Deep brain electrode and preparation process thereof

Abstract

The application relates to the technical field of electrodes, in particular to a deep brain electrode and a preparation process thereof. The preparation process of the deep brain electrode comprises the following steps: fixing the pipe wall of an electrode tube; laser etching the pipe wall of the electrode tube to form single conductors in a spaced distribution; and integrally forming by injection molding of silica gel. The single conductor comprises a continuous proximal electrode ring, an electrode lead and a distal electrode ring. The application realizes one-time forming of the laser etching process of the conductive body, omits the process of connecting multiple guide wires and electrode rings, and can solve the problem of stretching and winding forming in the traditional process.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of electrode, in particular to a deep brain electrode and a preparation process thereof. BACKGROUND

[0002] The deep brain electrode is widely used for brain nerve electric signal transmission, and is generally formed by a plurality of electrode contacts and corresponding lead wires to form a conductive circuit. At present, the preparation method of the deep brain electrode on the market is to first spiral a plurality of guide wires, to form a body section by sleeving a plastic protective metal tube on the surface of the guide wire after the guide wire is formed, and to respectively weld two ends with electrode rings and then to seal and fix by injection molding of silica gel. The method damages the toughness of the guide wire by stretching and forming, resulting in that the hardness of the deep brain electrode is relatively soft. SUMMARY

[0003] In order to solve the problems of the electrode preparation method in the prior art, the present application provides a deep brain electrode and a preparation process thereof.

[0004] In order to solve the above technical problems, in a first aspect, the present application provides a preparation process of a deep brain electrode, comprising: step S1, fixing a pipe wall of an electrode pipe in a three-dimensional space; step S2, laser etching the pipe wall of the electrode pipe to form a conductor, i.e. at least two single conductors distributed at intervals; step S7, integrally forming by injection molding of silica gel; wherein the single conductor comprises an electrode lead wire and electrode rings respectively and continuously arranged at both ends of the electrode lead wire.

[0005] Further, the fixing of the pipe wall of the electrode pipe in the three-dimensional space in step S1 comprises: setting an outer diameter of a support larger than an inner diameter of the electrode pipe and leaving a deformation allowance on an outer side of the support, so as to be inserted into the inside of the electrode pipe to fix the pipe wall of the electrode pipe.

[0006] Further, the support comprises: a core part located at a core; and a deformation layer located on an outer side of the core part; wherein the deformation layer is adapted to provide the deformation allowance.

[0007] Further, the support further comprises: an isolation layer located on a surface of the deformation layer; wherein the isolation layer is polyurethane or parylene, so as to facilitate stripping of the injection-molded silica gel; and a surface of the isolation layer is a smooth surface.

[0008] Further, the length of the support is not less than the length of the electrode pipe, so as to fix the entire pipe wall of the electrode pipe.

[0009] Further, the electrode lead wire and the two electrode rings in the same single conductor are formed at one time by laser etching the pipe wall of the electrode pipe.

[0010] Further, the electrode lead wire comprises: a spiral wire and straight lead wires respectively and continuously arranged at both ends of the spiral wire; wherein the straight lead wires are continuously arranged with the electrode rings at the same end.

[0011] Furthermore, the lengths of the straight leads of the single conductors are different, so that the electrode rings connected to the straight leads are arranged at intervals.

[0012] Furthermore, the electrode ring is in the shape of a ring with an opening on the side wall; the straight lead leads out of the end of the electrode ring along one side of the opening.

[0013] Furthermore, the preparation process of the deep brain electrode further includes: step S3 located between step S2 and step S7, respectively extending the two electrode rings radially outward so that the electrode leads are located within the outer contours of the two electrode rings.

[0014] Furthermore, the preparation process of the deep brain electrode also includes step S4 between step S2 and step S7, in which an insulating layer is coated on the surface of the electrode lead.

[0015] Furthermore, the preparation process of the deep brain electrode also includes step S5 between step S2 and step S7, in which a shielding tube is sheathed on the spiral line; the shielding tube is a mesh-shaped sheath.

[0016] Furthermore, the preparation process of the deep brain electrode also includes step S6 before step S7, in which a protective tube is sheathed on the spiral line.

[0017] In a second aspect, the present invention also provides a deep brain electrode, comprising: a conductor and silicone located outside the conductor; wherein the conductor comprises at least two single conductors distributed at intervals; and the single conductor comprises an electrode lead and electrode rings respectively continuous at both ends of the electrode lead.

[0018] Furthermore, the electrode lead includes: a spiral wire and straight leads respectively connected to both ends of the spiral wire; wherein the straight lead is connected to the electrode ring at the same end.

[0019] Furthermore, the electrode ring is annular and has an opening on its side wall; the straight lead leads out of the end of the electrode ring along one side of the opening; the straight lead of each single conductor has a different length so that the electrode rings connected to the straight lead are arranged at intervals; and the straight lead of the outer electrode ring passes through the opening of the inner electrode ring to connect to the spiral wire.

[0020] Beneficial effects of the present invention:

[0021] The conductor of the deep brain electrode of the present invention is obtained by laser etching the tube wall of the electrode tube and is formed in one step, which effectively solves the problem of the guide wire being destroyed in its toughness by stretching in the traditional process. At the same time, it also eliminates the welding process between the guide wire and the electrode ring, simplifying the process flow. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] The present invention will be further described below with reference to the accompanying drawings and examples.

[0023] Figure 1This is a process flow chart for preparing deep brain electrodes;

[0024] Figure 2 A perspective view of deep brain electrodes;

[0025] Figure 3 This is a perspective view of the deep brain electrode at the distal end;

[0026] Figure 4 This is a schematic diagram of the use position of the ring mold;

[0027] Figure 5 is a schematic diagram of the structure of the conductor;

[0028] Figure 6 Schematic diagram of the structure of the proximal electrode ring;

[0029] Figure 7 Schematic diagram of the structure of the distal electrode ring;

[0030] Figure 8 Schematic diagram of the shielding tube structure.

[0031] icon:

[0032] 1-conductor, 11-single conductor, 111-proximal electrode ring, 112-electrode lead, 1121-proximal straight lead, 1122-spiral wire, 1123-distal straight lead, 113-distal electrode ring, 114-opening;

[0033] 2-Silica gel;

[0034] 3-shielding tube;

[0035] 4-Protective tube;

[0036] 5-support member, 51-isolation layer;

[0037] 6-ring die, 61-notch. DETAILED DESCRIPTION

[0038] To make the above-mentioned objects, features, and advantages of the present invention more readily apparent, specific embodiments of the present invention are described in detail below with reference to the accompanying drawings. The following description sets forth numerous specific details to facilitate a full understanding of the present invention. However, the present invention can be implemented in many other ways than those described herein, and those skilled in the art may make similar modifications without departing from the scope of the present invention. Therefore, the present invention is not limited to the specific embodiments disclosed below.

[0039] In the description of the present application, it should be understood that the terms "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential" and the like indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present application and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as limiting the present application.

[0040] In addition, the terms "first", "second" are only for descriptive purposes and cannot be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Therefore, the features defined with "first", "second" can explicitly or implicitly include at least one of the features. In the description of the present application, the meaning of "a plurality of" is at least two, such as two, three, etc., unless otherwise explicitly specified and limited.

[0041] In the present application, unless otherwise explicitly specified and limited, the terms "mounting", "connection", "connection", "fixing" and the like should be broadly understood, for example, it can be fixedly connected, or it can be detachably connected, or it can be integrated; it can be mechanically connected, or it can be electrically connected; it can be directly connected, or it can be indirectly connected through an intermediate medium; it can be the internal communication of two elements or the interaction relationship between two elements, unless otherwise explicitly limited. For those skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances.

[0042] In order to solve the problem of destroying the ductility of the guide wire in the stretch forming, the present application realizes the integral forming of the conductive body by laser etching the wall of the electrode tube (or metal tube), and combines the corresponding silicone injection molding process to prepare the deep brain electrode provided by the present application. As shown in Figures 2 to 8 The deep brain electrode comprises: a conductive body 1, a silicone 2, a shielding tube 3, an insulation layer (generally a coating, relatively thin, not shown in the figure), a protective tube 4. See Figure 5, the conductor 1 includes at least two single conductors 11 distributed at intervals. The single conductor 11 includes a continuous proximal electrode ring 111, an electrode lead 112, and a distal electrode ring 113. The electrode lead 112 includes a parallel-wound spiral wire 1122 and proximal and distal straight leads 1121 and 1123 respectively located at both ends of the spiral wire 1122. The proximal straight lead 1121 is connected to the proximal electrode ring 111, and the distal straight lead 1123 is connected to the distal electrode ring 113. The outer surface of the distal electrode ring 113 is attached to the tissue of the organism for signal collection, and the signal is transmitted to other external devices such as stimulators, digital electroencephalographs, etc. in turn through the distal straight lead 1123, the spiral wire 1122, the proximal straight lead 1121, and the proximal electrode ring 111. When it is necessary to release a stimulation signal to the tissue of the organism, the signal is transmitted from the proximal electrode ring 111 to the distal electrode ring 113. In Figure 5 , the number of single conductors 11 is 4, wherein the outermost distal electrode ring 113 and the outermost proximal electrode ring 111 are connected through the corresponding distal straight lead 1123, spiral wire 1122, and proximal straight lead 1121, and the innermost distal electrode ring 113 and the innermost proximal electrode ring 111 are connected through the corresponding distal straight lead 1123, spiral wire 1122, and proximal straight lead 1121. Similarly, the distal electrode ring 113 and the proximal electrode ring 111 of the single conductor 11 form a positionally symmetrical and one-to-one correspondence relationship in turn.

[0043] Optionally, as shown in Figure 6 , the lengths of the proximal straight leads 1121 of the single conductors are different, so that the proximal electrode rings 111 are arranged at intervals. Meanwhile, the proximal electrode ring 111 is annular with an opening 114 in the side wall, and the proximal straight lead 1121 is led out from the end of the proximal electrode ring 111 along one side of the opening 114. The openings 114 on the proximal electrode rings 111 are distributed at different positions in the radial direction, so that the proximal straight leads 1121 led out from the proximal electrode rings 111 are distributed at intervals and are positioned by the support, realizing electrical isolation therebetween. As shown in Figure 7 , the lengths of the distal straight leads 1123 of the single conductors are different, so that the distal electrode rings 113 are arranged at intervals. The distal electrode ring 113 is annular with an opening 114 in the side wall, and the distal straight lead 1123 is led out from the end of the distal electrode ring 113 along one side of the opening 114. Similarly, the distal straight leads 1123 are also arranged at intervals, thereby ensuring electrical isolation between the single conductors. In addition, the side walls of the proximal electrode ring 111 and the distal electrode ring 113 are both provided with openings 114, which also facilitate manual or mechanical operation (e.g., as shown in Figure 4The annular mold 6 is inserted between the distal electrode ring 113 and the support 5, and the distal electrode ring 113 is expanded outwardly with force; similarly, the proximal electrode ring 111 is expanded outwardly, so that the two electrode rings are expanded outwardly, and the electrode leads are located within the outer contour of the electrode rings, so that the two electrode rings are exposed on the surface of the silicone during subsequent injection molding of the silicone, and the electrode leads are located inside the silicone. The distal electrode ring 113 is used to contact the tissue of the living body, collect bioelectric signals or release electrical stimulation signals, and the proximal electrode ring 111 is used to be connected to a stimulator or an external device to output bioelectric signals or transmit electrical stimulation signals. In addition, the openings 114 of the electrode rings can provide a path for the connection of the straight leads, that is, the straight leads of the outer electrode ring just pass through the openings 114 of the inner electrode ring, and the position of the straight leads will not be affected when the electrode rings are expanded outwardly. Taking the distal electrode ring 113 as an example, as shown in Figure 7 , the number of the distal electrode ring 113 is four, that is, the first distal electrode ring 1131, the second distal electrode ring 1132, the third distal electrode ring 1133 and the fourth distal electrode ring 1134 are sequentially and spaced apart from the outside to the inside along the axial direction of the deep brain electrode. The opening widths of the four distal electrode rings 113 are the same and are sequentially staggered along the circumference, so that the corresponding straight leads pass through the openings. The structure of the proximal electrode ring 111 is similar to that of the distal electrode ring 113, and will not be described here.

[0044] Preferably, after laser etching, an insulating layer can be coated on the outside of the electrode lead 112 by vapor deposition or coating to ensure that the single conductors 11 do not contact each other and further improve electrical isolation, which can prevent electrode signals from being confused during transmission and can simultaneously transmit multiple electrical signals.

[0045] Optionally, as shown in Figure 7 , the shielding tube 3 is located outside the spiral wire 1122 and can be a mesh metal tube. The shielding tube 3 makes the conductor 1 more flexible and has an anti-interference effect, ensuring the accuracy of signal transmission.

[0046] In this case, as shown in Figure 2 , Figure 3 , the silicone 2 is set outside the support 5 by injection molding, especially filling the gaps and end portions of the proximal electrode ring 111 and the distal electrode ring 113 and between the electrode leads 112. Preferably, the outer wall of the silicone 2 at these positions is approximately flush with the protective tube 4. The silicone 2 also fills between the protective tube 4, the shielding tube 3 and the spiral wire 1122.

[0047] Optionally, as shown in Figure 2The protective tube 4 is located at the outer side of the conductive body of the helical line 1122, and is generally made of plastic material. When the outer side of the helical line 1122 is provided with the shielding tube 3, the protective tube 4 wraps the shielding tube 3 and the helical line 1122, and combines the silica gel inside to form a body section; when the outer side of the helical line 1122 is not provided with the shielding tube 3, the protective tube 4 wraps the helical line 1122, and combines the silica gel inside to form a body section.

[0048] Optionally, the electrode tube is a biocompatible electrode material, such as platinum gold or platinum iridium alloy, which can improve the safety of the deep brain electrode applied to the human body, and is also suitable for laser etching of the tube wall, preferentially infrared cutting of femtosecond laser, accurate energy, which can prevent the problem of overcutting caused by difficulty in controlling the etching strength of laser.

[0049] Since the guide wire diameter of the deep brain electrode is generally 0.1-0.15mm, it is difficult to have a fixed rigidity, and it is difficult to be used for laser etching, therefore, the problem of difficult positioning of the laser etching electrode ring and helical line in three-dimensional space is a problem that must be solved for the laser etching method of integrally forming the conductive body. There are similar cases in the prior art to try to solve this problem, for example, WO2019033094A1-High-density lead body and method discloses an electrode preparation method, which cuts the hypotube into a plurality of straight leads arranged at intervals, and then arranges and welds a plurality of independent electrode rings on the straight leads to form an electrode. Obviously, this technical solution does not solve the problem of fixing the electrode tube in three-dimensional space, therefore, it cannot integrally etch a plurality of single conductors, nor can it etch a plurality of helical wires. In addition, the preparation process also needs welding, repeated positioning, preventing the lead from deviating, and other operations, and the process flow is complex.

[0050] Therefore, as shown in Figure 1 The present application provides a preparation process of a deep brain electrode, which etches the tube wall of the electrode tube into a conductive body with a set shape or structure by setting a laser etching path, and the plurality of single conductors formed after laser etching of the tube wall need to be distributed at intervals to form electrical isolation, and then molded by injecting silica gel, specifically including the following steps:

[0051] Step S1, fixing the tube wall of the electrode tube in three-dimensional space.

[0052] In order to solve the problem of difficult positioning in three-dimensional space etching, the present case inserts the inner wall of the electrode tube through the support 5 with a deformation allowance on the outer side, and fixes the entire tube wall of the electrode tube. Specifically as follows:

[0053] The electrode material such as platinum or platinum-iridium alloy can be selected as the electrode tube, the support 5 with the deformation amount on the outer side is arranged, the outer diameter of the support 5 is greater than the inner diameter of the electrode tube, and the length of the support 5 is not less than the length of the electrode tube, then the support 5 is inserted into the inside of the electrode tube, and the two ends of the support 5 are clamped or tightly pressed, so that the whole tube wall of the electrode tube is fixed in the three-dimensional space. Figure 6 The support 5 includes a core and a deformation layer on the outer side of the core, wherein the deformation layer is adapted to provide the deformation amount. The core needs to have a certain rigidity to prevent the tube wall of the electrode tube from shaking, deviating, bending and the like during the laser etching process, and is preferably a metal rod, which can also prevent the laser from cutting the two tube walls of the electrode tube, thereby affecting the quality of the conductor. The deformation layer can be a sleeve made of sponge, rubber, resin or the like, which is tightly sleeved on the side of the core and has a certain thickness to provide the deformation amount, so as to ensure that the support 5 is inserted into the electrode tube and tightly fits with the electrode tube to prevent the tube wall of the electrode tube from rotating along the support during the laser etching process.

[0054] Since the outer diameter of the deep brain electrode is generally 1.3 mm and the inner diameter is generally 0.4 mm, the outer diameter of the support 5 is also relatively small, and it is generally difficult to be used as a multi-layer composite. Therefore, a resin rod or a rubber rod can be used as the support 5. The center of the resin rod can be regarded as the core, and the outer part of the resin rod can be regarded as the deformation layer. Since the resin rod itself has a certain rigidity and flexible deformation, it can meet the requirement of fixing the tube wall of the electrode tube in the three-dimensional space. If a metal or rigid member is used as the support 5 and is in interference fit with the electrode tube, it can also meet the requirement of fixing the tube wall of the electrode tube in the three-dimensional space. However, the support 5 needs to be pulled out from the inside of the electrode tube after the deep brain electrode is integrally formed by injection molding. At this time, the interference fit becomes a resistance for pulling out the support 5, which may damage the conductor 1 during the process of pulling out the support 5, thereby affecting the normal use of the deep brain electrode. In addition, since the overall diameter of the electrode is small, the interference fit also needs to consider the factors such as the size tolerance, smoothness, friction, straightness along the axial direction and the like of the inner wall of the electrode tube, which is difficult to achieve in the process. In the present case, the deformation layer providing the deformation amount is arranged on the outer side of the core, and the deformation amount of the deformation layer forms the power for fixing the tube wall from the inside and the side wall of the electrode tube, so as to realize the laser etching and shaping maintenance of the conductor in the three-dimensional space, and facilitate the subsequent pulling out of the support 5, which has greater tolerance for operation errors in the process and is easier to achieve in the industry. Generally, the support 5 has different materials and different outer diameters, and the deformation amount provided thereby is different from the tight fit degree of the electrode tube. In the present case, the outer diameter of the support 5 is generally 0.4-0.5 mm, and preferably, the outer diameter of the support 5 is greater than the inner diameter of the deep brain electrode by about 0.05 mm when a resin rod is used, and the outer diameter of the support 5 is greater than the inner diameter of the deep brain electrode by about 0.1 mm when a rubber rod is used.

[0055] Step S2, laser engraving the tube wall of the electrode tube to form the conductor 1, i.e. at least two single conductors 11 distributed at intervals.

[0056] In the inert gas space, the existing rotating shaft laser engraving machine moves in one-dimensional space for cutting, while the underlying support keeps the electrode tube rotating, so as to achieve the purpose of rotating cutting to laser engrave the tube wall of the electrode tube to form the conductor 1, i.e. at least two single conductors 11 distributed at intervals, which include a continuous proximal electrode ring 111, an electrode lead 112 and a distal electrode ring 113; the electrode lead 112 includes a helical wire 1122 wound in parallel and a proximal straight lead 1121 and a distal straight lead 1123 located at both ends of the helical wire 1122 respectively. Not only the process step of welding multiple conductive wires with the electrode ring is omitted, but also the problems of deformation of the conductive wire caused by stretching and the difficulty of forming the parallel wound conductive wire are solved. At the same time, the laser engraving operation in the inert gas space can prevent the generation of residual substances on the surface of the engraved single conductor which are difficult to remove. Among them, the method of laser engraving and how to set the path of laser engraving belong to the conventional technology, and there are many ways to form the conductor by laser engraving the tube wall of the electrode tube. For example, at least two laser heads are arranged at equal intervals along the outer side of the tube wall of the electrode tube; then, the two laser heads travel synchronously along the tube wall of the electrode tube, respectively engraving a continuous proximal electrode ring 111, a proximal straight lead 1121, a helical wire 1122, a distal straight lead 1123 and a distal electrode ring 113 to form at least two single conductors 11, i.e. the conductor 1. For another example, one laser head is arranged along the outer side of the tube wall of the electrode tube; one laser head travels along the tube wall of the electrode tube to engrave one single conductor 11; then, the travel route of the laser head is adjusted to travel along the tube wall of the electrode tube to engrave the next single conductor 11 to form a continuous proximal electrode ring 111, a proximal straight lead 1121, a helical wire 1122, a distal straight lead 1123 and a distal electrode ring 113 to form the conductor 1. In this process, the proximal electrode ring 111, the electrode lead 112 and the distal electrode ring 113 in the same single conductor 11 are formed at one time by laser engraving the tube wall of the electrode tube. After the laser is finished, the corner material is removed.

[0057] Step S3, respectively expanding the two electrode rings in the radial direction to make the electrode lead located within the outer contour of the two electrode rings.

[0058] In the present case, since the proximal electrode ring 111, the electrode lead 112 and the distal electrode ring 113 are formed by one-time molding through the same electrode tube, the diameter of the electrode tube is also small, and it is difficult to achieve the diameter change processing, so the outer diameters of the three after laser etching can be considered to be the same size. If laser etching is directly injection molded, the proximal electrode ring 111, the proximal straight lead 1121, the spiral wire 1122, the distal straight lead 1123 and the distal electrode ring 113 are exposed on the surface of the silica gel. Among them, the proximal straight lead 1121, the spiral wire 1122 and the distal straight lead 1123 exposed on the surface of the silica gel will affect the normal use of the deep brain electrode. See Figure 4 Since the side walls of the proximal electrode ring 111 and the distal electrode ring 113 are provided with openings 114, two annular molds 6 can be respectively inserted between the proximal electrode ring 111 and the support 5 and between the distal electrode ring 113 and the support 5, so that the side walls of the proximal electrode ring 111 and the distal electrode ring 113 are expanded outward as a whole, and the proximal straight lead 1121, the spiral wire 1122 and the distal straight lead 1123 are located within the outer contour of the proximal electrode ring 111 and the distal electrode ring 113 in the radial direction, so as to be injection molded with silica gel subsequently. The annular mold 6 is a rigid member, especially a metal member, and the side wall thereof is provided with a notch 61 for facilitating assembly and disassembly. The width of the notch 61 can be slightly larger than the width of the opening 114, and the notch 61 corresponds to the opening 114, so as to avoid expanding the electrode ring to expand the straight lead outward or damaging the straight lead during installation.

[0059] Step S4, coating an insulating layer on the surface of the electrode lead 112.

[0060] Since the electrode lead 112 is relatively thin and has a small spacing, it is easy to be broken by a large current or short-circuited by being attached together, and the outer surfaces of the distal electrode ring 113 and the proximal electrode ring 111 need to be exposed on the surface of the silica gel, so an insulating layer can be coated on the surfaces of the proximal straight lead 1121, the spiral wire 1122 and the distal straight lead 1123.

[0061] The insulating layer is a parylene coating or a polytetrafluoroethylene coating, generally 0.01-0.1 mm thick, and can be applied to the surface of the single conductor 11 by spin coating, spray coating, or vapor deposition. After laser cutting is completed, two annular molds 6 are inserted between the proximal electrode ring 111 and the support member 5, and between the distal electrode ring 113 and the support member 5. The two electrode rings are radially expanded outward, while the support member 5 remains within the conductor 1. At this time, since the support member 5 and the inner wall of the conductor 1 at the electrode lead 112 are tightly fitted, and the annular molds, the electrode rings, and the support member 5 are tightly fitted, if no external force is applied, the proximal electrode ring 111, the electrode lead 112, and the distal electrode ring 113 in the single conductor 11 remain in their original state (including spatial position, spacing, shape, etc.). When applying the insulating layer, it is only necessary to cover the outer surfaces of the distal electrode ring 113 and the proximal electrode ring 111, or remove the insulating layer after coating. At the same time, short circuits and interconnections between the single conductors 11 can also be avoided, especially since the spacing between the electrode leads 112 is small and the silicone filled therebetween can be easily broken down by excessive stimulation current.

[0062] Step S5 , sleeve the shielding tube 3 on the spiral line 1122 outside the conductor 1 .

[0063] To avoid signal interference at the spiral 1122, a shielding tube 3 can be placed around the spiral 1122 on the outside of the conductor 1. For example, a mesh-shaped shielding tube 3 can be laser-etched using platinum, platinum-iridium alloy, or other metal materials. The etched shielding tube 3 can then be placed around the outside of the spiral 1122, making the conductor more resilient and achieving the desired effect of resisting interference while ensuring signal transmission accuracy. Since the outer diameters of the distal electrode ring 113 and the proximal electrode ring 111 are larger than the overall outer contour of the spiral 1122, and since the overall outer diameter of the deep brain electrode is between 1 and 2 mm, the inner diameter of the shielding tube 3 is larger than the overall outer contour of the spiral 1122, but the difference between the two is not significant. If the shielding tube 3 were a single tube, the gap between the shielding tube 3 and the support member 5 would be very small, making it difficult for silicone to enter the gap between the two during injection molding. Therefore, in this case, the shielding tube 3 is configured as a mesh sleeve, which can both shield signal interference and facilitate filling with silicone.

[0064] Step S6: a protective tube 4 is sheathed around the spiral line 1122 outside the conductor 1 .

[0065] In order to strengthen the protection of the spiral wire 1122, a protective tube 4 can be installed on the outside of the spiral wire 1122. The protective tube 4 is made of plastic. The shielding tube 3 is set as a mesh tube, which also facilitates the formation of a gap between the protective tube 4 and the support member 5 for filling with silicone.

[0066] When the outer side of the helical wire 1122 is sleeved with the shielding tube 3, a plastic protective tube 4 can be sleeved on the outer side of the shielding tube 3 to wrap and protect the shielding tube 3 and the helical wire 1122, and combine with the internally injected silica gel 2 to form the body section of the electrode.

[0067] When the outer side of the helical wire 1122 is not sleeved with the shielding tube 3, a plastic protective tube 4 can be sleeved on the outer side of the helical wire 1122 to wrap and protect the helical wire 1122, and combine with the internally injected silica gel 2 to form the body section of the electrode.

[0068] Step S7, integrally form the injected silica gel 2.

[0069] In the prior art, after the electrode ring is welded with the helical guide wire, the helical guide wire can only be tensioned by a mold to prevent deformation or contact of the helical guide wire. Since the helical guide wire itself has a certain shrinkage elasticity, and there is a pitch between the guide wires, it is difficult to control the tensioning size. At the same time, the electrode lead and the electrode ring need to maintain a specific structure and three-dimensional spatial position requirement to meet the injection molding process. The conventional preparation process is difficult to meet the three-dimensional spatial positioning during laser cutting, maintain the position and state of the conductive body 1 after cutting, and be used for injection molding. At the same time, after injection molding, the support 5 can be easily taken out to prevent it from being bonded with the silica gel. The present case provides a deformation allowance by setting a deformation layer on the outer side of the core to realize the positioning of the conductive body 1. However, the material of the deformation layer is generally elastic or flexible material such as sponge, rubber, resin, etc., which has high compatibility with silica gel. If the injection molding process is adopted, the adhesion of the deformation layer and the silica gel is relatively high, which makes it difficult to pull out the support 5 after injection molding.

[0070] Therefore, in the case, first, the isolation layer 63 is sprayed on the surface of the deformation layer, and the general thickness is 0.05-0.1 mm, that is, the outer surface of the support 5 is provided with an isolation layer, which plays a role of stripping the silica gel, and facilitates the pulling out of the support 5. The isolation layer 63 is polyurethane or parylene, and the surface of the isolation layer can be provided with a smooth surface to facilitate the stripping of the injection-molded silica gel. Before injection molding, the annular mold 6 is inserted between the electrode ring and the support 5, the diameter of the electrode ring is expanded, and the support 5 is kept inside the conductor 1, the proximal electrode ring 111, the electrode lead 112 and the distal electrode ring 113 in the single conductor 11 are kept in the original state, and then the injection mold is put into the injection mold, the injection port is arranged at the proximal electrode ring 111, the distal electrode ring 113 or the electrode lead 112, the silica gel is injection-molded in the gap between the single conductors 11 and outside the support 5 by vacuum extrusion, the silica gel 2 is integrally formed with the conductor 1, and finally, due to the existence of the isolation layer 63, the support 5 is conveniently pulled out from the inside of the single conductor, and the deep brain electrode is obtained. The two ends of the deep brain electrode are filled with silica gel, and the inside has a cavity formed by pulling out the support 5. The outer diameter of the protective tube 4 is slightly larger than the outer diameter of the proximal electrode ring 111 or the distal electrode ring 113, but since the spiral wire 1122 is lower than the outer contour surface of the proximal electrode ring 111 or the distal electrode ring 113, after injection molding, the silica gel can adhere to and limit the protective tube 4 at the spiral wire 1122, so that the deep brain electrode presents a relatively smooth whole.

[0071] Specifically, the preparation process of the deep brain electrode can have various implementation manners, and the present case only lists the following several kinds.

[0072] As a first embodiment for preparing the deep brain electrode.

[0073] (1) Select platinum material as electrode tube.

[0074] (2) Select a resin rod coated with a polyurethane isolation layer on the outside as the support 5, which is inserted into the inside of the electrode tube and tightly matched with the electrode tube.

[0075] (3) In the inert gas space, four laser heads are used to cut the wall of the electrode tube by femtosecond laser infrared at the same time, forming the conductor 1, that is, the four single conductors 11 are spaced apart.

[0076] (4) Two annular molds 6 are inserted between the proximal electrode ring 111 and the support 5, and between the distal electrode ring 113 and the support 5, respectively, to expand the proximal electrode ring 111 and the distal electrode ring 113 outward, and keep the support 5 inside the electrode tube, which plays a limiting role on the conductor 1.

[0077] (5) The surface of the electrode lead 112 is coated with a parylene coating as an insulating layer.

[0078] (6) Put the conductive body 1, two annular molds 6 and the support 5 into an injection mold, set an injection port at the proximal electrode ring 111, and inject silicone.

[0079] (7) After injection, first remove the two annular molds 6, and then pull out the support 5.

[0080] As a second embodiment for preparing a deep brain electrode.

[0081] (1) Select a platinum-iridium alloy material as the electrode tube.

[0082] (2) Select a rubber rod coated with a polyurethane isolation layer on the outside as the support 5, which is inserted into the inside of the electrode tube and tightly fitted with the electrode tube.

[0083] (3) In an inert gas space, use a femtosecond laser infrared to cut the wall of the electrode tube through a laser head, and sequentially form four single conductors 11, i.e., the conductive body 1.

[0084] (4) Insert the two annular molds 6 between the proximal electrode ring 111 and the support 5 and between the distal electrode ring 113 and the support 5, respectively, expand the proximal electrode ring 111 and the distal electrode ring 113 outward, and keep the support 5 inside the electrode tube, which plays a limiting role on the conductive body 1.

[0085] (5) Coat the surface of the electrode lead 112 with a paclitaxel coating as an insulation layer.

[0086] (6) Use platinum as a raw material to laser etch a mesh shielding tube 3, and set the etched shielding tube 3 outside the helical wire 1122.

[0087] (7) Put the conductive body 1, two annular molds 6, shielding tube 3 and support 5 into an injection mold, set an injection port at the distal electrode ring 113, and inject silicone.

[0088] (8) After injection, first remove the two annular molds 6, and then pull out the support 5.

[0089] As a third embodiment for preparing a deep brain electrode.

[0090] (1) Select a platinum-iridium alloy material as the electrode tube.

[0091] (2) Select a resin rod coated with a paclitaxel isolation layer on the outside as the support 5, which is inserted into the inside of the electrode tube and tightly fitted with the electrode tube.

[0092] (3) In an inert gas space, use a femtosecond laser infrared to cut the wall of the electrode tube through a laser head, and sequentially form four single conductors 11, i.e., the conductive body 1.

[0093] (4) Insert two annular molds 6 between the proximal electrode ring 111 and the support 5, between the distal electrode ring 113 and the support 5, respectively expand the proximal electrode ring 111 and the distal electrode ring 113 outward, and keep the support 5 inside the electrode tube, which limits the position of the conductor 1.

[0094] (5) Coating a polytetrafluoroethylene coating on the surface of the electrode lead 112 as an insulating layer.

[0095] (6) Fitting a protective tube 4 at the helical wire 1122 outside the conductor 1.

[0096] (7) Placing the conductor 1, two annular molds 6, protective tube 4, and support 5 into an injection mold, setting a glue injection port at the proximal electrode ring 111, and injecting silicone.

[0097] (8) After injection, first remove the two annular molds 6, and then pull out the support 5.

[0098] As the fourth embodiment of the preparation of a deep brain electrode.

[0099] (1) Selecting platinum-iridium alloy material as the electrode tube.

[0100] (2) Selecting a resin rod coated with a parylene isolation layer as the support 5, which is inserted into the inside of the electrode tube and tightly fits with the electrode tube.

[0101] (3) In the inert gas space, using a femtosecond laser infrared to cut the wall of the electrode tube through a laser head, and sequentially forming four single conductors 11, i.e., the conductor 1.

[0102] (4) Inserting two annular molds 6 between the proximal electrode ring 111 and the support 5, between the distal electrode ring 113 and the support 5, respectively expanding the proximal electrode ring 111 and the distal electrode ring 113 outward, and keeping the support 5 inside the electrode tube, which limits the position of the conductor 1.

[0103] (5) Coating a polytetrafluoroethylene coating on the surface of the electrode lead 112 as an insulating layer.

[0104] (6) Using platinum-iridium alloy as the raw material to laser etch a mesh shielding tube 3, and fitting the etched shielding tube 3 outside the helical wire 1122.

[0105] (7) Fitting a protective tube 4 at the helical wire 1122 outside the conductor 1.

[0106] (8) Placing the conductor 1, two annular molds 6, shielding tube 3, protective tube 4, and support 5 into an injection mold, setting a glue injection port at the proximal electrode ring 111, and injecting silicone.

[0107] (9) After injection molding, the two annular molds 7 are taken out first, and then the support 5 is pulled out.

[0108] The technical features of the above-described embodiments can be combined in any manner. To make the description concise, all possible combinations of the technical features in the above-described embodiments are not described, but as long as the combinations of the technical features do not exist in contradiction, they should be considered as falling within the scope of the present disclosure.

[0109] The above-described embodiments only express several implementation manners of the present application, and the description is relatively specific and detailed, but it should not be understood as a limitation on the scope of the patent. It should be pointed out that, for ordinary skilled persons in the art, several modifications and improvements can be made without departing from the concept of the present application, and these all fall within the protection scope of the present application. Therefore, the protection scope of the patent of the present application should be subject to the appended claims.

Claims

1. A process for preparing a deep brain electrode, characterized in that: include: Step S1, fixing the tube wall of the electrode tube in three-dimensional space; Step S2, laser etching the tube wall of the electrode tube to form a conductor, that is, at least two single conductors spaced apart; Step S7, injection molding of silicone rubber into one piece; wherein The single conductor includes an electrode lead and electrode rings respectively connected to both ends of the electrode lead.

2. The preparation process according to claim 1, characterized in that The step S1 of fixing the tube wall of the electrode tube in the three-dimensional space includes: The outer diameter of the support is set to be larger than the inner diameter of the electrode tube and a deformation margin is left on the outer side of the support so that it can be inserted into the interior of the electrode tube to fix the tube wall of the electrode tube.

3. The preparation process according to claim 2, characterized in that The support member comprises: The core is located in the core; The deformation layer is located on the outer side of the core; The deformable layer is adapted to provide the deformation allowance.

4. The preparation process according to claim 3, characterized in that The support member further comprises: an isolation layer located on the surface of the deformation layer; The isolation layer is made of polyurethane or parylene to facilitate separation from the injection-molded silicone; The surface of the isolation layer is a smooth surface.

5. The preparation process according to claim 2, characterized in that: The length of the support member is not less than the length of the electrode tube, so as to fix the entire tube wall of the electrode tube.

6. The preparation process according to claim 1, characterized in that The electrode lead and two electrode rings in the same single conductor are formed at one time by laser etching the tube wall of the electrode tube.

7. The preparation process according to claim 6, characterized in that: The electrode lead comprises: a spiral wire and straight leads respectively connected at both ends of the spiral wire; The straight lead is continuous with the electrode ring at the same end.

8. The preparation process according to claim 7, characterized in that: The straight leads of the single conductors have different lengths, so that the electrode rings connected to the straight leads are arranged at intervals.

9. The preparation process according to claim 7, characterized in that: The electrode ring is in the shape of a ring with an open side wall; The straight lead wire leads out of the end portion of the electrode ring along one side of the opening.

10. The preparation process according to claim 1, characterized in that: Also includes: In step S3 , which is located between step S2 and step S7 , the two electrode rings are respectively extended outward in the radial direction so that the electrode leads are located within the outer contours of the two electrode rings.

11. The preparation process according to claim 1, characterized in that: Also includes: In step S4 , located between step S2 and step S7 , an insulating layer is coated on the surface of the electrode lead.

12. The preparation process according to claim 7, characterized in that: Also includes: Step S5, located between step S2 and step S7, is to sheath a shielding tube on the spiral line; The shielding tube is a mesh sleeve.

13. The preparation process according to claim 7, characterized in that: Also includes: In step S6 , which is located before step S7 , a protective tube is sheathed on the spiral line.

14. A deep brain electrode prepared by the preparation process according to claim 1, characterized in that: include: A conductor and silicone located outside the conductor; in The electrical conductor includes at least two single conductors spaced apart from each other; and The single conductor includes an electrode lead and electrode rings respectively connected to both ends of the electrode lead.

15. The deep brain electrode according to claim 14, characterized in that The electrode lead comprises: a spiral wire and straight leads respectively connected at both ends of the spiral wire; The straight lead is continuous with the electrode ring at the same end.

16. The deep brain electrode according to claim 15, characterized in that The electrode ring is annular, and its side wall is provided with an opening; The straight lead wire leads out of the end of the electrode ring along one side of the opening; The straight leads of the single conductors are of different lengths so that the electrode rings connected to the straight leads are arranged at intervals; as well as The straight lead from the outer electrode ring passes through the opening of the inner electrode ring to connect to the spiral wire.

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