CN113499539A

CN113499539A - Artificial cochlea implant

Info

Publication number: CN113499539A
Application number: CN202110734437.8A
Authority: CN
Inventors: 王澄; 贺光明; 许车明; 杨烨; 翁丰雷
Original assignee: Shanghai Listent Medical Tech Co ltd
Current assignee: Shanghai Listent Medical Tech Co ltd
Priority date: 2021-06-30
Filing date: 2021-06-30
Publication date: 2021-10-15

Abstract

The invention discloses a cochlear implant, which comprises an implanted electrode, a decoder, an implanted antenna, an implanted magnet and a silica gel sleeve, wherein the decoder comprises an upper shell, a middle shell, a lower shell, a communicating vessel and a circuit board; the upper shell, the middle shell and the lower shell form a shell of the decoder; the mid-shell including a linker via near the front end; the front surface of the middle shell comprises a communicating vessel platform, a front supporting column and a front rear supporting column which are propped against the upper shell; the back of the middle shell comprises a circuit board cavity, a cavity supporting column which is positioned in the circuit board cavity and props against the lower shell, and a front supporting column which props against the back of the lower shell. This artifical cochlear implant passes through the linker leading for the rear end is compared to the size of decoder front end thick, is favorable to operation implantation and postoperative to resume, simultaneously, through optimizing decoder inner structure, makes it have stronger structural strength, effectively avoids deformation, can form stronger protection to the inside electronic components of decoder.

Description

Artificial cochlea implant

Technical Field

The invention relates to a cochlear implant, in particular to an implant of the cochlear implant.

Background

The working principle of the artificial cochlea is that an acoustoelectric transducer device is utilized to replace the hair cells which lose functions in the cochlea of the deaf person, and the auditory nerve is directly stimulated to enable the deaf person to generate auditory sense. The artificial cochlea comprises a sound processor (an external device) and an implanted body (an internal device), wherein the signal transmission between the sound processor and the implanted body is completed through electromagnetic induction, the sound processor and the implanted body are separated by skin, and no lead is connected. The implanted part is, in contrast, the critical part through which the sound processor can only achieve a recovery of hearing.

The implant includes electronic circuit-like components that act as the "brain" for the implant, and once a fault occurs, the implant will fail to operate. In the current development process of the implant, two major problems to be solved are that firstly, the long-term corrosion of moisture, biological salt and the like in a human body needs to be prevented, and secondly, because the implant is implanted into the subcutaneous part of the temporal bone of the head, the implant needs to have enough impact strength in daily life due to possible accidental impact. The conventional cochlear implant consists of a titanium shell and a communicating vessel, wherein the communicating vessel generally adopts a scheme of a single communicating vessel and multiple PIN needles or multiple communicating vessels according to the number of channels of the implant. The PIN needle of sealing circuit and external electrode is connected to single linker scheme, because electrode quantity is many, sealed requirement is high, and production technology is complicated, and is with high costs. The scheme of a plurality of communicating vessels is adopted by an individual implant, the number of the communicating vessels is increased, the part cost is also increased, meanwhile, the number of welding seams for welding and sealing the shell is increased by the scheme of a plurality of communicating vessels, the difficulty of the production process is correspondingly increased, and the sealing qualified rate is reduced. At present, the mainstream implant adopts a square appearance structure, and in order to prevent the displacement of the implant, a bone bed with the same size as an implant decoder needs to be ground, the operation incision is large, the grinding processing time of the bone bed is long, and the temporal bone wound is large.

Disclosure of Invention

In view of the above-mentioned drawbacks of the prior art, an object of the present invention is to provide a cochlear implant with a decoder having a relatively thin thickness and a relatively strong structural strength.

In order to achieve the above object, the present invention provides a cochlear implant, which includes an implant electrode, a decoder, an implant antenna, an implant magnet, and a silicone sleeve, wherein the implant magnet is located in the implant antenna, and the silicone sleeve encapsulates other components; the decoder comprises an upper shell, a middle shell, a lower shell, a communicating vessel, a circuit board, a distribution disc, a communicating vessel gasket, a circuit board upper gasket and a circuit board lower gasket; the upper shell, the middle shell and the lower shell form a shell of the decoder; the mid-shell including a linker via near the front end; the front surface of the middle shell comprises a communicating vessel platform positioned at the periphery of the communicating vessel through hole, a front support column close to the front end and propped against the front surface of the upper shell, a rear support column close to the rear end and propped against the front surface of the upper shell, an antenna channel close to the periphery, an electrode opening positioned at the front end and an antenna opening positioned at the rear end; the back of the middle shell comprises a circuit board cavity, a cavity supporting column which is positioned in the circuit board cavity and props against the lower shell, a circuit board platform which is positioned at the periphery of the circuit board cavity, and a front supporting column which is close to the communicating vessel through hole and props against the back of the lower shell; the connector is disposed on the connector platform, the distribution tray is disposed on the front side of the connector, the connector pad is disposed on the back side of the connector, the circuit board is disposed on the circuit board platform, the circuit board upper pad is disposed on the front side of the circuit board, and the circuit board lower pad is disposed on the back side of the circuit board.

The back of the decoder is provided with a positioning boss close to the front end.

The front surface of the upper shell is provided with a plurality of convex tops.

The connector comprises a flange, a feed-through, a plurality of PIN needles and a connector support column, wherein the flange frames the feed-through, the PIN needles are inserted into the feed-through, and the connector support column is arranged on the front face of the flange and is abutted against the upper shell.

The PIN needle head is flat and attached to the front surface of the feed-through and connected with an electrode lead of the implanted electrode.

The clearance packing that should go up shell, this mesochite and this linker each other has buffering silica gel, and the hardness of this buffering silica gel is greater than this silica gel cover.

The front surface of the middle shell also comprises a peripheral block close to the periphery and an inner side wall positioned at the inner side.

The front side of the middle shell further comprises an upper shell step located on the periphery, the upper shell is arranged on the upper shell step, the back side of the middle shell further comprises a lower shell step located on the periphery, and the lower shell is arranged on the lower shell step.

The implantation electrode is provided with a plurality of auxiliary reinforcing rings which are arranged at the electrode lead leading-out end of the implantation electrode.

The implanted magnet is packaged inside the silica gel sleeve, the front surface of the implanted magnet is exposed and is flush with the silica gel sleeve, and the implanted magnet is provided with a clamping groove.

The artificial cochlea implant body of the invention leads the size of the front end of the decoder to be thicker than that of the rear end by the front end of the communicating vessel, thereby being beneficial to surgical implantation and postoperative recovery.

The conception, the specific structure and the technical effects of the present invention will be further described with reference to the accompanying drawings to fully understand the objects, the features and the effects of the present invention.

Drawings

Fig. 1 is a schematic view of a cochlear implant of the present invention.

Fig. 2 is an exploded view of the decoder.

Fig. 3 is a schematic front view of the middle shell.

Fig. 4 is a schematic view of the back of the middle shell.

Fig. 5 is a schematic view of a communicator.

Fig. 6 is a schematic front view of the interconnector mounted in the middle case.

Fig. 7 is a rear view of the assembled interconnector and circuit board.

Fig. 8 is a side sectional view of the assembled mid-shell and lower shell.

Fig. 9 is a schematic front view of the assembled connector, implanted electrode and implanted antenna.

Fig. 10 is a schematic view of an implanted electrode.

Fig. 11 is a schematic view of an implant magnet and a specialized tool.

Fig. 12 is a side view of a cochlear implant of the present invention.

Detailed Description

The invention is further elucidated with reference to the drawing.

As shown in fig. 1 and 9, the present invention provides a cochlear implant, including an implanted electrode 1, a decoder 2, an implanted antenna 3, an implanted magnet 4, and a silicone sleeve 5, wherein the implanted electrode 1, the decoder 2, and the implanted antenna 3 are electrically connected in sequence, the implanted magnet 4 is located in the implanted antenna 3, and the silicone sleeve 5 encapsulates other components.

As shown in fig. 2, the decoder 2 includes an upper casing 21, a middle casing 22, a lower casing 23, a connector 24, a circuit board 25, a distribution plate 26, a connector pad 27, a circuit board upper pad 28, and a circuit board lower pad 29, wherein the upper casing 21, the middle casing 22, and the lower casing 23 form a casing of the decoder 2, the upper casing 21 is made of pure titanium or titanium alloy material, the front surface of the upper casing 21 is provided with a plurality of protruding bumps 211 to enhance the structural strength of the upper casing 21 and improve the impact resistance, the distribution plate 26 is disposed on the front surface of the connector 24, the connector pad 27 is disposed on the back surface of the connector 24, the circuit board upper pad 28 is disposed on the front surface of the circuit board 25, and the circuit board lower pad 29 is disposed on the back surface of the circuit board 25. It is worth noting that the references to "front" above or below are to be near the implanted electrode 1, "back" is to be near the implanted antenna 3, "front" is to face the skin, "back" is to face the temporal bone.

As shown in fig. 3, the middle shell 22 includes a communicator via 221 near the front end; the front face of the middle shell 22 includes a connector platform 2201 located at the periphery of the connector via hole 221, a front support column 2202 located near the front end, a front rear support column 2203 located near the rear end, an antenna channel 2204 located near the periphery, a peripheral baffle 2205 located near the periphery, an inner sidewall 2206 located inside, an electrode opening 2207 located at the front end, an antenna opening 2208 located at the rear end, and an upper shell step 2209 located at the periphery; as shown in fig. 4, the back of the middle housing 22 includes a circuit board cavity 2211 for receiving the circuit board 25, a cavity support column 2212 located within the circuit board cavity 2211, a circuit board platform 2213 located at the periphery of the circuit board cavity 2211, a back front support column 2214 adjacent to the connector via 221, and a lower housing step 2215 located at the periphery.

As shown in fig. 5, the communicating vessel 24 includes a flange 241, a feedthrough 242, a plurality of PIN 243, and a communicating vessel supporting pillar 244, wherein the flange 241 frames the feedthrough 242, the PIN 243 is inserted into the feedthrough 242, the communicating vessel supporting pillar 244 is disposed on the front surface of the flange 241, the flange 241 is electrically connected to one of the PIN 243 by soldering, the flange 241 is made of pure titanium or titanium alloy material, the feedthrough 242 is made of high-purity alumina or zirconia ceramic, the PIN 243 is made of pure platinum or platinum-iridium alloy material, and is cylindrical, so as to optimize the welding airtightness with the feedthrough 242, and the materials meet the biosafety requirements for long-term implantation into human body.

In assembling the decoder 2, in a first step, the interconnector 24 is placed in the interconnector via hole 221, see fig. 6, the flange 241 is laser welded to the edge of the interconnector platform 2201 to form a sealing weld, and the interconnector platform 2201 provides effective support for the interconnector 24; second, the interconnector pad 27 is placed on the back of the interconnector 24, positioned by the back front support column 2214; third, the circuit board upper pad 28 is placed in the circuit board cavity 2211, and is positioned by the cavity support column 2212; a fourth step, placing the circuit board 25 on the circuit board platform 2213, and positioning the circuit board through the cavity support column 2212 and the back front support column 2214, wherein the electrical components of the circuit board 25 are located in the circuit board cavity 2211, and the circuit board upper pad 28 is located on the front side of the circuit board 25; fifthly, bending the PIN 243 by ninety degrees to connect with the circuit board 25 by spot welding, wherein the circuit board platform 2213 provides bottom support for the spot welding, as shown in fig. 7, and at this time, the connector pad 27 provides insulation protection for the PIN 243 and the flange 241; sixthly, the lower gasket 29 of the circuit board is arranged on the back surface of the circuit board 25 and positioned through the cavity support column 2212 and the front support column 2214 on the back surface, the front surface and the back surface of the circuit board 25 are protected by gaskets and have an insulating function, the gaskets are positioned and cannot be displaced, and meanwhile, the lower gasket 29 of the circuit board can also protect the electrical connection point on the back surface of the communicating vessel 24 and the lower shell 23 from being insulated; seventhly, the lower shell 23 and the lower shell step 2215 are assembled in a matched mode, the lower shell 23 and the lower shell step 2215 are welded in a laser welding mode to form a sealing welding line, as shown in fig. 8, at the moment, the cavity support column 2212 and the back front support column 2214 abut against the lower shell 23 to form a strong support, the structural strength is strong, deformation is effectively avoided, and the circuit board 25 and the communicating device 24 can be protected strongly; eighthly, the two leading-out ends of the implanted antenna 3 are connected with the connector 24 through the antenna opening 2208 and the antenna channel 2204, and the two sides of the antenna channel 2204 are supported and protected by the peripheral barrier 2205 and the inner side wall 2206, so that the leading-out ends of the implanted antenna 3 can be prevented from being extruded and deformed; ninth, the distribution tray 26 is positioned over the front face of the interconnector 24, positioned by the interconnector support posts 244 and the front face front support post 2202; tenth, two connecting pieces 245 are arranged, the connecting pieces 245 are positioned on the front side of the distribution plate 26 and are insulated from the middle shell 22 and the flange 241, a clamping groove is formed in each connecting piece 245, the two PIN 243 are embedded into the clamping grooves, the PIN 243 is electrically connected with the connecting pieces 245 through spot welding, and the design of the clamping groove can greatly improve the connecting strength between the connecting pieces 245 and the PIN 243 and improve the reliability of electrical connection; step ten, a plurality of antenna wires are led out from the leading-out end of the implanted antenna 3 to be connected with the connecting sheet 245 in a spot welding manner; the twelfth step, pressing the head of the PIN 243 into a flat shape, and attaching the flat head to the front surface of the feedthrough 242; a thirteenth step, the distribution plate 26 is provided with an electrode distribution groove, a plurality of electrode wires are led out from the implanted electrode 1, the electrode wires are divided into 4 paths, embedded into the electrode distribution groove, and connected with the corresponding PIN 243 by spot welding, as shown in fig. 9; fourteenth, the gaps among the upper shell 21, the middle shell 22 and the communicating vessel 24 are filled with buffering silica gel, and the hardness of the buffering silica gel is greater than that of the silica gel sleeve 5, so that the silica gel sleeve 5, the upper shell 21, the buffering silica gel and the middle shell 22 form a soft-hard-soft-hard composite protection structure, thereby greatly improving the performance of resisting external impact; fifteenth, the upper shell 21 and the upper shell step 2209 are assembled in a matched manner, and are welded by laser welding to form a sealing welding line, at this time, the communicating vessel supporting column 244, the front supporting column 2202 and the front rear supporting column 2203 abut against the upper shell 21 to form a strong support, so that the structure strength is strong, deformation is effectively avoided, and the internal electronic components of the decoder 2 can be protected strongly.

Placing the assembled decoder 2, the implanted electrode 1, the implanted antenna 3 and the implanted magnet 4 into a packaging mold, filling silica gel, placing into a vacuum box for vacuum exhaust, heating to a silica gel curing temperature, and holding for a period of time to completely cure the silica gel to form the silica gel sleeve 5. The convex top 211 of the upper shell 21 of the decoder 2 is exposed on the front side, is not covered by silica gel, and is in contact with the tissue after being implanted into the human body, at this time, the PIN 243 is conducted with the upper shell 21 through the flange 241 and the middle shell 22, and the convex top 211 is used as a ground electrode. Although the surface of the silica gel sleeve 5 is windowed and broken by the convex top 211, the whole surfaces are still mutually related, and the influence on the strength of the silica gel is small.

As shown in fig. 10, the implant electrode 1 is provided with a plurality of auxiliary reinforcement rings 11, and the auxiliary reinforcement rings 11 are disposed at the electrode lead terminals 12 of the implant electrode 1 for improving the structural strength of the electrode lead terminals 12 and preventing the implant electrode 1 from being damaged by extrusion due to hyperosteogeny. The auxiliary reinforcing ring 11 can be made of silica gel with higher hardness, or other high molecular materials with biosafety, or other paramagnetic metal materials with biosafety. The auxiliary reinforcement ring 11 is disposed through the electrode opening 2207 up to the inside of the decoder 2.

As shown in fig. 11, the implanted magnet 4 is encapsulated inside the silica gel sleeve 5, the front surface of the implanted magnet 4 is exposed and flush with the silica gel sleeve 5, the implanted magnet 4 is provided with a slot 41, when the implanted magnet 4 needs to be taken out, only a small incision needs to be made above the implanted magnet 4, the implanted magnet can be taken out by using a special tool a to buckle the slot, and when the implanted magnet is put in, the operation is reversed. Compared with the traditional stripping operation mode, the device is simple and convenient, or compared with the mode that the implanted magnet 4 is ejected from the inside to the outside by using a tool, the incision is smaller.

Due to the front end of the communicating vessel 24, i.e. the front end of the decoder 2 is arranged near the front end, the front end of the decoder 2 is thicker than the rear end, and accordingly, by utilizing the structural characteristics, as shown in fig. 12, the rear surface of the decoder 2 near the front end is provided with a positioning boss 201. The back end thinning processing of the decoder 2 is calculated according to the embodiment, the back end thickness dimension of the decoder 2 is less than 3.5mm, while the thickness of the current mainstream implant decoder 2 is 3.9-6.3mm, and the dimension thickness of the back end of the decoder 2 in the embodiment is less than the packaging thickness of the implant antenna 3, so that the back end part of the decoder 2 does not need to grind a bone bed on a temporal bone, the postoperative appearance is not convex, flap pressure is reduced, and postoperative recovery is facilitated. The positioning boss 201 is in a strip shape and is arranged in a bone bed for grinding the temporal bone, so that the cochlear implant can be effectively prevented from rotating. Meanwhile, the positioning boss 201 is close to the implanted electrode 1, so that in the operation process, compared with a large-size grinding bone bed of a general square decoder 2, a small incision can be adopted, the temporal bone side skin flap does not need to be supported greatly, the wound of a patient is small, and the operation time of a doctor is short.

The foregoing detailed description of the preferred embodiments of the invention has been presented. It should be understood that numerous modifications and variations could be devised by those skilled in the art in light of the present teachings without departing from the inventive concepts. Therefore, the technical solutions available to those skilled in the art through logic analysis, reasoning and limited experiments based on the prior art according to the concept of the present invention should be within the scope of protection defined by the claims.

Claims

1. A cochlear implant, characterized by: the device comprises an implanted electrode, a decoder, an implanted antenna, an implanted magnet and a silica gel sleeve, wherein the implanted magnet is positioned in the implanted antenna, and the silica gel sleeve encapsulates other components; the decoder comprises an upper shell, a middle shell, a lower shell, a communicating vessel, a circuit board, a distribution disc, a communicating vessel gasket, a circuit board upper gasket and a circuit board lower gasket; the upper shell, the middle shell and the lower shell form a shell of the decoder; the mid-shell including a linker via near the front end; the front surface of the middle shell comprises a communicating vessel platform positioned at the periphery of the communicating vessel through hole, a front support column close to the front end and propped against the front surface of the upper shell, a rear support column close to the rear end and propped against the front surface of the upper shell, an antenna channel close to the periphery, an electrode opening positioned at the front end and an antenna opening positioned at the rear end; the back of the middle shell comprises a circuit board cavity, a cavity supporting column which is positioned in the circuit board cavity and props against the lower shell, a circuit board platform which is positioned at the periphery of the circuit board cavity, and a front supporting column which is close to the communicating vessel through hole and props against the back of the lower shell; the connector is disposed on the connector platform, the distribution tray is disposed on the front side of the connector, the connector pad is disposed on the back side of the connector, the circuit board is disposed on the circuit board platform, the circuit board upper pad is disposed on the front side of the circuit board, and the circuit board lower pad is disposed on the back side of the circuit board.

2. The cochlear implant of claim 1, wherein: the back of the decoder is provided with a positioning boss close to the front end.

3. The cochlear implant of claim 1, wherein: the front surface of the upper shell is provided with a plurality of convex tops.

4. The cochlear implant of claim 1, wherein: the connector comprises a flange, a feed-through, a plurality of PIN needles and a connector support column, wherein the flange frames the feed-through, the PIN needles are inserted into the feed-through, and the connector support column is arranged on the front face of the flange and is abutted against the upper shell.

5. The cochlear implant of claim 4, wherein: the PIN needle head is flat and attached to the front surface of the feed-through and connected with an electrode lead of the implanted electrode.

6. The cochlear implant of claim 1, wherein: the clearance packing that should go up shell, this mesochite and this linker each other has buffering silica gel, and the hardness of this buffering silica gel is greater than this silica gel cover.

7. The cochlear implant of claim 1, wherein: the front surface of the middle shell also comprises a peripheral block close to the periphery and an inner side wall positioned at the inner side.

8. The cochlear implant of claim 1, wherein: the front side of the middle shell further comprises an upper shell step located on the periphery, the upper shell is arranged on the upper shell step, the back side of the middle shell further comprises a lower shell step located on the periphery, and the lower shell is arranged on the lower shell step.

9. The cochlear implant of claim 1, wherein: the implantation electrode is provided with a plurality of auxiliary reinforcing rings which are arranged at the electrode lead leading-out end of the implantation electrode.

10. The cochlear implant of claim 1, wherein: the implanted magnet is packaged inside the silica gel sleeve, the front surface of the implanted magnet is exposed and is flush with the silica gel sleeve, and the implanted magnet is provided with a clamping groove.