Stimulating electrode and stimulating system

Abstract

The invention belongs to the technical field of medical instruments, and discloses a stimulation electrode and a stimulation system. The stimulating electrode includes an electrode body. A plurality of contact assemblies are distributed on the electrode body at intervals, each contact assembly comprises an inner layer structure and an outer layer structure which is arranged on the outer side of the inner layer structure and electrically connected with the inner layer structure, and a wire electrically connected with the inner layer structure is arranged between the inner layer structure and the outer layer structure. When the stimulating electrode is used, due to the fact that the appearance of the contact assembly is smooth and no protruding structure exists, the problem that plugging resistance is increased and plugging is hindered when the stimulating electrode is matched with a stimulator or an extension wire in a plugging mode is solved, and the possibility that brain tissue is damaged can be effectively reduced when the stimulating electrode is implanted into the brain.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a stimulation electrode and a stimulation system. Background Art

[0002] As a precision medical implant commonly used in neuromodulation technology, the stimulation electrode can effectively treat a variety of neurological diseases. Its working principle is to regulate the patient's brain neural activity through precise electrical stimulation of the electrode to achieve the effect of improving the condition.

[0003] In the prior art, one end of the stimulation electrode is connected to an implantable pulse generator (IPG) or an extension wire to achieve signal transmission and control, while the stimulation end is implanted in the patient's brain to apply electrical stimulation. The wire is connected to the contacts set at both ends of the stimulation electrode.

[0004] However, when the wires and contacts are connected, the connection structure will protrude from the contact shape, resulting in increased insertion and removal resistance of the electrode wires when inserted into the IPG and easy damage to brain tissue when implanted in the brain. Summary of the invention

[0005] The purpose of the present invention is to provide a stimulation electrode and a stimulation system, which solves the problem in the prior art that the connection structure between the wire and the contact in the stimulation electrode is exposed, resulting in increased insertion and removal resistance when plugging and unplugging with the IPG and easy damage to brain tissue when implanted in the brain.

[0006] To achieve this object, the present invention adopts the following technical solutions:

[0007] In a first aspect, the present application provides a stimulation electrode, which comprises:

[0008] The electrode body has a plurality of contact assemblies spaced apart therefrom, the contact assemblies comprising an inner layer structure and an outer layer structure disposed outside the inner layer structure and electrically connected to the inner layer structure, a wire electrically connected to the inner layer structure being disposed between the inner layer structure and the outer layer structure.

[0009] Optionally, the inner layer structure has a conductive protrusion, and the conductive protrusion is electrically connected to the outer layer structure.

[0010] Optionally, the conductive protrusion is elastic and elastically abuts against the outer layer structure.

[0011] Optionally, the inner layer structure is an inner conductive ring sleeved on the electrode body, an outer side wall of the inner conductive ring is electrically connected to the wire, and the conductive protrusion is arranged on the outer side wall of the inner conductive ring.

[0012] Optionally, the outer layer structure includes an outer conductive ring, which is sleeved on the inner layer structure and electrically connected to the conductive protrusion.

[0013] Optionally, the inner layer structure includes a plurality of inner conductive sheets, which are arranged in an insulated manner along the circumference of the electrode body, and each of the inner conductive sheets is provided with one conductive protrusion.

[0014] Optionally, the inner layer structure includes an inner insulating frame, which is sleeved on the electrode body, and the inner insulating frame is provided with a plurality of inner layer holes or inner layer grooves at intervals, each of the inner layer holes or inner layer grooves is provided with an inner conductive sheet, and each of the inner conductive sheets is provided with a conductive protrusion.

[0015] Optionally, the outer layer structure includes a plurality of outer conductive sheets, which are arranged in an insulating manner along the circumference of the outer layer structure, and each of the outer conductive sheets is electrically connected to the conductive protrusion.

[0016] Optionally, the outer layer structure includes an outer insulating frame, which is sleeved on the inner layer structure, and the outer insulating frame spacer ring is provided with a plurality of outer layer holes, each of which is provided with an outer conductive sheet, and each of the outer conductive sheets is electrically connected to the conductive protrusion.

[0017] Optionally, the inner layer structure comprises a plurality of inner conductive sheets, the plurality of inner conductive sheets are arranged in an insulating manner along the circumference of the electrode body, each of the inner conductive sheets is provided with one conductive protrusion, and the side surface of each inner conductive sheet has a first clamping portion that is clamped with the adhesive layer of the electrode body; and / or,

[0018] The outer layer structure includes a plurality of outer conductive sheets, which are arranged in an insulating ring along the circumference of the electrode body, each of which is electrically connected to the conductive protrusion, and the side surface of each of the outer conductive sheets has a second clamping portion that is clamped with the adhesive layer of the electrode body.

[0019] The second aspect is a stimulation system, which includes:

[0020] Stimulator;

[0021] The stimulation electrode as described in any one of the first aspects has one end electrically connected to the stimulator and the other end used for implantation in the patient's brain.

[0022] Optionally, the stimulation system further comprises:

[0023] An extension wire, through which the stimulator is electrically connected to the stimulation electrode.

[0024] Beneficial effects of the present invention:

[0025] In the first aspect, the contact assembly is formed by setting an inner layer structure and an outer layer structure, so that a space for installing the wire is formed inside the contact assembly, and the connection between the wire and the inner layer structure can be located between the inner layer structure and the outer layer structure, so that the connection structure between the wire and the contact assembly is located inside the contact assembly, and the connection structure will not protrude from the shape of the contact assembly to form a step difference. In this way, when the stimulation electrode is in use, since the contact assembly has a flat shape and no protruding structure, there will be no problem of increased plug-in resistance and obstruction of plug-in when the stimulation electrode is plugged in with the stimulator or the extension wire, and the possibility of damage to brain tissue can be effectively reduced when the stimulation electrode is implanted in the brain.

[0026] Secondly, when the stimulation system is in use, the contact assembly provided on the stimulation electrode will not have a protruding wire connection structure. When the connection segment of the stimulation electrode is connected to the stimulator or the extended conductive connection, the plugging and unplugging resistance will not increase due to the connection structure, ensuring that the connection segment can be plugged and unplugged smoothly to complete the connection. When the stimulation segment of the stimulation electrode is implanted in the patient's head, the brain tissue will not be damaged due to the protruding connection structure, thereby effectively improving the safety of the stimulation system. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] Figure 1 is a schematic diagram of the structure of the stimulation electrode in the first embodiment of the present invention;

[0028] Figure 2 is a schematic structural diagram of a contact assembly of a stimulation electrode in Embodiment 1 of the present invention;

[0029] Figure 3 is a schematic structural diagram of the inner sleeve of the stimulation electrode in the first embodiment of the present invention;

[0030] Figure 4 is a schematic diagram of a partial structure of a stimulation electrode in Embodiment 2 of the present invention;

[0031] Figure 5 is a schematic structural diagram of the inner conductive sheet of the stimulation electrode in the second embodiment of the present invention;

[0032] Figure 6 is a schematic diagram of the local structure of the stimulation electrode in the third embodiment of the present invention;

[0033] Figure 7 It is a schematic structural diagram of the inner insulating frame and the inner conductive sheet of the stimulation electrode in the third embodiment of the present invention;

[0034] Figure 8 is a schematic diagram of a partial structure of a stimulation electrode in Embodiment 2 of the present invention;

[0035] Fig. 9is a schematic structural diagram of the outer layer structure of the stimulation electrode in the second embodiment of the present invention;

[0036] Fig.10 is a schematic diagram of the partial structure of the stimulation electrode in the fourth embodiment of the present invention;

[0037] Fig.11 is a schematic diagram of the structure of the stimulation electrode in the fourth embodiment of the present invention;

[0038] Fig.12 It is a schematic diagram of the partial structure of the stimulation electrode in the fourth embodiment of the present invention.

[0039] In the figure:

[0040] 1. Electrode body; 2. Inner layer structure; 21. Inner conductive ring; 22. Inner conductive sheet; 221. First clamping part; 23. Inner insulating frame; 3. Outer layer structure; 31. Outer conductive ring; 32. Outer conductive sheet; 321. Second clamping part; 33. Outer insulating frame; 331. Outer layer hole; 4. Wire; 5. Conductive protrusion. DETAILED DESCRIPTION

[0041] 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 should also be noted that, for ease of description, only parts related to the present invention, rather than all structures, are shown in the accompanying drawings.

[0042] 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.

[0043] 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.

[0044] In the description of this embodiment, the terms "upper", "lower", "left", "right" and other 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 operate 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.

[0045] The embodiments of the present application disclose stimulation electrodes and stimulation systems.

[0046] The following is a brief description of the technical field and related terms of the embodiments of the present application.

[0047] Implantable medical systems include implantable neural stimulation systems, implantable cardiac stimulation systems (also known as pacemakers), implantable drug delivery systems (IDDS), and lead switching systems. Examples of implantable neural stimulation systems include deep brain stimulation (DBS), implantable cortical nerve stimulation (CNS), implantable spinal cord stimulation (SCS), implantable sacral nerve stimulation (SNS), and implantable vagus nerve stimulation (VNS).

[0048] The implantable neural electrical stimulation system includes a stimulator implanted in the patient's body (i.e., an implantable neural stimulator) and a programmable device disposed outside the patient's body. In other words, the stimulator is a medical device, or in other words, the medical device includes the stimulator. The relevant neural regulation technology mainly implants electrodes (electrodes, for example, in the form of electrode wires) in specific parts of the tissues of the organism (i.e., target points) through stereotactic surgery, and emits discharge pulses to the target points through the electrodes to regulate the electrical activity and function of the corresponding neural structures and networks, thereby improving symptoms and relieving pain.

[0049] As an example, DBS includes an IPG (Implantable Pulse Generator), an extension wire and an electrode wire, and the IPG is connected to the electrode wire via the extension wire. The IPG is implanted in the patient's body, for example, in the patient's chest or other body parts.

[0050] As another example, DBS includes an IPG and an electrode lead, and the IPG is directly connected to the electrode lead. The IPG is implanted in the patient's head, for example, a groove is made in the patient's skull, and then the IPG is installed in the groove of the skull. In this case, the IPG may not protrude from the outer surface of the skull, or may partially protrude from the outer surface of the skull.

[0051] The IPG responds to the program-controlled instructions sent by the program-controlled device, and relies on sealed batteries and circuits to provide controllable electrical stimulation therapy (or electrical stimulation energy) to the tissues in the body. The IPG delivers one or more controllable specific electrical stimulations to specific areas of the tissues in the body through electrode wires.

[0052] In some embodiments, the extension lead is used in conjunction with the IPG as a transmission medium for electrical stimulation, and transmits the electrical stimulation generated by the IPG to the electrode lead.

[0053] In some embodiments, the electrical stimulation may be delivered in the form of a pulse signal or in the form of a non-pulse signal. For example, the electrical stimulation may be delivered as a signal having various waveform shapes, frequencies, and amplitudes. Thus, the electrical stimulation in the form of a non-pulse signal may be a continuous signal, which may have a sinusoidal waveform or other continuous waveform.

[0054] After receiving the electrical stimulation transmitted by the IPG or the extension wire, the electrode wire delivers the electrical stimulation to a specific area of ​​the tissue in the body through a plurality of electrode contacts. The stimulator is provided with, for example, one or more electrode wires on one side or both sides, and a plurality of electrode contacts are provided on the electrode wire, and the electrode contacts can be arranged uniformly or non-uniformly in the circumferential direction of the electrode wire. As an example, the electrode contacts can be arranged in an array of 4 rows and 3 columns (a total of 12 electrode contacts) in the circumferential direction of the electrode wire. The electrode contacts can include stimulation electrode contacts and / or collection electrode contacts. The electrode contacts can be in the shape of sheets, rings, dots, etc., for example.

[0055] In some embodiments, the stimulated in vivo tissue may be the patient's brain tissue, and the stimulated site may be a specific site of the brain tissue. When the patient's disease type is different, the stimulated site is generally different, and the number of stimulation contacts (single source or multiple sources), the use of one or more (single channel or multiple channels) of specific electrical stimulation, and the stimulation parameters (values) are also different.

[0056] The embodiments of the present application do not limit the types of diseases that can be used, and they can be the types of diseases that deep brain stimulation (DBS), spinal cord stimulation (SCS), sacral nerve stimulation, gastric stimulation, peripheral nerve stimulation, and functional electrical stimulation can be used for. Among them, the types of diseases that DBS can be used to treat or manage include, but are not limited to: spastic diseases (e.g., epilepsy), pain, migraine, mental illness (e.g., major depressive disorder (MDD)), bipolar disorder, anxiety, post-traumatic stress disorder, mild depression, obsessive-compulsive disorder (OCD), behavioral disorders, mood disorders, memory disorders, mental state disorders, movement disorders (e.g., essential tremor or Parkinson's disease), Huntington's disease, Alzheimer's disease, drug addiction, autism or other neurological or psychiatric diseases and injuries.

[0057] In the embodiment of the present application, when the programmable device and the stimulator establish a programmable connection, the programmable device can be used to adjust one or more stimulation parameters of the stimulator (or one or more stimulation parameters of the pulse generator, different stimulation parameters correspond to different electrical stimulations), and the stimulator can also sense the patient's electrophysiological activities to collect electrophysiological signals, and the collected electrophysiological signals can be used to continue to adjust the stimulation parameters of the stimulator, thereby realizing closed-loop control (or adaptive adjustment) of the stimulation parameters.

[0058] The stimulation parameters may include at least one of the following: the electrode contact identification used to deliver electrical stimulation (for example, electrode contact #2 and electrode contact #3), frequency (for example, the number of electrical stimulation pulse signals within a unit time of 1s, in Hz), pulse width (the duration of each pulse, in μs), amplitude (generally expressed in voltage, that is, the intensity of each pulse, in V), timing (for example, it can be continuous or burst, and burst refers to discontinuous timing behavior composed of multiple processes), stimulation mode (including one or more of current mode, voltage mode, timed stimulation mode and cyclic stimulation mode), upper and lower limits controlled by the doctor (the range that can be adjusted by the doctor) and upper and lower limits controlled by the patient (the range that can be adjusted autonomously by the patient).

[0059] In some embodiments, various stimulation parameters of the stimulator can be adjusted in current mode or voltage mode.

[0060] Programmable devices may include doctor programmable devices (i.e. programmable devices used by doctors) and / or patient programmable devices (i.e. programmable devices used by patients). Doctor programmable devices are, for example, tablet computers, laptop computers, desktop computers, mobile phones and other intelligent terminal devices equipped with programmable software. Patient programmable devices are, for example, tablet computers, laptop computers, desktop computers, mobile phones and other intelligent terminal devices equipped with programmable software. Patient programmable devices may also be other electronic devices with programmable functions (e.g., chargers with programmable functions, electrophysiological acquisition devices, etc.).

[0061] Embodiment 1

[0062] Reference Figures 1 to 3 The stimulation electrode comprises an electrode body 1. The electrode body 1 is provided with a plurality of contact assemblies spaced apart from each other, the contact assemblies comprising an inner layer structure 2 and an outer layer structure 3 disposed outside the inner layer structure 2 and electrically connected to the inner layer structure 2, and a wire 4 electrically connected to the inner layer structure 2 is disposed between the inner layer structure 2 and the outer layer structure 3.

[0063] Specifically, the electrode body 1 has a stimulation section and a connection section, and a plurality of contact assemblies are distributed at intervals on the stimulation section or the connection section. The contact assembly includes an inner layer structure 2 and an outer layer structure 3. The inner layer structure 2 and the outer layer structure 3 can be arranged in a nested layout or in a piece-by-piece corresponding layout, which depends on the type of stimulation electrode. When the stimulation electrode is a directional electrode, a piece-by-piece corresponding layout is adopted, that is, a plurality of conductive sheets are arranged in a ring to form a contact assembly. When the stimulation electrode is not a directional electrode, the contact assembly can be in a ring shape to form a nested layout. In the above-mentioned multiple layouts, a space for installing the wire 4 is formed between the outer layer structure 3 and the inner layer structure 2, and the wire 4 can be electrically connected to the outer side wall of the inner layer structure 2 by welding or the like, so that the connection structure between the wire 4 and the contact assembly is located inside the contact assembly. Specifically, during assembly, the wire 4 can be effectively and stably connected to the inner layer structure 2 first, and then the inner layer structure 2 and the wire 4 can be loaded into the outer layer structure 3 together.

[0064] By providing the inner layer structure 2 and the outer layer structure 3 to form a contact assembly, a space for installing the wire 4 is formed inside the contact assembly, and the connection between the wire 4 and the inner layer structure 2 can be located between the inner layer structure 2 and the outer layer structure 3, so that the connection structure between the wire 4 and the contact assembly is located inside the contact assembly, and the connection structure will not protrude from the outer shape of the contact assembly to form a step difference. In this way, when the stimulation electrode is used, since the outer shape of the contact assembly is flat and there is no protruding structure, when the stimulation electrode is plugged in and matched with the stimulator or the extension wire, there will be no problem of increased plug-in resistance and obstruction of plug-in, and the stimulation electrode can effectively reduce the possibility of causing damage to brain tissue when implanted in the brain.

[0065] Optionally, the inner layer structure 2 has a conductive protrusion 5 , and the conductive protrusion 5 is electrically connected to the outer layer structure 3 .

[0066] Specifically, when the inner layer structure 2 is an annular structure, the inner side of the inner layer structure 2 is attached to the electrode body 1, and the outer side of the inner layer structure 2 is provided with a conductive protrusion 5, the conductive protrusion 5 and the inner layer structure 2 are an integrated structure, and the conductive protrusion 5 can be formed by stamping, CNC, laser cutting or welding, etc. The conductive protrusion 5 abuts against the inner side wall of the outer layer structure 3 to form an electrical connection between the outer layer structure 3 and the inner layer structure 2. The conductive protrusion 5 can be an arc-shaped protrusion and extend along the circumference of the electrode body 1, so that the inner conductive ring 21 is plugged into the outer conductive ring 31. The conductive protrusion 5 can also be in other shapes, as long as it can achieve a conductive connection between the inner layer structure 2 and the outer layer structure 3, and this application does not make specific restrictions on this.

[0067] Optionally, the conductive protrusion 5 is elastic and elastically abuts against the outer layer structure 3 .

[0068] Specifically, the conductive protrusion 5 is arc-shaped, and both ends are fixedly connected to the inner layer structure 2, and the middle part is arched toward the side away from the inner layer structure 2 to form a deformation gap with the inner layer structure 2, so that the conductive protrusion 5 can be elastically deformed within a certain range, thereby ensuring elastic abutment between the conductive protrusion 5 and the outer layer structure 3. When the inner layer structure 2 is installed in the outer layer structure 3, the conductive protrusion 5 can fully abut against the outer layer structure 3, thereby ensuring good electrical connection stability between the inner layer structure 2 and the outer layer structure 3.

[0069] Optionally, the inner layer structure 2 is an inner conductive ring 21 , which is sleeved on the electrode body 1 , the outer side wall of the inner conductive ring 21 is electrically connected to the wire 4 , and the conductive protrusion 5 is arranged on the outer side wall of the inner conductive ring 21 .

[0070] Specifically, the inner conductive ring 21 is sleeved on the stimulation section or the connection section of the electrode body 1, and the outer layer structure 3 is ringed on the outer side of the inner conductive ring 21, and a certain gap is reserved between the outer side wall of the inner conductive ring 21 and the outer layer structure 3 for the wire 4 to pass through. The wire 4 is fixed on the outer side wall of the inner conductive ring 21 by welding or other means and forms an electrical connection with the inner conductive ring 21. The above-mentioned conductive protrusions 5 are arranged on the outer side wall of the inner conductive ring 21, and a plurality of conductive protrusions 5 can be distributed at intervals along the circumference of the inner conductive ring 21 to form an effective electrical connection with the outer layer structure 3. During assembly, the wire 4 can be first fixed on the inner conductive ring 21, and then the inner conductive ring 21 can be installed in the outer layer structure 3.

[0071] Optionally, the outer layer structure 3 includes an outer conductive ring 31 , which is sleeved on the inner layer structure 2 and electrically connected to the conductive protrusion 5 .

[0072] Specifically, the outer conductive ring 31 and the inner conductive ring 21 are arranged in a nested manner, and the inner diameter of the outer conductive ring 31 is slightly larger than the outer diameter of the inner conductive ring 21, so that a corresponding gap is formed between the inner side of the outer conductive ring 31 and the outer side of the inner conductive ring 21 to accommodate the wire 4 and the conductive protrusion 5, and the thickness of the annular space is smaller than the height of the conductive protrusion 5, so that the conductive protrusion 5 can smoothly form abutment with the outer conductive ring 31.

[0073] By setting the outer layer structure 3 as an outer conductive ring 31, the overall shape of the contact assembly is smoother, and the connection structure between the wire 4 and the inner layer structure 2 can be better covered to further reduce the possibility of protruding from the shape of the contact assembly, and can form an effective electrical connection with the conductive protrusion 5 set at any position, so that the setting position of the conductive protrusion 5 does not need to consider the outer layer structure 3.

[0074] The stimulation system includes a stimulator, an extension wire and a stimulation electrode as in the above embodiment. One end of the stimulation electrode is electrically connected to the stimulator or electrically connected to the stimulator through the extension wire, and the other end is used to be implanted in the patient's brain.

[0075] When the stimulation system is in use, the contact assembly provided on the stimulation electrode does not have the protruding connection structure of the wire 4, so when the connection section of the stimulation electrode is connected to the stimulator or the extended conductive connection, the plugging and unplugging resistance will not increase due to the connection structure, ensuring that the connection section can be plugged and unplugged smoothly to complete the connection. When the stimulation section of the stimulation electrode is implanted in the patient's head, the brain tissue will not be damaged due to the protruding connection structure, thereby effectively improving the safety of the stimulation system.

[0076] Embodiment 2

[0077] On the basis of the first embodiment, the present embodiment differs from the first embodiment in the composition of the inner layer structure 2 and the location of the conductive protrusion 5 .

[0078] Reference Figure 4 and Figure 5 Optionally, the inner layer structure 2 includes a plurality of inner conductive sheets 22 , which are arranged in an insulating manner along the circumference of the electrode body 1 , and a conductive protrusion 5 is provided on each inner conductive sheet 22 .

[0079] Specifically, the inner conductive sheets 22 are all arc-shaped, and their inner sides are directly attached to the outer side wall of the electrode body 1, and the inner conductive sheets 22 and the electrode body 1 can be bonded and fixed. A plurality of inner conductive sheets 22 are arranged on the electrode body 1 at equal angles, so that the electrode body 1 is an electrode body 1 of a directional electrode. A certain interval can be maintained between two adjacent inner conductive sheets 22 to separate them and form an insulating ring, or an insulating structure can be provided between two adjacent inner conductive sheets 22 to ensure the insulation of the two. A wire 4 can be provided on each inner conductive sheet 22. At least one conductive protrusion 5 is provided on the outer side wall of each inner conductive sheet 22 to form an electrical connection with the outer layer structure 3.

[0080] By setting a plurality of inner conductive sheets 22 to form the inner layer structure 2, the difficulty of assembly can be effectively reduced. Meanwhile, compared with the inner layer structure 2 of a tubular structure, the production difficulty of the plurality of inner conductive sheets 22 is lower, so it is beneficial to improve the production efficiency of the inner layer structure 2. A conductive protrusion 5 is set on each inner conductive sheet 22 to ensure that each inner conductive sheet 22 forms an effective electrical connection with the outer layer structure 3.

[0081] Optionally, the side surface of each inner conductive sheet 22 has a first clamping portion 221 that is clamped with the adhesive layer of the electrode body 1 .

[0082] A first clamping portion 221 may be provided on the side wall or bottom wall of the inner conductive sheet 22, and the first clamping portion 221 may be partially embedded in the adhesive layer, so that the clamping can be formed after the adhesive layer solidifies. In this embodiment, the first clamping portion 221 is provided on the side wall of the inner conductive sheet 22 and is in a step shape. In other embodiments, the first clamping portion 221 may also be in other shapes, such as a concave groove shape or a convex curved protrusion shape, etc., and this application does not make specific limitations on this.

[0083] Reference Figure 6 and Figure 7 Optionally, the outer layer structure 3 includes a plurality of outer conductive sheets 32 , which are arranged in an insulating manner along the circumference of the inner layer structure 2 , and each outer conductive sheet 32 ​​is electrically connected to the conductive protrusion 5 .

[0084] Specifically, the plurality of outer conductive sheets 32 can be fixed to the inner layer structure 2 by bonding, and a certain interval can be maintained between two adjacent outer conductive sheets 32 to form an insulating ring, or an insulating structure can be provided between the two to improve the insulation between the two adjacent outer conductive sheets 32. When the inner layer structure 2 is an inner conductive sheet 22, the outer conductive sheet 32 ​​is provided in one-to-one correspondence with the inner conductive sheet 22, and the shapes and sizes of the two can be adapted to form an effective shielding of the connection structure between the inner conductive sheet 22 and the wire 4, and a conductive protrusion 5 is provided on each inner conductive sheet 22 to form an electrical connection with the corresponding outer conductive sheet 32.

[0085] The outer layer structure 3 is formed by a plurality of outer conductive sheets 32 . Compared with the outer layer structure 3 formed by an outer conductive ring 31 , the production difficulty of the outer conductive sheets 32 is lower, which is conducive to improving the production efficiency of the outer layer structure 3 .

[0086] Optionally, the side surface of each outer conductive sheet 32 ​​has a second clamping portion 321 that is clamped with the adhesive layer of the electrode body 1 .

[0087] A second clamping portion 321 may be provided on the side wall or bottom wall of the outer conductive sheet 32, and the second clamping portion 321 may be partially embedded in the adhesive layer, so that the clamping can be formed after the adhesive layer solidifies. In this embodiment, the second clamping portion 321 is provided on the side wall of the outer conductive sheet 32 ​​and is in a step shape. In other embodiments, the second clamping portion 321 may also be in other shapes, such as a concave groove shape or a convex curved protrusion shape, etc., and this application does not make specific limitations on this.

[0088] Embodiment 3

[0089] On the basis of the second embodiment, the difference between this embodiment and the second embodiment lies in the composition of the inner layer structure 2 .

[0090] Reference Figure 8 and Fig. 9 Optionally, the inner layer structure 2 includes an inner insulating frame 23, which is sleeved on the electrode body 1. The inner insulating frame 23 is provided with a plurality of inner layer holes or inner layer grooves at intervals, each inner layer hole or inner layer groove is provided with an inner conductive sheet 22, and each inner conductive sheet 22 is provided with a conductive protrusion 5.

[0091] Specifically, the inner insulating frame 23 can be formed by injection molding, and a plurality of inner holes or inner grooves can be opened through the inner insulating frame 23. An inner conductive sheet 22 is fixedly arranged in each inner hole or inner groove. The upper and lower ends of the inner conductive sheet 22 are both stepped to form a snap connection with the hole wall of the inner hole or inner groove. The inner conductive sheet 22 and the inner insulating frame 23 can be fixed by bonding to ensure that the connection strength between the two meets the requirements, and the outer wall of the inner conductive sheet 22 is flush with the outer wall of the inner insulating frame 23.

[0092] In this way, by setting the inner insulating frame 23, not only can good insulation be ensured between the multiple inner conductive sheets 22, but also space can be reserved for the installation of the inner conductive sheets 22, so that the difficulty of assembling the inner conductive sheets 22 is further reduced, so as to improve the assembly efficiency of the multiple inner conductive sheets 22, and a conductive protrusion 5 is set on each inner conductive sheet 22 to ensure that each inner conductive sheet 22 forms an effective electrical connection with the outer layer structure 3.

[0093] Optionally, the side surface of each inner conductive sheet 22 has a first clamping portion 221 that is clamped with the adhesive layer of the electrode body 1 .

[0094] A first clamping portion 221 can be provided on the side wall or bottom wall of the inner conductive sheet 22, and the first clamping portion 221 can be partially embedded in the adhesive layer, so that a clamping connection can be formed after the adhesive layer solidifies. The first clamping portion 221 can also be clamped with the inner insulating frame 23 to improve the connection strength between the first clamping portion 221 and the inner insulating frame 23. In this embodiment, the first clamping portion 221 is provided on the side wall of the inner conductive sheet 22 and is in a step shape. In other embodiments, the first clamping portion 221 can also be in other shapes, such as a concave groove shape or a convex curved protrusion shape, etc., and this application does not make specific limitations on this.

[0095] Embodiment 4

[0096] On the basis of the second or third embodiment, the present embodiment differs from the second or third embodiment in the composition of the outer layer structure 3 .

[0097] Reference Figures 10 to 12 Optionally, the outer layer structure 3 includes an outer insulating frame 33, which is sleeved on the inner layer structure 2, and the outer layer insulating tube spacing ring is provided with a plurality of outer layer holes 331, and an outer conductive sheet 32 ​​is arranged in each outer layer hole 331, and each outer conductive sheet 32 ​​is electrically connected to the conductive protrusion 5.

[0098] Specifically, the outer insulating frame 33 can also be injection molded, and a plurality of holes are formed on its surface as outer holes 331. An outer conductive sheet 32 ​​is correspondingly arranged in each outer hole 331. Steps are also formed at the upper and lower ends of the outer conductive sheet 32 ​​to be clamped and fixed with the outer hole 331. The outer conductive sheet 32 ​​and the outer insulating frame 33 can be fixed by bonding to ensure that the connection strength between the two meets the requirements, and the outer wall of the outer conductive sheet 32 ​​is flush with the outer wall of the outer insulating frame 33 to ensure that the appearance of the contact assembly remains flat.

[0099] By setting up the outer insulating frame 33, while ensuring that the multiple outer conductive sheets 32 can quickly form an insulating spacer ring, space can also be reserved for the installation of the outer conductive sheets 32, so that the difficulty of assembling the outer conductive sheets 32 is further reduced, so as to improve the assembly efficiency of the multiple outer conductive sheets 32, and a conductive protrusion 5 is set at the position corresponding to each outer conductive sheet 32 ​​to ensure that each outer conductive sheet 32 ​​forms an effective electrical connection with the inner layer structure 2.

[0100] Optionally, the side surface of each outer conductive sheet 32 ​​has a second clamping portion 321 that is clamped with the adhesive layer of the electrode body 1 .

[0101] A second clamping portion 321 can be provided on the side wall or bottom wall of the outer conductive sheet 32, and the second clamping portion 321 can be partially embedded in the adhesive layer, so that a clamping connection can be formed after the adhesive layer solidifies. The second clamping portion 321 can also be clamped with the outer insulating frame 33 to improve the connection strength between the second clamping portion 321 and the outer insulating frame 33. In this embodiment, the second clamping portion 321 is provided on the side wall of the outer conductive sheet 32 ​​and is in a step shape. In other embodiments, the second clamping portion 321 can also be in other shapes, such as a concave groove shape or a convex curved protrusion shape, etc., and this application does not make specific limitations on this.

[0102] 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. A stimulation electrode, characterized in that include: An electrode body (1), wherein the electrode body (1) is provided with a plurality of contact assemblies spaced apart from each other, wherein the contact assemblies include an inner layer structure (2) and an outer layer structure (3) disposed outside the inner layer structure (2) and electrically connected to the inner layer structure (2), and a wire (4) electrically connected to the inner layer structure (2) is disposed between the inner layer structure (2) and the outer layer structure (3).

2. The stimulation electrode according to claim 1, characterized in that: The inner layer structure (2) has a conductive protrusion (5), and the conductive protrusion (5) is electrically connected to the outer layer structure (3).

3. The stimulation electrode according to claim 2, characterized in that: The conductive protrusion (5) is elastic and elastically abuts against the outer layer structure (3).

4. The stimulation electrode according to claim 2, characterized in that: The inner layer structure (2) is an inner conductive ring (21) sleeved on the electrode body (1), the outer side wall of the inner conductive ring (21) is electrically connected to the wire (4), and the conductive protrusion (5) is arranged on the outer side wall of the inner conductive ring (21).

5. The stimulation electrode according to claim 4, characterized in that: The outer layer structure (3) comprises an outer conductive ring (31), wherein the outer conductive ring (31) is sleeved on the inner layer structure (2) and is electrically connected to the conductive protrusion (5).

6. The stimulation electrode according to claim 2, characterized in that: The inner layer structure (2) comprises a plurality of inner conductive sheets (22), the plurality of inner conductive sheets (22) being arranged in an insulating manner along the circumference of the electrode body (1), and each inner conductive sheet (22) being provided with one conductive protrusion (5).

7. The stimulation electrode according to claim 2, characterized in that: The inner layer structure (2) comprises an inner insulating frame (23), the inner insulating frame (23) being sleeved on the electrode body (1), the inner insulating frame (23) being provided with a plurality of inner layer holes or inner layer grooves spaced apart in a ring, each of the inner layer holes or inner layer grooves being provided with an inner conductive sheet (22), and each of the inner conductive sheets (22) being provided with a conductive protrusion (5).

8. The stimulation electrode according to claim 6 or 7, characterized in that: The outer layer structure (3) comprises a plurality of outer conductive sheets (32), the plurality of outer conductive sheets (32) being arranged in an insulating manner along the circumference of the outer layer structure (3), and each of the outer conductive sheets (32) being electrically connected to the conductive protrusion (5).

9. The stimulation electrode according to claim 6 or 7, characterized in that: The outer layer structure (3) comprises an outer insulating frame (33), the outer insulating frame (33) is sleeved on the inner layer structure (2), the outer insulating frame (33) is provided with a plurality of outer layer holes (331) in a spacer ring, an outer conductive sheet (32) is arranged in each of the outer layer holes (331), and each of the outer conductive sheets (32) is electrically connected to the conductive protrusion (5).

10. The stimulation electrode according to any one of claims 1 to 7, characterized in that: The inner layer structure (2) comprises a plurality of inner conductive sheets (22), and each of the inner conductive sheets (22) has a first clamping portion (221) that is clamped with the adhesive layer of the electrode body (1); and / or, The outer layer structure (3) comprises a plurality of outer conductive sheets (32), and each of the outer conductive sheets (32) has a second clamping portion (321) that is clamped with the adhesive layer of the electrode body (1).

11. A stimulation system, characterized in that include: Stimulator; The stimulation electrode according to any one of claims 1 to 10, one end of which is electrically connected to the stimulator, and the other end of which is used for implantation in the patient's brain.

12. The stimulation system according to claim 11, characterized in that The stimulation system further comprises: An extension wire, through which the stimulator is electrically connected to the stimulation electrode.

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