimulation. Similar to the selection of the length L of the electrode contact 10, the spacing P between adjacent electrode contacts 10 can be the same or different.

[0114] Specific electrode configuration examples are as follows:

[0115] Example 1: When n=8, the length L of each electrode contact 10 is ≥1.5 mm, and the spacing P between adjacent electrode contacts 10 is ≥0.5 mm;

[0116] Example 2: When n=12, the length L of each electrode contact 10 is ≥1.5 mm, and the spacing P between adjacent electrode contacts 10 is ≥0.5 mm.

[0117] As mentioned above, the selection of target combinations should depend on the specific symptoms of the patient and their treatment needs. The target combinations required for different symptoms usually involve different electrode configurations, such as the number n, length L, and spacing P of the electrode contacts 10 of the electrode contact combination 4 set on the corresponding electrode 100. Therefore, in order to meet the diverse stimulation needs, it is necessary to develop a variety of electrode models. However, this method may lead to a variety of electrode models and high production costs in practical applications, which is not conducive to clinical promotion and large-scale production.

[0118] To solve this problem, we can accumulate and analyze the electrode configurations required for different target combinations and identify several target combinations with similar electrode configurations. We can summarize and comprehensively analyze the electrode configuration requirements for these target combinations, and based on these analysis results, determine an electrode configuration that can take into account the stimulation requirements of these target combinations. This method can significantly reduce the number of required electrode models, and meet the stimulation requirements of multiple target combinations with a small number of electrode specifications, making it more suitable for large-scale production and clinical applications.

[0119] On this basis, 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 unified to further optimize the electrode design, reduce production requirements and improve clinical applicability. In order to ensure that the stimulation requirements of each target can be met in actual applications, the electrode contacts 10 can be accurately selected during surgery. For example, through intraoperative image analysis, the most suitable electrode contacts 10 can be screened out from the electrode contact combination 4 of the standardized electrode 100 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, and ultimately achieves dual optimization of production and clinical needs.

[0120] Specific electrode configuration examples are as follows:

[0121] Example 3: n=8, the length L of each electrode contact is 1.5 mm, and the spacing P between adjacent electrode contacts is ≥ 0.5 mm;

[0122] Example 4: n=12, the length L of each electrode contact is 1.5 mm, and the spacing P between adjacent electrode contacts is ≥ 0.5 mm;

[0123] Example 5: n=12, the length L of each electrode contact is 1.5 mm, and the spacing P between adjacent electrode contacts is 0.5 mm.

[0124] Example 6: n=24, the length L of each electrode contact is 1.0 mm, and the spacing P between adjacent electrode contacts is 0.5 mm.

[0125] It needs to be emphasized again that the discussion on 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-mentioned electrode configuration is limited to the configuration of the electrode contact combination 4 on the stimulation segment 1, and does not constitute a restriction on the electrode contacts 10 on the connecting segment 3.

[0126] Please continue reading Figure 3 The electrode contact combination 4 may further include at least one additional electrode contact 42, which is located on the proximal side of all electrode contact groups 41. When electrical stimulation of the brain is performed, the electric field area will extend from the deep brain area to the cortical area. In order to prevent the electrical stimulation from excessively affecting the cerebral cortex area, the additional electrode contact 42 can be set as a positive pole to form an electric field and cut off the stimulation area, so as to avoid the charge generated by the electrode contact group 41 when working from diffusing to the cortical area and reducing the patient's discomfort. In this embodiment, the number of additional electrode contacts 42 is one, and they are arranged in a ring shape.

[0127] The length of the additional electrode contact 42 is denoted as L a , preferably La is greater than or equal to the length L of the electrode contact 10. For example, in an optional embodiment, L≤2 mm, L a ≥2mm, the specific value is, for example, L a =3mm. Under the same voltage condition, the longer the length of the additional electrode contact 42 is, the smaller the current density is, so by increasing the length of the additional electrode contact 42, the discomfort of the patient caused by excessive current density is avoided.

[0128] In addition, 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 0.5 mm to 4 mm, preferably 0.5 mm, 1.5 mm, 2 mm, 3 mm or 4 mm, but not limited to the listed values, and other values ​​within this range are also applicable. This embodiment is described by taking 2 mm as an example. This design ensures that the additional electrode contacts 42 have sufficient contact area to form a current loop and cut off the stimulation area.

[0129] Preferably, the spacing between the additional electrode contact 42 and the adjacent electrode contact 10 is greater than or equal to the spacing 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 there is on 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, the circular electric field formed by the electrode contact 10 will be compressed into an ellipse, which may affect the effectiveness and accuracy of the stimulation.

[0130] Please continue reading Figure 3 In this embodiment, the distance between the additional electrode contact 42 and the distal end of the electrode stimulation segment 1 is recorded as Y, 14mm≤Y≤70mm, so that when the brain is electrically stimulated, the additional electrode contact 42 can be located in a non-target area of ​​the brain, such as a white matter or gray matter area. The electrophysiological signals in the brain are collected by the additional electrode contact 42, and the electrical stimulation parameters are adjusted based on the collected signals to achieve closed-loop control (or adaptive adjustment) of the electrical stimulation parameters, thereby further improving the treatment effect on complex diseases. Exemplarily, Y can be 14 mm, 22 mm, 34 mm, 48 mm, 60 mm or 70 mm, but is not limited to the values ​​listed, and other values ​​within this range are also applicable.

[0131] Furthermore, if Figure 3As shown, in this embodiment, the electrode contact assembly 4 further includes at least one cortical electrode contact 43, which is located at the proximal side of the additional electrode contact 42. When the brain is electrically stimulated, the cortical electrode contact 43 is located in the cerebral cortex. The cortical electrode contact 43 can not only collect electrophysiological signals of the cortical area for correcting the electrical stimulation parameters of the deep brain area, but also regulate the neural activity of the cortical area to enhance the overall treatment effect.

[0132] As mentioned above, in this embodiment, each electrode contact group 41 is used to output different electrical stimulation parameter combinations to ensure that the corresponding target point obtains the corresponding electrical stimulation. However, the electric fields formed by adjacent electrode contact groups 41 may overlap with each other, resulting in unstable or inaccurate electrical stimulation effects, thereby causing unexpected therapeutic effects and physiological reactions.

[0133] To solve the above problems, in a preferred 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, the independent electrode contact 10 serves as a positive electrode, a neutral electrode or a reference electrode. Its presence can effectively isolate the electric field generated by adjacent electrode contact groups 41, prevent the electric fields from interfering with or superimposing each other, and ensure that the electric field generated by each group of contacts acts independently on its designated target area.

[0134] As an alternative or further 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, etc. The specific spacing is determined according to the range of the electric field generated by the upper and lower adjacent electrode contact groups 41 to avoid problems caused by mutual interference or superposition of electric fields. Within this spacing, it is possible to choose not to set the electrode contacts 10. Of course, electrode contacts 10 can also be set, but there is no need to deliver electrical stimulation parameters to these electrode contacts 10.

[0135] like Figure 4 As shown, considering that the implantation position of the electrode 100 during the operation may be deeply offset from the expected position, and may also be offset to the left and right, although selecting different electrode contacts 10 can solve the problem of the depth offset from the expected position, it cannot solve the problem of the left and right offset of the implantation position of the electrode 100, resulting in the electric field acting on the non-treatment area and causing side effects, such as Figure 4As shown, at least one electrode contact 10 in at least one electrode contact combination 4 can be arranged in a sheet form. The electrode contact 10 arranged in the sheet form includes Z electrode sheets 101 arranged at intervals along the circumference of the electrode 100, where Z ≥ 3. Each electrode sheet 101 is individually connected to the pulse generator 300, so that the electrical stimulation parameters of each electrode sheet 101 can be adjusted individually. By controlling the delivery of electrical stimulation only to the electrode sheet 101 pointing to the target point, and not delivering electrical stimulation to the electrode sheet 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 accuracy of specific parts, thereby enhancing the treatment effect of complex diseases.

[0136] Preferably, Z can be 3, 6 or 12, but is not limited to the listed values, and other values ​​not listed in this range are also applicable. In this embodiment, three electrode sheets 101 are used as an example.

[0137] Below, in conjunction with specific embodiments, the present application is further described: Example 1

[0138] See also Figure 5 This embodiment relates to the treatment of mental illnesses, such as obsessive-compulsive disorder, by stimulating the functional targets in the brain based on the above-mentioned stimulation device. The selected targets are the nucleus accumbens NAc1000 and the anterior limb of the internal capsule ALIC2000. These targets play an important role in the brain and are closely related to the above-mentioned diseases. By stimulating these two targets at the same time, comprehensive regulation of the lesion area can be achieved and the treatment effect can be improved.

[0139] According to the situation that the electrode penetrates the anterior limb of the internal capsule ALIC2000 and the nucleus accumbens NAc1000, the length X of the electrode contact combination 4, the length L of the electrode contact 10, the spacing P of the electrode contacts 10 and the number n of the electrode contacts 10 are designed and selected as follows in this embodiment to ensure coverage of the target points while improving the accuracy of stimulation.

[0140] Length X of electrode contact combination 4: According to the anatomical structure of the anterior limb of the internal capsule ALIC2000 and the nucleus accumbens NAc1000, selecting X = 15 mm can ensure that the electrode contact group covers and penetrates the key areas of these two targets at the same time. So that the total length L of the electrode contact combination 4 covering the anterior limb of the internal capsule ALIC2000 and the nucleus accumbens NAc1000 t Greater than 7.5 mm ensures that the electrode contact 10 has sufficient coverage inside the two target points, thereby effectively releasing the electrical stimulation parameters and forming a sufficient electric field to affect the lesion area.

[0141] The number n of the electrode contacts 10 of the electrode contact assembly 4 is 8, the length L of each electrode contact 10 is 1.0 mm, and the spacing P between adjacent electrode contacts 10 is 1.0 mm. This arrangement can provide sufficient contact density within a total length of 15 mm to improve the accuracy of the alignment of the electrode 100 with the target point, thereby enhancing the treatment effect.

[0142] The length X of the electrode contact assembly 4, the number n of the electrode contacts 10, the length L of the electrode contacts 10, and the spacing P of the electrode contacts 10 are selected based on the following:

[0143] According to the penetration of the electrode in the length direction, the dimension of the anterior limb of the internal capsule ALIC2000 penetrated by the electrode is 18-27mm, and its optimal stimulation range is 12-18mm; the dimension of the nucleus accumbens NAc1000 penetrated by the electrode is D, 1mm<D≤7.5mm, and the maximum distance allowed for the electrode to be exposed after passing through the nucleus accumbens is 4mm. At the same time, the minimum distance between the electrode contact group 41 and the distal end of the electrode (the length of the electrode head insulator) is 1.5mm.

[0144] When X≤70mm, the electrode contact assembly 4 will be located below the brain cortex. When X is between 12mm and 70mm, the electrode contact assembly 4 will be located entirely at and below the brain cortex, and may penetrate the anterior limb of the internal capsule ALIC2000 and the nucleus accumbens NAc1000 at the same time.

[0145] Furthermore, when X is between 12 mm and 32 mm, it can ensure 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 areas of the two targets, thereby improving the effect of electrical stimulation of the anterior limb of the internal capsule ALIC2000 and the nucleus accumbens NAc1000.

[0146] Therefore, when X=15 mm, it is ensured that the electrode contact assembly 4 partially passes through the nucleus accumbens 1000 and extends into the anterior limb of the internal capsule 2000. It can be understood that when X=15 mm, the electrode contact assembly 4 can cover the total length L in the anterior limb of the internal capsule 2000 and the nucleus accumbens 1000. t The electrode contact combination 4 is 10 mm, ensuring that it penetrates both the anterior limb of the internal capsule ALIC2000 and the nucleus accumbens NAc1000 and maintains a certain length inside these two targets.

[0147] Of course, when using electrodes 100 of different lengths and considering individual differences of different patients, when the anterior limb of the internal capsule ALIC2000 and the nucleus accumbens NAc1000 are simultaneously electrically stimulated, the electrode contact combination 4 covers the total length L of the anterior limb of the internal capsule ALIC2000 and the nucleus accumbens NAc1000. t Between 7.5mm and 32mm.

[0148] Furthermore, 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 (taking individual differences into consideration), and the electrode contact 10 serves as a positive electrode.

[0149] In addition, in this embodiment, the electrode 100 further includes one or both of the additional electrode contact 42 and the cortical electrode contact 43. Correspondingly, the length X of the electrode contact combination 4 should satisfy the following conditions:

[0150] When an additional electrode contact 42 is provided: X should be greater than or equal to 15 mm to ensure effective coverage of the target area; for example, an additional electrode contact 42 is provided, the length of the additional electrode contact 42 is 3 mm, and the distance between the additional electrode contact 42 and the adjacent electrode contact 10 is 3 mm. At this time, n=9, X=21 mm.

[0151] When setting the cortical electrode contact 43: X should be greater than or equal to 50 mm to accommodate deeper brain targets while ensuring safe positioning under 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, and n=10 at this time.

[0152] In the specific surgical operation, the electrode 100 is gradually inserted into the predetermined target point through test stimulation. When the electrode 100 reaches the target point, the doctor can adjust the combination of electrical stimulation parameters of the two electrode contact groups 41 according to real-time feedback to ensure that the anterior limb of the internal capsule ALIC2000 and the nucleus accumbens NAc1000 can achieve the best treatment effect.

[0153] Specifically, during the treatment, in order to ensure effective stimulation of the anterior limb of the internal capsule ALIC2000 and the nucleus accumbens NAc1000, the following electrical stimulation parameter combinations were set:

[0154] Nucleus accumbens NAc1000: voltage is 3.5V, frequency is 130Hz, pulse width is 130μs.

[0155] ALIC2000 for the anterior limb of the internal capsule: voltage is 3.2V, frequency is 150Hz, and pulse width is 180μs.

[0156] This setting ensures that the anterior limb of the internal capsule ALIC2000 and the nucleus accumbens NAc1000 can be effectively stimulated at the same time, improving the therapeutic effect on psychiatric diseases.

[0157] It should be noted that, in the present application, "joint stimulation" means that within a time period of 1 second or longer, the stimulation of the electrode contact 10 in the nucleus accumbens 1000 and the anterior limb of the internal capsule 2000 is performed jointly, that is, effective electric field stimulation is generated in each target point. Of course, within a shorter time period (such as 15 milliseconds), the electrical stimulation of the two target points by the electrode contact 10 can be understood as being performed independently, synchronously or alternately. Among them, although the "alternating" stimulation can be understood as being performed "intermittently" within a very short time period, it can still affect the two target points at the same time in terms of the overall effect. Example 2

[0158] This embodiment is also based on the above-mentioned stimulation device to perform combined electrical stimulation on the functional targets in the brain, which is mainly used for addiction, obsessive-compulsive disorder and depression, etc. The targets selected in this embodiment are still the anterior limb of the internal capsule ALIC and the nucleus accumbens NAc. By stimulating these two targets at the same time, the purpose of comprehensive regulation of the lesion area is achieved.

[0159] Different from Example 1, in this embodiment, the length and spacing of the electrode contacts are set differently according to the anatomical characteristics of the anterior limb of the internal capsule ALIC and the nucleus accumbens NAc. Specifically, the length of each electrode contact in the electrode contact group corresponding to the nucleus accumbens NAc is 1.5 mm, the contact spacing is 1 mm, and the number of electrode contacts in the electrode contact group is 4; while the length of each electrode contact in the electrode contact group corresponding to the anterior limb of the internal capsule ALIC is 2 mm, the contact spacing is 2 mm, the number of electrode contacts in the electrode contact group is 8, and the number of all electrode contacts in the electrode contact combination 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.

[0160] This differentiated design helps to directly match the anatomical structure and functional requirements of different targets, thereby improving the accuracy and therapeutic effect of electrical stimulation. The total length and number of contacts of the electrode contact combination can be adjusted according to actual needs to ensure effective coverage and stimulation of the electrode in the target area. In addition, 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. Example 3

[0161] This embodiment involves the combined stimulation of the functional targets in the brain based on the above-mentioned stimulation device to treat movement disorders, such as Parkinson's disease. The selected targets are the Ventral Intermediate Nucleus of theThalamus (Vim) and the Subthalamic nucleus (STN), which play an important role in the brain and are closely related to the above-mentioned diseases. By electrically stimulating these targets, comprehensive regulation of the lesion area can be achieved to improve the treatment effect.

[0162] According to the situation that the electrode passes through the ventral intermediate nucleus Vim of the thalamus and the subthalamic nucleus STN, the length X of the electrode contact combination 4, the length L of the electrode contact, the spacing P of the electrode contacts and the number n of the electrode contacts are designed and selected as follows in this embodiment to ensure coverage of the target while improving the accuracy of stimulation.

[0163] The length of the electrode contact combination X: According to the anatomical structure of the target thalamic ventral intermediate nucleus Vim and the subthalamic nucleus STN, selecting X = 24mm can ensure that the electrode contact group covers and penetrates the key areas of the target Vim and STN at the same time. So that the total length L of the electrode contact combination covering the target thalamic ventral intermediate nucleus Vim and the subthalamic nucleus STN t The diameter of the electrode is 18.7 mm, ensuring that the electrode contacts have sufficient coverage within the target thalamic ventral intermediate nucleus Vim and subthalamic nucleus STN, thereby effectively releasing the electrical stimulation parameters and forming a sufficient electric field to affect the lesion area.

[0164] The number of electrode contacts n of the electrode contact combination: The number of electrode contacts 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 setting can provide sufficient contact density within a total length of 24 mm to improve the accuracy of electrode and target alignment, thereby enhancing the treatment effect.

[0165] The length X of the electrode contact combination, the number n of the electrode contacts, the length L of the electrode contacts, and the spacing P of the electrode contacts are selected based on the following:

[0166] According to the penetration of the electrode in the length direction, the size of the ventral intermediate nucleus Vim of the thalamus penetrated by the electrode is about 5.8mm, the size of the subthalamic nucleus STN of the electrode penetrated by the electrode is about 5.5mm, and the distance between the ventral intermediate nucleus Vim of the thalamus and the subthalamic nucleus STN is about 7.4mm. Therefore, the electrode wire with the parameters of electrode contact combination length X=24mm, number of electrode contacts n=10, length of electrode contact L=1.5mm, and distance P=1mm between electrode contacts 10 is selected to meet the above requirements for the treatment of Parkinson's disease.

[0167] In addition, the stimulation device provided in the present application can also stimulate the combination of functional targets in the brain as shown in the following Examples 4 to 16 to treat corresponding indications. Example 4

[0168] This embodiment provides a deep brain stimulation method based on dual-target combined stimulation, mainly 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 of the thalamus Vim as the target combination for combined stimulation. These targets play a key role in regulating motor function and controlling tremor.

[0169] In order to cover these targets and achieve the best treatment effect, the electrode contact combination is configured as follows in this embodiment:

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

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

[0172] The spacing P 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 are able to generate effective electric fields within the PSA and Vim targets, inhibiting abnormal neural activity in patients with Parkinson's disease and essential tremor and improving symptom control. Example 5

[0174] In this embodiment, the target combination of stimulation is the subthalamic nucleus STN and the substantia nigra (SN), which is mainly used for the treatment of Parkinson's disease. STN and SN are important nuclei closely related to motor control and have an important influence on the pathological mechanism of Parkinson's disease.

[0175] To this end, the electrode configuration in this embodiment is as follows:

[0176] The number of electrode contacts n: n = 6 was selected to cover the target area while reducing stimulation to the surrounding non-target areas.

[0177] Length of electrode contacts: Each electrode contact is 1.5 mm long, ensuring coverage of the critical areas of STN and SN.

[0178] The spacing P between adjacent electrode contacts is 0.5 mm, providing higher stimulation accuracy and effect.

[0179] Through this design, an effective electric field can be established in the STN and SN to suppress the symptoms of Parkinson's disease. Example 6

[0180] This embodiment provides a multi-target joint stimulation method for the treatment of Parkinson's disease, and the selected targets include the subthalamic nucleus STN, the substantia nigra SN and the caudal zona incerta (Czi). The joint stimulation of these targets can enhance the control effect of Parkinson's disease, especially in terms of motor control.

[0181] The electrode configuration is as follows:

[0182] Number of electrode contacts n: n = 8 contacts were selected to ensure effective electric field generation in multiple target areas.

[0183] Length L of electrode contacts: Each electrode contact is 1.5 mm long, covering all target areas.

[0184] The spacing P between adjacent electrode contacts is 0.5 mm to improve the accuracy and efficacy of stimulation.

[0185] Through this design, STN, SN and Czi can be stimulated simultaneously, significantly improving the motor symptoms of Parkinson's patients. Example 7

[0186] In this example, the hippocampus (Hippo) and amygdala (Amg) are selected as targets for joint stimulation for the treatment of epilepsy and panic attacks. These two targets play an important role in the regulation of emotion and memory and are closely related to the pathogenesis of epilepsy and panic attacks.

[0187] The electrode configuration is as follows:

[0188] Number of electrode contacts n: n = 8 was selected to ensure adequate target coverage.

[0189] Length L of electrode contact: The length of each electrode contact is 1.5 mm, covering the target area.

[0190] The spacing P between adjacent electrode contacts is 1.5 mm to optimize the electric field distribution and reduce stimulation of non-target areas.

[0191] With this design, epileptic seizures and panic attacks can be effectively controlled. Example 8

[0192] This example is aimed at the treatment of mental illnesses such as obsessive-compulsive disorder, depression and schizophrenia, and selects the subgenual cingulate gyrus (Cg25) and the anterior cingulate cortex (ACC) as the targets for joint stimulation. Cg25 and ACC play a key role in emotional processing and decision-making, and have an important impact on the pathological mechanisms of the above mental illnesses.

[0193] The electrode configuration is as follows:

[0194] Number of electrode contacts n: n = 8 was chosen to provide adequate target coverage and stimulation control.

[0195] Length L of electrode contacts: The length of each electrode contact is 1.5 mm to cover the target area.

[0196] The spacing between adjacent electrode contacts is 1.5 mm, ensuring precise stimulation control and optimized therapeutic effect.

[0197] Through this design, the symptoms of patients with obsessive-compulsive disorder, depression and schizophrenia can be effectively improved. Example 9

[0198] This study aims to treat addiction (including gambling addiction, alcohol addiction, drug addiction, etc.) and obsessive-compulsive disorder and other psychological disorders. The bed nucleus of the stria terminalis (BNST) and the anterior limb of the internal capsule ALIC were selected as the target combination for joint stimulation. BNST and ALIC play an important role in emotion regulation and reward circuits and are key targets for the treatment of addiction and obsessive-compulsive disorder.

[0199] The electrode configuration is as follows:

[0200] Number of electrode contacts n: n = 8 electrode contacts were selected to ensure adequate target coverage and provide precise stimulation.

[0201] Length L of electrode contact: The length of each electrode contact is 1.5 mm to cover the target area and achieve effective electric field distribution.

[0202] The spacing P between adjacent contacts is 1.0 mm to ensure the precise arrangement of the electrode contacts and enhance the stimulation effect.

[0203] With this design, the electrodes are able to generate effective electric fields within the BNST and ALIC targets, improving patients' addiction and compulsive symptoms. Example 10

[0204] In this embodiment, the target combination of stimulation is the ventral capsule / ventral striatum (VC / VS), which is mainly used to treat mental illnesses such as obsessive-compulsive disorder, depression, addiction, autism (autism spectrum disorder), anorexia nervosa, and bipolar disorder. VC / VS plays an important role in emotion regulation and reward system.

[0205] The electrode configuration is as follows:

[0206] Number of electrode contacts n: n = 8 was chosen to cover the target area and provide adequate stimulation control.

[0207] Length L of electrode contact: The length of each electrode contact is 1.5 mm, ensuring full coverage of the VC / VS area.

[0208] The spacing P between adjacent contacts is 1.5 mm, which optimizes the electric field distribution and avoids non-targeted stimulation of surrounding tissues.

[0209] Through this design, the patient's mental symptoms can be significantly improved, especially those related to emotional disorders. Embodiment 11

[0210] In this example, for the treatment of obsessive-compulsive disorder and bipolar disorder, the nucleus accumbens NAc and the supero-lateral Medial Forebrain Bundle (slMFB) were selected as targets for joint stimulation. NAc and slMFB are important components of the reward circuit and have a direct impact on controlling emotions and behaviors.

[0211] The electrode configuration is as follows:

[0212] Number of electrode contacts n: n = 8 contacts were selected to ensure sufficient coverage area for precise regulation of target activity.

[0213] Length of electrode contacts: Each electrode contact was 1.5 mm in length to adequately cover the NAc and slMFB regions.

[0214] The spacing P between adjacent contacts is 1.0 mm, ensuring precise stimulation and reducing non-target effects.

[0215] Through this design, the patient's emotional and behavioral responses can be effectively regulated, and the symptoms of obsessive-compulsive disorder and bipolar disorder can be alleviated. Example 12

[0216] This embodiment aims to treat consciousness disorders by dual-target combined stimulation. The selected target combination is the centromedian-parafascicular nuclei complex (CM-pf) of the thalamus, which plays a key role in consciousness regulation and awakening.

[0217] The electrode configuration is as follows:

[0218] Number of electrode contacts n: n = 5 contacts were selected to cover the target area and reduce the interference of stimulation to the surrounding non-target areas, where the number of electrode contacts was 4 and the number of additional electrode contacts was 1.

[0219] Electrode contact length L: Each electrode contact length is 1.5 mm, ensuring that the electrode can cover the key part of the CM-pf area. Additional electrode contact length L a is 3mm.

[0220] The spacing P between adjacent contacts is 1.5 mm, which provides uniform electric field distribution and improves the stimulation effect.

[0221] This electrode design helps enhance the patient's state of wakefulness and promotes recovery of consciousness. Example 13

[0222] In this example, the anterior nucleus of thalamus (ANT) and the mamillothalamic tract (MTT) are selected as joint stimulation targets for the treatment of epilepsy. ANT and MTT play an important role in memory circuits and epileptic seizures.

[0223] The electrode configuration is as follows:

[0224] The number of electrode contacts n: n = 6 contacts were selected to cover the key areas of ANT and MTT, of which the number of electrode contacts was 4 and the number of additional electrode contacts was 2.

[0225] Electrode contact length L: Each electrode contact is 1.5 mm long to provide adequate electric field coverage. Additional electrode contact length L a is 2mm.

[0226] The spacing P between adjacent contacts is 1.0 mm, ensuring that the electrode arrangement can achieve precise stimulation.

[0227] This design can effectively reduce the frequency and severity of epileptic seizures. Embodiment 14

[0228] In this embodiment, for the treatment of Parkinson's disease, the subthalamic nucleus STN and the substantia nigra pars reticulata (Snr) are selected as targets for joint stimulation. These two targets play an important role in motor control and tremor regulation.

[0229] The electrode configuration is as follows:

[0230] Number of electrode contacts n: n = 8 contacts were selected to ensure sufficient target coverage.

[0231] Length L of electrode contacts: The length of each electrode contact is 1.5 mm, covering the STN and Snr regions.

[0232] The spacing P between adjacent contacts is 0.5 mm to improve the stimulation accuracy.

[0233] This electrode design can significantly improve the motor symptoms of Parkinson's patients, especially in controlling tremors. Embodiment 15

[0234] In this embodiment, the globus pallidusinternus (GPi) and the subthalamic nucleus STN are selected as targets for joint stimulation for the treatment of movement disorders. These targets play an important role in regulating motor function and inhibiting involuntary movements.

[0235] The electrode configuration is as follows:

[0236] Number of electrode contacts n: n = 8 contacts were chosen to cover the key areas of GPi and STN.

[0237] Length L of electrode contact: The length of each electrode contact is 1.5 mm to ensure coverage of the stimulation area.

[0238] The spacing P between adjacent contacts is 1.5 mm, which provides uniform electric field distribution and avoids affecting the surrounding non-target areas.

[0239] With this design, motor function can be significantly improved in patients with Parkinson's disease, dystonia, spasmodic torticollis, essential tremor and Meige syndrome. Example 16

[0240] This embodiment aims to jointly stimulate the globus pallidus internus GPi and the substantia nigra pars reticulata SNr to treat Parkinson's disease, dystonia and spastic torticollis. GPi and SNR play a key role in regulating motor function and muscle tension, and their joint stimulation helps to improve the symptoms of related diseases.

[0241] The electrode configuration is as follows:

[0242] Number of electrode contacts n: n = 12 contacts were selected to ensure wide coverage of the target area for optimal treatment effect.

[0243] Length L of electrode contact: The length of each electrode contact is 1.5 mm, which fully covers the key areas of GPi and SNR and enhances the electrical stimulation effect.

[0244] The spacing P between adjacent contacts is 1.0 mm, which ensures the accuracy of electrical stimulation and reduces adverse effects on surrounding tissues.

[0245] This design can effectively alleviate the movement symptoms of Parkinson's patients, improve the condition of patients with dystonia and spasmodic torticollis, and improve their quality of life. Embodiment 17

[0246] This embodiment provides a use of the above-mentioned stimulation device to treat mental illness 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. Embodiment 18

[0247] This embodiment provides a method for deep brain electrical stimulation for treating the above-mentioned mental illnesses and movement disorders, the method comprising the following steps:

[0248] selecting at least two brain functional targets, the brain functional targets being located at different positions on the same straight line; and setting different electrical stimulation parameter combinations according to the treatment requirements of each brain functional target;

[0249] A plurality of electrode contact groups are arranged at the distal end of the electrode, and each electrode contact group corresponds to a functional target point in the brain;

[0250] Determine the electrode insertion path by preoperative medical imaging, insert a single electrode into the patient's brain along a predetermined channel, and allow the electrode to pass through or be inserted into each of the functional targets in the brain;

[0251] 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 each of the functional targets in the brain.

[0252] Among them, when determining the electrode insertion path through preoperative medical imaging, an implantation path that can avoid major blood vessels and sensitive cortical areas can be selected based on preoperative medical imaging, and among multiple possible implantation paths, the one with the largest coverage area of ​​the target area can be given priority to reduce treatment risks and meet treatment effects.

[0253] Furthermore, the implantation path of the above-mentioned electrode is preferably a linear path, so that after the electrode is implanted in the patient's brain, the functional targets in the brain can be distributed along the axis of the electrode. This not only simplifies the design and implantation process of the electrode and reduces surgical trauma, but also ensures precise stimulation of multiple targets and improves the treatment effect.

[0254] Of course, in some embodiments, the electrode implantation path may also be a nonlinear path to avoid specific brain structures. Nonlinear path design can improve surgical flexibility, avoid important brain structures, and reduce surgical risks.

[0255] The above-mentioned combination of electrical stimulation parameters (such as at least one of the frequency, pulse width, amplitude, timing, stimulation mode, upper and lower limits controlled by the doctor and upper and lower limits controlled by the patient, etc.) can be customized according to individual differences of the patient. By personalizing the electrical stimulation parameters, the effectiveness of the treatment and the patient's tolerance can be improved, and side effects can be reduced.

[0256] In addition, at least one additional electrode contact can be provided on the proximal side of the electrode contact group, and the additional electrode contact serves as a positive electrode. When the brain is electrically stimulated, the additional electrode contact can effectively form a current loop in the brain, limit the diffusion of the stimulation electric field to non-target areas, reduce the impact on surrounding healthy brain tissue, and improve the accuracy and safety of electrical stimulation.

[0257] Optionally, at least one cortical electrode contact can be set on the proximal side of the electrode contact group. During the operation, based on the feedback of electrophysiological signals obtained from the cortical electrode contacts, the patient's neural activity can be monitored in real time, and the electrical stimulation parameters can be dynamically adjusted according to the monitoring results to achieve closed-loop control, optimize the electrical stimulation parameters in real time, and improve the accuracy and effectiveness of the treatment.

[0258] In summary, the present invention aims to achieve combined, simultaneous and precise stimulation of multiple functional targets in the brain through a single electrode. The design of the electrode of the device is to have multiple independent electrode contact groups, each electrode contact group is composed of a number of independent electrode contacts, and each is independently electrically connected to the pulse generator.

[0259] In the specific electrode design, multiple electrode contacts in each electrode contact group are arranged along the axial direction of the electrode, and the electrode contact groups are arranged at intervals to ensure that different contact groups can cover different functional targets in the brain. Each electrode contact group can be independently controlled to allow directional electrical stimulation of the corresponding functional targets in the brain. The number and distribution of electrode contacts can be configured according to clinical needs to cover the required functional targets in the brain and achieve the best treatment effect.

[0260] In order to achieve high-precision stimulation of functional targets in the brain, the electrode design in this embodiment allows different electrode contact groups to act on different targets at the same time without interfering with each other. The electrical stimulation parameters of each electrode contact group, such as pulse frequency, pulse width and current intensity, can be independently adjusted by the pulse generator. This design ensures precise control of multiple functional targets in the brain and reduces the complexity of the surgical process.

[0261] During use, the surgeon can implant the electrodes into specific areas of the patient's brain through a pre-designed electrode implantation path to ensure that each contact group accurately covers the target point. The pulse generator can output corresponding stimulation signals to the electrode contacts in different contact groups according to the parameters set by the doctor, thereby achieving effective treatment of multiple functional targets in the brain.

[0262] This single electrode design effectively simplifies the surgical process of multi-target electrical stimulation, reduces surgical risks, and improves the accuracy and effect of electrical stimulation.

[0263] Obviously, the above embodiments of the present invention are merely examples for clearly illustrating the present invention, and are not intended to limit the embodiments of the present invention. For those skilled in the art, various obvious changes, readjustments and substitutions can be made without departing from the protection scope of the present invention. It is not necessary and impossible to list all the embodiments here. Any modifications, equivalent substitutions and improvements made within the spirit and principles of the present invention should be included in the protection scope of the claims of the present invention.

Claims

1. An electrode for deep brain stimulation, characterized in that: The electrode is used for stimulating two or more functional targets in the brain; When the electrode is implanted in the brain in a directionally manner, the electrode passes through or is inserted into two or more functional target points in the brain to jointly perform electrical stimulation on each of the functional target points in the brain; The electrode comprises a stimulation segment (1), the stimulation segment (1) being provided with an electrode contact assembly (4) arranged along the length direction of the stimulation segment (1), the electrode contact assembly (4) comprising at least two electrode contact groups (41), each of the electrode contact groups (41) corresponding to a different functional target point in the brain, each of the electrode contact groups (41) comprising at least one electrode contact (10), each electrode contact (10) in the same electrode contact group (41) being able to output the same electrical stimulation parameter combination, and different electrode contact groups (41) output different electrical stimulation parameter combinations; The total length of the electrode contact assembly (4) is X, 12 mm ≤ X ≤ 70 mm; The total number of the electrode contacts (10) included in the electrode contact assembly (4) is n, 5≤n≤24; The length of the electrode contact (10) is L, 1 mm ≤ L ≤ 3 mm; The distance between two adjacent electrode contacts (10) is P, where P≥0.5 mm, and the distance between every two adjacent electrode contacts (10) is the same.

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

3. The electrode according to claim 1, characterized in that 5≤n≤12。 4. The electrode according to claim 1, characterized in that n is 5 or 6 or 8 or 10 or 12.

5. The electrode according to claim 1, characterized in that The lengths of the electrode contacts (10) are the same or different.

6. The electrode according to claim 1, characterized in that n=8, and the length of each electrode contact (10) is 1.5 mm≤L≤3 mm.

7. The electrode according to claim 1, characterized in that n=8, and the length L of each electrode contact (10) is 1.5 mm.

8. The electrode according to claim 1, characterized in that n=12, and the length of each electrode contact (10) is 1.5 mm≤L≤3 mm.

9. The electrode according to claim 1, characterized in that n=12, and the length L of each electrode contact (10) is 1.5 mm.

10. The electrode according to claim 1, characterized in that The electrode contact assembly (4) further comprises at least one additional electrode contact (42), wherein the additional electrode contact (42) is located at the proximal side of all the electrode contact groups (41), and when the brain is electrically stimulated, the additional electrode contact (42) serves as a positive electrode.

11. The electrode according to claim 10, characterized in that The length of the additional electrode contact (42) is greater than or equal to the length of each of the electrode contacts (10).

12. The electrode according to claim 10, characterized in that The length of the additional electrode contact (42) is L a , L a ≥2mm.

13. The electrode according to claim 10, characterized in that The distance between the additional electrode contact (42) and the electrode contact (10) immediately adjacent thereto is greater than or equal to the distance between any two adjacent electrode contacts (10).

14. The electrode according to claim 10, characterized in that The distance between the additional electrode contact (42) and the distal end of the stimulation segment (1) is Y, 14 mm ≤ Y ≤ 70 mm.

15. The electrode according to claim 10, characterized in that The number of the additional electrode contacts (42) is two or more.

16. The electrode according to claim 10, characterized in that When electrically stimulating the brain, the additional electrode contacts (42) can be placed in non-functional target areas within the brain.

17. The electrode according to claim 10, characterized in that The electrode contact assembly (4) further comprises at least one cortical electrode contact (43), wherein the cortical electrode contact (43) is located on the proximal side of the additional electrode contact (42), and when the brain is electrically stimulated, the cortical electrode contact (43) is located in the cerebral cortex.

18. The electrode according to claim 1, characterized in that At least one independent electrode contact (10) is provided between adjacent electrode contact groups (41); when the brain is electrically stimulated, the electrode contact (10) serves as a positive electrode.

19. The electrode according to claim 1, characterized in that The spacing between adjacent electrode contact groups (41) is greater than 0.5 mm.

20. The electrode according to claim 1, characterized in that Each functional target point in the brain is stimulated by 1-6 electrode contacts (10).

21. The electrode according to claim 1, characterized in that The two or more brain functional targets are: Anterior limb of internal capsule (ALIC) and nucleus accumbens (NAc); or The posterior subthalamic area PSA and the ventral intermediate thalamic nucleus Vim; or, Subthalamic nucleus (STN) and substantia nigra (SN); or Subthalamic nucleus STN, substantia nigra SN and caudal zona incerta Czi; or, Hippocampus and Amg; or Subgenual cingulate gyrus Cg25 and anterior cingulate gyrus ACC; or, Bed nucleus of the stria terminalis (BNST) and anterior limb of the internal capsule (ALIC); or VC / VS; or NAc and slMFB; or CM-parafascicular nucleus complex of the thalamus; or, anterior thalamic nucleus ANT and mamithalamic tract MTT; or, Subthalamic nucleus (STN) and substantia nigra pars reticulata (SNr); or GPi and STN; or Globus pallidus internus (GPi) and substantia nigra pars reticulata (SNr); or, The ventral intermediate thalamic nucleus Vim and the subthalamic nucleus STN.

22. The electrode according to claim 21, characterized in that When electrical stimulation is applied to the anterior limb of the internal capsule ALIC (2000) and the nucleus accumbens NAc (1000) simultaneously, the total length of the electrode contact combination (4) covering the anterior limb of the internal capsule ALIC (2000) and the nucleus accumbens NAc (1000) is L t , 7.5mm≤L t ≤32mm.

23. The electrode according to claim 21, characterized in that When electrical stimulation is applied to the anterior limb of the internal capsule ALIC (2000) and the nucleus accumbens NAc (1000) simultaneously, 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 a positive electrode.

24. The electrode according to claim 1, characterized in that At least one electrode contact (10) in at least one of the electrode contact assemblies (4) is arranged in a segmented form.

25. The electrode according to claim 24, characterized in that The electrode contacts (10) arranged in slices include Z electrode slices (101) arranged at intervals in the circumferential direction of the electrode, where Z≥3.

26. A stimulation device, characterized in that The stimulation device comprises a pulse generator (300) and an electrode (100) as described in any one of claims 1 to 25, wherein the electrode (100) is electrically connected to the pulse generator (300), and the pulse generator (300) is used to output different electrical stimulation parameter combinations to each of the electrode contact groups (41) in the electrode contact combination (4).

27. The stimulation device according to claim 26, characterized in that The stimulation device further comprises an extension wire (200), and the electrode (100), the extension wire (200) and the pulse generator (300) are electrically connected in sequence.

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