KR100619105B1 - An implant package for prosthetic cochlea - Google Patents

Abstract

The present invention relates to an internal implant implanted in the body of a cochlear implant device that restores lost auditory function by inserting an electrode into the cochlea (snail tube) to stimulate the auditory nerve.

In the conventional inner graft, since the package and the electrode are integrated, there is a problem that the entire graft must be replaced when a circuit or chip in the graft package fails. However, the present invention eliminates risk factors such as osmosis and cochlear internal damage that may occur when removing an electrode inserted into a cochlea by separating the package protecting the circuit and chip from the electrode.

In addition, if a stimulation chip with better performance is developed after the implantation of the cochlear implant according to the present invention, the performance is improved by replacing the electrode with a package containing an improved stimulation chip without taking out the cochlear implant. Can be.

Description

An implant package for prosthetic cochlea}

1 is a cochlear implant system manufactured by Advanced Bionics of the United States,

2 is a cochlear implant system manufactured by Cochlear, Australia,

Figure 3 is an exploded perspective view of the inner graft according to the invention,

Figure 4 is a perspective view of the combined grafts according to the present invention,

Figure 5 is an exploded perspective view of the package portion of the inner graft according to the present invention,

6 is a cross-sectional view of the inner graft according to the invention,

7 is a cross-sectional view of a package portion showing a state in which a transformer is installed in an anchor;

8 is an exploded perspective view of an electrode unit of an inner graft according to the present invention;

Figure 9 is an exploded perspective view of another embodiment of the inner graft according to the present invention,

10 is a perspective view of the inner graft of Figure 9 combined.

<Explanation of symbols for the main parts of the drawings>

100: package 110: package body

120: packaging 130: package feed-through support plate

140: package feedthrough 145: coil feedthrough

160: package body cover 160a: anchor

170: screw hole 180: inner coil seating groove

190: transformer 200: electrode portion

210: electrode plate 220: electrode feed-through support plate

230: electrode feedthrough 240: through hole

250: Pt / Ir connection line 270: electrode

300: fastening member

The present invention relates to an internal implant implanted in the body of a cochlear implant device that restores lost auditory function by inserting an electrode into the cochlea (snail tube) to stimulate the auditory nerve.

Cochlear Implants are highly sensorineural hearing loss and congenital hearing impairments due to damage or absence of hair cells in the cochlear implant, which can electrically stimulate ganglion cells that are part of the auditory nerve inside the cochlear implant. It is a device that can restore the lost auditory function by inserting a removable electrode.

Cochlear implants can be largely divided into external and internal grafts.

The external part installed outside the body is composed of a microphone, a sound processor and an external coil. After processing the sound (voice signal) received from the microphone in the speech processor, the processed signal and power for starting the internal circuit are simultaneously transmitted to the inner graft through an external coil.

The implanted body implanted in the body includes an inner transplant circuit portion including a circuit and a stimulation chip, a package portion that completely seals them and protects them from harsh environments such as body fluids and ions, an electrode portion inserted into the cochlea, and an external stimulus chip drive and sound processor. And a coil part (inner coil) for receiving a voice signal processed by the inner part, and the inner transplanting circuit part, the package part, the electrode part and the coil part are electrically connected to each other. The signal transmitted from the outer coil of the body is received by the inner coil of the inner graft, and is separated into power and ganglion cell stimulus signals used for driving the circuit by the inner graft circuit, and the stimulus signal is then inserted into the cochlea. The stimulus stimulates ganglion cells in the cochlea, and electrical signals generated by the stimulated ganglion cells are transmitted to the brain through the auditory nerve, so that the deaf or hearing impaired person can hear the sound.

Since the first single channel cochlear implant was first commercialized in 1972 and performed on hearing-impaired people, tens of thousands of hearing-impaired people have been transplanted to date. After a cochlear implant or a hearing impaired patient has undergone a cochlear implant, ganglion cells, which are part of the auditory nerve, are stimulated by an electrical stimulation pulse encoded by a speech processing technique provided by an implanted device. These speech processing techniques continue to evolve at this very moment.

By the way, since the inner transplant body developed so far is manufactured integrally with the package portion and the electrode portion, in order to apply the improved speech processing technique even after implantation of the cochlear implant, the electrode, the coil, the magnetic pole chip and the circuit, and the magnetic pole chip and The entire internal implant consisting of a fully sealed package protecting the circuit must be replaced. In other words, if the inner graft is to be replaced according to the development of a new chip, the electrode inserted into the cochlea must be taken out again.

However, once the electrode has been implanted into the cochlea, it will ossify, so the cochlea must be damaged to separate the electrode from the cochlea. This damage affects not only the cochlea but also the survival of the auditory nerve (the higher the survival rate of the ganglion cells, the higher the result of language recognition), which in turn adversely affects the overall performance of the system. Due to this problem, even if a superior chip is developed, the replacement of the inner graft is practically difficult. In addition, even if an error occurs in the internal implant itself after transplantation, it is difficult to solve the problem by replacing the package.

The inner graft disclosed in U.S. Patent No. 4,991,582 is manufactured by Advanced Bionics of the United States (FIG. 1), and the package portion and the electrode portion are manufactured integrally, so that even if an excellent chip is developed, the implant is re-grafted. In order to do that, you have to take the wow damage. Therefore, because the upgrade of the inner graft is practically difficult, transplanted people are not easily able to benefit from technological development. The inner graft disclosed in U. S. Patent No. 5,105, 811 is manufactured by Cochlear of Australia (FIG. 2), which is also manufactured as an integral part of the package and the electrode, and thus is upgraded as in the case of U.S. Patent No. 4,991,582. Is difficult.

That is, the conventional inner graft has a disadvantage that the package portion and the electrode portion are permanently connected integrally and integrally, so that the upgrade of the inner graft circuit portion is impossible unless the entire inner graft is replaced.

Accordingly, the present inventors have studied to solve the problems described above, and as shown in the present invention, when the package and the electrode portion is designed to be detachable from each other, when fixing it with a fastening member, the electrode portion inserted into the cochlea It was confirmed that the upgrade of the inner graft body is possible without adding any manipulation, and completed the present invention. That is, the present invention is designed to be separated from each other, the electrode portion and the package portion, so that it can easily solve the problems that may occur after the application and implantation of the advanced system in the future.

Therefore, an object of the present invention is to provide an internal implant for the cochlear implant and the package portion capable of upgrading or replacing the package portion.

The present invention includes an electrode unit including an electrode inserted into the cochlea to stimulate the auditory nerve; A package unit for receiving and processing a signal transmitted from an external voice processor to protect a circuit unit for outputting a stimulus signal to the electrode unit, the package unit being detachably coupled to the electrode unit; And a fastening member for fixing the electrode part to the package part.

In the inner graft according to the invention, the package portion, the package body; A package feedthrough provided on one side of the package body to electrically connect the electrode portion and the circuit portion; A package feedthrough support plate for supporting the package feedthrough; And packaging between the package body and the package feed-through support plate.

Here, the package body and the package ring are preferably coupled by laser welding, and the package ring and the package feed-through support plate are made of a biocompatible metal, for example, a niobium-gold (Nb-Au) alloy or the like. It is preferable to bond by brazing.

In the package part, the material of the package body and the package ring is made of the same material as possible to enable laser welding with each other, and preferably titanium or a titanium alloy. It is preferable to use platinum as said package feedthrough, and it is preferable to use ceramic as said package feedthrough support plate.

On the other hand, an internal coil must be provided in order to receive a signal processed by a power transmission and an external sound processor for operating a circuit part in a package part inserted into the body in a circuit part in a package by an RF transmission method. In order to electrically connect the internal coil and the circuit unit, the package unit may include a coil feedthrough in addition to the package feedthrough. The coil feedthrough is preferably installed on the package feedthrough support plate by mechanical or resistance welding after the package ring, the package feedthrough support plate, and the package body are combined.

Preferably, a groove is formed outside the package body to provide a space for connecting the coil feedthrough and the internal coil.

In the inner graft according to the invention, the electrode portion, one end is electrically connected to the package portion, the other end is an electrode feed-through electrically connected to the electrode; An electrode feedthrough support plate supporting the electrode feedthrough; And an electrode plate which is a protective structure protecting a connection portion of the electrode and the electrode feedthrough.

Here, it is preferable to use titanium or titanium alloy as the electrode plate, it is preferable to use platinum as the electrode feedthrough, it is preferable to use a ceramic as the electrode feedthrough support plate.

In the electrode unit, the electrode plate and the electrode feed-through support plate are joined by brazing with a biocompatible metal, for example, an Nb-Au alloy.

In the inner graft according to the invention,

The package unit, a package body; A package feedthrough installed at one side of the package body to electrically connect the electrode portion and the circuit portion; A package feedthrough support plate for supporting the package feedthrough; And a package ring interposed between the package body and the package feed-through support plate, wherein one side of the package body includes a screw hole spaced apart from the package ring.

The electrode unit, one end is electrically connected to the package portion, the other end is an electrode feed-through electrically connected to the electrode; An electrode feedthrough support plate supporting the electrode feedthrough; And an electrode plate protecting a connection portion between the electrode and the electrode feedthrough, wherein the electrode plate has a through hole into which the fastening member is inserted.

Preferably, the fastening member is a bolt fastened to the screw hole through the through hole.

In order to electrically connect the package portion and the electrode portion, the structures thereof correspond to each other, and are mechanically coupled by the fastening member.

In addition, when the package unit and the electrode unit are coupled, it is preferable that a hole for introducing a coil to be connected to the coil feedthrough is formed at a portion where the package body of the package unit and the electrode plate of the electrode unit are coupled to each other.

In addition, the fastening member is preferably made of titanium or titanium alloy.

As described above, it is preferable that the screw hole to which the fastening member is fastened is formed in the case of the receiving part spaced apart from the sealing ring of the receiving part, and the screw hole is not formed in the sealing ring. If a screw hole is also formed in the sealing ring, a gap is formed between the screw hole of the case and the screw hole of the sealing ring, and body fluid can penetrate.

On the other hand, the package portion is provided with a plurality of anchors spaced apart from each other by a predetermined interval for fixing the package portion to the skull. The anchor is hollow, and a transformer (transfomer) for converting the magnitude of the voltage may be installed inside the anchor. In general, a circuit unit for receiving and processing a signal transmitted from an external voice processor and outputting a stimulus signal to the electrode unit includes a transformer for boosting the voltage transmitted from the coil so that the maximum stimulation current can flow to the nerve. .

In the related art, since the height of the transformer is large, there is a limit to minimizing the thickness of the package part. However, in the present invention, the transformer can be installed inside the hollow anchor. Therefore, the thickness of the package body according to the present invention can be manufactured smaller than the height of the transformer, it is possible to minimize the bonework (bonework) to cut the skull to fix the package to the skull during implantation surgery. The anchor may be formed in any shape, including a cylindrical shape.

In addition, the present invention, the package body; On one side of the package main body for electrically connecting the electrode unit including an electrode inserted into the cochlea to stimulate the auditory nerve and a circuit unit receiving and processing a signal transmitted from an external voice processor and outputting a stimulus signal to the electrode unit. Installed package feedthroughs; A package feedthrough support plate for supporting the package feedthrough; And a package ring interposed between the package body and the package feed-through support plate, wherein one side of the package body has a screw hole spaced apart from the package ring so that a fastening member fastens the electrode part and the package body. The present invention relates to a package for an internal transplantation body of a cochlear implant.

Hereinafter, with reference to the drawings will be described an embodiment of the inner graft according to the present invention in detail. However, the present invention is not limited by the following examples.

Figure 3 is an exploded perspective view of the inner graft according to the present invention. The inner graft body is separated from the package portion 100 and the electrode portion 200. Since the fastening member 300 is fastened to the screw hole 170 of the package part through the through hole 240 of the electrode part and fixes the electrode part to the package part 100, the electrode part 200 and the package part. 100 is detachable.

Figure 4 is a perspective view of the combination of the inner graft according to the present invention.

5 is an exploded perspective view of the package portion 100 of the inner graft according to the present invention. The package unit package body 110; A package feedthrough 140 installed at one side of the package body 110 to electrically connect the electrode unit 200 and the circuit unit (not shown); A package feedthrough support plate 130 for supporting the package feedthrough 140; And packaging 120. The package ring 120 is interposed between the package body 110 and the package feedthrough support plate 130. One side surface of the package body 110 is spaced apart from the package ring 120, the screw hole 170 is formed.

The package body 110 includes a package cover 160 that can cover the bottom of the package, and the package cover 160 includes an anchor 160a that can fix the package to the skull.

As the feedthrough, only the package feedthrough 140 connected to the electrode is illustrated for convenience of description. In general, however, coil feedthroughs (not shown) that connect the circuitry and the internal coils in the package are also formed.

In order to manufacture the package part 100, first, the package feedthrough support plate 130 and the package feedthrough 140 are sintered and sealed. Thereafter, the package feedthrough support plate 130 including the package feedthrough 140 and the package ring 120 are sealed by brazing (Nb-Au). Thereafter, the circuit unit (not shown) is soldered and electrically connected to the package feedthrough 140, and then the circuit unit is installed inside the package body 110 through a portion into which the package ring 120 is inserted. Thereafter, the package part 120 is manufactured by laser welding the package ring 120 and the package main body 110 and coupling the package cover 160 and the package main body 110 by laser welding. do. Laser welding is a processing method that locally melts and combines two objects of the same material, and does not affect a circuit existing inside the package.

The anchor 160a is formed in a hollow shape and space can be saved by installing a transformer for converting the magnitude of the voltage inside the anchor. This will be described again in the section related to FIG. 7.

The package body 110 uses a titanium alloy, the package feedthrough 140 uses a platinum material for electrical connection inside and outside the package unit 100, and the package feedthrough support plate 130 is ceramic. Use materials.

In the present invention, the package part is excellent in sealing ability to prevent fluid infiltration, and thus can be used as a package part of all neural prosthetic devices for implanting a circuit part inside the human body, such as a cardiac stimulator, a pacemaker or a vagus nerve stimulator.

6 is a cross-sectional view taken along the line A-A of FIG. 4. The package unit 100 includes a circuit unit (not shown) for converting a voice signal processed by the sound processor into an electrical stimulus signal therein to protect the package. The electrode feedthrough 230 and the package feedthrough 140 are electrically connected to each other, whereby a signal may be transmitted from the circuit unit (not shown) in the package unit 100 to the electrode unit 200.

The electrode feedthrough 230 and the package feedthrough 140 are coupled to each other in a male and female structure so as to be electrically and mechanically connected to each other. For example, a coupling groove is formed at the front end of the package feedthrough 140, and the electrode feedthrough 230 is inserted into the coupling groove to be electrically and mechanically connected to the package feedthrough.

7 is a cross-sectional view of the package unit 100 showing a state in which the transformer 190 is installed in the package unit 100. The transformer 190 is installed inside the hollow cylindrical anchor 160a. As such, by installing the transformer 190 inside the anchor 160a, the thickness of the package body according to the present invention can be made smaller than the height of the transformer, and space can be saved as much as possible. In addition, the amount of the bone work can be reduced.

8 is an exploded perspective view of the electrode unit 200 of the inner graft according to the present invention. The electrode unit includes an electrode 270, an electrode feedthrough 230, an electrode feedthrough support plate 220, and an electrode plate 210.

One end of the electrode feedthrough 230 is electrically connected to the package part, and the other end is electrically connected to each site of the multichannel cochlear implant electrode 270 inserted into the cochlea. The electrode feedthrough support plate 220 supports the electrode feedthrough 230.

The electrode plate 210 protects a connection portion of the electrode 270 and the electrode feedthrough 230 (including a Pt / Ir connection line 250 of the electrode 270, a silicon elastomer, and the like). In addition, the electrode plate 210 is provided with a through hole 240, and the fastening member 300 may be fastened to the screw hole 140 of the package part through the through hole 230.

As the electrode feed-through support plate 220, an electrically insulator is used, and a biocompatible ceramic material is used. Titanium alloy is used as the electrode plate 210.

The electrode feedthrough 230 and the Pt / Ir connection line 250 of the electrode 270 are coupled by micro resistive welding. The electrode feedthrough 230 and the electrode feedthrough support plate 220 are joined by sintering bonding. The electrode feed-through support plate 220 of the ceramic material and the electrode plate 210 of the titanium alloy material are bonded to each other by brazing (Nb-Au).

9 and 10 show another embodiment of the inner graft according to the present invention. 9 is an exploded perspective view, Figure 10 is a combined perspective view.

The package 100 and the electrode 200 is also separated from the inner graft. Since the fastening member 300 is fastened to the screw hole 170 of the package part through the through hole 240 of the electrode part and fixes the electrode part to the package part 100, the electrode part 200 and the package part. 100 is detachable.

The package unit 100 includes a package body 110; A package feedthrough 140 installed at one side of the package body 110 to electrically connect the electrode unit 200 and the circuit unit (not shown); A package feedthrough support plate 130 for supporting the package feedthrough 140; And packaging 120. The package ring 120 is interposed between the package body 110 and the package feedthrough support plate 130. One side surface of the package body 110 is spaced apart from the package ring 120, the screw hole 170 is formed.

The side surface of the package body 110 is formed with a groove 180 for seating the internal coil.

The package unit 100 may include a coil feedthrough 145 in addition to the package feedthrough 140 to electrically connect an internal coil to a circuit unit (not shown).

The electrode unit 200 includes an electrode (not shown), an electrode feedthrough 230, an electrode feedthrough support plate 220, and an electrode plate 210.

When the package unit 100 and the electrode unit 200 are coupled to each other, the coil feedthrough 145 is formed at a portion where the package body 110 of the package unit 100 and the electrode plate of the electrode unit 200 are coupled to each other. A hole 185 is formed for introducing a coil to be connected to the coil.

As described above, the cochlear implantable implantable inner graft according to the present invention is detachable from the electrode portion and the package portion. Therefore, if the stimulation chip forming the internal implant for the cochlear implant according to the present invention is greatly developed, or if a new sound processing technique has been developed to change the internal stimulation chip, or if a failure occurs in the internal implant, the implant is inserted into the cochlea. The inner graft can be easily replaced without removing the electrode. Therefore, those who have been implanted with cochlear implants can continue to receive the benefits of technological advancement, eliminating the additional risks associated with exchanging whole internal implants.

Claims (15)

An electrode part including an electrode inserted into the cochlea to stimulate the auditory nerve; A package unit for receiving and processing a signal transmitted from an external voice processor to protect a circuit unit for outputting a stimulus signal to the electrode unit, the package unit being detachably coupled to the electrode unit; And And a fastening member for fixing the electrode part to the package part. The method of claim 1, wherein the package portion, Package body; A package feedthrough provided on one side of the package body to electrically connect the electrode portion and the circuit portion; A package feedthrough support plate for supporting the package feedthrough; And An inner graft body comprising a package ring interposed between the package body and the package feed-through support plate. The inner graft of claim 2, wherein the package body is made of titanium or titanium alloy, the package feedthrough is made of platinum, and the package feedthrough support plate is made of ceramic. The inner graft body of claim 3, wherein the package body and the package ring are coupled by laser welding, and the package ring and the package feed-through support plate are brazed and bonded to a biocompatible metal. The inner graft of claim 2, wherein a groove is formed on a side surface of the package main body to receive an inner coil for receiving power and a signal transmitted from an external sound processor. The method of claim 1, wherein the electrode unit, An electrode feedthrough, one end of which is electrically connected to the package portion, and the other end of which is electrically connected to the electrode; An electrode feedthrough support plate supporting the electrode feedthrough; And And an electrode plate for protecting a connection portion between the electrode and the electrode feedthrough. 7. The inner graft of claim 6, wherein the electrode plate is made of titanium or titanium alloy, the electrode feedthrough is made of platinum, and the electrode feedthrough support plate is made of ceramic. 8. The inner graft of claim 7 wherein the electrode plate and the electrode feedthrough support plate are brazed and bonded with a biocompatible metal. The method of claim 1, The package unit, a package body; A package feedthrough installed at one side of the package body to electrically connect the electrode portion and the circuit portion; A package feedthrough support plate for supporting the package feedthrough; And a package ring interposed between the package body and the package feed-through support plate, wherein one side of the package body includes a screw hole spaced apart from the package ring. The electrode unit, one end is electrically connected to the package portion, the other end is an electrode feed-through electrically connected to the electrode; An electrode feedthrough support plate supporting the electrode feedthrough; And an electrode plate protecting a connection portion between the electrode and the electrode feedthrough, wherein the electrode plate has a through hole into which the fastening member is inserted. The fastening member is an inner graft member, characterized in that the bolt is fastened to the screw hole through the through hole. The inner graft body of claim 9, wherein the electrode feedthrough and the package feedthrough are coupled to each other in a male and female structure and electrically and mechanically connected to each other. 10. The inner graft of claim 9, wherein a coupling groove is formed at a tip of the package feedthrough, and the electrode feedthrough is inserted into the coupling groove and electrically and mechanically connected to the package feedthrough. According to claim 1, The fastening member is a material of the inner graft, characterized in that the titanium or titanium alloy. The transformer of claim 1, wherein the package unit includes a plurality of anchors spaced apart from each other by a predetermined distance to fix the package unit to the skull, wherein the anchors are hollow and convert a voltage. The inner graft body characterized in that is installed inside the anchor. Package body; On one side of the package main body for electrically connecting the electrode unit including an electrode inserted into the cochlea to stimulate the auditory nerve and a circuit unit receiving and processing a signal transmitted from an external voice processor and outputting a stimulus signal to the electrode unit. Installed package feedthroughs; A package feedthrough support plate for supporting the package feedthrough; And It includes packaging between the package body and the package feed-through support plate, The cochlear implant package for a cochlear implant, characterized in that, on one side of the package main body, a fastening member is formed with a screw hole for fastening the electrode unit and the package main body to be spaced apart from the package ring. 15. The package of claim 14, wherein a groove is formed on a side surface of the package body to receive an inner coil for receiving power and a signal transmitted from the outside.

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