Molding device and implantable electrode

Abstract

The utility model belongs to the electric stimulation technical field discloses electrode piece subassembly, forming device and implantable electrode. Electrode piece subassembly includes electrode piece and with electrode piece pressure joint integrative guide wire, and electrode piece includes the arc contact surface of arch shape, opposite installation surface with contact surface and connect contact surface with the arc side of installation face. Through the utility model, the sharp structure produced by the split type structure reassembly of electrode piece subassembly and the problem that the sharp structure is easy to produce the tip discharge in the electric stimulation process, thereby has affected the use of implantable electrode.

Description

Technical Field

[0001] This utility model relates to the field of electrical stimulation technology, and in particular to a molding device and an implantable electrode. Background Technology

[0002] Implantable electrodes are advanced electrode systems that achieve directional control of electrical stimulation through specific segmented contacts and independent current control. This design allows medical staff to more precisely locate and stimulate target nerve nuclei during surgery, thereby improving treatment outcomes and reducing side effects.

[0003] Implantable electrodes have wide applications in the medical field, particularly in deep brain stimulation (DBS). DBS is a treatment method that uses electrodes implanted in the brain to deliver electrical pulses to stimulate specific nuclei deep within the brain, thereby improving patients' symptoms and quality of life. The introduction of patch electrodes has made DBS treatment more precise and personalized, bringing new hope to patients with neurological disorders such as Parkinson's disease, dystonia, essential tremor, and epilepsy. Implantable electrodes are formed by arranging multiple electrode patch components in a specific orientation.

[0004] Currently, existing implantable electrodes use a split electrode assembly, with the guide wire and electrode piece connected by welding or other assembly methods. The surface of existing electrode assemblies often has sharp structures, which can easily generate tip discharge during electrical stimulation, thus affecting the use of the split electrodes. Utility Model Content

[0005] The purpose of this invention is to provide a molding device and an implantable electrode to solve the problems of sharp structures resulting from the reassembly of existing electrode sheet assemblies with a split structure, and the sharp structures being prone to tip discharge during electrical stimulation, thereby affecting the use of implantable electrodes.

[0006] To achieve this objective, the present invention adopts the following technical solution:

[0007] An electrode assembly includes an electrode sheet and a guide wire integrally pressed with the electrode sheet. The electrode sheet includes an arched arc-shaped contact surface, a mounting surface opposite to the contact surface, and an arc-shaped side connecting the contact surface and the mounting surface.

[0008] A forming apparatus for forming the electrode sheet assembly described above, the forming apparatus comprising:

[0009] A mold base, wherein a limiting groove is formed on the mold base along a first direction, and the electrode sheet raw material is placed in the limiting groove;

[0010] A pressure head that can extend into the limiting groove along the first direction and squeeze the electrode sheet raw material.

[0011] As an alternative to the forming device, the cross-section of the electrode sheet raw material is circular or elliptical.

[0012] As an alternative to the forming device, the bottom wall of the limiting groove is an arc-shaped surface, and the bottom wall is adapted to the shape of the contact surface of the electrode sheet protruding outward after forming.

[0013] As an alternative to the molding device, a limiting space is formed between two opposite sidewalls extending toward the bottom wall along the first direction in the limiting groove, and the pressure head is slidably disposed in the limiting space.

[0014] As an alternative to the forming apparatus, the pressure head includes a first extrusion section, the first extrusion section including an arc surface, the arc surface of the first extrusion section being used to extrude the electrode sheet raw material to form a mounting surface opposite to the contact surface of the electrode sheet.

[0015] As an alternative to the forming device, the pressure head further includes two second extrusion sections respectively disposed on both sides of the first extrusion section. The second extrusion sections are used to extrude the electrode sheet to form arc-shaped sides at both ends of the electrode sheet.

[0016] As an alternative to the forming device, the extrusion surfaces of the first extrusion section and the second extrusion section are connected by an arc-shaped transition.

[0017] As an alternative to the molding device, the molding device includes a plurality of pressure heads, and the mold base is provided with a plurality of limiting grooves spaced apart along the second direction. The pressure heads and the limiting grooves are arranged in a one-to-one correspondence in the first direction.

[0018] An implantable electrode, comprising a scaffold and a plurality of electrode pad assemblies according to any one of the above embodiments, wherein the plurality of electrode pad assemblies are mounted on the scaffold with circumferential insulating spacing.

[0019] Beneficial effects:

[0020] In the first aspect of this utility model, the electrode sheet and the guide wire are directly pressed together to form an integral structure, so that the contact surface and the side are both arc-shaped. This avoids the sharp structure caused by the reassembly of the separate structure of the electrode sheet assembly, and solves the problem that the sharp structure is prone to tip discharge during electrical stimulation, which affects the use of implantable electrodes.

[0021] In a second aspect of this invention, the forming device can complete the connection between the guide wire and the electrode sheet through a single extrusion molding process, thereby forming the electrode sheet assembly, reducing the forming process, improving manufacturing efficiency, and lowering costs.

[0022] In a third aspect of this invention, the implantable electrode can effectively avoid sharp structures, thereby solving the problem that existing sharp structures affect the use of implantable electrodes. Attached Figure Description

[0023] Figure 1 This is an exploded view of the implantable electrode provided in an embodiment of this utility model;

[0024] Figure 2 This is a schematic diagram of the structure of the implantable electrode provided in an embodiment of the present invention;

[0025] Figure 3 This is a schematic diagram of the implantable electrode of the hidden stent provided in this embodiment of the utility model;

[0026] Figure 4 This is a schematic diagram of the structure of the electrode sheet assembly provided in this embodiment of the utility model;

[0027] Figure 5 This is a schematic diagram of the state of the molding device provided in this embodiment of the present invention before the molding process;

[0028] Figure 6 This is a schematic diagram of the state of the molding device provided in this embodiment of the present invention during the molding process;

[0029] Figure 7 This is a schematic diagram of the state of the molding device provided in this embodiment after the molding process;

[0030] Figure 8 This is a schematic diagram of the structure of the raw material used in the irregularly shaped electrode sheet provided in this embodiment of the utility model;

[0031] Figure 9 This is a schematic diagram of the structure of the irregularly shaped electrode sheet assembly after extrusion molding provided in this embodiment of the utility model.

[0032] In the picture:

[0033] X, first direction; Y, second direction;

[0034] 100, Electrode sheet; 200, Bracket; 210, Mounting slot;

[0035] 1. Electrode sheet raw materials; 2. Guide wire;

[0036] 3. Mold base; 31. Limiting groove; 311. Bottom wall; 312. Side wall;

[0037] 4. Press head; 41. First extrusion section; 42. Second extrusion section. Detailed Implementation

[0038] The present invention will now be described in further detail with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the present invention and not intended to limit it. Furthermore, it should be noted that, for ease of description, the accompanying drawings show only the parts relevant to the present invention, not the entire structure.

[0039] In the description of this utility model, unless otherwise explicitly specified and limited, the terms "connected," "linked," and "fixed" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this utility model based on the specific circumstances.

[0040] In this invention, unless otherwise explicitly specified and limited, "above" or "below" the second feature can include direct contact between the first and second features, or contact between the first and second features through another feature between them. Furthermore, "above," "over," and "on top" of the second feature includes the first feature directly above or diagonally above the second feature, or simply indicates that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature includes the first feature directly below or diagonally below the second feature, or simply indicates that the first feature is at a lower horizontal level than the second feature.

[0041] In the description of this embodiment, the terms "upper," "lower," "right," etc., refer to the orientation or positional relationship shown in the accompanying drawings. They are used only for ease of description and simplification of operation, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this utility model. In addition, the terms "first" and "second" are only used for distinction in description and have no special meaning.

[0042] The technical field and related terms involved in the embodiments of this application will be briefly described below.

[0043] 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).

[0044] Implantable neurostimulation systems consist of a stimulator implanted in the patient's body (i.e., an implantable neurostimulator) and a programmed device placed outside the patient's body. In other words, the stimulator is a medical device, or medical devices include stimulators. Related neuromodulation techniques primarily involve stereotactic surgery to implant electrodes (e.g., electrode wires) at specific sites (target points) in the body's tissues. Discharge pulses are then delivered through these electrodes to the target points, modulating the electrical activity and function of corresponding neural structures and networks, thereby improving symptoms and alleviating pain.

[0045] 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.

[0046] 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.

[0047] The extension leads are used in conjunction with the IPG as a medium for transmitting electrical stimulation, transferring the electrical stimulation generated by the IPG to the electrode leads.

[0048] The implantable electrode includes a proximal end and a distal end. The proximal end has several electrodes electrically connected to an IPG or an extension lead. The distal end is the stimulation end, which includes at least one set of sheet electrodes. Each set of sheet electrodes includes at least two electrically isolated electrode pads. Each electrode pad includes an arched arc-shaped contact surface, a mounting surface opposite the contact surface, and an arc-shaped side connecting the contact surface and the mounting surface. The proximal and distal electrodes are electrically connected via a guidewire.

[0049] Please see the appendix Figure 1 -Appendix Figure 4 The first aspect of this embodiment relates to an electrode assembly, which includes an electrode 100 and a guide wire 2 integrally pressed with the electrode 100. The electrode 100 includes an arched arc-shaped contact surface, a mounting surface opposite to the contact surface, and an arc-shaped side connecting the contact surface and the mounting surface.

[0050] In this embodiment, the electrode sheet 100 and the guide wire 2 are directly pressed together to form an integral structure, so that the contact surface, mounting surface and side are all arc-shaped. This avoids the sharp structure caused by the reassembly of the separate structure of the electrode sheet assembly, and solves the problem that the sharp structure is prone to point discharge during electrical stimulation, which affects the use of implantable electrodes.

[0051] Please see the appendix Figure 4 -Appendix Figure 7 The molding process of this electrode assembly specifically includes:

[0052] Step S1: Use tubing as the electrode sheet raw material 1;

[0053] Step S2: Insert guide wire 2 into electrode sheet raw material 1;

[0054] Step S3: Form an arc transition on both sides of the electrode sheet raw material 1, shape the electrode sheet raw material 1 into an electrode sheet 100 and press the guide wire 2 into the inside of the electrode sheet 100.

[0055] The electrode assembly consists of two parts: a wire and an electrode 100. The wire is composed of a guide wire 2 and an outer insulating sheath. In the prior art, a certain length of the insulating sheath is usually removed from one end of the wire, and the exposed guide wire is welded to the electrode 100 to form the electrode assembly.

[0056] This forming process uses a tube as the electrode sheet raw material 1 and inserts a guide wire 2 inside the electrode sheet raw material 1. A direct stamping forming method is used to extrude the outer wall of the electrode sheet raw material 1, shaping it into the electrode sheet 100. Pressure is maintained for a certain time to reduce the impact of springback on the shape of the electrode sheet 100. This forming process, through a single extrusion, not only transforms the electrode sheet raw material 1 into the electrode sheet 100 but also avoids the formation of sharp structures at certain angles on the sides and contact surfaces of the electrode sheet 100, reducing the probability of charge density concentration under electrical stimulation and effectively preventing the problem of tip discharge, thereby reducing damage and negative effects on human tissue. Furthermore, single extrusion forming avoids the subsequent grinding process of the electrode sheet 100, reducing manufacturing costs. Simultaneously, it avoids welding the guide wire 2 and the electrode sheet 100, effectively reducing forming steps, improving manufacturing efficiency, ensuring forming quality, and reducing costs.

[0057] Please continue to refer to the appendix. Figure 1 -Appendix Figure 4 The second aspect of this embodiment also relates to a forming apparatus (hereinafter referred to as the "apparatus") for forming the aforementioned electrode sheet assembly. The apparatus includes a mold base 3 and a pressure head 4. A limiting groove 31 is formed on the mold base 3 along a first direction X, and the electrode sheet raw material 1 is placed within the limiting groove 31. The pressure head 4 can extend into the limiting groove 31 along the first direction X and compress the electrode sheet raw material 1. Based on this electrode sheet assembly apparatus, the connection between the guide wire 2 and the electrode sheet 100 can be completed in a single extrusion molding process, reducing molding steps, improving manufacturing efficiency, and lowering costs.

[0058] In this embodiment, the first direction X is vertical, and the shape of the limiting groove 31 matches that of the pressure head 4. Those skilled in the art will understand that by optimizing the extrusion shape of the pressure head 4, it is possible to ensure that after extruding the electrode sheet raw material 1, the two ends and contact surfaces of the electrode sheet 100 remain curved, while avoiding the generation of burrs.

[0059] Optionally, the cross-section of the electrode sheet raw material 1 is circular or elliptical.

[0060] In this embodiment, the cross-section of the electrode sheet raw material 1 is circular. Of course, in other embodiments, those skilled in the art can also reasonably select the cross-sectional shape of the electrode sheet raw material 1 according to the molding quality. For example, it can be elliptical or other arc-shaped structures.

[0061] Optionally, the cross-section of the electrode sheet material 1 is polygonal, and the edges of the electrode sheet material 1 are transitioned by rounded corners.

[0062] Of course, the cross-section of the electrode sheet raw material 1 can also be designed as a polygon, and the edges of the polygonal electrode sheet raw material 1 can be transitioned by rounded corners to avoid stress concentration on the sharp corner structure of the edges during the extrusion process, so that the electrode sheet raw material 1 is crushed or cracked in the sharp corner structure.

[0063] Those skilled in the art will understand that the shape of the formed electrode sheet 100 can be adjusted by reasonably optimizing the shape of the electrode sheet raw material 1 and the shapes of the limiting groove 31 and the pressure head 4. Please refer to the appendix. Figure 8 and attached Figure 9 The two ends of the electrode sheet raw material 1 are cut to form a certain arc surface. By extruding through the pressure head 4, the irregular electrode sheet 100 can be formed. The adjustment scheme is simple and the forming efficiency is high.

[0064] Optionally, the bottom wall 311 of the limiting groove 31 is an arc-shaped surface, and the bottom wall 311 is adapted to the shape of the contact surface of the formed electrode sheet 100 protruding outward.

[0065] In this embodiment, the bottom wall 311 of the limiting groove 31 is an arc-shaped surface, which is concave inward to form the contact surface of the electrode sheet 100. In fact, the contact surface of the electrode sheet 100 is an outwardly convex arc-shaped surface with a certain radius. The pressure head 4 squeezes the electrode sheet raw material 1, causing the outer wall of the electrode sheet raw material 1 to gradually deform on the arc-shaped surface of the bottom wall 311 and finally form the contact surface. For the limiting groove 31, its bottom wall 311 needs to have high shape accuracy to ensure the accuracy of the contact surface shape of the electrode sheet 100.

[0066] Furthermore, a limiting space is formed between two opposing sidewalls 312 extending along the first direction X toward the bottom wall 311 within the limiting groove 31, and the pressure head 4 is slidably disposed in the limiting space.

[0067] In this embodiment, the limiting groove 31 also has a pair of oppositely arranged sidewalls 312. The sidewalls 312 extend from the top surface of the mold base 3 to the bottom wall 311 along the first direction X, and a limiting space is formed between the two opposite sidewalls 312. The pressure head 4 can slide along the first direction X within the limiting space. The two opposite sidewalls 312 have a guiding function to ensure the accuracy of the pressure head 4 running in the first direction X.

[0068] Optionally, the pressure head 4 includes a first extrusion section 41, which includes an arc surface. The arc surface of the first extrusion section 41 is used to extrude the electrode sheet raw material 1 to form a mounting surface opposite to the contact surface of the electrode sheet 100.

[0069] In this embodiment, the pressing head 4 has a first pressing part 41 on its pressing surface. The first pressing part 41 is an outwardly protruding arc surface. The arc surface of the first pressing part 41 presses the electrode sheet raw material 1 to form the mounting surface on the other side of the electrode sheet 100. Of course, those skilled in the art will understand that the shape of the first pressing part 41 is determined according to the shape of the electrode sheet 100, and therefore the shape of the first pressing part 41 can be adaptively adjusted according to the shape of the electrode sheet 100.

[0070] Optionally, the pressure head 4 also includes two second extrusion sections 42 respectively disposed on both sides of the first extrusion section 41. The second extrusion sections 42 are used to extrude the electrode sheet 100 so that the two sides of the electrode sheet 100 form an arc transition.

[0071] The electrode sheet 100 is connected by a transition arc surface at its two ends, which can avoid the problem of tip discharge. In this embodiment, a second extrusion part 42 is symmetrically arranged on both sides of the first extrusion part 41 of the pressure head 4. The second extrusion part 42 is a concave arc surface, which can ensure the transition arc surface shape at both ends of the electrode sheet 100.

[0072] The extrusion surfaces of the first extrusion section 41 and the second extrusion section 42 are connected by an arc-shaped transition surface.

[0073] In this embodiment, by forming an arc-shaped surface for transition between the extrusion surfaces of the first extrusion part 41 and the second extrusion part 42, it can be ensured that the mounting surface of the electrode sheet 100 and the transition arc surfaces at both ends of the electrode sheet 100 can be smoothly transitioned, avoiding sharp edges at the junction of the electrode sheet 100 at the mounting surface and both ends, thereby effectively avoiding the problem of tip discharge at the junction of the electrode sheet 100.

[0074] Optionally, the device includes multiple pressure heads 4, and the mold base 3 is provided with multiple limiting grooves 31 at intervals along the second direction Y. The pressure heads 4 and the limiting grooves 31 are arranged one-to-one in the first direction X.

[0075] In this embodiment, the device can be used in conjunction with a press to perform the extrusion molding process. Those skilled in the art can select an existing press of suitable specifications. The output end of the press can be equipped with a mounting base, and the mounting base is provided with multiple mounting positions for mounting the press head 4. Adaptively, corresponding to each press head 4, a limiting groove 31 is provided at intervals along the second direction Y in the die base 3. The second direction Y is a horizontal direction. Before extrusion, electrode sheet raw material 1 and guide wire 2 can be arranged in each limiting groove 31. Through the linkage action of the mounting base, the molding of multiple electrode components can be completed in one extrusion, which greatly improves the molding efficiency.

[0076] Please continue to refer to the appendix. Figure 1 -Appendix Figure 3The third aspect of this embodiment also relates to an implantable electrode, which includes a stent 200 and a plurality of electrode pad assemblies, the plurality of electrode pad assemblies being installed on the stent 200 with circumferential insulating spacing.

[0077] Specifically, the electrode assembly can be directly glued or snapped onto the bracket 200, which is made of insulating material. The bracket 200 has multiple mounting slots 210 spaced along the circumference for limiting the electrode 100, and the electrode 100 is fixed inside the mounting slots 210.

[0078] This implantable electrode effectively avoids sharp structures, thus solving the problem of existing sharp structures affecting the use of implantable electrodes.

[0079] Obviously, the above embodiments of this utility model are merely examples for clearly illustrating the present utility model, and are not intended to limit the implementation of the present utility model. Those skilled in the art can make various obvious changes, readjustments, and substitutions without departing from the protection scope of this utility model. It is neither necessary nor possible to exhaustively describe all embodiments here. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of this utility model should be included within the protection scope of the claims of this utility model.

Claims

1. A molding apparatus, characterized in that, For forming an electrode assembly, the electrode assembly includes an electrode sheet (100) and a guide wire (2) integrally pressed with the electrode sheet (100), the electrode sheet (100) includes an arched arc-shaped contact surface, a mounting surface opposite to the contact surface, and an arc-shaped side connecting the contact surface and the mounting surface; the forming device includes: A mold base (3) is provided with a limiting groove (31) along the first direction (X), and the electrode sheet raw material (1) is placed in the limiting groove (31); A pressure head (4) is capable of extending into the limiting groove (31) along the first direction (X) and pressing the electrode sheet raw material (1); wherein, The pressure head (4) includes a first extrusion part (41) and two second extrusion parts (42) respectively disposed on both sides of the first extrusion part (41). The first extrusion part (41) includes an arc surface. The arc surface of the first extrusion part (41) is used to extrude the electrode sheet raw material (1) to form a mounting surface opposite to the contact surface of the electrode sheet (100). The second extrusion part (42) is used to extrude the electrode sheet (100) so that the two ends of the electrode sheet (100) form arc sides.

2. The molding apparatus according to claim 1, characterized in that, The cross-section of the electrode sheet raw material (1) is circular or elliptical.

3. The molding apparatus according to claim 1, characterized in that, The bottom wall (311) of the limiting groove (31) is an arc-shaped surface, and the bottom wall (311) is adapted to the shape of the contact surface of the electrode sheet (100) protruding outward after being formed.

4. The molding apparatus according to claim 3, characterized in that, A limiting space is formed between two opposing sidewalls (312) extending along the first direction (X) toward the bottom wall (311) within the limiting groove (31), and the pressure head (4) slides in the limiting space.

5. The molding apparatus according to claim 1, characterized in that, The extrusion surfaces of the first extrusion part (41) and the second extrusion part (42) are connected by an arc-shaped transition.

6. The molding apparatus according to any one of claims 1-5, characterized in that, The molding device includes multiple pressure heads (4), and the mold base (3) is provided with multiple limiting grooves (31) spaced apart along the second direction (Y). The pressure heads (4) and the limiting grooves (31) are arranged one-to-one in the first direction (X).

7. An implantable electrode, characterized in that, The implantable electrode includes a stent (200) and a plurality of electrode sheet assemblies formed using the molding apparatus of any one of claims 1-6, the plurality of electrode sheet assemblies being mounted circumferentially insulated from the stent (200).

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