Modular positioning assembly type artificial cochlea implant and assembly method thereof

Abstract

The invention discloses a modular positioning and assembling type artificial cochlea implant and an assembling method thereof. A modular positioning assembly type artificial cochlea implant comprises a decoding stimulator, the decoding stimulator comprises a middle titanium shell and an electrode feed-through welded and fixedly connected with the middle titanium shell, a first PIN and a second PIN are arranged on the electrode feed-through, and a receiving antenna part comprises a receiving antenna and an insulated antenna prefabricated part. The leading-out end of the receiving antenna extends out of the antenna prefabricated part and is pressed into a flat antenna leading-out end; the implanted electrode part comprises an implanted electrode and an insulated electrode prefabricated part, and the electrode prefabricated part is provided with a feed-through channel used for exposing electrode feed-through, an electrode channel used for exposing an electrode wire and an antenna channel bent in an arc shape; the first PINs are in one-to-one correspondence with the end parts of the electrode wires and are in welded connection with the end parts; and the end part of the second PIN is welded and connected with the antenna leading-out end. Due to the modular component composition, the difficulty of the assembly process is reduced.

Description

Technical Field

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

[0002] A cochlear implant system is a biomedical engineering device that helps patients with severe and profound sensorineural hearing loss to 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, the cochlear implant system includes a sound processor (external device) and an implant (internal device). The signal transmission between the sound processor and the internal implant device is completed through electromagnetic induction. There is a skin separation between the two, and there is no wire connection. In the entire cochlear implant system, the implant is the most critical part, and the sound processor can only achieve hearing restoration through it. The implant mainly consists of a decoding stimulator, a receiving antenna, implant electrodes, and an external encapsulating silicone.

[0003] The structure of the decoding stimulator of the cochlear implant is a crucial part of the cochlear implant system. It is mainly responsible for receiving and decoding the electrical signals received and encoded from the external sound processor, and transmitting the stimulation signals to the inner ear through the electrode array to stimulate the auditory nerve fibers in the cochlea, thereby generating hearing. One end of the decoding stimulator is connected to the electrode array, and the other end is connected to the receiving antenna. The reliability and stability of the electrical connection are very important to ensure that the electrical signals can be transmitted accurately and without error. The mechanical structure of the decoding stimulator needs to provide sufficient mechanical strength while solving the sealing protection of the electrical part to prevent damage to the decoding stimulator of the implant caused by accidental collisions and impacts during the patient's daily life. Various measures need to be taken during the structural design to ensure the safety and reliability of the implant.

[0004] Therefore, the structure of the decoding stimulator of the cochlear implant needs to have high reliability, stability, and biocompatibility to ensure that it can safely and effectively help patients restore their auditory function.

[0005] Currently, how to achieve rapid assembly on the premise of ensuring the connection stability of each component in the cochlear implant is one of the directions that need to be continuously improved during the R & D process. Summary of the Invention

[0006] Aiming at the problems existing in the prior art, the present invention provides a modular positioning and assembling cochlear implant and its assembling method to solve at least one of the above technical problems.

[0007] To achieve the above object, the present invention provides a modular positioning and assembling cochlear implant, including a decoding stimulator, an implant electrode component, and a receiving antenna component, characterized in that the decoding stimulator includes a middle titanium shell and an electrode feedthrough fixedly connected to the middle titanium shell by welding, the electrode feedthrough is provided with a first PIN pin for connecting the electrode wire of the implant electrode part and a second PIN pin for connecting the antenna lead-out end of the receiving antenna part, and the length of the first PIN pin is shorter than that of the second PIN pin;

[0008] The receiving antenna part includes a receiving antenna and an insulating antenna preform, the middle titanium shell is positioned and inserted into the antenna preform, the lead-out end of the receiving antenna extends out of the antenna preform, and is pressed into a flat antenna lead-out end;

[0009] The implant electrode part includes an implant electrode and an insulating electrode preform, the middle titanium shell is positioned and inserted into the electrode preform, and the electrode preform is provided with a feedthrough channel for exposing the electrode feedthrough, an electrode channel for exposing the electrode wire, and an antenna channel bent in an arc shape;

[0010] The electrode channel is bent in a U shape, the electrode channel is arranged on the periphery of the feedthrough channel, and the opening side of the electrode channel is adjacent to the antenna channel, and the antenna channel is in butt connection and conduction with the feedthrough channel;

[0011] The end of the electrode wire extends outwards from the electrode channel, the first PIN pin and the second PIN pin extend outwards from the feedthrough channel, and the first PIN pin corresponds to the end of the electrode wire one by one and is welded;

[0012] The second PIN pin is bent at the antenna channel, and the end of the second PIN pin is welded to the antenna lead-out end.

[0013] By adding an electrode preform and an antenna preform, the present invention facilitates improving the positioning accuracy of modular assembly of components. By extending the antenna lead-out end from the antenna preform, it is convenient to prevent the antenna lead-out end from being pulled by external forces through the antenna preform, ensuring the connection stability between the antenna lead-out end and the electrode feedthrough, improving the anti-external force ability, and ensuring the reliability of electrical connection.

[0014] Further preferably, the electrode preform is a U-shaped part with mirror symmetry, the electrode preform is provided with two extension arms, and the feedthrough channel, the electrode channel, and the antenna channel are all opened on the two extension parts;

[0015] The second PIN pin is located on one side of the feedthrough channel adjacent to the antenna channel.

[0016] Further preferably, the antenna prefabrication includes a buffer section and two limiting sections. The buffer section is connected to the two limiting sections on both sides respectively, and the limiting sections are bent in an arc shape;

[0017] Positioning holes for inserting the positioning posts on the middle titanium shell are formed on both the buffer section and the limiting sections;

[0018] A first positioning step for positioning and plugging connection with the middle titanium shell is arranged at the bottom of the buffer section;

[0019] A second positioning step for positioning and plugging connection with the middle titanium shell is arranged at the bottom of the limiting section. A support step extending outwards is arranged at the bottom of the limiting section far away from the buffer section, and the antenna lead-out end is located above the support step.

[0020] The support step facilitates providing an operating platform for the electrical connection between the antenna lead end and the second PIN pin, and ensures an effective supporting force for the electrical connection operation.

[0021] Further preferably, the hardness of the buffer section is less than that of the limiting section.

[0022] The limiting section is made of a material with relatively high hardness. The main reasons are that the receiving antenna is generally composed of multi-strand stranded metal wires, having a certain hardness and elasticity. The limiting section with relatively high hardness can effectively shape and limit the receiving antenna. A support step is arranged on the limiting section, and the relatively high hardness can provide sufficient supporting force for the electrical connection operation of the receiving antenna.

[0023] Further preferably, the receiving antenna includes a spiral curling part. One end of the spiral curling part extends outwards after passing through the limiting section and a buffer section in sequence, and the other end of the spiral curling part extends outwards after passing through the limiting section and another buffer section in sequence. The ends of the antenna extending out of the two buffer sections are used as the antenna lead-out ends;

[0024] The receiving antenna is in a C-shaped buffer bending structure within the buffer section.

[0025] By the two ends of the spiral curling part extending outwards after passing through the limiting section and the buffer section in sequence, when the receiving antenna is bent, further buffer protection is provided to prevent pulling the solder joints of the second PIN pin and the antenna lead-out end.

[0026] Further preferably, the antenna channel is an arc-shaped groove with an upper opening and openings at both ends in the length direction;

[0027] When the antenna prefabrication and the electrode prefabrication are connected to the middle titanium shell, one end of the arc-shaped groove far away from the feed-through channel is butted against the support step, and the bottom of the arc-shaped groove is flush with the upper surface of the support step.

[0028] The antenna channel is flush with the plane of the support step. The second PIN pins and the antenna lead-out ends are electrically connected by means such as micro spot welding. The two second PIN pins can improve the reliability of the electrical connection. The antenna channel and the support step can provide electrical insulation protection from the middle titanium shell. The support step has a relatively high hardness and can provide the necessary support during the welding connection. Further preferably, a feed-through connection platform is fixed on the middle titanium shell. The feed-through connection platform is located on the periphery of the electrode feed-through. The feed-through connection platform is made of titanium alloy.

[0029] The first PIN pin is electrically connected to the electrode wire.

[0030] On the middle titanium shell, a first positioning platform for contacting the bottom surface of the first positioning step and a second positioning platform for contacting the bottom surface of the second positioning step are provided.

[0031] The top surface of the first positioning platform is lower than the top surface of the second positioning platform, and the top surface of the second positioning platform is lower than the top surface of the feed-through connection platform.

[0032] Further preferably, the bottom of the feed-through channel is open, the bottom of the electrode channel is closed, and the bottom of the antenna channel is closed.

[0033] The electrode channel is located above the feed-through connection platform.

[0034] Further preferably, a positioning boss is provided at the bottom of the electrode preform.

[0035] On the middle titanium shell, an electrode limit platform for embedding the positioning boss is provided.

[0036] Further preferably, it further includes an upper titanium shell. The upper titanium shell is welded to the middle titanium shell. A silica gel part is filled in the space surrounded by the upper titanium shell and the middle titanium shell. The connection part between the antenna lead-out end and the second PIN pin is buried in the silica gel part, and the connection part between the first PIN pin and the electrode wire is buried in the silica gel part.

[0037] It further includes a lower titanium shell. A PCBA board is clamped between the lower titanium shell and the middle titanium shell.

[0038] The first PIN pin and the second PIN pin on the electrode feed-through are both electrically connected to the corresponding pads of the PCBA circuit board.

[0039] Further preferably, it further includes an implanted magnet and a silica gel encapsulation. The implanted magnet is concentrically arranged with the receiving antenna component.

[0040] The silicone encapsulation integrally encapsulates the receiving antenna component, the decoding stimulator, and the implant magnet.

[0041] An assembly method of a modular positioning and assembled cochlear implant, characterized by comprising the following steps:

[0042] Step 1: Weld two electrode feedthroughs to the middle titanium shell, electrically connect the PCBA board to the electrode feedthroughs, and weld the lower titanium shell to the middle titanium shell;

[0043] Step 2: Positionally insert the electrode preform of the electrode part into the middle titanium shell;

[0044] Step 3: Connect the electrode wires in the electrode channels of the electrode preform to the first PIN pins one by one;

[0045] Step 4: Positionally insert the antenna preform of the receiving antenna part into the middle titanium shell;

[0046] Step 5: Bend the second PIN pin to pass through the antenna channel and weld it to the antenna lead-out end of the receiving antenna part;

[0047] Step 6: Fill the areas above the electrode channels, antenna channels, and feedthrough channels with silicone, and the height is the same as the upper surface of the highest part of the middle titanium shell;

[0048] Step 7: Weld the middle titanium shell to the upper titanium shell;

[0049] Step 8: Place the assembled decoding stimulator and implant magnet after Step 7 into a mold, and use silicone for the final product encapsulation to complete the silicone encapsulation.

[0050] Compared with the prior art, the beneficial effects of the present invention are:

[0051] 1) For the implanted electrode component and the receiving antenna component, by adding a positioning structure, the assembly of each component of the implant forms a modularization, improving the consistency of the components. Each component is accurately positioned, and corresponding connection channels are set for each electrical connection part, improving the reliability of the electrical connection.

[0052] 2) The modular component composition reduces the difficulty of the assembly process.

[0053] 3) The connection design between the electrode feedthrough and the receiving antenna is improved, and a buffer connection design is added, improving the connection reliability between the receiving antenna and the feedthrough.

[0054] 4) For the receiving antenna component, different parts adopt different hardness designs to meet different functional requirements. Parts that require excellent bending performance and elastic protection adopt soft silicone. Parts that require improved tensile strength and provide hard support adopt high-hardness silicone materials. Description of the Drawings

[0055] Figure 1 is a structural schematic diagram of the present invention;

[0056] Figure 2 is a partial explosion decomposition diagram of the present invention;

[0057] Figure 3 is a structural schematic diagram of the implantable electrode part of the present invention;

[0058] Figure 4 is a structural schematic diagram of the receiving antenna part of the present invention;

[0059] Figure 5 is a structural schematic diagram of the middle titanium shell of the present invention;

[0060] Figure 6 is a structural schematic diagram after the assembly of the middle titanium shell, the implantable electrode part and the receiving antenna part of the present invention.

[0061] In the figure: 1 is the decoding stimulator, 2 is the implantable electrode part, 3 is the silicone encapsulation, 4 is the implant magnet, 5 is the receiving antenna part;

[0062] 10 is the upper titanium shell, 11 is the middle titanium shell, 12 is the lower titanium shell, 13 is the electrode feedthrough, 14 is the PCBA board;

[0063] 111 is the electrode limiting platform, 112 is the first positioning platform, 113 is the positioning post, 114 is the second limiting platform, 115 is the feedthrough connection platform;

[0064] 131 is the first PIN needle, 132 is the second PIN needle, 133 is the titanium metal flange, 134 is the ceramic insulating board;

[0065] 21 is the implantable electrode, 211 is the electrode wire, 22 is the electrode preform, 221 is the electrode channel, 222 is the antenna channel, 223 is the feedthrough channel, 224 is the positioning boss;

[0066] 51 is the receiving antenna, 52 is the antenna preform, 511 is the antenna lead-out end, 512 is the C-shaped buffer bending structure, 521 is the buffer section, 5212 is the first positioning step, 5211 is the positioning hole, 522 is the limiting section, 5222 is the second positioning step, 5223 is the support step; Detailed implementation manners

[0067] The present invention will be further described below with reference to the accompanying drawings.

[0068] Refer to Figures 1 to 6, Specific Embodiment 1: A modular positioning and assembled cochlear implant includes a decoding stimulator 1, an implanted electrode component 2, a silicone encapsulation 3, an implanted magnet 4, and a receiving antenna component 5, which are composed of 5 parts in total. The core component containing the circuit part is the decoding stimulator 1, and the decoding stimulator 1 is composed of an upper titanium shell 10, a middle titanium shell 11, a lower titanium shell 12, 2 electrode feedthroughs 13, and a PCBA board 14. The PCBA board 14 is located in a sealed cavity formed by laser welding of the middle titanium shell 11, the lower titanium shell 12, and the electrode feedthrough 13, and the PCBA board 14 is electrically connected to the electrode feedthrough 13.

[0069] See Figure 2 , Figure 5 and Figure 6 , The decoding stimulator 1 includes the middle titanium shell 11 and the electrode feedthrough 13 fixedly connected by welding to the middle titanium shell 11. The electrode feedthrough 13 is provided with a first PIN pin 131 for connecting the electrode wire 211 of the implanted electrode part 2 and a second PIN pin 132 for connecting the antenna lead-out end 511 of the receiving antenna part 5. The length of the first PIN pin 131 is shorter than the length of the second PIN pin 132. The first PIN pin 131 is usually made of platinum-iridium alloy or platinum. The second PIN pin 132 is usually made of platinum-iridium alloy or platinum. The electrode feedthrough 13 includes a ceramic insulating plate 134, and the ceramic insulating plate 134 is provided with through holes for passing through the first PIN pin 131 and the second PIN pin 132. The upper and lower ends of the first PIN pin 131 and the second PIN pin 132 extend out of the ceramic insulating plate 134. The electrode feedthrough 13 includes a titanium metal flange 133, and the periphery of the ceramic insulating plate 134 is fixedly connected to the inner side of the titanium metal flange 133 through brazing solder.

[0070] See Figure 4 , The receiving antenna part 5 includes a receiving antenna 51 and an insulating antenna preform 52. The middle titanium shell 11 is positioned and inserted into the antenna preform 52. The lead-out end of the receiving antenna 51 extends out of the antenna preform 52 and is pressed into a flat antenna lead-out end 511. Specifically, the lead-out end of the receiving antenna 51 can be pressed into a flat antenna lead-out end 511 through techniques such as hot melting and micro spot welding.

[0071] See Figure 3, the implanted electrode part 2 includes an implanted electrode 21 and an insulating electrode preform 22. The middle titanium shell 11 is positioned and inserted into the electrode preform 22. The electrode preform 22 is provided with a feed-through channel 223 for exposing the electrode feed-through 13, an electrode channel 221 for exposing the electrode wire 211, and an antenna channel 222 bent in an arc shape. The electrode channel 221 is bent in a U shape. The electrode channel 221 is arranged on the periphery of the feed-through channel 223, and the opening side of the electrode channel 221 is adjacent to the antenna channel 222. The opening side of the electrode channel refers to the end of the electrode channel adjacent to the receiving antenna part. The antenna channel 222 is docked and conducted with the feed-through channel 223. The end of the electrode wire 211 extends outward from the electrode channel 221, and the first PIN pin 131 and the second PIN pin 132 extend outward from the feed-through channel 223. The first PIN pin 131 corresponds to the end of the electrode wire 211 one by one and is welded. The second PIN pin 132 is bent at the antenna channel 222, and the end of the second PIN pin 132 is welded to the antenna lead-out end 511. The electrode preform 22 is preferably made of silica gel, and the hardness of the silica gel is preferably Shore hardness 70A - 80A. It can also be made of other polymer materials with biosecurity, with the same hardness.

[0072] The antenna channel 222 is specially made into a curved arc shape so that after the second PIN pin 132 is electrically connected and connected, through its own deformation, it can buffer the external force brought by the deformation of the receiving antenna 51 and reduce the pulling force on the electrical connection point.

[0073] See Figure 3 , the electrode preform 22 is a U-shaped part with mirror symmetry. The electrode preform 22 is provided with two extension arms, and the feed-through channel 223, the electrode channel 221, and the antenna channel 222 are all opened on the two extension parts. The second PIN pin 132 is located on the side of the feed-through channel 223 adjacent to the antenna channel 222. The antenna channel 222 is located on the far side of the two feed-through channels 223, and on the side of the feed-through channel 223 far from the electrode channel 221.

[0074] See Figure 4, the antenna prefabrication 52 includes a buffer section 521 and two limiting sections 522. The two sides of the buffer section 521 are respectively connected to the limiting sections 522, and the limiting sections 522 are bent in an arc shape; positioning holes 5211 for inserting the positioning posts 113 on the middle titanium shell 11 are formed in both the buffer section 521 and the limiting sections 522; a first positioning step 5212 for positioning and plugging with the middle titanium shell 11 is arranged at the bottom of the buffer section 521; a second positioning step 5222 for positioning and plugging with the middle titanium shell 11 is arranged at the bottom of the limiting section 522, and a supporting step 5223 extending outward is arranged at the bottom of the limiting section 522 away from the buffer section 521, and the antenna lead-out end 511 is located above the supporting step 5223. The supporting step 5223 facilitates providing an operating platform for the electrical connection between the antenna lead and the second PIN pin 132, and ensures an effective supporting force for the electrical connection operation. The hardness of the buffer section 521 is less than that of the limiting section 522. The limiting section 522 is made of a material with a higher hardness. The main reason is that the receiving antenna 51 is generally composed of multiple stranded metal wires and has a certain hardness and elasticity. The limiting section 522 with a higher hardness can effectively shape and limit the receiving antenna 51. The supporting step 5223 is arranged on the limiting section 522, and the higher hardness can provide sufficient supporting force for the electrical connection operation of the receiving antenna 51.

[0075] See Figure 4 , the receiving antenna 51 includes a helically coiled portion. One end of the helically coiled portion extends outward after passing through the limiting section 522 and a buffer section 521 in sequence, and the other end of the helically coiled portion extends outward after passing through the limiting section 522 and another buffer section 521 in sequence. The end of the antenna extending out of the two buffer sections 521 is the antenna lead-out end 511; the receiving antenna 51 forms a C-shaped buffer bending structure 512 in the buffer section 521 (see Figure 6 ). By extending the two ends of the helically coiled portion outward after passing through the limiting section 522 and the buffer section 521 in sequence, when the receiving antenna 51 is bent, further buffer protection is provided to prevent pulling the solder joint between the second PIN pin 132 and the antenna lead-out end 511.

[0076] The buffer section 521 is preferably made of silica gel, and the hardness range is preferably Shore hardness 30A - 40A. During and after the implantation process, the receiving antenna 51 will bend at the junction with the decoding stimulator 1. At the same time, the receiving antenna 51 needs to be appropriately deformed to fit the skull contour. The buffer section 521 is made of a softer material, which can improve the bending performance while generating less stress during bending and less pressure on the scalp. The limiting section 522 is preferably made of silica gel, and the Shore hardness is preferably 70A - 80A. The main function of the limiting section 522 is to fix the lead-out end 511 of the receiving antenna 51 and prevent the receiving antenna 51 from being pulled by external forces. Therefore, a higher hardness is combined with the positioning post 113. At the same time, the receiving antenna 51 forms a C-shaped buffer bending structure 512 inside the limiting section 522, which further improves the positioning and anti-external force capabilities of the receiving coil and ensures the reliability of the electrical connection.

[0077] The antenna channel 222 is an arc-shaped groove with an open upper end and both ends open in the length direction. When the antenna preform 52 and the electrode preform 22 are connected to the middle titanium shell 11, the end of the arc-shaped groove far from the feed-through channel 223 is butted against the support step 5223, and the bottom of the arc-shaped groove is flush with the upper surface of the support step 5223. The antenna channel 222 is at the same height as the plane of the support step 5223. The second PIN pin 132 and the antenna lead-out end 511 are electrically connected by micro-spot welding or other methods. Two second PIN pins 132 can improve the reliability of the electrical connection. The antenna channel 222 and the support step 5223 can provide electrical insulation protection from the middle titanium shell 11. The support step 5223 has a higher hardness and can provide the necessary support during the welding connection.

[0078] See Figure 5 On the middle titanium shell 11, a feed-through connection platform 115 is fixed. The feed-through connection platform 115 is located on the periphery of the electrode feed-through. The feed-through connection platform 115 is made of titanium alloy, and the first PIN pin 131 is electrically connected to the electrode wire 211. On the middle titanium shell 11, a first positioning platform 112 for contacting the bottom surface of the first positioning step 5212 and a second positioning platform 114 for contacting the bottom surface of the second positioning step 5222 are provided. The top surface of the first positioning platform 112 is lower than the top surface of the second positioning platform 114, and the top surface of the second positioning platform 114 is lower than the top surface of the feed-through connection platform 115. The electrode feed-through 13 is placed on the feed-through connection platform 115, and the titanium metal flange 133 of the electrode feed-through 13 is laser-welded to the feed-through connection platform 115. The surface of the ceramic insulating plate 134 of the electrode feed-through 13 is slightly higher than the feed-through connection platform 115. The tops of the feed-through channel 223, the electrode channel 221, and the antenna channel 222 are all open. The bottom of the feed-through channel 223 is open, the bottom of the electrode channel 221 is closed, and the bottom of the antenna channel 222 is closed. The electrode channel 221 is located above the feed-through connection platform 115.

[0079] An electrode limiting platform 111 for embedding and positioning the boss 224 is provided on the middle titanium shell 11. Refer to Figure 3 , a positioning boss 224 is provided at the bottom of the electrode preform 22.

[0080] Refer to Figure 2 , further comprising an upper titanium shell 10, the upper titanium shell 10 is welded to the middle titanium shell 11, a silica gel part is filled in the space surrounded by the upper titanium shell 10 and the middle titanium shell 11, the connection part between the antenna lead-out end 511 and the second PIN pin 132 is embedded in the silica gel part, and the connection part between the first PIN pin 131 and the electrode wire 211 is embedded in the silica gel part; further comprising a lower titanium shell 12, a PCBA board 14 is clamped between the lower titanium shell 12 and the middle titanium shell 11; both the first PIN pin 131 and the second PIN pin 132 on the electrode feedthrough are electrically connected to the corresponding pads of the PCBA circuit board.

[0081] Further comprising an implanted magnet 4 and a silica gel package 3, the implanted magnet 4 is concentrically arranged with the receiving antenna 51 component; the silica gel package 3 integrally encapsulates the receiving antenna 51 component, the decoding stimulator 1 and the implanted magnet 4.

[0082] An assembly method of a modular positioning and assembled cochlear implant, characterized by comprising the following steps:

[0083] Step 1, welding two electrode feedthroughs 13 to the middle titanium shell 11, electrically connecting the PCBA board 14 to the electrode feedthrough 13, and welding the lower titanium shell 12 to the middle titanium shell 11;

[0084] Step 2, positioning and plugging the electrode preform 22 of the electrode part into the middle titanium shell 11;

[0085] Step 3, connecting the electrode wires 211 in the electrode channels 221 of the electrode preform 22 to the first PIN pins 131 in one-to-one correspondence;

[0086] Step 4, positioning and plugging the antenna preform 52 of the receiving antenna part 5 into the middle titanium shell 11;

[0087] Step 5, bending the second PIN pin 132 to pass through the antenna channel 222 and welding it to the antenna lead-out end 511 of the receiving antenna part 5;

[0088] Step 6, filling the electrode channels 221, the antenna channels 222, the feedthrough channels 223, and the area above the support step 5223 with silica gel, and the height is the same as the upper surface of the highest part of the middle titanium shell 11;

[0089] Step 7, welding the middle titanium shell 11 to the upper titanium shell 10;

[0090] Step eight: Place the assembled decoding stimulator 1 and the implanted magnet 4 after step seven into a mold, and use silicone to perform the final encapsulation of the product, completing the silicone encapsulation 3.

[0091] The above are only the preferred embodiments 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. A modular positioning and assembly type cochlear implant, comprising a decoding stimulator, an implanted electrode component, and a receiving antenna component, characterized in that, The decoding stimulator includes a middle titanium shell and an electrode feedthrough fixedly connected to the middle titanium shell by welding. A first PIN pin for connecting the electrode wire of the implant electrode part and a second PIN pin for connecting the antenna lead-out end of the receiving antenna part are provided on the electrode feedthrough. The length of the first PIN pin is shorter than that of the second PIN pin; The receiving antenna part includes a receiving antenna and an insulating antenna preform. The middle titanium shell is positioned and inserted into the antenna preform. The lead-out end of the receiving antenna extends out of the antenna preform and is pressed into a flat antenna lead-out end; The implant electrode part includes an implant electrode and an insulating electrode preform. The middle titanium shell is positioned and inserted into the electrode preform. A feedthrough channel for exposing the electrode feedthrough, an electrode channel for exposing the electrode wire, and an arc-shaped bent antenna channel are provided on the electrode preform; The electrode channel is U-shaped bent. The electrode channel is arranged on the periphery of the feedthrough channel, and the opening side of the electrode channel is adjacent to the antenna channel. The antenna channel is in butt connection and conduction with the feedthrough channel; The end of the electrode wire extends outwards from the electrode channel. The first PIN pin and the second PIN pin extend outwards from the feedthrough channel. The first PIN pin corresponds to the end of the electrode wire one by one and is welded; The second PIN pin is bent at the antenna channel, and the end of the second PIN pin is welded to the antenna lead-out end.

2. The modular positioning and assembled cochlear implant according to claim 1, characterized in that: The electrode preform is a U-shaped part with mirror symmetry. The electrode preform is provided with two extension arms, and the feedthrough channel, the electrode channel, and the antenna channel are all provided on the two extension parts; The second PIN pin is located on one side of the feedthrough channel adjacent to the antenna channel.

3. The modular positioning and assembling cochlear implant according to claim 1, wherein: The antenna preform includes a buffer section and two limiting sections. The two limiting sections are respectively connected to both sides of the buffer section, and the limiting sections are arc-shaped bent; Positioning holes for inserting the positioning posts on the middle titanium shell are provided on both the buffer section and the limiting section; A first positioning step for positioning and inserting with the middle titanium shell is provided at the bottom of the buffer section; A second positioning step for positioning and inserting with the middle titanium shell is provided at the bottom of the limiting section. A support step extending outwards is provided at the bottom of the limiting section away from the buffer section, and the antenna lead-out end is located above the support step.

4. The modular positioning and assembly type cochlear implant according to claim 3, wherein: The hardness of the buffer section is less than that of the limiting section.

5. A modular positioning and assembly type cochlear implant according to claim 3, characterized in that: The receiving antenna includes a spiral curling part. One end of the spiral curling part extends outwards after passing through the limiting section and one buffer section in sequence. The other end of the spiral curling part extends outwards after passing through the limiting section and the other buffer section in sequence. The end of the antenna extending out of the two buffer sections is the antenna lead-out end; The receiving antenna is in a C-shaped buffer bending structure within the buffer section.

6. The modular positioning and assembly type cochlear implant according to claim 3, wherein: The antenna channel is an arc-shaped groove with an upper opening and both ends opening in the length direction; When the antenna preform and the electrode preform are connected to the middle titanium shell, the end of the arc-shaped groove away from the feed-through channel is butted against the support step, and the bottom of the arc-shaped groove is flush with the upper surface of the support step.

7. A modular positioning and assembly type cochlear implant according to claim 1, characterized in that: A feed-through connection platform is fixed on the middle titanium shell. The feed-through connection platform is located on the periphery of the electrode feed-through. The feed-through connection platform is made of titanium alloy, and the first PIN pin is electrically connected to the electrode wire. A first positioning platform for contacting the bottom surface of the first positioning step and a second positioning platform for contacting the bottom surface of the second positioning step are provided on the middle titanium shell. The top surface of the first positioning platform is lower than the top surface of the second positioning platform, and the top surface of the second positioning platform is lower than the top surface of the feed-through connection platform.

8. A modular positioning and assembled cochlear implant according to claim 1, characterized in that: A positioning boss is provided at the bottom of the electrode preform. An electrode limiting platform for embedding the positioning boss is provided on the middle titanium shell.

9. The modular positioning and assembly type cochlear implant according to claim 1, wherein: It further includes an upper titanium shell. The upper titanium shell is welded to the middle titanium shell. A silica gel part is filled in the space surrounded by the upper titanium shell and the middle titanium shell. The connection part between the antenna lead-out end and the second PIN pin is buried in the silica gel part, and the connection part between the first PIN pin and the electrode wire is buried in the silica gel part. It further includes a lower titanium shell. A PCBA board is sandwiched between the lower titanium shell and the middle titanium shell. The first PIN pin and the second PIN pin on the electrode feed-through are both electrically connected to the corresponding pads of the PCBA circuit board.

10. The assembly method of a modular positioning and assembled cochlear implant according to claim 1, characterized in that: It includes the following steps: Step 1, weld two electrode feed-throughs to the middle titanium shell, electrically connect the PCBA board to the electrode feed-through, and weld the lower titanium shell to the middle titanium shell. Step 2, position and insert the electrode preform of the electrode part into the middle titanium shell. Step 3, connect the electrode wires in the electrode channels of the electrode preform to the first PIN pins one by one. Step 4, position and insert the antenna preform of the receiving antenna part into the middle titanium shell. Step 5, bend the second PIN pin to pass through the antenna channel and weld it to the antenna lead-out end of the receiving antenna part. Step 6, fill the areas above the electrode channel, antenna channel, and feed-through channel with silica gel, and the height is the same as the upper surface of the highest part of the middle titanium shell. Step 7, weld the middle titanium shell to the upper titanium shell. Step 8, place the assembled decoding stimulator and implant magnet after Step 7 into a mold, and use silica gel for the final product encapsulation to complete the silica gel encapsulation.

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