KR100619103B1 - Cochlear implants and its manufacturing method - Google Patents

Abstract

The present invention, in the inner graft (for example, cochlear implant for implantation) implanted in the body to stimulate the nerve or transmit the nerve signal in accordance with the external signal, the inside and outside of the inner graft electrically A method of sealing the inner graft by joining and sealing a feedthrough for connecting and a support plate thereof with an inorganic binder containing SiO ₂ or the like as a main component; A method for producing a feedthrough portion of an internal implant for a cochlear implant using the sealing method; A feed-through portion of the implanted inner implant for cochlear implant produced accordingly; A method for producing an internal implant for a cochlear implant using the sealing method; And it relates to a cochlear implant according to the present invention.

According to the present invention, it is possible to completely seal the support plate and the feedthrough of the inner graft. In addition, the binder is in a sol state before the crystallization operation, and since the melting point is higher than 1500 ° C. after the crystallization operation, the binder is not denatured even during the brazing process or the welding process of the inner graft.

Description

An implant package for prosthetic cochleas and a method for manufacturing the same}

1 is an internal implant for a cochlear implant,

Figure 2 is an exploded perspective view of the internal implant for the cochlear implant,

Figure 3a to 3e shows a method for producing an inner graft according to the present invention,

4 shows the completed feedthrough portion,

5 shows a cross section of the feedthrough,

Figure 6 shows the feed-through portion of the completed inner graft,

7 is a photograph taken with an electron microscope around the feedthrough when the support plate and the feedthrough are sealed according to the conventional method.

8 schematically illustrates a cross section of a conventional feedthrough portion,

9 is a photograph taken with an electron microscope around the feed-through when the SiO ₂ inorganic binder in a sol (Sol) state is coated and then heat-crystallized and sealed according to the present invention.

10 is a photograph taken by electron microscopy around the feed-through when the Al ₂ O ₃ inorganic binder in the sol state is coated according to the present invention, and then heat-treated and crystallized to seal.

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

100: inner graft body 110: inner graft body

120: packaging 130: support plate

140: feed-through 150: circuit portion

160: cover 200: electrode portion

270: cochlear implant electrode 300: fastening member

The present invention, in the inner graft (for example, cochlear implant for implantation) implanted in the body to stimulate the nerve or transmit the nerve signal in accordance with the external signal, the inside and outside of the inner graft electrically Sealing the endograft by bonding and sealing a feedthrough for connection and a support plate thereof with an inorganic binder such as SiO ₂ ; A method for producing a feedthrough portion of an internal implant for a cochlear implant using the sealing method; A feed-through portion of the implanted inner implant for cochlear implant produced accordingly; A method for producing an internal implant for a cochlear implant using the sealing method; And it relates to a cochlear implant according to the present invention.

Cochlea Implant is a highly sensorineural hearing loss patient and congenital deaf person due to damage or absence of hair cells in 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 should be completely sealed by the circuit part including the circuit and the stimulation chip to protect it from the harsh environment such as body fluid and ions.

The signal transmitted from the outer coil of the external body is received from the inner coil of the inner graft, and is separated into the power and ganglion cell stimulus signal used for driving the circuit by the circuit unit, and the stimulus signal is then inserted into the cochlea. By stimulating the ganglion cells in the cochlea and the 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 undergoes 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.

In the production of the inner graft, the sealing of the inner graft is problematic. If the sealant is not completely sealed, body fluid or ions may flow into the inner graft and the inner graft may not function properly.

U.S. Patent No. 4,991,582 discloses a sinter bonding method as a method of bonding a feedthrough and a support plate made of a ceramic material. However, such sintering alone does not completely seal the feedthrough and the support plate. As a result of measuring the vacuum degree of a conventionally produced feed-through portion, as a result of 10 ^-6 sccs (torr · l / sec), it is not a satisfactory level.

Therefore, there is a need for a sealing method capable of completely sealing the feedthrough and the support plate in the inner graft.

The present invention has been made to solve the above problems, the present invention after the sintering the feed-through in the vertical direction of the support plate, the feed-through and the support plate is coupled to one side of the support plate is inserted into the feed-through And an inorganic binder such as SiO ₂ , TiO ₂ , Al ₂ O ₃ , or ZrO ₂ in a sol state for sealing, followed by heat treatment to crystallize, thereby sealing the feedthrough and the support plate.

Accordingly, an object of the present invention is to provide a method for sealing an endograft.

It is also an object of the present invention to provide a feedthrough portion of a cochlear implant and a method of manufacturing the same.                         

It is also an object of the present invention to provide an endograft and a manufacturing method thereof.

The present invention, in the inner graft (for example, cochlear implant for implantation) implanted in the body to stimulate the nerve or transmit the nerve signal in accordance with the external signal, the inside and outside of the inner graft electrically The present invention relates to a method of sealing the endograft by engaging and sealing a feedthrough for connection and a support plate thereof.

More specifically, the present invention comprises the steps of inserting the feed-through in the vertical direction of the support plate and then sintering; Applying an inorganic binder for bonding and sealing the feedthrough and the support plate to both sides or one side of the support plate into which the feedthrough is inserted; Applying the inorganic binder and then heat-treating to crystallize the inorganic binder; And it relates to the endograft sealing method comprising the step of brazing the support plate and the packaging.

The present invention also relates to a feedthrough part manufacturing method of a cochlear implant, and a feedthrough part of a cochlear implant according to the present invention.

More specifically, the present invention is a cochlear implant for outputting the stimulus signal to the electrode unit to receive and process the signal transmitted from the voice processor outside the body, and inserted into the cochlear stimulation of the auditory nerve, the electrode portion and the inner graft A method of manufacturing a feed-through portion installed on one side of the inner graft to electrically connect the method, comprising: inserting a feed-through in a vertical direction of a feed-through support plate and then sintering; Applying an inorganic binder for bonding and sealing the feedthrough and the support plate to both sides or one side of the support plate into which the feedthrough is inserted; Applying the inorganic binder and then heat-treating to crystallize the inorganic binder; And it relates to a feed-through part manufacturing method comprising the step of brazing the support plate and the packaging.

In addition, the present invention is a cochlear implant in the cochlear implant to receive and process the signal transmitted from the voice processor outside the body, and outputs the stimulus signal to the electrode unit for stimulating the auditory nerve, the electrode unit and the inner graft electrical Feed through which is provided on one side of the inner graft to connect to the feedthrough, the feedthrough for electrically connecting the electrode portion and the inner graft; It includes a support plate for supporting the feed-through and the packaging ring interposed between the inner graft body and the support plate, both sides or one side of the support plate is coated with an inorganic binder for bonding and sealing the feed-through and the support plate It is about the feedthrough part which is made.

The present invention also relates to a method for producing a cochlear implant, and to a cochlear implant according to the present invention.

More specifically, the present invention provides a method for manufacturing an internal implant for a cochlear implant that receives and processes a signal transmitted from an external voice processor and outputs a stimulus signal to an electrode portion inserted into a cochlea to stimulate the auditory nerve. Inserting a feedthrough electrically connecting the inner graft body to the feedthrough support plate in a vertical direction, and then sintering the feedthrough; Applying an inorganic binder for bonding and sealing the feedthrough and the support plate to both surfaces or one side of the support plate into which the feedthrough is inserted; Applying the inorganic binder and then heat-treating to crystallize the inorganic binder; Manufacturing a feedthrough part by brazing the support plate and the package ring; Receiving and processing a signal transmitted from an external voice processor, and electrically connecting the circuit unit for outputting a stimulus signal and the feedthrough unit by soldering or welding; And installing the circuit part in the inner graft body and welding the package and the inner graft body.

In addition, the present invention includes an electrode unit including an electrode inserted into the cochlea to stimulate the auditory nerve; A circuit unit for receiving and processing a signal transmitted from an external voice processor and outputting a stimulus signal to the electrode unit; And a feedthrough part installed at one side of the inner graft body to electrically connect the electrode part and the circuit part, wherein the feedthrough part comprises: a feedthrough electrically connecting the electrode part and the inner graft body; A support plate for supporting the feedthrough; And a packaging ring interposed between the inner graft body and the support plate, wherein both sides or one side of the support plate are coated with an inorganic binder for bonding and sealing the feedthrough and the support plate. .

The sealing method of the inner graft can be similarly applied to sealing not only the inner graft, but also an electronic device mounted outside the body. Accordingly, the present invention is provided with a feed through of a metal material for electrically connecting the inside and the outside of a package (for example, an inner graft body or other electronic device), and a support plate made of a ceramic material to support the feed through. In the package, a method for sealing the coupling portion of the feed-through and the support plate, comprising the steps of inserting the feed-through in the vertical direction of the support plate and then sintering; Applying an inorganic binder for bonding and sealing the feedthrough and the support plate to both sides or one side of the support plate into which the feedthrough is inserted; And applying heat treatment to the inorganic binder to crystallize the inorganic binder.

In the present invention, the inorganic binder applied to bond and seal the feedthrough and the support plate on both sides or one side of the support plate into which the feedthrough is inserted may be SiO ₂ , TiO ₂ , Al ₂ O in a sol state. ₃ or ZrO ₂ is used.

SiO ₂ , TiO ₂ , Al ₂ O ₃ , or ZrO ₂ in the sol state is Si, Ti, Al or like TEOS (tetraethyl orthosilicate), TTIP (titanium tetraisopropoxide) or aluminum butoxide; Hydrolysis of the metal alkoxide comprising Zr; Condensation of the hydrate to polymerize; It can be prepared by solvating the polymer.

Since the doped SiO ₂ , TiO ₂ , Al ₂ O ₃ , or ZrO ₂ has a large surface energy as a nanoparticle state, the sintering temperature is lower than that of a general powder state. In other words, when SiO ₂ , TiO ₂ , Al ₂ O ₃ , or ZrO ₂ is used in a general powder state, a sintering temperature of 1500 ° C. or higher is required, but sintering is performed at 800 ° C. in the sol state. The film formed by sintering in this manner does not change any physical properties even at a high temperature of 1500 ° C or higher.

Therefore, as described above, when a material such as SiO ₂ , TiO ₂ , Al ₂ O ₃ , or ZrO ₂ in a sol state is applied as an inorganic binder, and then subjected to heat treatment to crystallize, even in a brazing process (1100 ° C.) or a welding process The binder is not denatured.

Hereinafter, with reference to the drawings will be described a preferred embodiment of the present invention. However, the present invention is not limited by the following examples.

1 illustrates an internal implant 100 for a cochlear implant that can be combined with an electrode unit 200. The fastening member 300 is fastened to the screw hole 170 of the inner graft body 100 through the through hole 240 of the electrode part 200 to fix the electrode part to the package part 100. Feedthrough 140 of the inner graft 200 is one end is electrically connected to the circuit portion (not shown) of the inner graft 200, the other end and each site of the multi-channel cochlear electrode 270 is inserted into the cochlear Electrically connected. The electrode feedthrough support plate 130 supports the electrode feedthrough 140.

2 is an exploded perspective view of the inner graft 100. The inner graft body 100 is an inner graft body 110; A feed-through 140 installed at one side of the package body 110 to electrically connect an electrode unit 200 of FIG. 1 to a circuit unit (not shown); A feed-through support plate 130 for supporting the feed-through 140; And packaging 120. The package ring 120 is interposed between the inner graft body 110 and the feedthrough support plate 130. The inner graft body 100 includes a cover 160 that can cover the lower portion of the inner graft body 110. The cover 160 is provided with an anchor 160a for fixing the inner graft to the skull.

Hereinafter, a method for manufacturing an internal implant for a cochlear implant according to the present invention will be described.

First, a hole (not shown) having a diameter of about 0.6 mm is formed to insert the feedthrough 140 into the ceramic support plate 130. It is preferable to use a platinum material as the feedthrough. Thereafter, as shown in FIG. 3A, the feedthrough 140 is inserted into the hole of the support plate 130. Thereafter, the feedthrough 140 is bonded by sintering at 1400 ° C.

Subsequently, an inorganic binder for bonding and sealing the feedthrough 140 and the support plate 130 to both surfaces or one side of the support plate into which the feedthrough 140 is inserted, uses a brush, or prints. Or spin coating method. As the inorganic binder, SiO ₂ , TiO ₂ , Al ₂ O ₃ , or ZrO ₂ in a sol state is used.

Thereafter, the organic material present in the SiO ₂ , TiO ₂ , Al ₂ O ₃ , or ZrO _{2 in} the sol state is removed and crystallized by heat treatment at about 800 to 900 ° C. for about 1 hour to sinter.

Thereafter, as shown in FIG. 3B, the feedthrough part 145 is completed by sealing the support plate 130 and the package ring 120 by brazing (Nb-Au).

4 shows the completed feedthrough portion.

5 shows a cross section of the feedthrough. The inorganic binder 135 is crystallized on one side of the support plate 130 through which the feedthrough 140 is penetrated, and the feedthrough 140 and the support plate 130 are formed by the inorganic binder 135. ) Is sealed. Since the melting point (about 1700 ° C. to 2000 ° C.) of the crystallized inorganic binder is higher than the temperature (1100 ° C.) during the brazing process, the inorganic binder does not denature during the brazing process.

Thereafter, as illustrated in FIG. 3C, the circuit unit 150 and the feedthrough unit 145 that receive and process a signal transmitted from an external voice processor (not shown) and output a stimulus signal are soldered to each other. Electrically connected

Thereafter, as shown in FIG. 3D, the circuit unit 150 is installed in the main body 110 of the inner graft body, and the packaging ring 120 and the main body 110 of the inner graft body are welded.

Then, as shown in Figure 3e, by welding the cover 160 and the main body 110 of the inner graft body, it is possible to completely seal the inner graft.

Figure 6 shows the feed-through portion of the completed inner graft.

The sealing method as described above can be applied both to the cochlear implant and to any electronic device mounted outside the body, as well as to any implanted body implanted in the body.

In addition, the process of applying the inorganic binder for bonding and sealing the feed-through 140 and the support plate 130 on both sides or one side of the support plate, the feed-through 140 is inserted, the support plate 130 ) And packaging 120 may be performed after brazing (Nb-Au, etc.) is combined.

As a result of measuring the vacuum degree of the feed-through portion manufactured as described above, it was confirmed that the feed-through portion can completely seal the inner graft as 10 ^-10 torr · l / sec.

Hereinafter, a process of manufacturing SiO ₂ , TiO ₂ , Al ₂ O ₃ , or ZrO ₂ in a sol state applied to bond and seal the support plate and the feedthrough will be described.

First, a hydrate is prepared by hydrating a metal alkoxide comprising Si, Ti, Al, or Zr, such as TEOS (tetraethyl orthosilicate), TTIP (titanium tetraisopropoxide) or aluminum butoxide.

Thereafter, the hydrate is polymerized by condensation reaction, and then the polymer is solvated to prepare SiO ₂ , TiO ₂ , Al ₂ O ₃ , or ZrO ₂ in a sol state.

7 is a photograph taken with a microscope around the feedthrough when the support plate and the feedthrough are sealed according to the conventional method. As can be seen from the figure, it can be seen that a gap of about 20 μm is formed at the entrance of the coupling portion of the feedthrough and the support plate. FIG. 8 illustrates a cross section of a conventional feedthrough portion, and a gap is formed between the feedthrough 140 and the ceramic support plate 130.

FIG. 9 is a photograph taken around an electron microscope (SEM) around a feedthrough when the SiO ₂ in the sol state is coated according to the present invention, and then heat-treated and crystallized to seal.

FIG. 10 is a photograph taken by electron microscopy around a feedthrough when Al ₂ O ₃ in a sol state is coated according to the present invention and then heat-treated to crystallize and sealed.

As can be seen from FIG. 9 and FIG. 10, when sealing the support plate and the feedthrough according to the present invention, it can be seen that no gap is formed. On the other hand, compared with Figure 9, it can be seen that less impurities are formed when using SiO ₂ as shown in FIG.

According to the present invention, it is possible to completely seal the support plate and the feedthrough of the inner graft. In addition, the inorganic binder is present in a sol state before the crystallization operation, and since the melting point is higher than 1500 ° C. after the crystallization operation, the binder is not denatured even during the brazing process or the welding process of the inner graft. .

Claims (17)

In an internal graft implanted in the body to stimulate nerves or transmit nerve signals in response to external signals, coupling and sealing feedthrough and its support plate for electrically connecting the inside and the outside of the graft. As a method of sealing the inner grafts, Inserting a feedthrough in a vertical direction of the support plate and then sintering the bond; Applying an inorganic binder in a sol state made of an inorganic oxide to bond and seal the feedthrough and the support plate on both sides or one side of the support plate into which the feedthrough is inserted; Applying the inorganic binder and then heat-treating to crystallize the inorganic binder; And And brazing coupling the support plate and the package ring. The method of claim 1, wherein the inorganic binder to be applied is SiO ₂ , TiO ₂ , Al ₂ O ₃ , or ZrO ₂ in a sol state. The method of claim 1, wherein after the inorganic binder is applied to one side of the support plate into which the feed-through is inserted, the heat treatment and crystallization may be performed before or after brazing bonding the support plate and the package. Endograft sealing method characterized in that carried out on. The method of claim 1, wherein the endograft is an endograft for a cochlear implant. In a cochlear implant, which receives and processes a signal transmitted from an external voice processor and outputs a stimulus signal to an electrode part inserted into a cochlear implant to stimulate the auditory nerve, the electrical part for electrically connecting the electrode part and the inner graft. As a method of manufacturing a feed-through portion installed on one side of the inner graft, Inserting a feedthrough in a vertical direction of the feedthrough support plate and then sintering; Applying an inorganic binder in a sol state made of an inorganic oxide to bond and seal the feedthrough and the support plate on both sides or one side of the support plate into which the feedthrough is inserted; Applying the inorganic binder and then heat-treating to crystallize the inorganic binder; And The method of manufacturing a feed-through portion comprising the step of brazing the support plate and the packaging. The method of claim 5, wherein the inorganic binder to be applied is SiO ₂ , TiO ₂ , Al ₂ O ₃ , or ZrO ₂ in a sol state. In a cochlear implant, which receives and processes a signal transmitted from an external voice processor and outputs a stimulus signal to an electrode part inserted into a cochlear implant to stimulate the auditory nerve, the electrical part for electrically connecting the electrode part and the inner graft. Feed-through portion installed on one side of the inner graft, A feedthrough for electrically connecting the electrode portion and the inner graft; A support plate for supporting the feed-through and Including packaging between the inner graft body and the support plate, Feed-through portion characterized in that the inorganic binder made of an inorganic oxide is coated on both sides or one side of the support plate to bond and seal the feed-through and the support plate. The feedthrough portion of claim 7, wherein the inorganic binder is SiO ₂ , TiO ₂ , Al ₂ O ₃ , or ZrO ₂ . A method of manufacturing an internal implant for a cochlear implant that receives and processes a signal transmitted from an external voice processor and outputs a stimulus signal to an electrode portion inserted into the cochlea to stimulate the auditory nerve, Inserting a feedthrough for electrically connecting the electrode portion and the inner graft body in a vertical direction to a feedthrough support plate, and then sintering and bonding; Applying an inorganic binder in a sol state made of an inorganic oxide to bond and seal the feedthrough and the support plate on both sides or one side of the support plate into which the feedthrough is inserted; Applying the inorganic binder and then heat-treating to crystallize the inorganic binder; Manufacturing a feedthrough part by brazing the support plate and the package ring; Receiving and processing a signal transmitted from an external voice processor, and electrically connecting the circuit unit for outputting a stimulus signal and the feedthrough unit by soldering or welding; And And installing the circuit part on the inner graft body and welding the package and the inner graft body. 10. The method of claim 9, wherein the inorganic binder to be applied is SiO ₂ , TiO ₂ , Al ₂ O ₃ , or ZrO ₂ in a sol state. An electrode part including an electrode inserted into the cochlea to stimulate the auditory nerve; A circuit unit for receiving and processing a signal transmitted from an external voice processor and outputting a stimulus signal to the electrode unit; And Including a feed-through portion installed on one side of the inner graft body to electrically connect the electrode portion and the circuit portion, The feed-through portion, A feedthrough for electrically connecting the electrode portion and the inner graft; A support plate for supporting the feedthrough; And It includes packaging between the inner graft body and the support plate, Inner graft body characterized in that the inorganic binder made of an inorganic oxide is coated on both sides or one side of the support plate to bond and seal the feed-through and the support plate. 12. The inner graft of claim 11 wherein the inorganic binder is SiO ₂ , TiO ₂ , Al ₂ O ₃ , or ZrO ₂ . As a method of sealing a coupling portion of the feedthrough and the support plate in a package provided with a metal feedthrough for electrically connecting the inside and the outside of the package and a ceramic support plate for supporting the feedthrough, Inserting a feedthrough in a vertical direction of the support plate and then sintering the bond; Applying an inorganic binder in a sol state made of an inorganic oxide to bond and seal the feedthrough and the support plate on both sides or one side of the support plate into which the feedthrough is inserted; And Sealing the inorganic binder by applying heat treatment after applying the inorganic binder. 14. The method of claim 13, wherein the inorganic binder applied is SiO ₂ , TiO ₂ , Al ₂ O ₃ , or ZrO ₂ in a sol state. 14. The method of claim 13, wherein the package is an internal implant or an electronic device mounted external to the body. Claim 2, claim 6, claim 10 or claim 14 according to any one of, wherein the sol of _{SiO 2, TiO 2, Al 2} O 3, or ZrO _2, the Hydrating a metal alkoxide comprising Si, Ti, Al, or Zr; Condensation of the hydrate to polymerize; And Characterized in that it is prepared through the step of solvating the polymer. The method of claim 14, wherein the metal alkoxide comprising Si, Ti, or Al is TEOS (tetraethyl orthosilicate), TTIP (titanium tetraisopropoxide) or aluminum butoxide.

Images