Split bracket for mounting electrode contacts, directional electrode, implantable stimulation system

Abstract

The application discloses a split support for mounting electrode contacts, a directional electrode, and an implantable stimulation system. The split support comprises a plurality of axially arranged first split components, the first split components having hollow inner cavities; and a plurality of first mounting positions which are circumferentially spaced and formed by the cooperation between two adjacent first split components, the first mounting positions being suitable for mounting sheet-shaped electrode contacts. The split support for mounting electrode contacts can reduce the manufacturing difficulty of the directional electrode, facilitate disassembly and assembly, and simplify the welding of the electrode contacts and the guide wire, thereby overcoming the technical problems of great process difficulty, low production efficiency, low yield, and high cost caused by the grinding method for preparing the directional electrode contacts in the prior art.

Description

Technical Field

[0001] This invention relates to the field of implantable medical device technology, specifically to a split-type bracket for mounting electrode contacts, a directional electrode, and an implantable stimulation system. Background Technology

[0002] Deep brain stimulation (DBS) is a therapeutic technique that uses stereotactic precision to implant electrodes into specific nuclei deep within the brain. Under the control of a pulse generator, electrical pulses are emitted through these electrodes to stimulate the target area. By externally programming the pulse generator with specific stimulation parameters, the excitability of the nuclei can be altered, thereby modulating neural function. The pulse generator can adjust stimulation parameters such as frequency, pulse width, and voltage to maximize the neuromodulation function of DBS. With the development of neurostimulation technology, an increasing number of symptoms have been proven to be effective with DBS. Symptoms of various limb and mental disorders, including Parkinson's disease, essential tremor or Parkinsonian tremor, dystonia, epilepsy, and obsessive-compulsive disorder, have shown significant improvement after using this therapy.

[0003] Traditional DBS products primarily adjust stimulation parameters such as frequency, pulse width, and voltage. However, in clinical practice, there are also specific requirements regarding the direction of electrode stimulation. This is because stimulating different areas of the brain yields different effects, and even stimulating the same area in different directions can have varying results. Traditional electrode stimulation tips are ring-shaped contacts, making it impossible to control the stimulation direction, thus hindering precise stimulation and optimal control.

[0004] Chinese patent document CN105246542A discloses a segmented electrode (also known as a directional electrode) guide formed from a preparation electrode with recesses or perforations, and a method for manufacturing the same. The disclosed preparation electrode includes individual segmented electrode contacts joined together by a connecting material. Multiple segmented electrode contacts are grouped together and surround the circumference of the electrode guide, allowing control of the stimulation direction. However, because the electrode contacts are formed by removing the connecting material through grinding or other methods, the manufacturing process is difficult, inefficient, has a low yield, and is costly.

[0005] This invention solves at least one of the above problems. Summary of the Invention

[0006] The purpose of this invention is to provide a split bracket for mounting electrode contacts that can reduce the manufacturing difficulty of directional electrodes and is easy to disassemble, so as to overcome the technical problems of high process difficulty, low manufacturing efficiency, low yield and high cost caused by the method of preparing directional electrode contacts by grinding electrodes in the prior art.

[0007] The objective of this invention is achieved through the following technical solution:

[0008] A first aspect of the present invention provides a split-type bracket for mounting electrode contacts, comprising:

[0009] Multiple first split components arranged along the axial direction, each first split component having a hollow inner cavity;

[0010] Two adjacent first split components can cooperate to form a plurality of first mounting positions distributed circumferentially, and the first mounting positions are suitable for mounting sheet electrode contacts.

[0011] Compared with the prior art, the beneficial effects of the present invention are as follows: by axially integrating two adjacent first separate components, multiple circumferentially spaced first mounting positions are formed, allowing each first mounting position on the separate support to be fitted with a sheet electrode contact as needed. This enables the sheet electrode contacts on the first mounting positions to stimulate different target points in different directions. Furthermore, regardless of whether two first mounting positions are axially or circumferentially adjacent, they are spaced apart, physically isolating adjacent sheet electrode contacts. This ensures that each sheet electrode contact can independently perform its stimulation task, avoiding short circuits caused by interactions between sheet electrode contacts, and also reduces signal interference between sheet electrode contacts to a certain extent, thereby improving the stability and reliability of the implantation stimulation surgery.

[0012] In some possible implementations of the first aspect, each of the first split components is provided with a plurality of first mounting slots spaced apart circumferentially, the first mounting slots being used to form the first mounting positions.

[0013] In some possible embodiments of the first aspect, the first split component includes a first body and a plurality of first support columns extending outward from one side of the first body and spaced apart circumferentially, wherein the first mounting groove is formed between two adjacent first support columns circumferentially.

[0014] In some possible embodiments of the first aspect, the first support column includes a first layer and a second layer protruding outward from the outer surface of the first layer, the first layer and the second layer can form a bidirectional step structure, and the first mounting groove can be formed between two adjacent bidirectional step structures along the circumferential direction.

[0015] In some possible implementations of the first aspect, the lengths of the first layer and the second layer in the axial direction can be configured to be equal or unequal, at least one of the following:

[0016] In some possible embodiments of the first aspect, the first split assembly further includes a support ring extending outward from the other side of the first body, the outer diameter of the support ring being smaller than the outer diameter of the first body, the support ring being used to mount annular electrode contacts; or the first split assembly further includes a plurality of second support columns extending outward from the other side of the first body and spaced apart circumferentially, the second support columns including a third layer and a fourth layer protruding outward from the outer surface of the third layer, the third layer and the fourth layer forming the bidirectional stepped structure.

[0017] In some possible embodiments of the first aspect, the outer surface of the support ring is provided with a plurality of fifth layers spaced apart in the circumferential direction, and a first mounting groove is formed between two adjacent fifth layers in the circumferential direction on the outer surface of the support ring.

[0018] In some possible implementations of the first aspect, a gap exists between two adjacent first split components.

[0019] In some possible implementations of the first aspect, a slot is provided on the inner side of the first body, and in two adjacent first bodies, the portion of the first layer of one first body that is longer than the second layer can be accommodated in the slot of the other first body.

[0020] In some possible embodiments of the first aspect, the split bracket further includes a second split assembly, the second split assembly including a second body and a third support column extending outward from the second body, the circumferential diameter of the third support column being smaller than the outer diameter of the second body, the end of the third support column being accommodating in a slot of an adjacent first body or second body, so that the outer periphery of the third support column forms a second mounting position for mounting an annular electrode contact.

[0021] In some possible implementations of the first aspect, in two adjacent first split components, two first mounting slots that are axially adjacent can cooperate to form the first mounting position.

[0022] In some possible implementations of the first aspect, the first mounting groove can form the first mounting position.

[0023] A second aspect of the present invention provides a directional electrode, comprising:

[0024] The stimulation segment includes the split support described in the first aspect and electrode contacts mounted on the split support, the electrode contacts including sheet electrode contacts and / or annular electrode contacts;

[0025] A connecting segment, the connecting segment comprising a plurality of mutually insulated connecting contacts;

[0026] The intermediate segment connects the stimulation segment and the connecting segment. The intermediate segment includes several electrode wires, and the connecting contact point and the electrode contact point are electrically connected one-to-one through the electrode wires.

[0027] A third aspect of the present invention provides an implantable stimulation system, the implantable stimulation system comprising a pulse generator and the directional electrode described in the second aspect, wherein the pulse generator and the directional electrode are electrically connected by a connection contact.

[0028] In some possible implementations of the third aspect, the implantable stimulation system further includes an extension lead, through which the pulse generator is electrically connected to the directional electrode. Attached Figure Description

[0029] Figure 1 This is a schematic diagram of the structure of the first split component in the second embodiment of the first technical solution of the present invention;

[0030] Figure 2 This is a schematic diagram of the structure of the first split component in the first embodiment of the first technical solution of the present invention;

[0031] Figure 3 This is a schematic diagram of the structure of the first split component in the third embodiment of the first technical solution of the present invention;

[0032] Figure 4 This is a schematic diagram of the structure of the first split component in the first embodiment and / or the second embodiment of the second technical solution of the present invention;

[0033] Figure 5 This is a schematic diagram of the structure of the first split component in the third embodiment of the second technical solution of the present invention;

[0034] Figure 6 This is a schematic diagram of the structure of a directional electrode according to a second aspect of the present invention;

[0035] Figure 7 This is a schematic diagram of the structure of a 1-3-3-1 type 8-contact directional electrode according to Embodiment 1 of the present invention;

[0036] Figure 8 This is a schematic diagram of another 1-3-3-1 type 8-contact directional electrode structure in Embodiment 3 of the present invention;

[0037] Figure 9 This is a schematic diagram of the structure of a 3-3-3-3 type 8-contact directional electrode according to Embodiment 5 of the present invention;

[0038] Figure 10 This is a schematic diagram of another 3-3-3-3 type 8-contact directional electrode according to Embodiment 6 of the present invention.

[0039] In the diagram, 11 is the first main body; 111 is the slot; 12 is the first support column; 121 is the first layer; 122 is the second layer; 13 is the second support column; 131 is the third layer; 132 is the fourth layer; 14 is the support ring; 15 is the fifth layer; 21 is the second main body; 22 is the third support column; 10 is the stimulation segment; 20 is the connecting segment; 30 is the middle segment; 40 is the sheet electrode contact; 50 is the ring electrode contact; 60 is the contact segment; 70 is the first connector segment; 80 is the second connector segment; 90 is the third connector segment; 100 is the fourth connector segment; and 201 is the connecting contact point. Detailed Implementation

[0040] Exemplary embodiments will now be described more fully with reference to the accompanying drawings. However, these exemplary embodiments can be implemented in many forms and should not be construed as limited to the embodiments set forth herein; rather, they are provided to make the invention more comprehensive and complete, and to fully convey the concept of the exemplary embodiments to those skilled in the art. The same reference numerals in the drawings denote the same or similar structures, and therefore repeated descriptions of them will be omitted.

[0041] Combined with appendix Figure 1-5 As shown in Figures 7-10, in a first aspect of this embodiment, a split-type bracket for mounting electrode contacts is provided, comprising a plurality of first split components arranged axially. It should be noted that the first split components in this application are made of insulating material.

[0042] The first split component has a hollow inner cavity, which can be used to house electrode wires to achieve the convergence of electrode wires.

[0043] Two adjacent first sub-assemblies can cooperate to form a plurality of first mounting positions spaced apart circumferentially, and the first mounting positions are suitable for mounting the sheet electrode contacts 40. It should be noted that two adjacent first mounting positions along the axial direction are also spaced apart.

[0044] It should be noted that the sheet-like design of the sheet electrode contact 40 can be a segmented design, that is, the annular electrode contact 50 is divided into multiple independent sheet-like structures.

[0045] This application utilizes an axially integrated mounting system of two adjacent first separate components to form multiple circumferentially spaced first mounting positions. This allows each first mounting position on the split-type support to accommodate a sheet electrode contact 40 as needed. Thus, the sheet electrode contacts 40 at each first mounting position can stimulate different target points in different directions. Furthermore, regardless of whether two first mounting positions are adjacent axially or circumferentially, they are spaced apart, providing physical insulation between adjacent sheet electrode contacts 40. This ensures that each sheet electrode contact 40 can independently perform its stimulation task, preventing short circuits caused by interactions between sheet electrode contacts 40. It also mitigates signal interference between sheet electrode contacts 40 to a certain extent, thereby improving the stability and reliability of the implantable stimulation surgery.

[0046] Furthermore, by combining and separating the first split components, it is not only convenient to replace a new sheet electrode contact 40 when it is damaged, but also convenient to replace a new first split component when it is damaged. This greatly improves the efficiency of installation and disassembly, making the installation and disassembly of electrode contacts more flexible.

[0047] It should be further explained that, because the sheet electrode contacts 40 typically have a smaller area, they can more precisely locate and stimulate the target point, reducing interference with surrounding non-target points. At the same time, the design of the sheet electrode contacts 40 often allows physicians to flexibly adjust the position and stimulation direction of the electrode contacts according to the patient's specific condition to achieve the best therapeutic effect. For example, in some directional electrode systems, by independently controlling the current of each sheet electrode contact 40, physicians can precisely control the direction and intensity of stimulation, achieving the treatment goal of "maximizing therapeutic effect and minimizing side effects."

[0048] As a more specific implementation of this embodiment, each first split component is provided with a plurality of first mounting slots distributed circumferentially, the first mounting slots being used to form first mounting positions.

[0049] As a more specific implementation of this embodiment, the first split component includes a first main body 11 and a plurality of first support columns 12 extending outward from one side of the first main body 11 and spaced apart in the circumferential direction, with a first mounting groove formed between two adjacent first support columns 12 in the circumferential direction.

[0050] The first support column 12 not only serves as a radial segment to achieve physical insulation between the sheet electrode contacts 40 in the circumferential direction, but also forms a first mounting groove to achieve stable installation and fixation of the sheet electrode contacts 40.

[0051] As a more specific implementation of this embodiment, the first support column 12 includes a first layer 121 and a second layer 122 protruding outward from the outer surface of the first layer 121. The first layer 121 and the second layer 122 can form a bidirectional step structure, and a first mounting groove can be formed between two adjacent bidirectional step structures along the circumferential direction.

[0052] The bidirectional stepped structure design of the first layer 121 and the second layer 122 allows each step to provide a solid support point. When two adjacent stepped structures are combined, they together form a more stable mounting base, which can ensure that the sheet electrode contacts 40 installed on it remain stable and are not easy to shake or tilt.

[0053] The second layer 122 can serve as a radial separator to achieve circumferential insulation between the sheet electrode contacts 40, and can also cooperate with the first layer 121 to form a bidirectional stepped structure, thereby improving the stability of the installation of the sheet electrode contacts 40.

[0054] It should be noted that, since there is a gap between the adjacent second layers 122 along the circumferential direction, space is provided for the connection between the electrode wire and the sheet electrode contact 40, so that the sheet electrode contact 40 on the first mounting position can be smoothly connected to the electrode wire.

[0055] As a first technical solution of the above embodiment, in two adjacent first split components, two first mounting slots that are adjacent along the axial direction can cooperate to form a first mounting position. That is, the first mounting slot of one first split component can be combined with the first mounting slot of the other first split component to form a first mounting position. In other words, one end of the sheet electrode contact 40 can be embedded in the first mounting slot of one first split component, and the other end of the sheet electrode contact 40 can be embedded in the first mounting slot of the other first split component.

[0056] Combined with appendix Figure 2 As shown, in the first embodiment of the first technical solution, the first split component also includes a support ring 14 extending outward from the other side of the first body 11. The outer diameter of the support ring 14 is smaller than the outer diameter of the first body 11. The support ring 14 is used to install the annular electrode contact 50.

[0057] By adding a support ring 14 to the first split assembly, and the outer diameter of the support ring 14 being smaller than the outer diameter of the first main body 11, the entire outer surface of the electrode is made to be on the same plane when the annular electrode contact 50 is fitted onto the support ring 14, ensuring the flatness of the electrode's outer surface. The split bracket also achieves a composite installation of the annular electrode contact 50 and the sheet electrode contact 40, enabling the split bracket to simultaneously meet different stimulation needs. It should be noted that the first main body 11 acts as an axial segment, providing insulation between the annular electrode contact 50 and the sheet electrode contact 40.

[0058] For example, the ring electrode contact 50 enables omnidirectional stimulation of the target point. Since the ring electrode contact 50 is designed to cover a 360-degree range, it can provide omnidirectional stimulation, which is highly advantageous for scenarios requiring extensive stimulation of surrounding nerve tissue. Furthermore, because the stimulation distribution of the ring electrode contact 50 is uniform, it ensures that the stimulation signal propagates evenly in the surrounding tissue, reducing discomfort or complications caused by uneven stimulation.

[0059] Combined with appendix Figure 1 and 2 As shown, in the second embodiment of the first technical solution, the outer surface of the support ring 14 is provided with a plurality of fifth layer bodies 15 arranged circumferentially, and a first mounting groove is formed between two adjacent fifth layer bodies 15 in the circumferential direction on the outer surface of the support ring 14.

[0060] The fifth layer 15 protrudes from the outer surface of the support ring 14, forming a first mounting groove to securely install and fix the first pair of sheet electrode contacts 40. At the same time, the fifth layer 15 acts as a radial segment, enabling the two adjacent sheet electrode contacts 40 along the circumferential direction to achieve insulation isolation.

[0061] As some specific embodiments of the second implementation, there is a gap between two adjacent first split components. In the two adjacent first split components, the first mounting grooves of the two first split components are formed by the second implementation. The purpose of setting the gap is to provide space for the connection between the electrode wire and the sheet electrode contact 40, so that the sheet electrode contact 40 on the second mounting position can be smoothly connected to the electrode wire.

[0062] Combined with appendix Figure 3 As shown, as a third embodiment of the first technical solution, the first split component also includes a plurality of second support columns 13 extending outward from the other side of the first main body 11 and spaced apart along the circumference. The second support column 13 includes a third layer 131 and a fourth layer 132 protruding outward from the outer surface of the third layer 131. The third layer 131 and the fourth layer 132 can form a two-way stepped structure.

[0063] In other words, the first support column 12 and the second support column 13 are symmetrical with respect to the first main body 11, and both can support and install the sheet electrode contacts 40 through a bidirectional stepped structure. It should be noted that the first main body 11 acts as an axial segment, providing insulation between two adjacent sheet electrode contacts 40 along the axial direction. The fourth layer 132 acts as a radial segment, providing insulation between two adjacent sheet electrode contacts 40 along the circumferential direction.

[0064] In a preferred embodiment of the first technical solution, the lengths of the first layer 121 and the second layer 122 are equal in the axial direction, and the lengths of the third layer 131 and the fourth layer 132 are equal in the axial direction.

[0065] Combined with appendix Figure 4 and 5 As shown, as a second technical solution of the above embodiment, the first mounting groove can form a first mounting position. That is, among two adjacent first split components, the first mounting groove of one first split component can be combined with the first mounting groove of another first split component (not the first mounting groove of the first split component) to form a first mounting position, that is, the sheet electrode contact 40 is embedded in the first mounting groove.

[0066] Combined with appendix Figure 4 As shown, in the first embodiment of the second technical solution, when the lengths of the first layer 121 and the second layer 122 are equal in the axial direction, the bidirectional step structure of one of the two adjacent first bodies 11 can be combined with the other side of the other first body 11 (i.e. the side away from the bidirectional step structure of the first body 11) to form a first mounting position.

[0067] Combined with appendix Figure 4 As shown, in a second embodiment of the second technical solution, the first layer 121 is longer than the second layer 122 in the axial direction. A slot 111 is provided on the inner side of the first main body 11. In two adjacent first main bodies 11, the portion of the first layer 121 that is longer than the second layer 122 in one first main body 11 can be accommodated in the slot 111 of the other first main body 11. Alternatively, the first layer 121 is shorter than the second layer 122 in the axial direction, and a slot (not shown in the figure) is provided on the outer side of the first main body 11. In two adjacent first main bodies 11, the portion of the second layer 122 that is longer than the first layer 121 in one first main body 11 can be accommodated in the slot of the other first main body 11.

[0068] In two adjacent first bodies 11, since the first layer 121 and the second layer 122 of one of the bodies form a two-way stepped structure, when the part of the first layer 121 that is longer than the second layer 122 in the first body 11 is accommodated in the slot 111 of the other first body 11, the first mounting groove formed by the two circumferentially adjacent two-way stepped structures in the first body 11 can provide space for the formation of the first mounting position. It can form the first mounting position by combining with the slot 111 side of the other first body 11.

[0069] It should be noted that in the two embodiments described above, the first body 11 serves as an axially segmented section, enabling the two adjacent sheet electrode contacts 40 along the axial direction to achieve insulation and barrier.

[0070] Combined with appendix Figure 5 As shown, in the third embodiment of the second technical solution, the split bracket also includes a second split component. The second split component includes a second main body 21 and a third support column 22 extending outward from the second main body 21. The circumferential diameter formed by the third support column 22 is smaller than the outer diameter of the second main body 21. The end of the third support column 22 can be received in the slot 111 of the adjacent first main body 11 or second main body 21, so that the outer periphery of the third support column 22 forms a second mounting position. The second mounting position is used to install the annular electrode contact 50. This design makes the overall outer surface of the electrode flush after the annular electrode contact 50 is installed.

[0071] When the end of the third support column 22 can be received within the slot 111 of the adjacent second body 21, and the circumferential diameter formed by the third support column 22 is smaller than the outer diameter of the second body 21, the annular electrode contact 50 can be fitted onto the second mounting position formed on the outer periphery of the third support column 22. This allows for a composite installation of the annular electrode contact 50 and the sheet electrode contact 40 on the split bracket, enabling the split bracket to simultaneously meet different stimulation requirements. It should be noted that the second body 21 acts as an axial segment, providing insulation between the annular electrode contact 50 and the sheet electrode contact 40.

[0072] Combined with appendix Figure 6 As shown, in a second aspect of this embodiment, a directional electrode is provided, which includes a stimulation segment 10, a connecting segment 20, and an intermediate segment 30.

[0073] The stimulation segment 10 includes a split support in the first aspect and electrode contacts mounted on the split support, the electrode contacts including sheet electrode contacts 40 and / or ring electrode contacts 50.

[0074] The connecting section 20 includes a plurality of mutually insulated connecting contacts 201.

[0075] The intermediate segment 30 is used to connect the stimulation segment 10 and the connecting segment 20 (i.e., one end of the intermediate segment 30 is connected to the stimulation segment 10 and the other end is connected to the connecting segment 20). The intermediate segment 30 includes several electrode wires, and the contact point 201 and the electrode contact point are electrically connected one-to-one through the electrode wires.

[0076] The directional electrode of the present invention can be assembled and disassembled separately by means of a split bracket for the ring electrode contact 50 and / or the sheet electrode contact 40; by means of the connecting contact 201 of the connecting section 20, the ring electrode contact 50 and / or the sheet electrode contact 40 are electrically connected one-to-one with the electrode wires, so as to provide non-conflicting stimulation signals between the ring electrode contact 50 and / or the sheet electrode contact 40.

[0077] A third aspect of this embodiment provides an implantable stimulation system, which includes a pulse generator and a directional electrode, wherein the pulse generator and the directional electrode are electrically connected via a connection contact 201. Further, the implantable stimulation system also includes an extension wire, through which the pulse generator is electrically connected to the directional electrode.

[0078] First, one application area of ​​this application (i.e., implantable neurostimulation system) will be briefly described.

[0079] Implantable medical systems include implantable neurostimulation systems, implantable cardiac stimulation systems (also known as pacemakers), implantable drug delivery systems (IDDS), and lead transfer systems. Examples of implantable neurostimulation systems include deep brain stimulation (DBS), cortical nerve stimulation (CNS), spinal cord stimulation (SCS), sacral nerve stimulation (SNS), and vagus nerve stimulation (VNS).

[0080] Implantable neurostimulation systems consist of a stimulator implanted in the patient's body (i.e., an implantable neurostimulator) and a programmed device placed outside the patient's body. In other words, the stimulator is a medical device, or medical devices include stimulators. Related neuromodulation techniques primarily involve stereotactic surgery to implant electrode contacts (e.g., electrode wires) at specific sites (target points) in the body's tissues. Discharge pulses are then sent from these electrode contacts to the target points, modulating the electrical activity and function of corresponding neural structures and networks, thereby improving symptoms and alleviating pain.

[0081] As an example, a DBS includes an IPG (Implantable Pulse Generator), extension leads, and electrode leads. The IPG is connected to the electrode leads via the extension leads. The IPG is implanted in the patient's body, for example, in the chest or other internal locations.

[0082] As another example, DBS includes an IPG and electrode leads, with the IPG directly connected to the electrode leads. The IPG is implanted in the patient's head, for example, by creating a groove in the patient's skull and then placing the IPG in the groove. In this case, the IPG may not protrude from the outer surface of the skull, or it may protrude partially from the outer surface of the skull.

[0083] The IPG (Intracytoplasmic Gyroscope) responds to sample brain mask information sent by a programmable device, delivering controllable electrical stimulation (or electrical stimulation energy) to tissues within the body via a sealed battery and circuitry. When the battery is low, it needs to be recharged, which can be done wirelessly using an electromagnetic induction coil, bypassing the skin or other epidermal tissue. The IPG delivers one or more controllable electrical stimuli to specific areas of tissue within the body via electrode wires.

[0084] In some embodiments of the third aspect, the extension wire is used in conjunction with the IPG as a medium for transmitting electrical stimulation, thereby transmitting the electrical stimulation generated by the IPG to the electrode wire.

[0085] In some embodiments of the third aspect, electrical stimulation can be delivered in the form of a pulsed signal or a non-pulsed signal. For example, electrical stimulation can be delivered as a signal with various waveform shapes, frequencies, and amplitudes. Therefore, electrical stimulation in the form of a non-pulsed signal can be a continuous signal, which can have a sinusoidal waveform or other continuous waveforms.

[0086] After receiving electrical stimulation from the IPG or extension leads, the electrode leads deliver the stimulation to specific areas of tissue within the body via multiple electrode contacts. The stimulator may have one or more electrode leads on one or both sides, with multiple electrode contacts on each lead. These contacts may be evenly or non-uniformly arranged circumferentially on the electrode leads. As an example, the electrode contacts may be arranged in a 4x3 array (a total of 12 contacts) circumferentially on the electrode leads. The electrode contacts may include stimulating electrode contacts and / or collecting electrode contacts. The electrode contacts may be in shapes such as sheet-like, ring-like, or dot-like.

[0087] In some implementations of the third aspect, the stimulated tissue may be the patient's brain tissue, and the stimulated site may be a specific location within the brain tissue. Generally, the stimulated site differs depending on the patient's disease type, and the number of stimulation contacts (single-source or multi-source), the application of one or more specific electrical stimulation pathways (single-channel or multi-channel), and the stimulation parameters (values) also vary.

[0088] This application does not limit the applicable disease types, but can be any disease type applicable to deep brain stimulation (DBS), spinal cord stimulation (SCS), sacral nerve stimulation, gastric stimulation, peripheral nerve stimulation, or functional electrical stimulation. Among these, DBS can be used to treat or manage diseases including, but not limited to: spastic disorders (e.g., epilepsy), pain, migraines, mental illnesses (e.g., major depressive disorder (MDD)), bipolar disorder, anxiety disorders, post-traumatic stress disorder, mild depression, obsessive-compulsive disorder (OCD), behavioral disorders, mood disorders, memory disorders, mental state disorders, mobility disorders (e.g., essential tremor or Parkinson's disease), Huntington's disease, Alzheimer's disease, drug addiction, autism, or other neurological or psychiatric diseases and impairments.

[0089] In this embodiment of the application, when the programmable device and the stimulator establish a programmable connection, the programmable device can be used to adjust one or more stimulation parameters of the stimulator (or one or more stimulation parameters of the pulse generator, with different stimulation parameters corresponding to different electrical stimuli). Alternatively, the stimulator can sense the patient's electrophysiological activity to collect electrophysiological signals, and the collected electrophysiological signals can be used to continue adjusting the stimulation parameters of the stimulator to achieve closed-loop control (or adaptive adjustment) of the stimulation parameters.

[0090] Stimulation parameters may include at least one of the following: electrode contact identification for delivering electrical stimulation (e.g., electrode contact #2 and electrode contact #3), frequency (e.g., the number of electrical stimulation pulse signals per second, in Hz), pulse width (duration of each pulse, in μs), amplitude (generally expressed as voltage, i.e., the intensity of each pulse, in V), timing (e.g., continuous or bursty, bursty refers to discontinuous timing behavior composed of multiple processes), stimulation mode (including one or more of current mode, voltage mode, timed stimulation mode, and cyclic stimulation mode), physician control upper and lower limits (the range that the physician can adjust), and patient control upper and lower limits (the range that the patient can adjust independently).

[0091] In some embodiments, the stimulation parameters of the stimulator can be adjusted in current mode or voltage mode.

[0092] Programmable devices can include physician-controlled devices (i.e., devices used by physicians) and / or patient-controlled devices (i.e., devices used by patients). Physician-controlled devices are, for example, smart terminal devices such as tablets, laptops, desktop computers, and mobile phones equipped with programming software. Patient-controlled devices are, for example, smart terminal devices such as tablets, laptops, desktop computers, and mobile phones equipped with programming software; patient-controlled devices can also be other electronic devices with programming functions (e.g., chargers with programming functions, electrophysiological acquisition devices, etc.).

[0093] This application does not limit the data interaction between the doctor's programming device and the stimulator. When the doctor programs remotely, the doctor's programming device can interact with the stimulator through a server or the patient's programming device. When the doctor programs in person with the patient, the doctor's programming device can interact with the stimulator through the patient's programming device, or it can interact directly with the stimulator. The doctor sends a set of programming parameters to the stimulator through the programming device. The set of programming parameters (or the preset programming parameters mentioned below) includes multiple electrode contacts and stimulation parameters corresponding to each electrode contact.

[0094] In some embodiments, the patient programming device may include a host (communicating with a server) and a slave (communicating with a stimulator), the host and slave being communicatively connected. The doctor programming device can interact with the server via a 3G / 4G / 5G network, the server can interact with the host via a 3G / 4G / 5G network, the host can interact with the slave via Bluetooth / Wi-Fi / USB protocols, the slave can interact with the stimulator via a 401MHz-406MHz / 2.4GHz-2.48GHz operating frequency band, and the doctor programming device can directly interact with the stimulator via the 401MHz-406MHz / 2.4GHz-2.48GHz operating frequency band.

[0095] The directional electrode scheme in this application will be described in detail below with reference to specific embodiments.

[0096] Example 1:

[0097] Combined with appendix Figure 7 As shown, a 1-3-3-1 type 8-contact directional electrode is provided, including a stimulation segment 10, a connecting segment 20 and an intermediate segment 30.

[0098] The stimulation segment 10 includes a split support and electrode contacts mounted on the split support. The electrode contacts include sheet electrode contacts 40 and ring electrode contacts 50. The connecting segment 20 includes a plurality of interconnected connecting contacts 201 that are insulated from each other. The intermediate segment 30 is used to connect the stimulation segment 10 and the connecting segment 20 (i.e., one end of the intermediate segment 30 is connected to the stimulation segment 10 and the other end is connected to the connecting segment 20). The intermediate segment 30 includes a plurality of electrode wires, and the connecting contacts 201 and the electrode contacts are electrically connected one-to-one through the electrode wires.

[0099] The split-type support adopts a first split component (named the first first split component) in the first embodiment of the first technical solution and two first split components (named the second first split component and the third first split component, respectively) in the second embodiment of the first technical solution.

[0100] The first first split component includes a first main body 11 and three first support columns 12 extending outward from one side of the first main body 11 and spaced apart circumferentially. A first mounting groove is formed between two adjacent first support columns 12 circumferentially. The first support column 12 includes a first layer 121 and a second layer 122 protruding outward from the outer surface of the first layer 121. The first layer 121 and the second layer 122 can form a bidirectional step structure, and a first mounting groove can be formed between two adjacent bidirectional step structures circumferentially. The first first split component also includes a support ring 14 extending outward from the other side of the first main body 11. The outer diameter of the support ring 14 is smaller than the outer diameter of the first main body 11. Three fifth layers 15 protruding outward from the outer surface of the support ring 14 are spaced apart circumferentially. A first mounting groove is formed between two adjacent fifth layers 15 on the outer surface of the support ring 14.

[0101] The second and third first split components each include a first main body 11 and three first support columns 12 extending outward from one side of the first main body 11 and spaced apart circumferentially. A first mounting groove is formed between two adjacent first support columns 12 circumferentially. Each first support column 12 includes a first layer 121 and a second layer 122 protruding outward from the outer surface of the first layer 121. The first layer 121 and the second layer 122 can form a bidirectional step structure, and a first mounting groove can be formed between two adjacent bidirectional step structures circumferentially. The second and third first split components also include a support ring 14 extending outward from the other side of the first main body 11. The outer diameter of the support ring 14 is smaller than the outer diameter of the first main body 11.

[0102] The second, first, and third first split components are arranged sequentially along the axial direction, with or without intervals between them. The first first split component is located in the middle, and its two ends have first mounting slots that correspond one-to-one with the first mounting slots of the second and third first split components, respectively, forming first mounting positions. Each first mounting position is equipped with a sheet electrode contact 40. The support rings 14 of the second and third first split components are each equipped with an annular electrode contact 50.

[0103] Furthermore, the 1-3-3-1 type 8-contact directional electrode also includes a contact segment 60, a first connector segment 70, and a second connector segment 80. One end of the contact segment 60 is designed with an arc surface to allow the directional electrode to penetrate deep into the patient's brain tissue and reduce contact stimulation to the brain tissue. The other end of the contact segment 60 is embedded in one end of the first connector segment 70, and the other end of the first connector segment 70 is embedded in the annular electrode contact 50 on the second first split assembly. One end of the second connector segment 80 is embedded in the annular electrode contact 50 on the third first split assembly, and the other end of the second connector segment 80 is connected to the intermediate segment 30.

[0104] Example 2:

[0105] The difference from Embodiment 1 is that the first split component in the first embodiment of the first technical solution is replaced with the first split component in the third embodiment of the first technical solution.

[0106] Example 3:

[0107] Combined with appendix Figure 8 As shown, another 1-3-3-1 type 8-contact directional electrode is provided, including a stimulation segment 10, a connecting segment 20 and an intermediate segment 30.

[0108] The stimulation segment 10 includes a split support and electrode contacts mounted on the split support. The electrode contacts include sheet electrode contacts 40 and ring electrode contacts 50. The connecting segment 20 includes a plurality of interconnected connecting contacts 201 that are insulated from each other. The intermediate segment 30 is used to connect the stimulation segment 10 and the connecting segment 20 (i.e., one end of the intermediate segment 30 is connected to the stimulation segment 10 and the other end is connected to the connecting segment 20). The intermediate segment 30 includes a plurality of electrode wires, and the connecting contacts 201 and the electrode contacts are electrically connected one-to-one through the electrode wires.

[0109] The split-type stent adopts two first split components (named the first first split component and the second first split component, respectively) in the second embodiment of the second technical solution and two second split components (named the first second split component and the second second split component, respectively) in the third embodiment.

[0110] The first and second first split components each include a first main body 11 and three first support columns 12 extending outward from one side of the first main body 11 and spaced apart circumferentially. A first mounting groove is formed between two adjacent first support columns 12 circumferentially. Each first support column 12 includes a first layer 121 and a second layer 122 protruding outward from the outer surface of the first layer 121. The first layer 121 and the second layer 122 can form a bidirectional stepped structure, and a first mounting groove can be formed between two adjacent bidirectional stepped structures circumferentially. The first layer 121 is longer than the second layer 122 in the axial direction. A slot 111 is provided on the inner side of the first main body 11. In two adjacent first main bodies 11, the portion of the first layer 121 that is longer than the second layer 122 in one of the first main bodies 11 is received in the slot 111 of the other first main body 11.

[0111] The first second split assembly and the second second split assembly each include a second body 21 and a third support post 22 extending outward from the second body 21. The circumferential diameter formed by the third support post 22 is smaller than the outer diameter of the second body 21. The end of the third support post 22 can be received in a slot 111 of an adjacent first body 11 or second body 21, so that the outer periphery of the third support post 22 forms a second mounting position for mounting the annular electrode contact 50.

[0112] The first second split assembly, the first first split assembly, the second first split assembly, and the second second split assembly are arranged sequentially along the axial direction; wherein, in the first body 11 of the first second split assembly, the portion of the first layer 121 that is longer than the second layer 122 is accommodated in the slot 111 of the first body 11 of the adjacent first first split assembly, so that the outer periphery of the third support column 22 in the first second split assembly forms a second mounting position, and a ring electrode contact 50 is installed in the second mounting position; the portion of the first layer 121 that is longer than the second layer 122 in the first body 11 of the first first split assembly The first body 11 of the second first split assembly is housed in the slot 111 of the adjacent second body 21 of the second second split assembly, forming three first mounting positions spaced apart circumferentially, each mounting position housing a sheet electrode contact 40; the third support post 22 of the second first split assembly is housed in the slot 111 of the adjacent second body 21 of the second second split assembly, forming three first mounting positions spaced apart circumferentially, each mounting position housing a sheet electrode contact 40; the outer periphery of the third support post 22 in the second second split assembly forms a second mounting position, one of the second mounting positions housing an annular electrode contact 50.

[0113] Furthermore, the 1-3-3-1 type 8-contact directional electrode also includes a contact segment 60 and a third connector segment 90. One end of the contact segment 60 is designed with an arc surface to allow the directional electrode to penetrate deep into the patient's brain tissue and reduce contact stimulation to the brain tissue. The other end of the contact segment 60 is embedded in the slot 111 of the second main body 21 in the first second split assembly. The end of the third support column 22 in the second second split assembly is received in one end of the third connector segment 90, and the other end of the third connector segment 90 is connected to the intermediate segment 30.

[0114] Example 4:

[0115] A 3-3-3-3 type 8-contact directional electrode is provided, which differs from Embodiment 3 in that the two second split components of the third embodiment are replaced with the first split component of the second embodiment in the second technical solution.

[0116] Example 5:

[0117] Combined with appendix Figure 9As shown, another 3-3-3-3 type 8-contact directional electrode is provided, including a stimulation segment 10, a connecting segment 20 and a middle segment 30.

[0118] The stimulation segment 10 includes a split support and electrode contacts mounted on the split support. The electrode contacts include sheet electrode contacts 40 and ring electrode contacts 50. The connecting segment 20 includes a plurality of interconnected connecting contacts 201 that are insulated from each other. The intermediate segment 30 is used to connect the stimulation segment 10 and the connecting segment 20 (i.e., one end of the intermediate segment 30 is connected to the stimulation segment 10 and the other end is connected to the connecting segment 20). The intermediate segment 30 includes a plurality of electrode wires, and the connecting contacts 201 and the electrode contacts are electrically connected one-to-one through the electrode wires.

[0119] The split-type support adopts three first split components (named the first first split component, the second first split component, and the third first split component, respectively) in the first embodiment of the first technical solution, one first split component (named the fourth first split component) in the first embodiment of the second technical solution, and one first split component (named the fifth first split component) in the second embodiment of the first technical solution.

[0120] The first, second, and third first split components each include a first main body 11 and three first support columns 12 extending outward from one side of the first main body 11 and spaced apart circumferentially. A first mounting groove is formed between two adjacent first support columns 12 circumferentially. Each first support column 12 includes a first layer 121 and a second layer 122 protruding outward from the outer surface of the first layer 121. The first layer 121 and the second layer 122 can form a bidirectional step structure, and a first mounting groove can be formed between two adjacent bidirectional step structures circumferentially. The first first split component also includes a support ring 14 extending outward from the other side of the first main body 11. The outer diameter of the support ring 14 is smaller than the outer diameter of the first main body 11. Three fifth layers 15 protruding outward from the outer surface of the support ring 14 and spaced apart circumferentially are formed therein. A first mounting groove is formed between two adjacent fifth layers 15 on the outer surface of the support ring 14.

[0121] The fourth first sub-assembly includes a first main body 11 and three first support columns 12 extending outward from one side of the first main body 11 and spaced apart circumferentially. A first mounting groove is formed between two adjacent first support columns 12 circumferentially. Each first support column 12 includes a first layer 121 and a second layer 122 protruding outward from the outer surface of the first layer 121. The first layer 121 and the second layer 122 can form a bidirectional stepped structure, and a first mounting groove can be formed between two adjacent bidirectional stepped structures circumferentially. The first layer 121 is longer than the second layer 122 in the axial direction, and a slot 111 is provided on the inner side of the first main body 11.

[0122] The fifth first split component includes a first main body 11 and three first support columns 12 extending outward from one side of the first main body 11 and spaced apart circumferentially. A first mounting groove is formed between two adjacent first support columns 12 circumferentially. The first support column 12 includes a first layer 121 and a second layer 122 protruding outward from the outer surface of the first layer 121. The first layer 121 and the second layer 122 can form a bidirectional step structure, and a first mounting groove can be formed between two adjacent bidirectional step structures circumferentially. The second and third first split components also include a support ring 14 extending outward from the other side of the first main body 11. The outer diameter of the support ring 14 is smaller than the outer diameter of the first main body 11.

[0123] When there is no gap between any two adjacent first split components, second first split components, and third first split components, if one of the first mounting slots is formed by the fifth layer body 15 on the support ring 14, then the other adjacent first mounting slot should be formed by the second layer body 122 on the first layer body; or if two adjacent first mounting slots are formed by the fifth layer body 15 on the support ring 14 respectively, then the two adjacent first split components should be spaced to provide space for the connection path of the electrode wire and the sheet electrode contact 40.

[0124] The fourth, first, second, third, and fifth first split components are arranged sequentially along the axial direction. The first mounting slot of the fourth first split component corresponds one-to-one with the first mounting slot at one end of the first first split component to form a first mounting position, with each first mounting position housing a sheet electrode contact 40. Similarly, the first mounting slot at the other end of the first first split component corresponds one-to-one with the first mounting slot at one end of the second first split component to form a first mounting position, with each first mounting position housing a sheet electrode contact 40. Likewise, the first mounting slot at the other end of the second first split component corresponds one-to-one with the first mounting slot at one end of the third first split component to form a first mounting position, with each first mounting position housing a sheet electrode contact 40. Finally, the first mounting slot at the other end of the third first split component corresponds one-to-one with the first mounting slot at the fifth first split component to form a first mounting position, with each first mounting position housing a sheet electrode contact 40.

[0125] Furthermore, the 3-3-3-3 type 8-contact directional electrode also includes a contact segment 60 and a fourth connector segment 100. One end of the contact segment 60 is designed with an arc surface to allow the directional electrode to penetrate deep into the patient's brain tissue and reduce contact stimulation to the brain tissue. The other end of the contact segment 60 is embedded in the slot 111 of the first main body 11 in the fourth first split assembly. The support column of the fifth first split assembly is embedded in the middle segment 30.

[0126] Example 6:

[0127] Combined with appendix Figure 10 As shown, another 3-3-3-3 type 8-contact directional electrode is provided, which differs from Embodiment 5 in that one or more of the three first split components in the first embodiment of the first technical solution are replaced with the first split components in the third embodiment of the first technical solution.

[0128] It should be further explained that the aforementioned directional electrodes need to be encapsulated after the electrode contacts are installed. This is to strengthen the fixation of the electrode contacts in the installation position, and to fill the gaps on the surface of the distributed support to ensure the flatness of the directional electrode surface and reduce the contact stimulation of the directional electrodes into human tissue. Encapsulation is generally carried out by potting. After potting, the glue on the electrode contacts is removed to expose the electrode contacts so that the electrode contacts can contact human tissue to provide electrical stimulation.

[0129] Although embodiments of the present invention have been shown and described above, it is understood that the above embodiments are exemplary and should not be construed as limiting the present invention. Those skilled in the art can make changes, modifications, substitutions and variations to the above embodiments within the scope of the invention without departing from the principles and spirit of the invention, and all such changes should fall within the protection scope of the claims of the present invention.

Claims

1. A split-type bracket for mounting electrode contacts, characterized in that, include: Multiple first split components arranged along the axial direction, each first split component having a hollow inner cavity; Two adjacent first split components can cooperate to form a plurality of first mounting positions distributed circumferentially, the first mounting positions being suitable for mounting sheet electrode contacts (40); Each of the first split components is provided with a plurality of first mounting slots spaced apart along the circumference, the first mounting slots being used to form the first mounting positions; The first split component includes a first main body (11) and a plurality of first support columns (12) extending outward from one side of the first main body (11) and spaced apart in the circumferential direction, with the first mounting groove formed between two adjacent first support columns (12) in the circumferential direction. The first support column (12) includes a first layer (121) and a second layer (122) protruding outward from the outer surface of the first layer (121). The first layer (121) and the second layer (122) can form a bidirectional step structure, and the first mounting groove can be formed between two adjacent bidirectional step structures along the circumferential direction.

2. The split-type support according to claim 1, characterized in that, The lengths of the first layer (121) and the second layer (122) in the axial direction can be configured to be equal or unequal, at least one of the following:

3. The split-type support according to claim 1, characterized in that, The first split assembly further includes a support ring (14) extending outward from the other side of the first body (11), the outer diameter of the support ring (14) being smaller than the outer diameter of the first body (11), and the support ring (14) being used to install annular electrode contacts (50); or the first split assembly further includes a plurality of second support columns (13) extending outward from the other side of the first body (11) and spaced apart circumferentially, the second support column (13) including a third layer (131) and a fourth layer (132) protruding outward from the outer surface of the third layer (131), the third layer (131) and the fourth layer (132) being able to form the bidirectional step structure.

4. The split-type support according to claim 3, characterized in that, The outer surface of the support ring (14) is provided with a plurality of fifth layer bodies (15) arranged circumferentially, and the first mounting groove located on the outer surface of the support ring (14) is formed between two adjacent fifth layer bodies (15) in the circumferential direction.

5. The split-type support according to claim 4, characterized in that, There is a gap between two adjacent first split components.

6. The split-type support according to claim 2, characterized in that, The inner side of the first body (11) is provided with a slot (111). In two adjacent first bodies (11), the part of the first layer (121) of one first body (11) that is longer than the second layer (122) can be accommodated in the slot (111) of the other first body (11).

7. The split-type support according to claim 2, characterized in that, The split bracket also includes a second split assembly, which includes a second main body (21) and a third support column (22) extending outward from the second main body (21). The circumferential diameter formed by the third support column (22) is smaller than the outer diameter of the second main body (21). The end of the third support column (22) can be received in a slot (111) of an adjacent first main body (11) or second main body (21) so that the outer periphery of the third support column (22) forms a second mounting position, which is used to install an annular electrode contact (50).

8. The split-type support according to any one of claims 1-5, characterized in that, In two adjacent first split components, two first mounting slots that are adjacent along the axial direction can cooperate to form the first mounting position.

9. The split-type support according to any one of claims 1-5 and 6-7, characterized in that, The first mounting slot can form the first mounting position.

10. A directional electrode, characterized in that, include: The stimulation segment (10) includes a split support as described in any one of claims 1-9 and electrode contacts mounted on the split support, wherein the electrode contacts include sheet electrode contacts (40) and / or annular electrode contacts (50); The connecting section (20) includes a plurality of mutually insulated connecting contacts (201); The intermediate section (30) connects the stimulation section (10) and the connecting section (20). The intermediate section (30) includes several electrode wires. The connecting contact point (201) and the electrode contact point are electrically connected one-to-one through the electrode wires.

11. An implantable stimulation system, characterized in that, The implantable stimulation system includes a pulse generator and a directional electrode as described in claim 10, wherein the pulse generator and the directional electrode are electrically connected at a connection contact (201).

12. The implantable stimulation system according to claim 11, characterized in that, The implantable stimulation system also includes an extension lead, through which the pulse generator is electrically connected to the directional electrode.

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