Integrated cochlear implant external device

Abstract

The present invention discloses an integrated external cochlear implant device. The main shell assembly includes a main shell, a spring pin, a debugging copper column, a waterproof ring, a light guide plate, a button, a fixing part, a waterproof pad, a microphone, a microphone cover, a fixing foam, a waterproof sound-permeable membrane, a D-shaped dustproof membrane, a microphone fixing part, a PCBA soft-rigid combination board, a PCB small board, and a double-hole soft board. The main shell is also provided with an X-axis buckle position, a Y-axis buckle position, and a Z-axis buckle position; the bottom shell assembly includes a bottom shell, a switch, a spring piece, and a waterproof groove. The waterproof groove is the buckled connection between the main shell assembly and the bottom shell assembly, and a waterproof fixing glue is also provided in the waterproof groove. The present invention combines the existing product with a three-in-one design and eliminates the use of precious metal titanium alloy, significantly reducing production, material, and maintenance costs, reducing volume and weight to make it more sophisticated, and effectively improving multiple technical quality indicators such as the product's waterproof effect, functional connection stability, and production efficiency.

Description

Technical Field

[0001] The present invention belongs to the field of medical devices, and in particular relates to an integrated cochlear implant external device. Background Art

[0002] See the current product structure Figure 1 The device consists of four parts: a signal processing unit 1, a transmission coil 4, a transmission conductor 3, and a behind-the-ear battery 2. The signal processing unit 1 is assembled from a left and right housing and titanium alloy connectors to form an internal space; connectors connect the components. At least the following disadvantages exist: The product currently has a large number of components and accessories, resulting in significant costs for materials, assembly labor, production yield, and packaging. Furthermore, user experience is complicated and cumbersome. Titanium alloy (machined parts with high precision requirements) is used in numerous locations, resulting in high material costs. There is no waterproof structure between the signal processing unit 1 housing and the titanium alloy connectors, and relying solely on glue for waterproofing is ineffective. The transmission conductor 3 is connected and disconnected to the signal processing unit 1 and transmission coil 4 via plug-in connections. The waterproof ring on the transmission conductor 3 is easily worn, resulting in waterproofing failure, which in turn causes rust or dirt on the contacts, impacting product performance and service life. Connectors are used in three locations, and the large number of connection points increases the risk of poor contact. During use, the transmission conductor 3 is susceptible to wear and tear, breakage, and other factors, such as sweat, heat, and twisting, which can lead to malfunction. Summary of the Invention

[0003] In order to solve the above problems, the technical solution of the present invention is as follows: an integrated cochlear implant external device, including a speech processor and a whole battery, wherein the speech processor includes a main shell assembly and a bottom shell assembly, and the whole battery includes a battery shell, a battery bottom shell assembly and a battery cell;

[0004] The main shell assembly includes a main shell, a spring pin, a debugging copper column, a waterproof ring, a light guide plate, a button, a fixing part, a waterproof pad, a microphone, a microphone cover, a fixing foam, a waterproof and sound-permeable membrane, a D-shaped dustproof film, a microphone fixing part, a PCBA soft-rigid board, a PCB small board and a double-hole soft board. The main shell is also provided with an X-axis buckle position, a Y-axis buckle position and a Z-axis buckle position; wherein, the spring pin, the debugging copper column, the waterproof ring and the D-shaped dustproof film are arranged on the surface of the main shell, and the button is arranged on both sides of the main shell;

[0005] The bottom shell assembly includes a bottom shell, a switch, a spring and a waterproof groove, wherein the waterproof groove is the buckle connection between the main shell assembly and the bottom shell assembly, and a waterproof fixing glue is also provided in the waterproof groove;

[0006] The battery shell and the battery bottom shell assembly form a confined space in which the battery cell is located, wherein a conductive copper sheet, an X-axis fastener, a Y-axis fastener and a battery switch buckle are provided on the lower surface of the battery bottom shell assembly, the conductive copper sheet forms an electrical connection with the spring pin, a mirror polished surface is provided around the conductive copper sheet, and the position and size of the mirror polished surface correspond to the waterproof ring; a Z-axis fastener is provided on the side of the battery shell, and the X-axis fastener, the Y-axis fastener and the Z-axis fastener match the position and shape of the X-axis buckle, the Y-axis buckle and the Z-axis buckle; the battery switch buckle and the switch of the bottom shell assembly are in a buckling relationship in the default assembly state.

[0007] Preferably, the main shell and the debugging copper column are injection molded together using an injection molding machine. A groove structure is designed on the debugging copper column. During injection molding, the plastic fills the groove structure, and the end of the debugging copper column is 0.05±0.02mm higher than the surface of the main shell.

[0008] Preferably, a plurality of dot-shaped grooves are provided on the side of the waterproof ring in contact with the main shell, and a triangular protrusion structure is provided along the edge of the side not in contact with the main shell, that is, a structure with the same shape as the waterproof ring and a triangular cross-section is formed, and the height of the triangle is 0.1±0.02mm.

[0009] Preferably, the spring pin is 0.7±0.05 mm higher than the surface of the main shell.

[0010] Preferably, the button is pressed by a button waterproof pad, a fixing part and a PCB board, the waterproof pad and the main shell have an interference of 0.15mm, and the inner side of the button position of the main shell is mirror polished.

[0011] Preferably, the waterproof and sound-permeable membrane is attached to the end of the microphone, the microphone cover is arranged around the side of the microphone, the microphone cover is tightly fitted with the side of the microphone, the outer side of the microphone cover is coated with waterproof fixing glue, and is installed in the corresponding positioning groove in the main shell; two microphones are provided, one microphone is fixed into the main shell through a microphone fixing part, a positioning hole is provided on the microphone fixing part, and a positioning column is provided at the corresponding position of the main shell. The positioning column is hexagonal and the top is chamfered for easy assembly. The size is 0.90±0.03mm, and the diameter of the positioning hole on the microphone fixing part is 0.75±0.05mm. The two are tightly fitted, and the microphone is firmly pressed by the microphone fixing part; the top of the other microphone is fixed with foam, and the PCBA soft-hard combination board is assembled to press the microphone firmly.

[0012] Preferably, the switch includes a battery locking buckle, a hand buckle and a guide bevel buckle. The battery locking buckle and the battery switch buckle are buckled and locked in the default assembly state. After the hand buckle is assembled, the bottom shell is exposed. The hand buckle is pulled to deform the spring piece, and the battery switch buckle is loosened from the battery locking buckle, and the entire battery is separated from the speech processor; when the hand buckle is released, the spring piece rebounds the switch to its original position, and sun patterns are set on the hand buckle; the guide bevel buckles are set one on each side of the switch, with a side bevel and a top flat structure.

[0013] Preferably, a surface of the Y-axis fastener close to the battery switch buckle position is at an angle of 70°±0.2° to the lower surface of the bottom shell.

[0014] Preferably, the upper inclined surface of the Z-axis fastener is at an angle of 10°±0.2° to the horizontal plane.

[0015] Preferably, the main shell component is also provided with a main hanging rope component, which includes a boss; the bottom shell component is also provided with a bottom hanging rope component, which includes a buckle hole. After the main shell component and the bottom shell component are assembled, the boss and the buckle hole are engaged, and the main hanging rope component and the bottom hanging rope component form a hanging rope hole.

[0016] The beneficial effects of the present invention are:

[0017] Cost reduction: Existing products have numerous components and accessories, and titanium alloy is often used (machined parts with high precision requirements). This leads to significant costs, including material costs, assembly labor costs, production yield, and packaging. However, this new invention integrates the signal processing unit and transmission coil PCBA into a single unit. This flexible board connection and folding effectively reduce product size and eliminate the need for transmission wires, achieving a three-in-one design. The battery is connected to the signal processor using a snap-on design, eliminating the need for expensive materials like titanium alloy. This significantly reduces production costs. Based on an annual production volume of 5,000 units, this product can save 10 million RMB annually.

[0018] Improved functional reliability of the entire device, providing a better user experience: Existing technologies, due to the large number of components and accessories, make use more complex and cumbersome. The numerous connectors and connection points increase the risk of poor contact. Transmission wires are susceptible to wear and tear, and the cores can break, causing malfunctions, due to factors such as sweat, heat, and twisting. In contrast, the present invention connects only the battery and signal processor, significantly reducing the risk of poor contact and malfunction. The integrated device simply attaches to the implant when worn, making operation simple and quick. This improves the functional reliability of the entire device, provides a better user experience, and enhances the product's market competitiveness. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 Schematic diagram of the structure of an external cochlear implant in the prior art;

[0020] Figure 2 This is a schematic diagram of the external structure of the main housing component of an integrated cochlear implant external device according to a specific embodiment of the present invention;

[0021] Figure 3 This is a schematic diagram of the internal structure of the main housing component of an integrated cochlear implant external device according to a specific embodiment of the present invention;

[0022] Figure 4 This is a schematic diagram of the circuit structure of an integrated cochlear implant external device according to a specific embodiment of the present invention;

[0023] Figure 5 This is a schematic structural diagram of a bottom shell assembly of an integrated cochlear implant external device according to a specific embodiment of the present invention;

[0024] Figure 6 A schematic diagram of a hook hole structure of an integrated cochlear implant external device according to another specific embodiment of the present invention;

[0025] Figure 7 A schematic structural diagram of a battery bottom housing assembly including an integrated cochlear implant external device according to a specific embodiment of the present invention;

[0026] Figure 8 This is a schematic diagram of the upper surface structure of the main housing component of an integrated cochlear implant external device according to a specific embodiment of the present invention;

[0027] Figure 9 This is a schematic diagram of the entire battery structure of an integrated cochlear implant external device according to a specific embodiment of the present invention;

[0028] Figure 10 Schematic diagram of the overall structure of an integrated cochlear implant external device according to a specific embodiment of the present invention. DETAILED DESCRIPTION

[0029] The preferred embodiments of the present invention will be described in detail below with reference to the accompanying drawings.

[0030] See also Figure 2-10, an integrated cochlear implant external device, including a speech processor 50 and a battery 34, wherein the speech processor 50 includes a main shell assembly and a bottom shell assembly, and the battery 34 includes a battery shell 31, a battery bottom shell assembly 32 and a battery cell 33; the main shell assembly includes a main shell 11, a spring pin 14, a debugging copper column 13, a waterproof ring 12, a light guide plate 22, a button 231, a fixing part 232, a waterproof pad 233, a microphone 251, a microphone cover 252, and a fixing foam 2 53, waterproof and sound-permeable membrane 254, D-shaped dustproof membrane 255, microphone fixing part 256, PCBA soft-rigid board 261, PCB small board 262 and double-hole soft board 263, the main shell 11 is also provided with X-axis buckle 112, Y-axis buckle 113 and Z-axis buckle 111; among them, the spring pin 14, debugging copper column 13, waterproof ring 12 and D-shaped dustproof membrane 255 are arranged on the surface of the main shell 11, and the button 231 is arranged on both sides of the main shell 11; bottom shell assembly It includes a bottom shell 21, a switch 22, a spring 23 and a waterproof groove 24, wherein the waterproof groove 24 is the buckling connection between the main shell assembly and the bottom shell assembly, and a waterproof fixing glue is also provided in the waterproof groove 24; the battery shell 31 and the battery bottom shell assembly 32 form a closed space, in which the battery cell 33 is located, wherein a conductive copper sheet 322, an X-axis fastener 36, a Y-axis fastener 37 and a battery switch buckle 38 are provided on the lower surface of the battery bottom shell assembly 32, the conductive copper sheet 322 forms an electrical connection with the spring pin 14, and a mirror-polished surface is provided around the conductive copper sheet 322, the position and size of the mirror-polished surface correspond to the waterproof ring 12; a Z-axis fastener 35 is provided on the side of the battery shell 31, and the X-axis fastener 36, the Y-axis fastener 37 and the Z-axis fastener 35 match the position and shape of the X-axis buckle 112, the Y-axis buckle 113 and the Z-axis buckle 111; the battery switch buckle 38 and the switch 22 of the bottom shell assembly are in a buckling relationship in the default assembly state.

[0031] See Figure 2 、 Figure 3 , main shell assembly, wherein the main shell 11 & debugging copper column 13 are injection molded together using an injection molding machine, and a groove structure is designed on the debugging copper column 13. During injection molding, the plastic fills the groove to achieve better waterproof effect and bonding firmness (see Figure 2 , size 5, 12), the end of the copper column 13 is adjusted to be 0.05mm higher than the plastic to prevent the plastic covering the end from affecting the electrical conduction stability (see Figure 2 , size 11); then replace the injection molding machine and the overmolding mold to perform soft overmolding of the waterproof ring 12, and design a 0.2*0.3mm groove on the hard plastic part of the shell and evenly distribute several small dots with a diameter of 0.5mm (see Figure 2 , size 7, 13, 14), the small dots increase the complexity of the groove to improve the waterproof ring 12 soft glue filled with the groove during injection molding has better bonding firmness and will not cause poor injection shrinkage due to too thick glue, the top of the waterproof ring 12 is set with a 0.15*0.1mm triangular small protrusion structure (see Figure 2 , size 8, 9), when pressed together with the battery, it can compensate for the size difference and the influence of deformation, so as to achieve an excellent sealing and waterproof effect. Moreover, this triangular protrusion structure is small and will not affect the strength during assembly. Then the spring pin 14 is installed into the main shell 11 in an interference fit manner. The spring pin 14 is tightly matched with the barb position with a diameter of 1.08mm, corresponding to the diameter of the hole in the main shell 11 of 1.05mm (see Figure 2 , size 4, 6), and the main shell 11 is designed to be 0.1mm higher than the end of the spring needle 14 sleeve (see Figure 2 , size 10), which can protect the closing position of the spring pin 14 to prevent damage during assembly and use, thereby improving reliability and life; this four-in-one can achieve better waterproof effect and higher product strength.

[0032] See also Figure 3 The buttons 231 on both sides of the main shell assembly are pressed tightly by using waterproof pads 233, fixing parts 232 and PCB small boards 262, so that the waterproof pads 233 and the main shell 11 have an interference of 0.15mm. At the same time, the inner side of the button 231 position of the main shell 11 is mirror polished to achieve a sealing and waterproof effect; this is a mechanical installation, which can be disassembled multiple times, facilitating maintenance and reuse of related parts, thereby reducing production and maintenance costs.

[0033] The light guide plate 22 is installed in the main shell 11. The main shell 11 is designed with a corresponding glue groove 221. The positioning column 222 designed in the main shell 11 is hexagonal and chamfered at the top for easy assembly. The size is 0.90mm. The positioning hole 223 with a diameter of 0.75mm is set corresponding to the light guide plate 22. The assembly and fixation are achieved by tight fit. When assembling, first fill the glue groove 221 with waterproof fixing glue, and then assemble the light guide plate 22 with the main shell assembly. When assembling, the waterproof fixing glue overflows the glue gap of the light guide plate 22 (see Figure 3 B, size 1), thereby achieving the assembly, fixation and waterproof design requirements of the light guide plate 22.

[0034] The microphone 251 is installed in the main shell assembly. The main shell 11 is designed to correspond to the positioning groove 257 of the microphone 251. First, the waterproof sound-permeable membrane 254 (including waterproof adhesive) is attached to the end of the microphone 251 to ensure smooth sound transmission while preventing water from entering the interior of the microphone 251. Then, the microphone cover 252 is put on (tightly matched with the side of the microphone 251 for waterproofing). Next, waterproof fixing glue is applied to the outer side of the microphone cover 252, and then it is installed in the corresponding positioning groove 257 of the microphone 251. During assembly, the waterproof fixing glue overflows the outer side of the microphone cover 252, tightly fitting the microphone 251 and the main shell 11. Tightly combined, thus playing a waterproof role; then the microphone fixing part 256 of the microphone 251 is installed into the main shell assembly, and the assembly is similar to the light guide plate 22. The positioning column corresponding to the setting position of the main shell 11 is hexagonal and the top is chamfered for easy assembly. The size is 0.90mm, and the positioning hole diameter is 0.75mm corresponding to the microphone fixing part 256 of the microphone 251 is set. The tight fit realizes assembly and fixation, and presses the microphone 251 firmly; the foam 253 is pasted on the top of the microphone 251 on the other side, and the PCBA soft-rigid combination board 261 is assembled to press the microphone 251 firmly (see Figure 3 D), thereby achieving the assembly, fixation and waterproof design requirements of the microphone 251.

[0035] See also Figure 4 , the circuit structure diagram is one of the key design technologies. The use of PCBA soft and hard board 261 expands the electronic device arrangement area. The upper part is designed with a circular structure hard board transmission coil line to achieve compatibility with the current implant (see Figure 4 , size 1 and 2), and another part of the hard board is also made into an arc shape (see Figure 4 , sizes 3 and 4); soft boards (see Figure 4 The electronic circuits in the mesh part of the circuit board replace the current transmission wires and organically unify the existing signal processing unit PCBA and transmission coil PCBA. The flexible board can be folded to effectively reduce the product volume, thus achieving the purpose of the three-in-one design of the signal processing unit 1 & transmission wire 3 & transmission coil 4 in the existing technology (see Figure 1 ); thereby achieving multiple design goals such as reducing production costs, improving yield, improving reliability, reducing the size of the entire machine, reducing the number of components to make it more compact. The PCB small board 262 and the double-hole soft board 263 are connected and conducted through welding and the PCBA soft-rigid board 261 components, and then folded and installed in the main shell assembly in an orderly manner (see Figure 3 and Figure 4 ).

[0036] join Figure 5The bottom shell assembly includes a bottom shell 21, a switch 22, a spring 23, and a waterproof groove 24. The waterproof groove 24 is the buckle connection between the main shell assembly and the bottom shell assembly. Waterproof fixing glue is also provided in the waterproof groove 24. The position of the switch 22 on the bottom shell 21 is a buckle position. Grooved structures are provided on both sides of the buckle position to ensure toughness in a small height space to prevent the switch 22 from not being able to be installed or being deformed and damaged during assembly. After assembly with the main shell 11, the ribs of the main shell 11 firmly press against the back of the buckle position of the bottom shell 21 to ensure that the switch 22 does not loosen when sliding. A guide bevel buckle 212 is provided for the corresponding switch 22 and is made smooth to ensure smooth installation. The battery locking buckle 213 of the switch 22 is a setting that locks the entire battery 34 in the default assembly state. The buckle design features rounded corners and a smooth top surface to ensure smooth sliding of the switch 22. A tan pattern is provided on the hand buckle 211, which is exposed outside the bottom housing assembly. Pressing the hand buckle 211 presses the spring 23, disengaging the battery switch 22 from the battery locking buckle 213, thereby separating the battery 34 from the speech processor 50. The spring 23 has four curved arcs on each side to ensure sufficient rebound travel and resilience, thereby ensuring the life of the switch 22.

[0037] In a specific embodiment, the main housing 11 is assembled with the light guide plate 22, the button 231, the PCBA and other steps completed (see Figure 3 D), the bottom shell assembly is completed (see Figure 5 ), and then the waterproof fixing glue is applied to the waterproof groove 24 of the bottom shell 21. The two are assembled by tightly fitting through six positioning holes and positioning columns, thereby achieving a full range of waterproof sealing and strength design of the signal processor; the positioning holes do not require glue to achieve multiple disassembly and assembly, thereby reducing maintenance costs.

[0038] See also Figure 6 , Figure 6 (1) is the overall structure of the lanyard hole 40, Figure 6 (2) is a bottom view of the lanyard hole 40, which has two holes 401. Figure 6 (3) The main hanging rope member 41 structure, Figure 6 (4) It is a bottom hanging rope component 42 structure. The main shell assembly is also provided with a main hanging rope component 41. The main hanging rope component 41 includes a boss 411. The bottom shell assembly is also provided with a bottom hanging rope component 42. The bottom hanging rope component 42 includes a buckle hole 421. After the main shell assembly and the bottom shell assembly are assembled, the boss 411 and the buckle hole 421 are engaged. The main hanging rope component 41 and the bottom hanging rope component 42 form a hanging rope hole 40. The main hanging rope component 41 corresponds to a glue thickness of 0.79mm, the boss 411 has a thickness of 0.31mm and a width of 2.00mm. The bottom hanging rope component 42 corresponds to a glue thickness of 0.61mm and a buckle hole 421 with a width of 2.45mm. After the two are assembled, the glue position overlaps with a thickness of 1.4mm, and the interference amount at the buckle is 0.25mm. When the hanging rope is pulled in the direction a (see Figure 6(1), as shown by arrow a), the bottom hanging rope member 42 is pressed against the main shell 11, and the boss 411 is locked tightly against the top of the buckle hole 421. At the same time, the colloid strength of the two is increased due to the close contact and superposition, thereby meeting the pulling strength requirement of the hanging rope; when the hanging rope is pulled in the direction b and the left and right directions (see Figure 6 (1), as indicated by arrow b), the bottom hanging rope member 42 is also pressed against the main shell 11. At this time, the 4.56mm width buckle hole 421 and the 4.76mm width boss 411 will overlap and work together to meet the pulling strength requirements of the hanging rope. When the hanging rope is pulled in the direction c (see Figure 6 (1), as indicated by the arrow c), the bottom hanging rope member 42 will also be pressed against the main shell 11, and the top of the buckle hole 421 will be locked and pulled by the boss 411. At the same time, the strength of the glue between the two is increased due to the close contact and superposition, thereby meeting the pulling strength requirement of the hanging rope; in this way, the design requirement of greater hanging rope pulling strength can be achieved in all directions under the condition of smaller space and thinner glue thickness.

[0039] See also Figure 7The lower surface of the battery bottom shell assembly 32 is provided with a conductive copper sheet 322, an X-axis fastener 36, a Y-axis fastener 37, and a snap-on position for the battery switch 22. The conductive copper sheet 322 forms an electrical connection with the spring pin 14. The conductive copper sheet 322 is surrounded by a mirror-polished surface, the position and size of which correspond to the waterproof ring 12. A Z-axis fastener 35 is provided on the side of the battery housing 31. The X-axis fastener 36, Y-axis fastener 37, and Z-axis fastener 35 match the position and shape of the X-axis snap-on positions 112, Y-axis snap-on positions 113, and Z-axis snap-on positions 111. The battery switch snap-on position 38 snaps into place with the bottom shell assembly's switch 22 in the default assembly state. The battery bottom shell assembly 32 is integrally injection-molded with the conductive copper sheet 322, achieving excellent strength and waterproofing. If integrated injection molding is to be achieved, the conductive copper sheet 322 must be placed in the injection mold for positioning first. Therefore, each PCS conductive copper sheet 322 requires two positioning holes 326 to prevent left and right rotation. To prevent thin iron tips from appearing in the mold, the corresponding plastic position is designed to give way. It also requires up and down positioning to achieve complete fixation. Therefore, three positioning process holes 325 must be made on the shell of the battery bottom shell assembly 32 to fix the three conductive copper sheets 322 respectively. The total thickness of the plastic position corresponding to the three conductive copper sheets 322 is only 1.05mm. The three conductive copper sheets 322 must be clamped together to achieve injection molding and strength requirements. A conductive copper sheet 322 with a thickness of 0.15mm is selected and a 0.5mm bend design is performed. In this way, the upper part of the copper sheet can be covered with 0.5mm of plastic, the lower part can be covered with 0.4mm of plastic, and the plastic thickness at the connector position of the battery cell 33 at both ends is 0.9mm, thereby achieving the fullness, waterproofness, and strength requirements of the injection molding in the thickness direction and the design requirement that the battery cell 33 will not be deformed by welding. The length and width of the plastic part corresponding to the three conductive copper sheets 322 are only 12.40*6.50mm. In order to ensure that the exposed conductive area outside the three conductive copper sheets 322 and the welding area of the internal battery core 33 are large enough and to achieve injection molding strength, appearance and waterproof effect, the ends of the conductive copper sheets 322 are serrated with a depth of 0.15mm. In this way, the distance from the copper sheet to the outer side of the plastic can reach 0.2mm and 0.35mm (see Figure 7 , dimensions 2 and 3) can avoid incomplete injection molding and poor copper exposure caused by too thin a glue layer, thereby ensuring both appearance and electrical performance. The distance between the conductive copper sheet 322 and the outer side of the plastic part is 0.2mm, corresponding to a distance of 0.3mm from the inner side of the plastic part, thus ensuring sufficient bonding strength on the inside. This ensures that the exposed conductive area 323 outside the three conductive copper sheets 322 and the soldering area of the internal battery cell 33 are sufficiently large, ensuring injection molding strength, appearance, and waterproofing.

[0040] See also Figure 8The D-shaped dust shield 255, with its own high-temperature-resistant adhesive backing, is attached to the dust shield fixing slots 2551 located near the microphone 251 holes on both sides, effectively shielding the microphone 251 from external dust and extending the product's lifespan. Customers can easily replace and clean the shield themselves, significantly reducing shipping and repair costs. Customers also avoid long wait times for repairs, ensuring a positive user experience.

[0041] See also Figure 10 , a schematic diagram of the overall structure, shows the complete battery 34 comprising a battery housing 31, a battery bottom assembly 32, and a battery cell 33. The connectors of the battery cell 33 are welded to the battery bottom assembly 32 and secured. The battery housing 31 and battery bottom assembly 32 are then ultrasonically welded together to achieve a waterproof seal. The signal processor and the complete battery 34 are assembled using three-axis snap fasteners and a battery switch snap 38. To disassemble, the switch 22 is activated, and the interference of the waterproof ring 12 automatically ejects the complete battery 34, allowing for easy removal. The Z-axis fastener 35 of the entire battery 34 is first aligned with the Z-axis buckle 111 of the signal processor, and then the rear end of the entire battery 34 is pressed to press the X-axis fastener 36 and the X-axis buckle 112 into and lock the battery switch buckle 38; wherein the Z-axis fastener 35 and the Z-axis buckle 111 are positioned in the Z-axis direction, and the upper surfaces of the two are tilted at a 10° angle for smooth assembly and disassembly, and the design value of the assembly clearance is 0.06mm; wherein the X-axis fastener 36 and the X-axis buckle 112 are positioned in the X-axis direction, the design size of the X-axis buckle 112 is 33.87mm, and the design size of the X-axis fastener 36 is 33.70mm The assembly clearance is designed to be 0.1mm. The Y-axis fastener 37 and the Y-axis buckle 113 are positioned in the Y-axis direction. The design dimensions of the Y-axis buckle 113 are 33.70mm. To ensure smooth assembly and disassembly, a small positioning clearance, and good positioning, the Y-axis fastener 37 and the Y-axis buckle 113 must be designed with a reasonable tilt angle. The angle between the sides of the two components closest to the battery switch buckle 38 and the horizontal direction is designed to be 70°, achieving a post-assembly clearance value of less than 0.1mm. The entire battery 34 is mirror-polished at the position corresponding to the signal processor waterproof ring 12, thereby better sealing and tightening the waterproof ring 12, thereby meeting the waterproof and dustproof design requirements of the entire product.

[0042] The present invention has carried out waterproof test, and the scheme is as follows:

[0043] a. Test Purpose:

[0044] The integrated cochlear implant external device is subjected to a simulated IPX4 waterproof performance test, i.e. a test of its ability to prevent splashing water intrusion, to confirm the waterproof performance of the sample.

[0045] b. Test methods and procedures:

[0046] b.1 Check the appearance of the sample. The sample surface should have no obvious damage, deformation, or looseness.

[0047] b.2 Hold the sample so that the distance between the top of the sample and the faucet outlet is about 300 mm.

[0048] b.3 Turn on the faucet so that the water drips continuously.

[0049] b.4 Hold the sample in hand and rotate it 360° at a constant speed under water flow, and keep the time.

[0050] b.5 After five minutes, remove the sample from the water flow and gently wipe the sample surface with a dust-free paper until there is no obvious water mark.

[0051] b.6 Remove the battery, open the upper and lower covers of the sample, and observe whether there is water ingress into the waterproof ring, the inside of the shell, and the PCB board, and record the results.

[0052] c. Test data record:

[0053] Table 1 Record of water ingress after testing of integrated cochlear implant in vitro device samples

[0054]

[0055] d. Experimental conclusion:

[0056] The integrated cochlear implant device has passed a simulated IPX4 waterproof rating test, and no water intrusion was observed inside the waterproof ring, the battery housing, the signal processor housing, or the PCB. The integrated cochlear implant device sample has passed the simulated IPX4 waterproof rating test, demonstrating effective protection against splashing water.

[0057] A strength drop test was also carried out, the scheme is as follows:

[0058] a. Test Purpose:

[0059] The assembled integrated cochlear implant in vitro device was subjected to a drop strength performance test to confirm the strength and drop resistance of the sample.

[0060] b. Test methods and procedures:

[0061] b.1 Check the appearance and performance of the sample. The sample surface should have no obvious damage or deformation, no looseness, and no abnormal function.

[0062] b.2 The room temperature sample is freely dropped from 1.5 meters onto a cement floor, with each side falling twice for a total of 12 times.

[0063] b.3 Perform appearance and performance inspection on the sample to ensure it is free of damage, deformation, loose batteries, and function properly; record the results. b.4 Perform a drop test after the high and low temperature cycle. The high and low temperature cycle conditions are: high temperature (60°C) for 1 hour, low temperature (-20°C) for 1 hour, 25 cycles. After completion, remove the sample and allow it to rest for 2 hours. If no abnormalities are detected, perform a free drop test using the same method as at room temperature.

[0064] b.5 Perform appearance and performance inspection on the sample. There should be no damage, deformation, loose batteries, and normal function. Record. b.6 Disassemble and analyze the final failed sample and record.

[0065] c. Test data record:

[0066] Table 2. Appearance and function of integrated cochlear implant in vitro device samples after testing

[0067]

[0068] d. Experimental conclusion:

[0069] The assembled integrated cochlear implant external device was subjected to a 1.5-meter free drop test, a high and low temperature cycle test, and a subsequent 1.5-meter free drop test. The sample showed no loose batteries or internal abnormal noises, and there were no obvious abnormalities in the appearance and function of the entire battery and signal processor.

[0070] Finally, it should be noted that the above preferred embodiments are only used to illustrate the technical solutions of the present invention and are not limiting. Although the present invention has been described in detail through the above preferred embodiments, those skilled in the art should understand that various changes can be made in form and details without departing from the scope defined by the claims of the present invention.

Claims

1. An integrated cochlear implant external device, characterized in that: The invention comprises a speech processor and a whole battery, wherein the speech processor comprises a main shell component and a bottom shell component, and the whole battery comprises a battery shell, a battery bottom shell component and a battery cell; The main shell assembly includes a main shell, a spring pin, a debugging copper column, a waterproof ring, a light guide plate, a button, a fixing part, a waterproof pad, a microphone, a microphone cover, a fixing foam, a waterproof and sound-permeable membrane, a D-shaped dustproof membrane, a microphone fixing part, a PCBA soft-hard combination board, a PCB small board and a double-hole soft board. The main shell is also provided with an X-axis buckle position, a Y-axis buckle position and a Z-axis buckle position; wherein, the spring pin, the debugging copper column, the waterproof ring and the D-shaped dustproof membrane are arranged on the surface of the main shell, and the button is arranged on both sides of the main shell; the main shell and the debugging copper column are injection molded; the button is pressed by the waterproof pad, the fixing part and the PCB small board; the waterproof and sound-permeable membrane is attached to the end of the microphone, the microphone cover is arranged around the side of the microphone, and the microphone cover is tightly fitted with the side of the microphone; two microphones are provided, one microphone is fixedly assembled into the main shell by a microphone fixing part; the top of the other microphone is pasted with fixed foam, and the PCBA soft-hard combination board presses the microphone firmly after assembly; the PCB small board and the double-hole soft board are connected and conductive to the PCBA soft-hard combination board through welding; The bottom shell assembly includes a bottom shell, a switch, a spring and a waterproof groove, wherein the waterproof groove is the buckle connection between the main shell assembly and the bottom shell assembly, and a waterproof fixing glue is also provided in the waterproof groove; The battery shell and the battery bottom shell assembly form a confined space in which the battery cell is located. A conductive copper sheet, an X-axis fastener, a Y-axis fastener and a battery switch buckle are provided on the lower surface of the battery bottom shell assembly. The conductive copper sheet forms an electrical connection with the spring pin. A mirror polished surface is provided around the conductive copper sheet. The position and size of the mirror polished surface correspond to the waterproof ring. A Z-axis fastener is provided on the side of the battery shell. The X-axis fastener, the Y-axis fastener and the Z-axis fastener match the position and shape of the X-axis buckle, the Y-axis buckle and the Z-axis buckle. The battery switch buckle and the switch of the bottom shell assembly are in a buckling relationship in the default assembly state.

2. The integrated cochlear implant external device according to claim 1, characterized in that: The main shell and the debugging copper column are injection molded together using an injection molding machine. A groove structure is designed on the debugging copper column. During injection molding, the plastic fills the groove structure, and the end of the debugging copper column is 0.05±0.02mm higher than the surface of the main shell.

3. The integrated cochlear implant external device according to claim 1, characterized in that: The waterproof ring is provided with several dot-shaped grooves on the side in contact with the main shell, and a triangular protrusion structure is provided along the edge on the side not in contact with the main shell, forming a structure with the same shape as the waterproof ring and a triangular cross-section. The height of the triangle is 0.1±0.02mm.

4. The integrated cochlear implant external device according to claim 1, characterized in that: The spring pin is 0.7±0.05 mm higher than the surface of the main shell.

5. The integrated cochlear implant external device according to claim 1, characterized in that: The waterproof pad and the main shell have an interference of 0.15mm, and the inner side of the main shell at the button position is mirror polished.

6. The integrated cochlear implant external device according to claim 1, characterized in that: The outer side of the microphone cover is coated with waterproof fixing glue and installed in the corresponding positioning groove in the main shell; a positioning hole is set on the microphone fixing part, and a positioning column is set at the corresponding position of the main shell. The positioning column is hexagonal and the top is chamfered for easy assembly. The size is 0.90±0.03mm. The diameter of the positioning hole on the microphone fixing part is 0.75±0.05mm. The two are tightly matched, and the microphone fixing part presses the microphone firmly.

7. The integrated cochlear implant external device according to claim 1, characterized in that: The switch includes a battery locking buckle, a hand buckle and a guide bevel buckle. The battery locking buckle and the battery switch buckle are buckled and locked in the default assembly state. After the hand buckle is assembled, the bottom shell is exposed. The hand buckle is pulled to deform the spring piece, and the battery switch buckle is loosened from the battery locking buckle, and the entire battery is separated from the speech processor; when the hand buckle is released, the spring piece rebounds the switch to its original position, and a sunburst pattern is set on the hand buckle; the guide bevel buckle is set on each side of the switch, with a side bevel and a top flat structure.

8. The integrated cochlear implant external device according to claim 1, characterized in that: The side of the Y-axis fastener close to the battery switch buckle position is 70°±0.2° with the lower surface of the bottom shell.

9. The integrated cochlear implant external device according to claim 1, characterized in that: The upper inclined surface of the Z-axis fastener is 10°±0.2° with the horizontal plane.

10. The integrated cochlear implant external device according to claim 1, characterized in that: The main shell assembly is also provided with a main hanging rope part, which includes a boss; the bottom shell assembly is also provided with a bottom hanging rope part, which includes a buckle hole. After the main shell assembly and the bottom shell assembly are assembled, the boss and the buckle hole are engaged, and the main hanging rope part and the bottom hanging rope part form a hanging rope hole.

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