KR100506503B1 - Mold for cochlear electrode and its fabricating method using micro-machining technology - Google Patents

Abstract

The present invention is to solve the problem of non-uniformity of the interface impedance between the electrode site, which is a disadvantage caused by the difficulty of microfabrication of the metal mold (Metal Mold) that is used to fabricate the conventional cochlear electrode structure, The cochlear electrode enables the fabrication of an electrode site with a constant interfacial impedance by replacing the site that determines the electrode impedance with a non-metallic (Silicon) structure processed to an accurate size using micro-machining technology. The present invention relates to a structure manufacturing apparatus and a method for manufacturing the cochlear implant structure according to the present invention, wherein the apparatus for manufacturing a cochlear electrode structure having two metallic molds, the upper side and the lower side, wherein each of the upper and lower molds The mold for forming the electrode carrier is symmetrically inside It is formed in the shape of a line trough, grooves having a predetermined width and depth in the direction parallel to the molding die is formed in the lower portion of the inner mold of the lower mold, the grooves of the inner mold lower portion The electrode site mold having a width and depth corresponding thereto is characterized in that it is formed with fine grooves for the electrode site for manufacturing the electrode site on the top.

Description

Apparatus and method for manufacturing electrode structure for cochlear implant using micromachining technology {Mold for cochlear electrode and its fabricating method using micro-machining technology}

The present invention relates to an apparatus for fabricating a cochlear electrode structure, and more particularly, to fabricating an electrode site groove for determining an impedance of an electrode site in a cochlear electrode structure using a micromachining technique instead of machining a metal using a conventional drill. The present invention relates to an apparatus for manufacturing a cochlear electrode structure and a method of manufacturing the same, in which electrodes can be manufactured so that each electrode site has a constant interface impedance by replacing a size error with a mold for an electrode site precisely processed within a few μm.

Cochlear implant is a device that enables hearing rehabilitation by stimulating the auditory nerve of hearing impaired person due to congenital deafness, disease or accident, severely deaf or hearing impaired person who can't hear even when wearing hearing aid. The structure of a cochlear implant can be divided into two parts: the extracorporeal part and the internal part.

The external part installed outside the body is composed of a microphone, a sound processor, and a transmitting antenna. In this case, the microphone and the transmitting antenna are collectively called a headset. The body that is implanted in the body consists of a handset, an electrode structure.

Briefly, the process of listening to sound through a cochlear implant is as follows.

When sound is detected by a small microphone installed in a headset hanging behind the ear, it is passed along a thin wire to the sound processor, a powerful small computer. The sound processor filters and analyzes the sound, converts it into a digital signal encoded for each frequency, and sends it to the transmitting antenna. The transmitting antenna transmits the digital signal and power used for the operation of the stimulus chip in the cochlear implant to the receiver, which is a cochlear implant in the skin, through the skin, and the power transmitted through the handset activates the chip supplying the stimulus signal to the electrode. And digital signals are transmitted through the chip to specific electrode sites of an electrode structure that are randomly arranged to excite specific frequencies inserted into the cochlea in a predetermined electrical stimulation format. The electrode site subjected to electrical energy stimulates the living auditory fibers in the cochlea for the specific frequency according to the position, and finally the electrical sound information is transmitted to the cerebrum through the auditory nerve to recognize the sound.

In the cochlear implant, one of the core components of the electrode structure is composed of the following components in detail.

As shown in FIG. 1, an electrode carrier 101 having an elongated shape and a shape of an entire cochlear electrode structure made of a flexible elastic material is a basic component, and an electrode is provided in the electrode carrier 101. An electrode site 102 inserted into one side of the carrier 101 to directly stimulate auditory cells in the cochlea, and a wire 103 positioned in the electrode carrier 101 to electrically and physically connect the electrode site 102 to the electrode site 102. ) Is formed. The electrode carrier 101 may have a flexible characteristic and may have a shape suitable for insertion into the cochlear wow.

The method of manufacturing a cochlear electrode structure having the above configuration generally uses a method of molding using a mold, and the method is referred to a perspective view of a mold structure for molding the general cochlear electrode structure of FIG. 2. This will be described.

First, the mold structure is composed of the upper and lower metallic molds 201 and 202 as shown in FIG. 2, and each of the upper and lower molds 201 and 202 is formed in a symmetrically straight line. 203a and 203b are excavated. The molds 203a and 203b are for shaping the shape of the electrode carrier of the electrode structure. In addition, each of the upper and lower molds are provided with a fixing screw 204 and the coupling hole 205 for coupling during molding. Meanwhile, as shown in FIG. 3, fine grooves 301 for forming electrode sites for stimulating a specific portion in the cochlea are formed at random intervals in the lower portion inside the mold 203b of the lower mold 202. An electrode site 302 is formed in the fine groove (see FIG. 4).

In the fabrication of a cochlear electrode structure, an electrode site must first be installed in a fine groove in the mold structure before the electrode carrier is formed using the mold structure.

The method of forming the electrode site in the fine groove is as shown in FIG.

First, as shown in FIG. 5, in the groove 301 of the lower mold 202, the processed metal 302 having a diameter similar to the diameter of the groove 301 and connected to the wire 103 is positioned in the groove. Let's do it. Subsequently, the uncured elastomeric material or biocompatible adhesive 502 is applied around the processed metal 302, and then the entire mold 202 is heat-treated at a temperature of about 120 to 150 ° C. to form the elastomeric material 502. ) Is cured to form an elastic gasket.

Subsequently, the elastic polymer material 502 which repeatedly manufactured the desired number of electrode sites in the above-described manner, properly arranged the wire 103 connected with the metal 302 in the straight mold 203, and was used to manufacture the site. To be fixed.

Finally, although not shown in the drawing, the preparation of the electrode carrier having the plurality of electrode sites is completed by injecting and curing the elastic polymer material 502 into the entire forming mold 203 in order to mold the shape of the entire electrode.

On the other hand, the interface impedance of the electrode site is deeply related to the area where the metal, which is the electrode site material, is exposed, and as the area is increased, the double layer capacitance in parallel with the charge transfer resistance increases. The overall interface impedance of the electrode is reduced. Therefore, if the exposed area of the metal constituting the electrode site is not accurately controlled, an electrode having an uneven interface impedance between each electrode site is produced, and a complicated process of compensating the difference in impedance by electrical circuit is performed afterwards. It is very important to fabricate the electrode to have a constant interfacial impedance at each site forming a.

Conventional cochlear electrode structures use metal drills to fabricate grooves of several hundred μm for determining electrode sites in the metal of the mold, but drills having arbitrary diameters corresponding to the diameters of the grooves for producing the desired impedance. It is very difficult to find and machined grooves also have many differences in size (more than tens of micrometers or more), making it difficult to obtain a constant impedance between sites.

In the process of manufacturing the electrode, if the electrode metal forming the electrode site gets stuck in the mold, the entire area of the mold or the excessive extraction of the metal for the electrode is damaged. Overall, there was a significant difficulty keeping them constant over time. Therefore, a great deal of money has been invested in mold making and securing spare molds.

However, when the part that determines the electrode site is replaced with a structure using a processing technology of the semiconductor process, the size and shape can be adjusted very precisely as desired, and the electrode site part is disposable by using the electrode site mold proposed by the present invention. It can be easily replaced with a part of the mold is damaged and do not discard the whole, the mold can be used semi-permanently and because there is no need to secure an extra mold is economical large.

The present invention has been made to solve the above problems, the constant and accurate interface impedance between electrode sites by replacing the electrode site groove in the cochlear electrode structure with a mold for electrode sites using micro machining technology instead of conventional metal It is an object of the present invention to provide an apparatus for producing a cochlear electrode structure and a method for manufacturing the cochlear electrode having a cochlear implant.

The cochlear electrode structure manufacturing apparatus of the present invention for achieving the above object is a cochlear electrode structure manufacturing apparatus having two metallic molds of the upper side and the lower side, the upper and lower in each of the mold in the electrode The forming mold for forming the carrier is symmetrically formed in the shape of a straight trough, and a groove having a predetermined width and depth in a direction parallel to the forming die is formed in the lower part of the lower mold inside the mold. It is characterized in that the mold for the electrode site having a width and depth corresponding to the groove in the inner lower portion of the mold is formed with fine grooves for the electrode site for manufacturing the electrode site.

The manufacturing method of the electrode structure manufacturing apparatus for cochlear implant of the present invention is provided with a metal mold of the upper side and the lower side, and the forming mold for forming the electrode carrier in each of the upper and lower molds has a symmetrically linear horse trough shape. In the manufacture of the electrode structure manufacturing apparatus for cochlear implant, the step of preparing the upper and lower molds, forming an elongated groove having a predetermined width and depth in the inner lower portion of the molding mold of the lower mold, Mounting a mold for an electrode site, which has a size corresponding to the width and depth of the groove through a series of processes and has micro grooves for the electrode site for manufacturing the electrode site, in a groove of the inner lower part; It is characterized by including.

The manufacturing of the mold for the electrode site may include forming an oxide film with a predetermined thickness on a nonmetal substrate, patterning a predetermined portion of the oxide film using a photolithography process, and using the patterned oxide film as a mask. Dry etching the non-metal substrate to a predetermined depth to form fine grooves for the electrode site, and cutting the non-metal substrate on which the fine grooves for the electrode site are formed to a predetermined length and width to form a mold for the electrode site. It is characterized by including.

The electrode structure manufacturing apparatus for cochlear implant of the present invention can improve the precision of electrode site manufacturing by mounting a mold for electrode sites manufactured by a micromachining process on the inner lower part of the mold of the lower mold, and accurately adjust the interface impedance of the electrode site. And can be adjusted constantly.

Hereinafter, an apparatus for manufacturing a cochlear electrode structure and a method of manufacturing the same according to the present invention will be described in detail with reference to the accompanying drawings.

Figure 6 is a perspective view of the lower mold of the cochlear electrode structure manufacturing apparatus of the present invention.

As shown in FIG. 6, upper (not shown) and lower molds 601 are provided, and in the molds of the upper and lower sides 601, groove-shaped forming molds 602 are provided symmetrically. Formed. The mold 602 is shaped like the outer shape of the electrode carrier which is a basic shape of the electrode structure.

The electrode site mold 603 having a predetermined thickness is formed long in the longitudinal direction of the molding die at a predetermined portion of the lower portion of the mold 602 inside the lower mold, and the upper portion of the mold 603 for the electrode site. In the central portion of the fine grooves 604 for electrode sites are provided at random intervals. The material of the mold for the electrode site is preferably a non-metallic material such as silicon (Si), but a metal or the like may be acceptable if micro-machining is possible. The electrode groove fine groove 604 may be processed so that the lower shape is curved in addition to having a rectangular shape as shown in the drawing, and the preferred size when the rectangular shape is processed is 300 to 500 μm in width and 300 in length. The preferred size in the case where the bottom shape of the microgrooves for electrode sites is curved is preferably 300 to 500 µm and a depth of 100 to 200 µm.

The distance between the microgrooves for the electrode site has an arbitrary distance. The distance between the microgrooves determines a specific region to be stimulated in the cochlea and thus recognizes a specific frequency.

7A to 7C are process perspective views for explaining a method of manufacturing an apparatus for manufacturing a cochlear electrode structure according to the present invention.

First, as shown in FIG. 7A, an upper mold (not shown) and a lower mold 601 are prepared, and then a mold 602 for forming electrode carriers is formed in each of the upper and lower molds. Subsequently, an elongated groove 605 having a predetermined width and depth is formed in an inner lower portion of the mold 602 of the lower mold 601.

Subsequently, as shown in FIG. 7B, a width corresponding to the width and depth of the groove 605 is passed through a series of processes, and manufactured to have fine grooves 604 for electrode sites for electrode site fabrication thereon. A mold 603 for electrode sites is prepared (see FIG. 9).

Finally, as shown in FIG. 7C, when the mold for the electrode site is mounted in the groove of the inner lower portion of the mold, the manufacturing process of the cochlear electrode structure manufacturing apparatus of the present invention is completed. As described above, the apparatus for manufacturing a cochlear electrode structure according to the present invention is a method of mounting a mold for an electrode site on a lower mold, and thus only a corresponding part can be replaced without replacing the entire lower mold when the electrode site mold is damaged.

Here, the manufacturing method of the electrode site mold is as follows.

8A to 8E are cross-sectional views for explaining the manufacturing method of the electrode site mold of the present invention.

First, as shown in FIGS. 8A and 8B, an oxide film 802 is formed on the nonmetal substrate 801 to a predetermined thickness. Here, the nonmetallic substrate 801 is preferably a nonmetallic material such as silicon (Si), but a metal or the like may be acceptable if micro-machining is possible. The thickness of the oxide film can be changed depending on the depth of the fine groove 604 for electrode sites described later.

Subsequently, a photoresist film is coated on the entire surface of the oxide film 802 and then selectively patterned to form a mask 803. A predetermined portion of the oxide film 802 is etched and removed using the mask 803.

Next, as shown in FIGS. 8D and 8E, the non-metal substrate 801 is dry-etched to a predetermined size using the patterned oxide film 802 to form fine grooves 604 for electrode sites. The fine grooves 604 may have a rectangular shape as shown in the drawing, and may be processed so that the lower shape is curved. The preferred size in the case of the rectangular shape is 300 to 500 μm in width and 300 to 500 μm in length. When the bottom shape of the fine groove 604 for electrode sites is curved, the preferred size is 300 to 500 µm in diameter and about 100 to 200 µm in depth. Further, about 8 to 16 fine grooves for the electrode site are formed.

Lastly, although not shown in the drawings, the non-metal substrate 801 on which the fine grooves 604 for the electrode sites are formed is cut to a predetermined length and width, thereby completing the manufacture of the mold for the electrode sites of the present invention. The preferred size of the electrode site mold is preferably 500 to 600 µm in width, 20000 to 21000 µm in length, and 300 to 600 µm in height.

Furthermore, the method of forming the electrode site in the cochlear electrode structure manufacturing apparatus in which the fine groove for the electrode site is formed as described above is as follows.

The manufacturing method of the electrode site is similar to the conventional method, but the overall manufacturing process is similar, but is characterized by the material and size of the electrode site formed according to the characteristics of the mold for the electrode site of the present invention.

First, 90% platinum (Pt) and 10% iridium (Ir) alloy wires with a diameter of 2.5 to 5 μm coated with a polymer material such as TEFLON are dissolved in acetylene gas to form a sphere having a diameter of 400 to 440 μm. Alternatively, platinum is processed into a cube shape having a width of 380 to 420 μm, a length of 380 to 420 μm, and a height of 380 to 420 μm, and then an electrode is manufactured by the method described in the technical field to which the invention belongs and the prior art in that field. 10 and 11).

When the electrode site is produced by the above method, the interface impedance of the electrode site is about 10 to 12 kW.

Since the electrode manufactured using the cochlear electrode structure fabrication apparatus of the present invention can precisely control the interfacial impedance, it is widely used for the recording of nerve stimulation or nerve signal in the field of neural prosthetics such as cardiac stimulation as well as cochlear implant electrode. Can be.

The apparatus for forming a cochlear electrode structure according to the present invention has the following effects.

The present invention significantly improves the precision of electrode site manufacturing by replacing grooves used for fabricating electrode sites in cochlear electrode structures with precisely micromachined silicon structures having an error of several micrometers or less instead of conventionally error-producing metal processing. .

And the electrode site interface impedance between one electrode or several electrodes can be adjusted accurately and uniformly. That is, it is possible to repeatedly manufacture the electrode with a constant electrical characteristics.

In addition, it is possible to eliminate additional mold fabrication costs by simply dealing with mold damage caused by the use of metal molds with inexpensive silicon structures. For example, in Korea, when manufacturing the metal mold integrated with the electrode site, it costs about 1.5 million won (about 10 times the domestic amount in foreign countries). The additional cost is sharply increased when the shape of the electrode is changed, such as securing a spare mold, reworking the mold when the mold is damaged, or changing the position of the electrode site. When using the present invention, about 300 silicon structures can be manufactured per wafer, and the cost is about several hundred thousand won including both process and material costs, and the mold can be used semi-permanently by changing the silicon structure.

In addition, the electrode produced as a by-product of the present invention can be widely used for recording stimulation of nerves or nerve signals in the field of neural prosthetics such as cardiac stimulation as well as cochlear implant electrodes.

1 is a cross-sectional view conceptually showing the shape of a common cochlear electrode structure.

2 is a perspective view of a mold structure for forming a common cochlear electrode structure.

3 is an enlarged perspective view of portion A of FIG. 2;

4 is a cross-sectional view taken along line BB ′ of FIG. 3.

Figure 5 is a process cross-sectional view for explaining a method for forming an electrode site of a common cochlear electrode structure.

Figure 6 is a perspective view of the lower mold of the electrode structure manufacturing apparatus for cochlear implant of the present invention.

7A to 7C are process perspective views for explaining a method for manufacturing an apparatus for producing a cochlear electrode structure according to the present invention.

8A to 8E are cross-sectional views illustrating a method of manufacturing a mold for an electrode site according to the present invention.

9 is an actual production photograph of a mold for an electrode site of the present invention.

10 is a photograph showing a wire connected to the electrode site and the electrode site in a state in which the mold for the electrode site is coupled to the lower mold of the cochlear electrode structure of the present invention.

Figure 11 is a photograph of the electrode site formed on the mold for the electrode site of the cochlear electrode structure of the present invention.

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

602: forming mold 603: mold for electrode site

604: Fine groove for electrode site

Claims (13)

In the cochlear electrode structure manufacturing apparatus having two upper and lower metallic molds, In each of the upper and lower molds, a mold for forming an electrode carrier is symmetrically formed in a linear trough shape, Grooves are formed in a long direction in a direction parallel to the mold in the inner mold lower portion of the lower mold, An apparatus for manufacturing a cochlear implant according to claim 1, wherein a mold for an electrode site having a width and a depth corresponding thereto is formed in the groove on the inner lower part of the mold, and having fine grooves for the electrode site for manufacturing the electrode site. . The apparatus of claim 1, wherein the mold for the electrode site is made of silicon (Si). The apparatus of claim 1, wherein the number of fine grooves for the electrode site is 8 to 16. The apparatus for manufacturing a cochlear implant according to claim 1, wherein the fine groove for the electrode site has a square shape having a width of 300 to 500 µm, a length of 300 to 500 µm, and a depth of 50 to 100 µm. The apparatus for manufacturing a cochlear implant according to claim 1, wherein the fine groove for the electrode site has a well shape having a diameter of 300 to 500 µm and a depth of 100 to 200 µm. delete delete The apparatus for manufacturing a cochlear implant according to claim 1, wherein the size of the mold for electrode sites is 500 to 600 µm in width, 20000 to 21000 µm in length, and 300 to 600 µm in height. In the manufacture of a cochlear electrode structure manufacturing apparatus having an upper and lower metallic mold and the forming mold for forming an electrode carrier in each of the upper and lower molds has a symmetrically linear horse trough shape, Preparing the upper and lower molds; Forming an elongated groove in an inner lower portion of a mold of the lower mold; And mounting a mold for an electrode site formed in the groove of the inner side of the mold to have a size corresponding to the width and depth of the groove and having fine grooves for the electrode site for manufacturing the electrode site thereon. Method for producing a cochlear electrode structure manufacturing apparatus characterized in that. The method of claim 9, wherein the production of the mold for electrode site, Forming an oxide film on the nonmetal substrate; Patterning the oxide film using a photolithography process; Dry etching the non-metal substrate using the patterned oxide film as a mask to form fine grooves for an electrode site; And a step of forming a mold for an electrode site by cutting a non-metal substrate on which the fine grooves for the electrode site are formed. As a method of manufacturing a cochlear electrode structure using the apparatus for producing a cochlear implant structure according to claim 1, Melting the alloy wires of platinum and iridium coated with a polymer material into a sphere or a cube shape (a); (B) placing the alloy processed in the step (a) into a fine groove of the lower mold of the apparatus for fabricating a cochlear implant structure according to claim 1; (C) applying an uncured elastomeric polymeric material around the processed alloy; Heat treating the lower mold to cure the elastic polymer material to form an elastic gasket, thereby forming one electrode site; (E) forming each of the plurality of electrode sites by repeating steps (a) to (d); (F) arranging a wire connected to the alloy of the electrode site in a mold of the apparatus for manufacturing a cochlear implant structure according to claim 1, and then fixing the wire with an elastic polymer material; And (G) forming an electrode carrier by injecting an elastic polymer material into the entire molding frame and curing it. It is manufactured by the method of manufacturing a cochlear electrode structure according to claim 11, An electrode carrier having an elongated shape and made of a flexible elastic material; A plurality of electrode sites inserted into one side of the electrode carrier to stimulate auditory cells in the cochlea; And A wire located within the electrode carrier to electrically and physically connect the electrode site, An electrode structure for a cochlear implant, characterized in that the interface impedance of each electrode site is constant. The electrode structure for cochlear implant manufactured by the apparatus for manufacturing a cochlear implant structure according to claim 1, wherein the interface impedance of the electrode site is constant.