Artificial cochlea electrode and preparation method thereof

Abstract

The invention discloses an artificial cochlea electrode and a preparation method thereof. An artificial cochlea electrode comprises a plurality of electrode contacts and packaging silica gel, the inner wall of each electrode contact is connected with an electrode wire, and each electrode contact is of a split ring structure defined by electrode slices; the electrode contact comprises a first flanging part, a groove body structure and a second flanging part which are sequentially connected in the axial direction, and the opening direction of the groove body structure faces the center of the split ring structure; the inner side of the groove body structure is welded with the electrode wire; the depth of the groove body structure is greater than the outer diameter of the electrode wire; at least more than 80% of the area of the radial outer side wall of the groove body structure is flush with the side wall of the packaging silica gel; the axial projection area of the first flanging part and the axial projection area of the second flanging part do not exceed the axial projection area of the radial outer side wall of the groove body structure, and the first flanging part and the second flanging part are embedded in the packaging silica gel. The risk of short circuit between the electrode contacts is reduced, and the damage risk of the electrode wire coating in the electrode assembling process is reduced.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, specifically cochlear implant electrodes. Background Art

[0002] The cochlear implant system is a biomedical engineering device that helps patients with severe and profound sensorineural hearing loss restore their hearing and language communication abilities. Its basic principle is to bypass the diseased inner ear hair cells and convert sound energy into electrical signals to directly stimulate the remaining neuron cells in the cochlea to generate hearing. For patients with severe or profound deafness.

[0003] The electrodes of cochlear implants are multi-channel electrodes, which are synthesized by electrode contacts, electrode wires, and silicone encapsulation. The electrode contacts mostly use platinum-iridium alloy and platinum materials, and the electrode wires mostly use platinum-iridium alloy wires and are coated with an insulating coating. First, the electrode contacts and the electrode wires are welded, then linearly arranged and assembled, and placed in a mold to be encapsulated with silicone and cured to make cochlear electrodes. The sides of traditional electrode contacts are mostly straight edges. During the electrode assembly process, the coating of the electrode wire is likely to come into contact with and be damaged by rubbing against the straight edges of the sides of the electrode contacts, affecting the insulation performance between the electrode contacts and the electrode wires. Seriously, it may cause a short circuit between them. If it is not discovered during the manufacturing process and a short circuit fault occurs after implantation into the human body, it will cause serious consequences, and even the cochlear implant may need to be removed and re-implanted.

[0004] In addition, the traditional welding method of electrode contacts and electrode wires is to weld the inner surface of the contact and the end of the electrode wire after removing the coating. During the linear arrangement and assembly of the electrodes, the solder joints come into contact with and rub against other electrode wires, which also has a certain impact on the welding strength of the solder joints.

[0005] For the contacts of traditional electrodes, in order to reduce the risk of electrode detachment, the flat electrodes are usually wrapped in silicone, and the surface of the electrode contacts is lower than the outer surface of the electrode, that is, lower than the surface of the encapsulating silicone of the electrode. This causes the surface of the electrode to be uneven, and the uneven surface is not smooth and is likely to cause additional damage to the patient's cochlea during the implantation process. Since the electrode contacts are lower than the electrode surface, air bubbles are likely to form on the surface of the contacts in lymphatic fluid, affecting intraoperative electrode detection, as well as postoperative electrode impedance detection and adjustment for rehabilitation.

[0006] Currently, there is a lack of a cochlear implant electrode structure that can reduce the risk of short circuit between electrode contacts, reduce the risk of damage to the coating of the electrode wire during the electrode assembly process, and the risk of intraoperative and postoperative detachment of the electrode contacts. At the same time, it can reduce the phenomenon of air bubble generation at the contact part during the electrode implantation process. Summary of the Invention

[0007] Aiming at the problems existing in the prior art, the present invention provides a cochlear implant electrode and its preparation method to solve at least one of the above technical problems.

[0008] To achieve the above object, the present invention provides a cochlear implant electrode, which includes a plurality of electrode contacts and encapsulating silicone. A wire electrode is connected to the inner wall of each electrode contact. It is characterized in that the electrode contact is an open-loop structure formed by electrode sheets;

[0009] The electrode contact includes a first flanging portion, a groove structure, and a second flanging portion that are sequentially connected along the axial direction. The opening direction of the groove structure faces the center of the open-loop structure;

[0010] The inner side of the groove structure is welded to the wire electrode, and the depth of the groove structure is greater than the outer diameter of the wire electrode;

[0011] At least 80% or more of the area of the outer sidewall of the groove structure in the radial direction is flush with the sidewall of the encapsulating silicone;

[0012] The axial projection areas of the first flanging portion and the second flanging portion do not exceed the axial projection area of the outer sidewall of the groove structure in the radial direction, and the first flanging portion and the second flanging portion are embedded in the encapsulating silicone.

[0013] By optimizing the structure of the electrode contact, the present invention arranges the welding point of the wire electrode and the electrode contact within the groove structure, which can ensure that the height of the welding point of the wire electrode and the electrode contact is lower than the depth of the groove structure. During the subsequent arrangement and assembly process of the electrode contacts, the influence of the operation arrangement process on the welding point can be reduced, and the risk of welding point detachment can be reduced.

[0014] The axial projection areas of the first flanging portion and the second flanging portion do not exceed the outer sidewall of the groove structure in the radial direction, so as to ensure that the outer sidewall of the groove structure of the electrode contact is flush with the silicone during subsequent electrode encapsulation. At the same time, the first flanging portion and the second flanging portion are located within the encapsulating silicone, reducing the risk of electrode contact detachment.

[0015] Further preferably, the included angle between the outer sidewall of the groove structure in the radial direction and the extending direction of the first flanging portion or the second flanging portion is 3° - 8°.

[0016] Further preferably, the electrode sheet is a platinum sheet or a platinum-iridium alloy sheet, and the thickness of the electrode sheet is 0.03 mm - 0.06 mm.

[0017] Further preferably, the groove structure includes an inner arc surface and an outer arc surface arranged inside and outside along the thickness direction, and the axial length of the outer arc surface is 0.25 - 0.35 mm.

[0018] Further preferably, the lengths of the first flanging portion and the second flanging portion extending outward are 0.15 - 0.25 mm.

[0019] Further preferably, when the central angle of the opening of the split ring structure is not greater than 10°, the cochlear implant electrode is a linear electrode, the length direction of the cochlear implant electrode is linear, and the outer side wall in the radial direction of the groove structure is flush with the side wall of the encapsulating silica gel.

[0020] A method for preparing a cochlear implant electrode, comprising the following steps:

[0021] Step 1, stamping an electrode sheet and polishing it smooth. The electrode sheet is formed into a first bent portion, a first arc transition portion, a second bent portion, a second arc transition portion, and a third bent portion that are sequentially connected by stamping the electrode sheet; the first bent portion is used to form a first flanging portion, the third bent portion is used to form a second flanging portion, and the first arc transition portion, the second bent portion, and the second arc transition portion are used to form a groove structure.

[0022] Step 2, welding the electrode wire along the circumferential direction of the electrode sheet to the inner side of the second bent portion, and bending the electrode wire to the axial direction of the electrode sheet and extending axially outward.

[0023] Coating and curing silica gel in the groove structure, and the height of the silica gel does not exceed the depth of the groove structure.

[0024] Step 3, pressing the electrode sheet into a U-shaped electrode sheet with a mold for pre-shaping.

[0025] Step 4, pressing and shaping the U-shaped electrode sheet into an electrode contact of a split ring structure with a mold.

[0026] Step 5, arranging the electrode contacts at equal intervals along the axial direction.

[0027] Step 6, placing the arranged electrode contacts into an electrode encapsulation mold, injecting silica gel, curing, demolding, cleaning, inspecting, and completing the processing of the linear electrode of the cochlear implant.

[0028] Further preferably, in Step 2, the number of welding points between the electrode wire and the electrode sheet is not less than 1; the height of the welding points is less than the depth of the groove structure.

[0029] Alternatively, when the central angle of the opening of the split ring structure is greater than 10° and less than 120°, the cochlear implant electrode is an arc-shaped electrode; the length direction of the cochlear implant electrode is arc-shaped and curved, more than 80% of the area region of the outer side wall in the radial direction of the groove structure is flush with the side wall of the encapsulating silica gel, and the outer side wall at the open end of the split ring structure in the radial direction is buried in the encapsulating silica gel.

[0030] Further preferably, the outer side wall in the radial direction of the groove structure points to the expected implanted modiolus direction.

[0031] A method for preparing a cochlear implant electrode, characterized by comprising the following steps:

[0032] Step 1: Stamp the electrode sheet and polish it smoothly. The electrode sheet is formed into a first bent portion, a first arc transition portion, a second bent portion, a second arc transition portion, and a third bent portion that are sequentially connected by stamping the electrode sheet; the first bent portion is used to form a first flanging portion, the third bent portion is used to form a second flanging portion, and the first arc transition portion, the second bent portion, and the second arc transition portion are used to form a groove structure;

[0033] Step 2: Weld the electrode wire along the circumferential direction of the electrode sheet to the inner side of the second bent portion, and bend the electrode wire to the axial direction of the electrode sheet and extend axially outward;

[0034] Apply and cure silica gel in the groove structure, and the height of the silica gel does not exceed the depth of the groove structure;

[0035] Step 3: Press the electrode sheet into a C-shaped electrode sheet with a mold as an electrode contact;

[0036] Step 4: Arrange the electrode contacts equidistantly along the arc;

[0037] Step 5: Place the arranged electrode contacts into an electrode encapsulation mold, inject silica gel, cure, demold, clean, inspect, and complete the processing of the arc-shaped electrode of the cochlear implant.

[0038] Further preferably, in Step 2, the number of solder joints between the electrode wire and the electrode sheet is not less than 1; the height of the solder joint is less than the depth of the groove structure.

[0039] Compared with the prior art, the beneficial effects of the present invention are:

[0040] By optimizing the structure of the electrode contacts, the present invention reduces the risk of short circuit between the electrode contacts, reduces the risk of damage to the electrode wire coating during the electrode assembly process, and reduces the risk of intraoperative and postoperative detachment of the electrode contacts.

[0041] At the same time, the electrode contacts are made flush with the silica gel on the electrode surface, reducing the phenomenon of air bubbles generated at the contact part during the electrode implantation process and improving the intraoperative detection and postoperative adjustment effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0042] Figure 1 It is a schematic structural diagram of Specific Embodiment 1 of the present invention;

[0043] Figure 2 For the present invention Figure 1 The cross-sectional view taken along A-A in;

[0044] Figure 3 It is a cross-sectional view of the electrode contact of Specific Embodiment 1 of the present invention;

[0045] Figure 4 Schematic diagram of the structure of the receiving antenna part in Specific Embodiment 1 of the present invention;

[0046] Figure 5 Schematic diagram of the structure of the electrode piece in Specific Embodiment 1 of the present invention;

[0047] Figure 6 Schematic diagram of the welding of the electrode piece and the electrode wire in Specific Embodiment 1 of the present invention;

[0048] Figure 7 Schematic diagram of the structure of the U-shaped electrode piece in Specific Embodiment 1 of the present invention;

[0049] Figure 8 Schematic diagram of the structure of the split ring structure in Specific Embodiment 1 of the present invention;

[0050] Figure 9 Schematic diagram of the structure of the linear electrode in Specific Embodiment 1 of the present invention;

[0051] Figure 10 For the present invention Figure 9 Cross-sectional view taken along line C-C in;

[0052] Figure 11 Schematic diagram of a structure of the arc-shaped electrode in Specific Embodiment 2 of the present invention;

[0053] Figure 12 For the present invention Figure 11 Cross-sectional view taken along line B-B in.

[0054] In the figure: 1 is the electrode contact, 2 is the encapsulating silica gel, 3 is the electrode wire, 11 is the first flanging part, 12 is the second flanging part, 13 is the groove structure, 14 is the convex arc surface, 15 is the first bending part, 16 is the second bending part, 17 is the third bending part, 18 is the U-shaped electrode piece, 19 is the split ring structure. Detailed implementation manners

[0055] The present invention will be further described below with reference to the accompanying drawings.

[0056] Referring to Figures 1 to 10 , Specific Embodiment 1: A cochlear implant electrode includes a plurality of electrode contacts 1 and an encapsulating silica gel 2. A electrode wire 3 is connected to the inner wall of each electrode contact 1. The electrode contact 1 is a split ring structure formed by electrode pieces; the electrode contact 1 includes a first flanging part 11, a groove structure 13 and a second flanging part 12 connected in sequence along the axial direction. The opening direction of the groove structure 13 faces the center of the split ring structure; the inner side of the groove structure 13 is welded to the electrode wire 3, and the depth of the groove structure 13 ( Figure 3The F in () is greater than the outer diameter of the electrode wire 3; at least 80% or more of the area of the outer sidewall (i.e., the outer arc surface 14) in the radial direction of the groove body structure 13 is flush with the sidewall of the encapsulating silica gel 2; the axial projection areas of the first flanging part 11 and the second flanging part 12 do not exceed the axial projection area of the radial outer sidewall of the groove body structure 13. The axial projection areas of the first flanging part 11 and the second flanging part 12 are arranged inside and outside the axial projection area of the radial outer sidewall of the groove body structure 13. That is, in the radial direction, the axial projection areas of the first flanging part 11 and the second flanging part 12 do not extend beyond the axial projection area of the radial outer sidewall of the groove body structure 13. The first flanging part 11 and the second flanging part 12 are embedded in the encapsulating silica gel 2.

[0057] By optimizing the structure of the electrode contact 1 in the present invention, the welding joint of the electrode wire 3 and the electrode contact 1 is arranged in the groove body structure 13, which can ensure that the height of the solder joint of the electrode wire 3 and the electrode contact 1 is lower than the depth of the groove body structure 13. During the subsequent arrangement and assembly process of the electrode contacts 1, the influence of the operation arrangement process on the solder joint is reduced, and the risk of solder joint de-welding is reduced.

[0058] The insulating coating is removed from the area of the electrode wire 3 located in the groove body structure 13. The insulating coating is provided in the remaining areas.

[0059] After the electrode wire 3 is welded and connected to the inner side of the groove body structure 13, silica gel is applied and cured in the groove body structure 13, and the area where the insulating coating of the electrode wire is removed is coated with silica gel.

[0060] The axial projection areas of the first flanging part 11 and the second flanging part 12 do not exceed the radial outer sidewall of the groove body structure 13, which is for subsequent electrode encapsulation to ensure that the outer sidewall in the radial direction of the groove body structure 13 of the electrode contact 1 is flush with the silica gel. At the same time, the first flanging part 11 and the second flanging part 12 are located in the encapsulating silica gel 2, reducing the risk of the electrode contact 1 falling off.

[0061] The included angle (E in ()) between the radial outer sidewall of the groove body structure 13 and the extending direction of the first flanging part 11 or the second flanging part 12 Figure 3 is 3° - 8°.

[0062] The electrode piece is a platinum piece or a platinum-iridium alloy piece, and the thickness of the electrode piece is 0.03 mm - 0.06 mm.

[0063] The groove body structure 13 includes an inner arc surface and an outer arc surface 14 arranged inside and outside along the thickness direction. The axial length of the outer arc surface 14 is 0.25 - 0.35 mm. The thickness direction is the radial direction.

[0064] The lengths by which the first flanging part 11 and the second flanging part 12 extend outward are 0.15 - 0.25 mm.

[0065] When the central angle of the opening of the split ring structure is not greater than 10°, the cochlear implant electrode is a straight electrode, the length direction of the cochlear implant electrode is linear, and the outer side wall in the radial direction of the groove structure 13 is flush with the side wall of the encapsulating silica gel 2.

[0066] A method for preparing a cochlear implant electrode, characterized by comprising the following steps:

[0067] Step 1, stamping an electrode sheet and polishing it smooth. The electrode sheet is formed into a first bent portion 15, a first arc transition portion, a second bent portion 16, a second arc transition portion, and a third bent portion 17 that are sequentially connected by stamping the electrode sheet; the first bent portion 15 is used to form the first flanging portion 11, the third bent portion 17 is used to form the second flanging portion 12, and the first arc transition portion, the second bent portion 16, and the second arc transition portion are used to form the groove structure 13.

[0068] When polishing smooth, by placing it in a polishing machine, burrs generated during the stamping process are removed by abrasives, and at the same time, the edges and sharp edges of the electrode sheet are slightly rounded, and the fillet is not greater than 0.02 mm.

[0069] Step 2, welding the electrode wire 3 along the circumferential direction of the electrode sheet to the inner side of the second bent portion 16, and bending the electrode wire 3 to the axial direction of the electrode sheet and extending axially outward; see Figure 5 in (a) of Figure 5 in (b) of Figure 5 in (c) of Figure 5 in (a) of Figure 5 in (b) of Figure 5 in (c) of

[0070] Silica gel is coated and cured in the groove structure 13, and the height of the silica gel does not exceed the depth of the groove structure 13. The solder joints and the electrode wire 3 are pre-protected by coating silica gel, further reducing the risk of damage and open circuit of the solder joints during subsequent shaping operations and the process of threading and arranging the electrode wire 3. The insulating coating is removed from the area of the electrode wire 3 located in the groove structure 13. The remaining areas are provided with insulating coatings. When the electrode wire 3 is welded and connected to the inner side of the groove structure 13, silica gel is coated and cured in the groove structure 13, and the area where the insulating coating of the electrode wire is removed is covered by silica gel.

[0071] Step 3, pressing the electrode sheet into a U-shaped electrode sheet 18 with a mold for pre-shaping; see Figure 6 ;

[0072] Step 4: Use a mold to press and shape the U-shaped electrode sheet 18 onto the electrode contact 1 of the open-ring structure 19; see Figure 7 ;

[0073] Step 5: Arrange the electrode contacts 1 at equal intervals along the axial direction; see Figure 8 ;

[0074] Step 6: Place the arranged electrode contacts 1 into an electrode encapsulation mold, inject silicone, cure, demold, clean, inspect, and complete the processing of the straight electrode of the cochlear implant. See Figure 9 and Figure 10 .

[0075] On the entire surface of the straight electrode, the outer arc surface of the electrode contact is flush with the outer surface of the encapsulating silicone. During the implantation process, local air bubbles are not easily generated. At the same time, the bending part of the groove structure of the electrode contact has a rounded corner, reducing the damage caused when the electrode contact contacts the cochlear tissue.

[0076] In Step 2, the number of solder joints between the electrode wire 3 and the electrode sheet is not less than 1; the height of the solder joint is less than the depth of the groove structure 13.

[0077] See Figure 11 and Figure 12 , Specific Example 2. Based on Specific Example 1, the difference is that the open-ring structure is a C-shaped structure.

[0078] When the central angle of the opening of the open-ring structure is greater than 10° and less than 120°, the cochlear implant electrode is an arc-shaped electrode; the length direction of the cochlear implant electrode is arc-shaped, and more than 80% of the area of the outer wall in the radial direction of the groove structure 13 is flush with the side wall of the encapsulating silicone 2, and the outer wall at the open end of the open-ring structure in the radial direction is buried in the encapsulating silicone 2.

[0079] The outer wall in the radial direction of the groove structure 13 points to the expected implanted modiolus direction.

[0080] A method for preparing a cochlear implant electrode, characterized by comprising the following steps:

[0081] Step 1: Stamp the electrode sheet and polish it smoothly. The electrode sheet is formed into a first bending part 15, a first arc transition part, a second bending part 16, a second arc transition part, and a third bending part 17 that are sequentially connected by stamping the electrode sheet; the first bending part 15 is used to form the first flanging part 11, the third bending part 17 is used to form the second flanging part 12, and the first arc transition part, the second bending part 16, and the second arc transition part are used to form the groove structure 13.

[0082] When polishing smoothly, place it in a polishing machine to remove the burrs generated during the stamping process with abrasives. At the same time, slightly chamfer the edges and sharp edges of the electrode sheet, and the fillet is not more than 0.02 mm.

[0083] Step 2: Weld the electrode wire 3 along the circumferential direction of the electrode sheet to the inner side of the second bending part 16, and bend the electrode wire 3 to the axial direction of the electrode sheet and extend axially outward; see Figure 5 in (a) of Figure 5 in (b) of Figure 5 and (c) of Figure 5 in (a) of Figure 5 in (b) of Figure 5 and (c) of

[0084] Coat and cure silicone in the groove structure 13, and the height of the silicone does not exceed the depth of the groove structure 13; coat and cure silicone in the groove structure 13, and the height of the silicone does not exceed the depth of the groove structure 13. Pre-protect the solder joints and the electrode wire 3 by coating silicone, and further reduce the risk of damage and open circuit of the solder joints during subsequent shaping operations and the process of threading and arranging the electrode wire 3. Remove the insulation coating from the area of the electrode wire 3 located in the groove structure 13. The remaining areas are provided with insulation coatings. After the electrode wire 3 is welded and connected to the inner side of the groove structure 13, coat and cure silicone in the groove structure 13, and cover the area where the electrode wire removes the insulation coating with silicone.

[0085] Step 3: Press the electrode sheet into a C-shaped electrode sheet with a mold as the electrode contact 1;

[0086] Step 4: Arrange the electrode contacts 1 equidistantly along the arc;

[0087] Step 5: Place the arranged electrode contacts 1 into the electrode encapsulation mold, inject silicone, cure, demold, clean, inspect, and complete the processing of the arc-shaped electrode of the cochlear implant. See Figure 10 and Figure 11 .

[0088] In Step 2, the number of solder joints between the electrode wire 3 and the electrode sheet is not less than 1; the height of the solder joints is less than the depth of the groove structure 13.

[0089] The above is only the preferred embodiment of the present invention. It should be noted that for those of ordinary skill in the art, without departing from the principle of the present invention, several improvements and refinements can be made, and these improvements and refinements should also be regarded as the protection scope of the present invention.

Claims

1. An artificial cochlear electrode, comprising a plurality of electrode contacts and a packaging silicone, and an electrode wire is connected to the inner wall of each electrode contact, characterized in that, The electrode contact is an open-ring structure formed by electrode sheets; The electrode contact includes a first flanging portion, a groove structure, and a second flanging portion that are sequentially connected along the axial direction. The opening direction of the groove structure faces the center of the open-ring structure; The inner side of the groove structure is welded to the electrode wire, and the depth of the groove structure is greater than the outer diameter of the electrode wire; At least 80% or more of the area region of the outer side wall of the groove structure in the radial direction is flush with the side wall of the encapsulating silica gel; The axial projection regions of the first flanging portion and the second flanging portion do not exceed the axial projection region of the outer side wall of the groove structure in the radial direction, and the first flanging portion and the second flanging portion are embedded in the encapsulating silica gel.

2. The cochlear implant electrode according to claim 1, wherein: The included angle between the outer side wall of the groove structure in the radial direction and the extending direction of the first flanging portion or the second flanging portion is 3°-8°; 3. The cochlear implant electrode according to claim 1, wherein: The electrode sheet is a platinum sheet or a platinum-iridium alloy sheet, and the thickness of the electrode sheet is 0.03 mm - 0.06 mm; 4. The cochlear implant electrode according to claim 1, wherein: The groove structure includes an inner arc surface and an outer arc surface that are arranged inside and outside along the thickness direction, and the axial length of the outer arc surface is 0.25 - 0.35 mm; 5. An artificial cochlear electrode according to claim 1, wherein: The lengths of the first flanging portion and the second flanging portion extending outward are 0.15 - 0.25 mm; 6. The cochlear implant electrode according to claim 1, characterized in that: When the central angle of the opening of the open-ring structure is not greater than 10°, the cochlear implant electrode is a linear electrode, the length direction of the cochlear implant electrode is linear, and the outer side wall of the groove structure in the radial direction is flush with the side wall of the encapsulating silica gel; 7. An artificial cochlear electrode according to claim 1, characterized in that: When the central angle of the opening of the open-ring structure is greater than 10° and less than 120°, the cochlear implant electrode is an arc-shaped electrode; the length direction of the cochlear implant electrode is arc-shaped and curved, more than 80% of the area region of the outer side wall of the groove structure in the radial direction is flush with the side wall of the encapsulating silica gel, and the outer side wall of the opening end of the open-ring structure in the radial direction is embedded in the encapsulating silica gel; 8. The preparation method of a cochlear implant electrode according to claim 6, wherein, It includes the following steps: Step 1, stamping the electrode sheet and polishing it smooth. The electrode sheet is formed into a first bending portion, a first arc transition portion, a second bending portion, a second arc transition portion, and a third bending portion that are sequentially connected by stamping the electrode sheet; the first bending portion is used to form the first flanging portion, the third bending portion is used to form the second flanging portion, and the first arc transition portion, the second bending portion, and the second arc transition portion are used to form the groove structure; Step 2, welding the electrode wire to the inner side of the second bending portion along the circumferential direction of the electrode sheet, and bending the electrode wire to the axial direction of the electrode sheet and extending axially outward; Coating and curing silica gel in the groove structure, and the height of the silica gel does not exceed the depth of the groove structure; Step 3, pressing the electrode sheet into a U-shaped electrode sheet with a mold for pre-forming; Step 4, pressing and shaping the U-shaped electrode sheet into the electrode contact of the open-ring structure with a mold; Step 5, arranging the electrode contacts at equal intervals along the axial direction; Step 6, placing the arranged electrode contacts into an electrode encapsulation mold, injecting silica gel, curing, demolding, cleaning, inspecting, and completing the processing of the linear electrode of the cochlear implant.

9. The preparation method of a cochlear implant electrode according to claim 7, characterized in that, It includes the following steps: Step 1: Stamp the electrode sheet and polish it smoothly. The electrode sheet is formed into a first bent portion, a first arc transition portion, a second bent portion, a second arc transition portion, and a third bent portion that are sequentially connected by stamping the electrode sheet. The first bent portion is used to form a first flanging portion, the third bent portion is used to form a second flanging portion, and the first arc transition portion, the second bent portion, and the second arc transition portion are used to form a groove structure. Step 2: Weld the electrode wire along the circumferential direction of the electrode sheet to the inner side of the second bent portion, and bend the electrode wire to the axial direction of the electrode sheet and extend axially outward. Apply and cure silicone in the groove structure, and the height of the silicone does not exceed the depth of the groove structure. Step 3: Press the electrode sheet into a C-shaped electrode sheet with a mold as an electrode contact. Step 4: Arrange the electrode contacts equidistantly along an arc. Step 5: Place the arranged electrode contacts into an electrode encapsulation mold, inject silicone, cure, demold, clean, inspect, and complete the processing of the arc-shaped electrode of the cochlear implant.

10. The preparation method of a cochlear implant electrode according to claim 8 or 9, characterized in that, In Step 2, the number of solder joints between the electrode wire and the electrode sheet is not less than 1; the height of the solder joint is less than the depth of the groove structure.

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